Acromegaly
Conditions
Keywords
Acromegaly, hormone disorder, growth hormone, insulin like growth factor-1, pituitary tumor, pasireotide, SOM230
Brief summary
This study will evaluate the efficacy and safety of pasireotide LAR 40 and 60 mg versus octreotide LAR or lanreotide ATG in patients with inadequately controlled acromegaly.
Interventions
DRUGPasireotide
* Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or * Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks
DRUGoctreotide LAR 30mg
In an open-label, active control arm, continue on the same treatment with octreotide LAR 30 mg every 28 ± 2 days as received for at least 6 months prior to randomization
DRUGlanreotide ATG 120mg
In an open-label, active control arm, continue on the same treatment with lanreotide ATG 120 mg every 28 ± 2 days as received for at least 6 months prior to randomization
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with written informed consent prior to any study related activity 2. Patients who had inadequately controlled acromegaly as defined by a mean GH concentration of a 5-point profile over a 2-hour period \> 2.5 µg/L and sex- and age-adjusted IGF-1 \> 1.3 x upper limit of normal (ULN) 3. Patients who had been treated with maximum indicated doses of octreotide LAR or lanreotide ATG for at least 6 months prior to visit 1 (screening). The maximum indicated dose for octreotide LAR was 30mg and for lanreotide ATG iwas120 mg 4. Patients who had a diagnosis of pituitary micro- or macro adenoma. Patients could have been previously submitted to surgery 5. Patients who completed the 24-week treatment period in core according to the requirements of the core study protocol or corresponding amendments could enter extension
Exclusion criteria
1. Patients who had received pasireotide (SOM 230) prior to enrolment 2. Concomitant treatment with Growth Hormone Receptor (GHR)-antagonist or dopamine agonists unless concomitant treatment was discontinued 8 weeks prior to visit 1 (screening)(8 weeks wash out period). Such patients must have been treated with octreotide LAR 30 mg or lanreotide ATG 120 mg monotherapy continuously for a minimum of 6 months prior to starting combination therapy and they should have been inadequately controlled on monotherapy. 3. Patients who had compression of the optic chiasm causing acute clinically significant visual field defects 4. Patients who required a surgical intervention for relief of any sign or symptom associated with tumor compression 5. Patients who had received pituitary irradiation within 10 years prior to visit 1 (screening). 6. Patients who had undergone major surgery/surgical therapy for any cause within 4 weeks prior to visit 1 (screening). 7. Patients who were hypothyroid and not adequately treated with a stable dose of thyroid hormone replacement therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. | At 24 weeks | The primary objective of this study was to compare the percentage of patients achieving biochemical control (defined as mean GH levels \<2.5 µg/L and normalization of sex- and age- adjusted IGF-1) at 24 weeks with pasireotide LAR 40 mg and pasireotide LAR 60 mg separately versus continued treatment with octreotide LAR 30 mg or lanreotide autogel (ATG) 120 mg. The primary efficacy variable is the proportion of patients with a reduction of mean GH levels to \< 2.5 µg/L and normalization of sex- and age-adjusted IGF-1 at 24 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Extension baseline up to approximately week 268 | The percentage of patients achieving normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set) |
| Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Extension baseline up to approximately week 268 | The percentage of patients achieving mean growth hormone (GH) levels \< 2.5 μg/L was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Concomitant medication known to affect GH levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set) |
| Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Extension baseline up to approximately week 268 | The percentage of patients achieving mean growth hormone (GH) levels \< 1.0 μg/L and normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect GH or IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set |
| Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Extension baseline up to approximately week 268 | The percentage of patients achieving mean growth hormone (GH) levels \< 1.0 μg/L was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Concomitant medication known to affect GH levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set) |
| Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) | CORE baseline up to approximately 24 weeks | — |
| Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | CORE and extension baseline up to approximately 268 weeks | Change from CORE baseline at each scheduled assessment was performed for patients randomized to pasireotide arms. Change from extension baseline at each scheduled assessment was performed for patients randomized to active control arm. |
| Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Extension baseline up to approximately week 268 | The percentage of patients achieving mean growth hormone (GH) levels \< 2.5 μg/L and normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect GH or IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (extension full analysis set) |
| Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | CORE and extension baseline up to approximately 268 weeks | Change from CORE baseline at each scheduled assessment was performed for patients randomized to pasireotide arms. Change from extension baseline at each scheduled assessment was performed for patients randomized to active control arm. Standardized IGF-1 = IGF-1 value / ULN, where ULN is the upper limit of the normal range |
| Duration of the First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | CORE baseline up to approximately 268 weeks | n is the number of patients achieving response criteria. The weeks correspond to duration of first response (in weeks) for patients achieving biomedical control. Median and 95% CI are derived from Kaplan-Meier curves. Kaplan-Meier estimates \[95% CI\] at each time point are estimates of probability of response. |
