Hyperprolactinemia, Parkinson's Disease
Conditions
Keywords
compliance study, effectiveness study, hyperprolactinemia, Parkinson's disease, retrospective cohort study
Brief summary
The overall goal of this study will be to assess and monitor the adherence to and effectiveness of the new prescribing guidelines for cabergoline. Specific objectives will be to assess: 1. The indication for use of cabergoline (Parkinson, hyperprolactinemia, other) 2. Prior treatment strategies in patients who start cabergoline treatment for Parkinson's Disease 3. The percentage of cabergoline users who are prescribed doses above 3 mg per day 4. Whether cabergoline users are monitored by echocardiography prior and during treatment. 5. The incidence and prevalence of valvular fibrosis
Detailed description
does not involve random selection
Interventions
DRUGStudy Drug
non interventional study - usage as per usual care
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Treated with cabergoline during the study period (January 1st, 2006 and will end on July 1st 2012) and identified in one of 6 databases: The Health Information Network, Health Search Database, Integrated Primary Care Information database, PHARMO, Aarhus hospital databases, and the Universitaet Bremen - Bremen Institute for Prevention
Exclusion criteria
* Patients with eligibility dates that start after July 1st 2007 (meaning that they would have less than one year of valid data before publication of the results of the EMEA review), will be excluded as well as patients whose eligibility ends before July 1st 2008 (date of SmPC changes).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Cabergoline Prescriptions by Database and Indication: Year 1 | Year 1 (Year 2006) | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Number of Cabergoline Prescriptions by Database and Indication: Year 2 | Year 2 (Year 2007) | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Number of Cabergoline Prescriptions by Database and Indication: Year 3 | Year 3 (Year 2008) | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Number of Cabergoline Prescriptions by Database and Indication: Year 4 | Year 4 (Year 2009) | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Number of Cabergoline Prescriptions by Database and Indication: Year 5 | Year 5 (Year 2010) | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Number of Cabergoline Prescriptions by Database and Indication: Year 6 | Year 6 (Year 2011) | Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication. |
| Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1 | Year 1 (Year 2006) | Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2 | Year 2 (Year 2007) | Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3 | Year 3 (Year 2008) | Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4 | Year 4 (Year 2009) | Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5 | Year 5 (Year 2010) | Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6 | Year 6 (Year 2011) | Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson's disease only in participants who have already taken or cannot take other treatments, that is as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported. |
| Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1 | Year 1 (Year 2006) | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2 | Year 2 (Year 2007) | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3 | Year 3 (Year 2008) | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4 | Year 4 (Year 2009) | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5 | Year 5 (Year 2010) | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6 | Year 6 (Year 2011) | The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period. |
| Total Number of Echocardiography Examinations in Cabergoline Users | Baseline (Week 1) up to Week 339 | The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment. To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography. |
| Incidence of Valvular Fibrosis | Baseline (Week 1) up to Week 339 | Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment. Percentage of participants with valvular fibrosis are reported. |
| Prevalence of Valvular Fibrosis | Baseline (Week 1) up to Week 339 | Prevalence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment divided by number of participants with at least 1 echocardiography examination. Percentage of participants with valvular fibrosis are reported. |
Participant flow
Recruitment details
Part 1 recruited participants from North, Middle and South Europe and Part 2 from specialized clinical centers in Italy.
Pre-assignment details
Part 1 assessed adherence (compliance) with prescribing guidelines (PG) by using automated health care data which had information on strength, indication, referrals for echocardiography, recognized reputation in area of drug utilization, safety research. Part 2 assessed effectiveness of PG for cabergoline in participants with Parkinson's disease.