| Time to First Response (Weeks) by Treatment for Patients Achieving a Reduction of Mean GH Level to < 2.5 µg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly | CORE baseline up to approximately 268 weeks | Time to first response is defined as the time from the date of first dose to the date of first occurrence of a reduction of mean GH \< 2.5 µg/L and the normalization of IGF-1. The weeks correspond to time taken to achieve first mean GH \< 2.5 µg/L and the normalization of IGF-1. |
| Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set) | CORE baseline up to approximately 24 weeks | Acromegaly Quality of Life questionnaire (AcroQoL) is a validated disease specific questionnaire. It contains 22 items divided into two scales: physical aspects (8 items) and psychological aspects (14 items) which is divided in two sub-scales: physical appearance and personal relationships of the patient (seven items each). The total score and sub-scores were calculated using the following formula: ((X -Y) / 4Y) x 100, X=sum of the scores for individual items (between 1 and 5 for each item), Y=number of individual items included in above sum (i.e. 22 for the total score, 8 for the physical sub-score, 14 for the psychological sub-score, 7 for the sub-score 'appearance' and 'personal relations'). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. If more than 25% of items are not completed, results were considered invalid. |
| Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | CORE Baseline and extension baseline up to approximately 268 weeks | Acromegaly Quality of Life questionnaire (AcroQoL) is a validated disease specific questionnaire. It contains 22 items divided into two scales: physical aspects (8 items) and psychological aspects (14 items) which is divided in two sub-scales: physical appearance and personal relationships of the patient (seven items each). The total score and sub-scores were calculated using the following formula: ((X -Y) / 4Y) x 100, X=sum of the scores for individual items (between 1 and 5 for each item), Y=number of individual items included in above sum (i.e. 22 for the total score, 8 for the physical sub-score, 14 for the psychological sub-score, 7 for the sub-score 'appearance' and 'personal relations'). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. If more than 25% of items are not completed, results were considered invalid. |
| Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set) | Extension baseline up to approximately 196 weeks | PK samples were collected for those patients treated with pasireotide LAR in the core study and who continued on pasireotide LAR in the extension phase. PK samples were collected before the injection of pasireotide LAR only at weeks 112 and 196. PK samples were also collected at weeks 48 and 132 only for all patients treated with octreotide LAR 30 mg or lanreotide ATG 120 mg in the core study who started treatment with pasireotide LAR in the extension study. Blood samples (2.5 mL each sample) were collected to yield 1-mL plasma for analysis of pasireotide LAR oncentration. |
| Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) | CORE baseline up to approximately 24 weeks | Standardized IGF-1 = IGF-1 value / ULN, where ULN is the upper limit of the normal range |
Countries
Argentina, Belgium, Brazil, Canada, Colombia, France, Germany, Israel, Italy, Norway, Poland, Romania, Russia, Saudi Arabia, Spain, Turkey (Türkiye), United Kingdom, United States
Participant flow
Pre-assignment details
One hundred ninety-eight patients were randomized and 5 patients in CORE and 1 patient in extension did not receive any study treatment
Participants by arm
| Arm | Count |
|---|---|
| Pasireotide LAR 40 mg Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) | 65 |
| Pasireotide LAR 60 mg Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution) | 65 |
| Control Arm (Octreotide or Lanreotide) Open label octreotide LAR 30 mg or lanreotide ATG 120 mg supplied either locally or from designated depot. Administered intramuscular every 28 days | 68 |
| Total | 198 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Administrative problems-CORE | 2 | 1 | 0 |
| Overall Study | Administrative problems-Extension | 0 | 2 | 0 |
| Overall Study | Adverse Event-CORE | 2 | 4 | 0 |
| Overall Study | Adverse Event-Extension | 4 | 8 | 7 |
| Overall Study | Death-Extension | 2 | 0 | 0 |
| Overall Study | Did not enter extension | 2 | 3 | 2 |
| Overall Study | Did not receive treatment in extension | 0 | 0 | 1 |
| Overall Study | Lack of Efficacy-Extension | 15 | 9 | 13 |
| Overall Study | Lost to Follow Up-Extension | 0 | 1 | 0 |
| Overall Study | Protocol Violation-CORE | 0 | 1 | 1 |
| Overall Study | Protocol Violation-Extension | 2 | 1 | 0 |
| Overall Study | Withdrawal by Subject-CORE | 2 | 2 | 2 |
| Overall Study | Withdrawal by Subject-Extension | 6 | 8 | 8 |
Baseline characteristics
| Characteristic | Pasireotide LAR 40 mg | Pasireotide LAR 60 mg | Control Arm (Octreotide or Lanreotide) | Total |
|---|---|---|---|---|
| Age, Customized <65 Years | 62 Participants | 57 Participants | 63 Participants | 182 Participants |
| Age, Customized ≥ 65 Years | 3 Participants | 8 Participants | 5 Participants | 16 Participants |
| Race/Ethnicity, Customized Asian | 3 Participants | 1 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Black | 3 Participants | 8 Participants | 4 Participants | 15 Participants |
| Race/Ethnicity, Customized Caucasian | 53 Participants | 52 Participants | 56 Participants | 161 Participants |
| Race/Ethnicity, Customized Native American | 2 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 3 Participants | 7 Participants | 14 Participants |
| Sex: Female, Male Female | 38 Participants | 35 Participants | 38 Participants | 111 Participants |
| Sex: Female, Male Male | 27 Participants | 30 Participants | 30 Participants | 87 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 63 | 0 / 62 | 0 / 62 |
| other Total, other adverse events | 59 / 63 | 58 / 62 | 61 / 62 |
| serious Total, serious adverse events | 18 / 63 | 14 / 62 | 20 / 62 |
Outcome results
Primary
Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1.
The primary objective of this study was to compare the percentage of patients achieving biochemical control (defined as mean GH levels \<2.5 µg/L and normalization of sex- and age- adjusted IGF-1) at 24 weeks with pasireotide LAR 40 mg and pasireotide LAR 60 mg separately versus continued treatment with octreotide LAR 30 mg or lanreotide autogel (ATG) 120 mg. The primary efficacy variable is the proportion of patients with a reduction of mean GH levels to \< 2.5 µg/L and normalization of sex- and age-adjusted IGF-1 at 24 weeks.
Time frame: At 24 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Pasireotide LAR 40 mg | Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. | 15.4 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. | 20.0 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With a Reduction of Mean GH Levels to < 2.5 µg/L and Normalization of Sex- and Age-adjusted IGF-1. | 0 percentage of participants |
p-value: 0.0006Regression, Logistic
p-value: <0.0001Regression, Logistic
Secondary
Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set)
Acromegaly Quality of Life questionnaire (AcroQoL) is a validated disease specific questionnaire. It contains 22 items divided into two scales: physical aspects (8 items) and psychological aspects (14 items) which is divided in two sub-scales: physical appearance and personal relationships of the patient (seven items each). The total score and sub-scores were calculated using the following formula: ((X -Y) / 4Y) x 100, X=sum of the scores for individual items (between 1 and 5 for each item), Y=number of individual items included in above sum (i.e. 22 for the total score, 8 for the physical sub-score, 14 for the psychological sub-score, 7 for the sub-score 'appearance' and 'personal relations'). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. If more than 25% of items are not completed, results were considered invalid.
Time frame: CORE baseline up to approximately 24 weeks
Population: Available data available for analysis differed from visit to visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set) | Week 4 CORE | 3.5 scores on a scale | Standard Deviation 11.28 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set) | Week 8 CORE | 2.4 scores on a scale | Standard Deviation 12.97 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set) | Week 12 CORE | 3.0 scores on a scale | Standard Deviation 12.41 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set) | Week 16 CORE | 3.3 scores on a scale | Standard Deviation 12.99 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set) | Week 20 CORE | 3.5 scores on a scale | Standard Deviation 12.89 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set) | Week24 CORE | 3.0 scores on a scale | Standard Deviation 16.61 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set) | Week 20 CORE | 4.0 scores on a scale | Standard Deviation 16.02 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set) | Week 4 CORE | 2.3 scores on a scale | Standard Deviation 11.08 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set) | Week 16 CORE | 6.6 scores on a scale | Standard Deviation 15.33 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set) | Week 8 CORE | 2.5 scores on a scale | Standard Deviation 12.11 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set) | Week24 CORE | 5.4 scores on a scale | Standard Deviation 17.77 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits(Extension Full Analysis Set) | Week 12 CORE | 1.9 scores on a scale | Standard Deviation 11.5 |
Secondary
Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set)
Acromegaly Quality of Life questionnaire (AcroQoL) is a validated disease specific questionnaire. It contains 22 items divided into two scales: physical aspects (8 items) and psychological aspects (14 items) which is divided in two sub-scales: physical appearance and personal relationships of the patient (seven items each). The total score and sub-scores were calculated using the following formula: ((X -Y) / 4Y) x 100, X=sum of the scores for individual items (between 1 and 5 for each item), Y=number of individual items included in above sum (i.e. 22 for the total score, 8 for the physical sub-score, 14 for the psychological sub-score, 7 for the sub-score 'appearance' and 'personal relations'). The scoring of the questionnaire was performed as specified by the instrument developers. Total scores range from 0 to 100. Higher scores represent better quality of life. If more than 25% of items are not completed, results were considered invalid.
Time frame: CORE Baseline and extension baseline up to approximately 268 weeks
Population: completed and valid questionnaires at visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 220 extension | 4.8 scores on a scale | Standard Deviation 21.99 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 148 extension | 7.6 scores on a scale | Standard Deviation 18.56 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 52 extension | 6.1 scores on a scale | Standard Deviation 14.28 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 196 extension | 6.1 scores on a scale | Standard Deviation 16.94 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 136 extension | 7.5 scores on a scale | Standard Deviation 18.72 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 64 extension | 5.8 scores on a scale | Standard Deviation 13.65 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 208 extension | 1.2 scores on a scale | Standard Deviation 13.27 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 124 extension | 5.8 scores on a scale | Standard Deviation 16.46 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 76 extension | 7.7 scores on a scale | Standard Deviation 14.93 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 88 extension | 4.6 scores on a scale | Standard Deviation 15.11 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 112 extension | 4.6 scores on a scale | Standard Deviation 15.83 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 268 extension | 0.6 scores on a scale | Standard Deviation 16.74 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 100 extension | 4.3 scores on a scale | Standard Deviation 14.8 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 232 extension | 2.1 scores on a scale | Standard Deviation 17.51 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 184 extension | 5.8 scores on a scale | Standard Deviation 15.31 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 16 extension | 4.2 scores on a scale | Standard Deviation 16.34 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 256 extension | 6.1 scores on a scale | Standard Deviation 25.91 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 172 extension | 4.8 scores on a scale | Standard Deviation 17.97 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 28 extension | 5.6 scores on a scale | Standard Deviation 13.21 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 244 extension | 4.5 scores on a scale | Standard Deviation 20.06 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 160 extension | 7.0 scores on a scale | Standard Deviation 19.1 |