Participants by arm
| Arm | Count |
|---|---|
| Aarhus [Part 1] Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region. | 7,537 |
| HSD [Part 1] Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy. | 6,580 |
| IPCI [Part 1] Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands. | 326 |
| PHARMO [Part 1] Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants' medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands. | 5,486 |
| THIN [Part 1] Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom. | 2,024 |
| Cabergoline in Pre-SPC Change Period [Part 2] Participants who started cabergoline treatment for Parkinson's disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC. | 11 |
| Cabergoline in Post- SPC Change Period [Part 2] Participants who started cabergoline treatment for Parkinson's disease after the date of the recommended SPC change, 26 June 2008 (Week 130). | 2 |
| Cabergoline in Cross-SPC Change Period [Part 2] Participants who started cabergoline treatment for Parkinson's disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC. | 48 |
| Total | 22,014 |
Baseline characteristics
| Characteristic | Aarhus [Part 1] | HSD [Part 1] | IPCI [Part 1] | PHARMO [Part 1] | THIN [Part 1] | Cabergoline in Pre-SPC Change Period [Part 2] | Cabergoline in Post- SPC Change Period [Part 2] | Cabergoline in Cross-SPC Change Period [Part 2] | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized Part 1, Compliance: G02CB03 | 33.6 years STANDARD_DEVIATION 10.7 | 39.0 years STANDARD_DEVIATION 12.3 | 42.1 years STANDARD_DEVIATION 14 | 41.3 years STANDARD_DEVIATION 15.8 | 47.1 years STANDARD_DEVIATION 16.2 | NA years | NA years | NA years | 40.8 years STANDARD_DEVIATION 14.8 |
| Age, Customized Part 1, Compliance: N04BC06 | 66.4 years STANDARD_DEVIATION 13.2 | 73.1 years STANDARD_DEVIATION 11.3 | NA years | NA years | 69.7 years STANDARD_DEVIATION 13.6 | NA years | NA years | NA years | 70.4 years STANDARD_DEVIATION 13 |
| Age, Customized Part 2, Effectiveness | NA years | NA years | NA years | NA years | NA years | 62.7 years STANDARD_DEVIATION 5.6 | 58.7 years STANDARD_DEVIATION 8.5 | 63.7 years STANDARD_DEVIATION 13.9 | 63.3 years STANDARD_DEVIATION 12.5 |
| Sex: Female, Male Female | 7429 Participants | 6180 Participants | 288 Participants | 5180 Participants | 1468 Participants | 2 Participants | 0 Participants | 13 Participants | 20560 Participants |
| Sex: Female, Male Male | 108 Participants | 400 Participants | 38 Participants | 306 Participants | 556 Participants | 9 Participants | 2 Participants | 35 Participants | 1454 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Incidence of Valvular Fibrosis
Incidence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment and absence of any valve damage at baseline divided by number of participants without any valve damage at baseline and at least 1 additional echocardiography examination during follow-up while on cabergoline treatment. Percentage of participants with valvular fibrosis are reported.
Time frame: Baseline (Week 1) up to Week 339
Population: Study population:all participants recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson's disease during study period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aarhus [Part 1] | Incidence of Valvular Fibrosis | 100 percentage of participants |
| HSD [Part 1] | Incidence of Valvular Fibrosis | 0 percentage of participants |
| IPCI [Part 1] | Incidence of Valvular Fibrosis | 57.1 percentage of participants |
Primary
Number of Cabergoline Prescriptions by Database and Indication: Year 1
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Time frame: Year 1 (Year 2006)
Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aarhus [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 1 | G02CB03 | 17 prescriptions |
| Aarhus [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 1 | N04BC06 | 87 prescriptions |
| HSD [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 1 | G02CB03 | 1782 prescriptions |
| HSD [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 1 | N04BC06 | 1483 prescriptions |
| IPCI [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 1 | G02CB03 | 6 prescriptions |
| IPCI [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 1 | N04BC06 | 0 prescriptions |
| PHARMO [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 1 | N04BC06 | 0 prescriptions |
| PHARMO [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 1 | G02CB03 | 293 prescriptions |
| THIN [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 1 | G02CB03 | 198 prescriptions |
| THIN [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 1 | N04BC06 | 577 prescriptions |
Primary
Number of Cabergoline Prescriptions by Database and Indication: Year 2
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Time frame: Year 2 (Year 2007)
Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aarhus [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 2 | G02CB03 | 1925 prescriptions |
| Aarhus [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 2 | N04BC06 | 741 prescriptions |
| HSD [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 2 | G02CB03 | 3616 prescriptions |
| HSD [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 2 | N04BC06 | 2139 prescriptions |
| IPCI [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 2 | G02CB03 | 64 prescriptions |
| IPCI [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 2 | N04BC06 | 0 prescriptions |
| PHARMO [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 2 | N04BC06 | 0 prescriptions |
| PHARMO [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 2 | G02CB03 | 2698 prescriptions |
| THIN [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 2 | G02CB03 | 3537 prescriptions |
| THIN [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 2 | N04BC06 | 3325 prescriptions |
Primary
Number of Cabergoline Prescriptions by Database and Indication: Year 3
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Time frame: Year 3 (Year 2008)
Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aarhus [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 3 | G02CB03 | 2098 prescriptions |
| Aarhus [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 3 | N04BC06 | 507 prescriptions |
| HSD [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 3 | G02CB03 | 3493 prescriptions |
| HSD [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 3 | N04BC06 | 807 prescriptions |
| IPCI [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 3 | G02CB03 | 152 prescriptions |
| IPCI [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 3 | N04BC06 | 0 prescriptions |
| PHARMO [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 3 | N04BC06 | 0 prescriptions |
| PHARMO [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 3 | G02CB03 | 2621 prescriptions |
| THIN [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 3 | G02CB03 | 3556 prescriptions |
| THIN [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 3 | N04BC06 | 1656 prescriptions |
Primary
Number of Cabergoline Prescriptions by Database and Indication: Year 4
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Time frame: Year 4 (Year 2009)
Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aarhus [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 4 | G02CB03 | 2260 prescriptions |