| Pasireotide LAR 40 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 40 extension | 3.2 scores on a scale | Standard Deviation 15.78 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 184 extension | 5.8 scores on a scale | Standard Deviation 16.83 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 220 extension | 5.8 scores on a scale | Standard Deviation 17.12 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 232 extension | -0.2 scores on a scale | Standard Deviation 16.73 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 244 extension | 6.3 scores on a scale | Standard Deviation 11.05 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 256 extension | -3.0 scores on a scale | Standard Deviation 7.07 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 268 extension | -4.9 scores on a scale | Standard Deviation 4.3 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 16 extension | 2.9 scores on a scale | Standard Deviation 19.09 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 28 extension | 4.8 scores on a scale | Standard Deviation 16.83 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 40 extension | 2.5 scores on a scale | Standard Deviation 18.21 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 52 extension | 5.7 scores on a scale | Standard Deviation 18.69 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 64 extension | 4.2 scores on a scale | Standard Deviation 18.89 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 76 extension | 2.5 scores on a scale | Standard Deviation 19.3 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 88 extension | 5.6 scores on a scale | Standard Deviation 18.08 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 100 extension | 3.9 scores on a scale | Standard Deviation 16.91 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 112 extension | 6.5 scores on a scale | Standard Deviation 18.36 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 124 extension | 2.0 scores on a scale | Standard Deviation 17.95 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 136 extension | 5.4 scores on a scale | Standard Deviation 16.73 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 148 extension | 6.8 scores on a scale | Standard Deviation 16.65 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 160 extension | 5.1 scores on a scale | Standard Deviation 15.7 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 172 extension | 5.7 scores on a scale | Standard Deviation 17.52 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 196 extension | 6.0 scores on a scale | Standard Deviation 18.58 |
| Pasireotide LAR 60 mg | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 208 extension | 6.2 scores on a scale | Standard Deviation 17.31 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 52 extension | 4.2 scores on a scale | Standard Deviation 11.01 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 208 extension | 4.5 scores on a scale | Standard Deviation 12.62 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 136 extension | 6.5 scores on a scale | Standard Deviation 11.82 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 40 extension | 3.2 scores on a scale | Standard Deviation 10.31 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 196 extension | 3.8 scores on a scale | Standard Deviation 13.11 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 148 extension | 5.5 scores on a scale | Standard Deviation 12.95 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 28 extension | 3.3 scores on a scale | Standard Deviation 10.7 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 220 extension | 7.3 scores on a scale | Standard Deviation 16.28 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 160 extension | 1.5 scores on a scale | Standard Deviation 13.36 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 16 extension | 0.8 scores on a scale | Standard Deviation 10.22 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 232 extension | 7.0 scores on a scale | Standard Deviation 15.15 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 172 extension | 2.1 scores on a scale | Standard Deviation 12.13 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 268 extension | -10.6 scores on a scale | Standard Deviation 7.57 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 88 extension | 6.4 scores on a scale | Standard Deviation 10.29 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 256 extension | 0.3 scores on a scale | Standard Deviation 14.08 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 100 extension | 5.9 scores on a scale | Standard Deviation 11.13 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 76 extension | 7.7 scores on a scale | Standard Deviation 15.17 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 184 extension | 1.6 scores on a scale | Standard Deviation 12.45 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 112 extension | 4.1 scores on a scale | Standard Deviation 10.35 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 64 extension | 5.4 scores on a scale | Standard Deviation 12.12 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 244 extension | 3.0 scores on a scale | Standard Deviation 18.65 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in AcroQoL Total Scores for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 124 extension | 2.0 scores on a scale | Standard Deviation 10.97 |
Secondary
Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set)
Time frame: CORE baseline up to approximately 24 weeks
Population: Number analyzed is based on available data at specific visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) | Week 12 - CORE | -0.8 mcg/L | Standard Deviation 29.77 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) | Week 24 - CORE | -0.6 mcg/L | Standard Deviation 32.38 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) | Week 12 - CORE | -6.4 mcg/L | Standard Deviation 14.35 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) | Week 24 - CORE | -7.2 mcg/L | Standard Deviation 15.19 |
Secondary
Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set)
Change from CORE baseline at each scheduled assessment was performed for patients randomized to pasireotide arms. Change from extension baseline at each scheduled assessment was performed for patients randomized to active control arm.
Time frame: CORE and extension baseline up to approximately 268 weeks
Population: Available data for analysis differed from visit to visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 100 - extension | -5.6 mcg/L | Standard Deviation 5.71 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 256 - extension | -6.4 mcg/L | Standard Deviation 5.91 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 196 - extension | -7.1 mcg/L | Standard Deviation 6.81 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 112 - extension | -5.8 mcg/L | Standard Deviation 6.03 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 40 - extension | -9.7 mcg/L | Standard Deviation 25.4 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 184 - extension | -6.3 mcg/L | Standard Deviation 5.44 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 124 - extension | -5.5 mcg/L | Standard Deviation 5.85 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 148 - extension | -6.3 mcg/L | Standard Deviation 6.21 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 172 - extension | -6.3 mcg/L | Standard Deviation 6.34 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 136 - extension | -6.0 mcg/L | Standard Deviation 6.59 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 244 - extension | -6.0 mcg/L | Standard Deviation 6.03 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 160 - extension | -5.5 mcg/L | Standard Deviation 4.7 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 232 - extension | -5.7 mcg/L | Standard Deviation 5.46 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 64 - extension | -11.3 mcg/L | Standard Deviation 28.37 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 268 - extension | -3.6 mcg/L | Standard Deviation 1.58 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 220 - extension | -7.1 mcg/L | Standard Deviation 6.91 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 76 - extension | -5.5 mcg/L | Standard Deviation 5.96 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 28 - extension | -9.0 mcg/L | Standard Deviation 24.21 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 52 - extension | -10.7 mcg/L | Standard Deviation 26.6 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 88 - extension | -5.7 mcg/L | Standard Deviation 6.21 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 16 - extension | -7.9 mcg/L | Standard Deviation 24.9 |
| Pasireotide LAR 40 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 208 - extension (n=22,20,23) | -7.0 mcg/L | Standard Deviation 6.82 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 208 - extension (n=22,20,23) | -6.2 mcg/L | Standard Deviation 6.22 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 52 - extension | -7.1 mcg/L | Standard Deviation 17.08 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 16 - extension | -6.9 mcg/L | Standard Deviation 14.88 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 28 - extension | -4.5 mcg/L | Standard Deviation 4.12 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 40 - extension | -5.8 mcg/L | Standard Deviation 13.93 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 64 - extension | -7.9 mcg/L | Standard Deviation 17.3 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 76 - extension | -7.2 mcg/L | Standard Deviation 16.16 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 88 - extension | -6.2 mcg/L | Standard Deviation 8.55 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 100 - extension | -5.3 mcg/L | Standard Deviation 5.06 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 112 - extension | -4.4 mcg/L | Standard Deviation 6.57 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 124 - extension | -6.0 mcg/L | Standard Deviation 6.26 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 136 - extension | -5.3 mcg/L | Standard Deviation 4.99 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 148 - extension | 6.1 mcg/L | Standard Deviation 6.28 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 160 - extension | -4.9 mcg/L | Standard Deviation 5.33 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 172 - extension | -5.9 mcg/L | Standard Deviation 5.97 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 184 - extension | -5.8 mcg/L | Standard Deviation 5.79 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 196 - extension | -6.5 mcg/L | Standard Deviation 7.17 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 220 - extension | -7.1 mcg/L | Standard Deviation 8.12 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 232 - extension | -6.8 mcg/L | Standard Deviation 8.1 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 244 - extension | -2.4 mcg/L | Standard Deviation 0.9 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 256 - extension | -4.9 mcg/L | Standard Deviation 3.49 |
| Pasireotide LAR 60 mg | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 268 - extension | -2.5 mcg/L | Standard Deviation 0.57 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 184 - extension | -3.3 mcg/L | Standard Deviation 2.31 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 100 - extension | -3.8 mcg/L | Standard Deviation 4.28 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 28 - extension | -3.0 mcg/L | Standard Deviation 3.86 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 196 - extension | -3.4 mcg/L | Standard Deviation 2.71 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 88 - extension | -3.6 mcg/L | Standard Deviation 3.22 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 76 - extension | -3.5 mcg/L | Standard Deviation 4.27 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 208 - extension (n=22,20,23) | -3.5 mcg/L | Standard Deviation 2.5 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 64 - extension | -15.7 mcg/L | Standard Deviation 76.06 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 268 - extension | -3.7 mcg/L | Standard Deviation 2.23 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 220 - extension | -3.8 mcg/L | Standard Deviation 2.48 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 52 - extension | -2.5 mcg/L | Standard Deviation 3.02 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 256 - extension | -5.0 mcg/L | Standard Deviation 3.26 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 232 - extension | -4.2 mcg/L | Standard Deviation 2.46 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 148 - extension | -3.8 mcg/L | Standard Deviation 3.11 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 136 - extension | -4.0 mcg/L | Standard Deviation 4.44 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 40 - extension | -11.2 mcg/L | Standard Deviation 58.28 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 160 - extension | -3.2 mcg/L | Standard Deviation 2.25 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 124 - extension | -4.0 mcg/L | Standard Deviation 4.36 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 16 - extension | -8.4 mcg/L | Standard Deviation 49.64 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 172 - extension | -3.0 mcg/L | Standard Deviation 2.47 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 112 - extension | -3.9 mcg/L | Standard Deviation 5.13 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Mean GH Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 244 - extension | -4.2 mcg/L | Standard Deviation 2.58 |
Secondary
Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set)
Standardized IGF-1 = IGF-1 value / ULN, where ULN is the upper limit of the normal range
Time frame: CORE baseline up to approximately 24 weeks
Population: Available data for analysis varies from visit to visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) | CORE Week 12 | 0.7 mcg/L | Standard Deviation 0.97 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) | CORE Week 24 | -0.7 mcg/L | Standard Deviation 0.97 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) | CORE Week 12 | -1.1 mcg/L | Standard Deviation 1.03 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for CORE Visits (Extension Full Analysis Set) | CORE Week 24 | -1.1 mcg/L | Standard Deviation 1.12 |
Secondary
Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set)
Change from CORE baseline at each scheduled assessment was performed for patients randomized to pasireotide arms. Change from extension baseline at each scheduled assessment was performed for patients randomized to active control arm. Standardized IGF-1 = IGF-1 value / ULN, where ULN is the upper limit of the normal range
Time frame: CORE and extension baseline up to approximately 268 weeks
Population: Available data for analysis differed from visit to visit
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 88 extension | -1.3 mcg/L | Standard Deviation 0.8 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 256 extension | -1.3 mcg/L | Standard Deviation 0.58 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 172 extension | -1.5 mcg/L | Standard Deviation 0.81 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 100 extension | -1.4 mcg/L | Standard Deviation 0.93 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 232 extension | -1.4 mcg/L | Standard Deviation 0.92 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 160 extension | -1.4 mcg/L | Standard Deviation 0.9 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 112 extension | -1.5 mcg/L | Standard Deviation 0.87 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 40 extension | -1.1 mcg/L | Standard Deviation 0.95 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 148 extension | -1.4 mcg/L | Standard Deviation 0.86 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 124 extension | -1.4 mcg/L | Standard Deviation 0.86 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 136 extension | -1.4 mcg/L | Standard Deviation 0.91 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 16 extension | -0.8 mcg/L | Standard Deviation 0.99 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 220 extension | -1.4 mcg/L | Standard Deviation 0.94 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 52 extension | -1.1 mcg/L | Standard Deviation 0.9 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 268 extension | -1.4 mcg/L | Standard Deviation 0.43 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 208 extension | -1.4 mcg/L | Standard Deviation 0.79 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 64 extension | -1.3 mcg/L | Standard Deviation 0.99 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 244 extension | -1.3 mcg/L | Standard Deviation 0.75 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 196 extension | -1.4 mcg/L | Standard Deviation 0.81 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 76 extension | -1.3 mcg/L | Standard Deviation 0.87 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 28 extension | -0.9 mcg/L | Standard Deviation 1 |
| Pasireotide LAR 40 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 184 extension | -1.3 mcg/L | Standard Deviation 0.7 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 208 extension | -1.6 mcg/L | Standard Deviation 1 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 136 extension | -1.7 mcg/L | Standard Deviation 0.92 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 16 extension | -1.4 mcg/L | Standard Deviation 0.97 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 28 extension | -1.3 mcg/L | Standard Deviation 1.13 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 40 extension | -1.4 mcg/L | Standard Deviation 0.94 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 52 extension | -1.3 mcg/L | Standard Deviation 0.95 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 64 extension | -1.4 mcg/L | Standard Deviation 0.98 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 76 extension | -1.5 mcg/L | Standard Deviation 0.94 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 88 extension | -1.6 mcg/L | Standard Deviation 1.01 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 100 extension | -1.5 mcg/L | Standard Deviation 0.95 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 112 extension | -1.5 mcg/L | Standard Deviation 1 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 148 extension | -1.5 mcg/L | Standard Deviation 0.99 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 160 extension | -1.6 mcg/L | Standard Deviation 0.87 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 172 extension | -1.6 mcg/L | Standard Deviation 0.97 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 184 extension | -1.5 mcg/L | Standard Deviation 1.03 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 196 extension | -1.5 mcg/L | Standard Deviation 1.11 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 124 extension | -1.5 mcg/L | Standard Deviation 0.95 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 220 extension | -1.6 mcg/L | Standard Deviation 1.06 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 232 extension | -1.5 mcg/L | Standard Deviation 1.13 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 244 extension | -1.9 mcg/L | Standard Deviation 1.12 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 256 extension | -1.4 mcg/L | Standard Deviation 1.39 |
| Pasireotide LAR 60 mg | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 268 extension | -1.7 mcg/L | Standard Deviation 0.39 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 184 extension | -1.4 mcg/L | Standard Deviation 0.93 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 64 extension | -1.3 mcg/L | Standard Deviation 0.81 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 244 extension | -1.5 mcg/L | Standard Deviation 0.79 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 196 extension | -1.3 mcg/L | Standard Deviation 1.11 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 52 extension | -1.1 mcg/L | Standard Deviation 0.95 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 136 extension | -1.4 mcg/L | Standard Deviation 0.86 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 208 extension | -1.2 mcg/L | Standard Deviation 0.98 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 40 extension | -1.1 mcg/L | Standard Deviation 0.91 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 268 extension | -1.7 mcg/L | Standard Deviation 0.81 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 220 extension | -1.4 mcg/L | Standard Deviation 0.91 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 28 extension | -0.9 mcg/L | Standard Deviation 0.88 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 112 extension | -1.4 mcg/L | Standard Deviation 0.89 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 256 extension | -1.8 mcg/L | Standard Deviation 0.9 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 148 extension | -1.3 mcg/L | Standard Deviation 0.84 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 100 extension | -1.3 mcg/L | Standard Deviation 0.92 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 232 extension | -1.7 mcg/L | Standard Deviation 0.82 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 160 extension | -1.4 mcg/L | Standard Deviation 0.94 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 88 extension | -1.3 mcg/L | Standard Deviation 0.9 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 16 extension | -0.9 mcg/L | Standard Deviation 0.81 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 172 extension | -1.3 mcg/L | Standard Deviation 0.98 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 76 extension | -1.3 mcg/L | Standard Deviation 0.84 |
| Control Arm (Octreotide or Lanreotide) | Change From Baseline in Standardized IGF-1 Values for Patients Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly for Extension Visits (Extension Full Analysis Set) | Week 124 extension | -1.3 mcg/L | Standard Deviation 0.97 |
Secondary
Duration of the First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
n is the number of patients achieving response criteria. The weeks correspond to duration of first response (in weeks) for patients achieving biomedical control. Median and 95% CI are derived from Kaplan-Meier curves. Kaplan-Meier estimates \[95% CI\] at each time point are estimates of probability of response.
Time frame: CORE baseline up to approximately 268 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pasireotide LAR 40 mg | Duration of the First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | 29.1 weeks |
| Pasireotide LAR 60 mg | Duration of the First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | 26.9 weeks |
| Control Arm (Octreotide or Lanreotide) | Duration of the First Response for Patients Achieving a Reduction of Mean GH Level to < 2.5 μg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | 24.9 weeks |
Secondary
Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set).
The percentage of patients achieving normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set)
Time frame: Extension baseline up to approximately week 268
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 184 | 19.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 100 | 31.6 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 40 | 36.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 172 | 26.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 112 | 31.6 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 268 | 5.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 160 | 24.6 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 124 | 24.6 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 220 | 22.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 148 | 26.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 136 | 21.1 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 52 | 28.1 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 244 | 14.0 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 16 | 33.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 64 | 33.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 28 | 29.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 208 | 22.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 76 | 26.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 256 | 12.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 196 | 24.6 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 88 | 28.1 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 232 | 14.0 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 208 | 22.2 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 16 | 29.0 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 28 | 33.3 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 40 | 37.0 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 52 | 33.3 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 64 | 27.8 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 76 | 35.2 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 88 | 35.2 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 100 | 29.6 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 112 | 27.8 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 124 | 31.5 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 136 | 25.9 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 148 | 22.2 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 160 | 25.9 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 172 | 22.2 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 184 | 22.2 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 196 | 22.2 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 220 | 11.1 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 232 | 14.8 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 244 | 9.3 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 256 | 7.4 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 268 | 5.6 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 244 | 14.5 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 76 | 29.0 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 184 | 22.6 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 196 | 27.4 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 64 | 29.0 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 52 | 25.8 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 208 | 21.0 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 40 | 24.2 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 268 | 1.6 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 220 | 19.4 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 28 | 22.6 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 256 | 6.5 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 136 | 37.1 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 124 | 29.0 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 232 | 17.7 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 148 | 33.9 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 112 | 30.6 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 16 | 25.8 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 100 | 32.3 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 160 | 33.9 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 172 | 22.6 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Participants With Normalization of Sex- and Age-adjusted IGF-1treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set). | Week 88 | 25.8 percentage of participants |
Secondary
Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
The percentage of patients achieving mean growth hormone (GH) levels \< 1.0 μg/L and normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect GH or IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set
Time frame: Extension baseline up to approximately week 268
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 100 | 12.3 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 268 | 1.8 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 172 | 14.0 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 112 | 14.0 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 244 | 8.8 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 160 | 8.8 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 124 | 7.0 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 232 | 10.5 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 148 | 10.5 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 136 | 3.5 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 52 | 8.8 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 16 | 10.5 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 220 | 10.5 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 64 | 8.8 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 40 | 10.5 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 208 | 8.8 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 76 | 10.5 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 28 | 8.8 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 196 | 8.8 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 88 | 7.0 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 256 | 8.8 Participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 184 | 7.0 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 40 | 9.3 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 16 | 16.7 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 28 | 14.8 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 52 | 13.0 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 64 | 13.0 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 76 | 13.0 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 88 | 20.4 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 100 | 14.8 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 112 | 20.4 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 124 | 14.8 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 136 | 18.5 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 148 | 14.8 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 160 | 14.8 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 172 | 13.0 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 184 | 13.0 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 196 | 13.0 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 208 | 9.3 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 220 | 7.4 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 232 | 3.7 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 244 | 3.7 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 256 | 3.7 Participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 268 | 3.7 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 16 | 6.5 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 184 | 3.2 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 76 | 6.5 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 28 | 8.1 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 196 | 8.1 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 64 | 9.7 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 244 | 6.5 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 208 | 6.5 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 52 | 4.8 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 268 | 1.6 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 220 | 6.5 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 136 | 11.3 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 124 | 8.1 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 40 | 4.8 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 148 | 8.1 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 112 | 9.7 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 256 | 3.2 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 160 | 9.7 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 100 | 8.1 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 232 | 4.8 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 172 | 8.1 Participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 1.0 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 88 | 4.8 Participants |
Secondary
Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
The percentage of patients achieving mean growth hormone (GH) levels \< 1.0 μg/L was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Concomitant medication known to affect GH levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set)
Time frame: Extension baseline up to approximately week 268
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 172 | 17.5 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 100 | 17.5 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 196 | 15.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 160 | 17.5 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 112 | 17.5 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 244 | 12.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 148 | 14.0 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 124 | 12.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 40 | 14.0 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 28 | 14.0 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 136 | 8.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 232 | 15.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 52 | 12.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 220 | 15.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 208 | 17.5 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 64 | 15.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 16 | 14.0 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 184 | 17.5 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 76 | 12.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 268 | 3.5 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 88 | 15.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 256 | 12.3 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 136 | 25.9 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 40 | 13.0 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 16 | 27.8 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 28 | 22.2 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 52 | 22.2 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 64 | 18.5 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 76 | 22.2 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 88 | 22.2 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 100 | 20.4 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 112 | 25.9 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 124 | 16.7 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 148 | 16.7 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 160 | 18.5 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 172 | 14.8 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 184 | 18.5 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 196 | 13.0 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 208 | 13.0 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 220 | 11.1 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 232 | 3.7 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 244 | 5.6 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 256 | 3.7 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 268 | 3.7 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 64 | 11.3 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 76 | 11.3 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 184 | 6.5 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 244 | 8.1 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 196 | 12.9 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 52 | 9.7 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 16 | 8.1 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 208 | 9.7 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 268 | 1.6 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 220 | 9.7 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 40 | 4.8 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 124 | 14.5 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 136 | 14.5 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 112 | 16.1 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 256 | 4.8 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 148 | 14.5 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 100 | 17.7 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 232 | 8.1 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 160 | 14.5 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 88 | 11.3 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 28 | 9.7 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH <1.0 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 172 | 14.5 percentage of participants |
Secondary
Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
The percentage of patients achieving mean growth hormone (GH) levels \< 2.5 μg/L and normalization of sex and age-adjusted IGF-1 was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Total insulin-like growth factor (IGF-1) levels were assessed with one pre-dose sample at the same visits as GH. Concomitant medication known to affect GH or IGF-1 levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (extension full analysis set)
Time frame: Extension baseline up to approximately week 268
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 100 | 24.6 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 244 | 14.0 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 172 | 22.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 112 | 24.6 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 40 | 21.1 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 160 | 19.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 124 | 21.1 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 16 | 19.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 148 | 21.1 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 136 | 15.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 232 | 14.0 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 52 | 21.1 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 256 | 10.5 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 220 | 21.1 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 64 | 22.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 28 | 17.5 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 208 | 17.5 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 76 | 21.1 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 196 | 15.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 88 | 24.6 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 268 | 5.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 184 | 17.5 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 208 | 18.5 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 76 | 29.6 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 28 | 25.9 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 40 | 27.8 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 52 | 29.6 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 64 | 20.4 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 88 | 31.5 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 100 | 24.1 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 112 | 25.9 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 124 | 24.1 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 136 | 24.1 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 148 | 20.4 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 160 | 20.4 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 172 | 20.4 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 184 | 20.4 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 196 | 20.4 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 16 | 25.9 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 220 | 11.1 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 232 | 14.8 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 244 | 7.4 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 256 | 7.4 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 268 | 5.6 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 196 | 24.2 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 184 | 17.7 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 76 | 27.4 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 244 | 11.3 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 64 | 25.8 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 16 | 19.4 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 208 | 19.4 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 52 | 21.0 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 268 | 1.6 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 220 | 14.5 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 40 | 17.7 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 136 | 29.0 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 124 | 25.8 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 256 | 3.2 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 148 | 29.0 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 112 | 25.8 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 232 | 14.5 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 160 | 30.6 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 100 | 32.3 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 28 | 19.4 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 172 | 21.0 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L and Normalization of IGF-1, Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 88 | 25.8 percentage of participants |
Secondary
Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set)
The percentage of patients achieving mean growth hormone (GH) levels \< 2.5 μg/L was calculated with two sided 95% confidence interval. All GH assessments were based on a 5-point mean growth hormone (GH) assessed from a 2-hour profile. Scheduled time points for blood sampling were pre-dose at 0, 30, 60, 90 and 120 minutes. Concomitant medication known to affect GH levels were allowed in patients who were not biochemically controlled after at least one year treatment with pasireotide LAR monotherapy: dopamine agonists and growth hormone receptor antagonists (Extension full analysis set)
Time frame: Extension baseline up to approximately week 268
Population: Full analysis set (FAS): comprised all patients who were randomized. Following the intent-to-treat principle, patients were analyzed according to the study drug they were assigned to at randomization and actual stratum.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 232 | 24.6 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 184 | 33.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 52 | 38.6 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 196 | 29.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 208 | 31.6 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 64 | 40.4 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 220 | 29.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 244 | 19.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 76 | 33.3 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 256 | 15.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 268 | 7.0 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 16 | 38.6 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 88 | 40.4 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 100 | 40.4 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 28 | 40.4 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 112 | 36.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 124 | 40.4 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 136 | 36.8 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 148 | 40.4 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 40 | 38.6 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 160 | 38.6 percentage of participants |
| Pasireotide LAR 40 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 172 | 40.4 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 172 | 37.0 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 88 | 42.6 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 184 | 31.5 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 16 | 55.6 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 136 | 35.2 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 196 | 29.6 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 52 | 46.3 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 100 | 40.7 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 208 | 24.1 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 160 | 33.3 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 148 | 33.3 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 64 | 37.0 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 232 | 18.5 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 112 | 44.4 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 244 | 11.1 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 28 | 44.4 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 40 | 42.6 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 256 | 9.3 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 76 | 44.4 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 124 | 31.5 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 268 | 5.6 percentage of participants |
| Pasireotide LAR 60 mg | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 220 | 18.5 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 268 | 3.2 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 52 | 41.9 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 136 | 43.5 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 28 | 43.5 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 40 | 40.3 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 64 | 41.9 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 76 | 45.2 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 88 | 45.2 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 100 | 46.8 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 112 | 40.3 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 124 | 41.9 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 148 | 43.5 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 160 | 40.3 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 172 | 38.7 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 184 | 33.9 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 196 | 35.5 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 208 | 25.8 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 220 | 22.6 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 232 | 21.0 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 244 | 12.9 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 256 | 6.5 percentage of participants |
| Control Arm (Octreotide or Lanreotide) | Percentage of Patients With Mean GH < 2.5 μg/L Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly (Extension Full Analysis Set) | Week 16 | 33.9 percentage of participants |
Secondary
Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set)
PK samples were collected for those patients treated with pasireotide LAR in the core study and who continued on pasireotide LAR in the extension phase. PK samples were collected before the injection of pasireotide LAR only at weeks 112 and 196. PK samples were also collected at weeks 48 and 132 only for all patients treated with octreotide LAR 30 mg or lanreotide ATG 120 mg in the core study who started treatment with pasireotide LAR in the extension study. Blood samples (2.5 mL each sample) were collected to yield 1-mL plasma for analysis of pasireotide LAR oncentration.
Time frame: Extension baseline up to approximately 196 weeks
Population: Available data for analysis varies at visits
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Pasireotide LAR 40 mg | Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set) | Week 48 | 5.70 mL | Standard Deviation 3.159 |
| Pasireotide LAR 40 mg | Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set) | Week 112 | 8.66 mL | Standard Deviation 4.154 |
| Pasireotide LAR 40 mg | Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set) | Week 132 | 9.28 mL | Standard Deviation 5.067 |
| Pasireotide LAR 40 mg | Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set) | Week 196 | 10.32 mL | Standard Deviation 5.473 |
| Pasireotide LAR 60 mg | Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set) | Week 196 | 14.96 mL | Standard Deviation 10.21 |
| Pasireotide LAR 60 mg | Summary of Pasireotide Trough Concentrations in Acromegaly Patients Following Monthly i.m. Injections of Pasireotide LAR by Incident Dose From Start of Extension Phase up to Week 196 of the Extension Phase (PK Set) | Week 112 | 14.06 mL | Standard Deviation 9.807 |
Secondary
Time to First Response (Weeks) by Treatment for Patients Achieving a Reduction of Mean GH Level to < 2.5 µg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly
Time to first response is defined as the time from the date of first dose to the date of first occurrence of a reduction of mean GH \< 2.5 µg/L and the normalization of IGF-1. The weeks correspond to time taken to achieve first mean GH \< 2.5 µg/L and the normalization of IGF-1.
Time frame: CORE baseline up to approximately 268 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Pasireotide LAR 40 mg | Time to First Response (Weeks) by Treatment for Patients Achieving a Reduction of Mean GH Level to < 2.5 µg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly | 112.3 weeks |
| Pasireotide LAR 60 mg | Time to First Response (Weeks) by Treatment for Patients Achieving a Reduction of Mean GH Level to < 2.5 µg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly | 65.3 weeks |
| Control Arm (Octreotide or Lanreotide) | Time to First Response (Weeks) by Treatment for Patients Achieving a Reduction of Mean GH Level to < 2.5 µg/L and Normalization of IGF-1 and Treated With Pasireotide LAR Alone or With Concomitant Medications Used to Treat Acromegaly | 95.1 weeks |