| Aarhus [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 4 | N04BC06 | 306 prescriptions |
| HSD [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 4 | G02CB03 | 3629 prescriptions |
| HSD [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 4 | N04BC06 | 463 prescriptions |
| IPCI [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 4 | G02CB03 | 226 prescriptions |
| IPCI [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 4 | N04BC06 | 0 prescriptions |
| PHARMO [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 4 | N04BC06 | 0 prescriptions |
| PHARMO [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 4 | G02CB03 | 2684 prescriptions |
| THIN [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 4 | G02CB03 | 3240 prescriptions |
| THIN [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 4 | N04BC06 | 1119 prescriptions |
Primary
Number of Cabergoline Prescriptions by Database and Indication: Year 5
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Time frame: Year 5 (Year 2010)
Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aarhus [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 5 | G02CB03 | 2395 prescriptions |
| Aarhus [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 5 | N04BC06 | 201 prescriptions |
| HSD [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 5 | G02CB03 | 3793 prescriptions |
| HSD [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 5 | N04BC06 | 274 prescriptions |
| IPCI [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 5 | G02CB03 | 283 prescriptions |
| IPCI [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 5 | N04BC06 | 0 prescriptions |
| PHARMO [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 5 | N04BC06 | 0 prescriptions |
| PHARMO [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 5 | G02CB03 | 2752 prescriptions |
| THIN [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 5 | G02CB03 | 3170 prescriptions |
| THIN [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 5 | N04BC06 | 981 prescriptions |
Primary
Number of Cabergoline Prescriptions by Database and Indication: Year 6
Cabergoline prescriptions were stratified by indications per year. Indications were coded using Anatomical Therapeutic Code (ATC) which included G02CB03 for prolactin reduction indication and N04BC06 for neurological indication.
Time frame: Year 6 (Year 2011)
Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Aarhus [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 6 | N04BC06 | 141 prescriptions |
| Aarhus [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 6 | G02CB03 | 2286 prescriptions |
| HSD [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 6 | G02CB03 | 3686 prescriptions |
| HSD [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 6 | N04BC06 | 143 prescriptions |
| IPCI [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 6 | G02CB03 | 183 prescriptions |
| IPCI [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 6 | N04BC06 | 0 prescriptions |
| PHARMO [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 6 | N04BC06 | 0 prescriptions |
| PHARMO [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 6 | G02CB03 | 2660 prescriptions |
| THIN [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 6 | G02CB03 | 3212 prescriptions |
| THIN [Part 1] | Number of Cabergoline Prescriptions by Database and Indication: Year 6 | N04BC06 | 859 prescriptions |
Primary
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Time frame: Year 1 (Year 2006)
Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aarhus [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1 | 0 percentage of prescriptions |
| HSD [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1 | 5 percentage of prescriptions |
| IPCI [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1 | 0 percentage of prescriptions |
| PHARMO [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1 | 0 percentage of prescriptions |
| THIN [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 1 | 17 percentage of prescriptions |
Primary
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Time frame: Year 2 (Year 2007)
Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aarhus [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2 | 0.2 percentage of prescriptions |
| HSD [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2 | 5 percentage of prescriptions |
| IPCI [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2 | 2 percentage of prescriptions |
| PHARMO [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2 | 0 percentage of prescriptions |
| THIN [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 2 | 13 percentage of prescriptions |
Primary
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Time frame: Year 3 (Year 2008)
Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aarhus [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3 | 0 percentage of prescriptions |
| HSD [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3 | 3 percentage of prescriptions |
| IPCI [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3 | 5 percentage of prescriptions |
| PHARMO [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3 | 0 percentage of prescriptions |
| THIN [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 3 | 7 percentage of prescriptions |
Primary
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Time frame: Year 4 (Year 2009)
Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aarhus [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4 | 0 percentage of prescriptions |
| HSD [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4 | 2 percentage of prescriptions |
| IPCI [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4 | 1 percentage of prescriptions |
| PHARMO [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4 | 0 percentage of prescriptions |
| THIN [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 4 | 5 percentage of prescriptions |
Primary
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Time frame: Year 5 (Year 2010)
Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aarhus [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5 | 0 percentage of prescriptions |
| HSD [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5 | 3 percentage of prescriptions |
| IPCI [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5 | 1 percentage of prescriptions |
| PHARMO [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5 | 0 percentage of prescriptions |
| THIN [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 5 | 2 percentage of prescriptions |
Primary
Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6
The Committee for Medicinal Products for Human Use (CHMP) recommended that the prescribing information for cabergoline should be updated to include: a reduction of the maximum recommended dose to 3 mg per day. To evaluate compliance with the new prescription guidelines, it was assessed whether the dose exceeded 3 mg per day during the study period.
Time frame: Year 6 (Year 2011)
Population: Study population included all participants who were registered in one of the databases and were treated with cabergoline during the study period. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aarhus [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6 | 0 percentage of prescriptions |
| HSD [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6 | 1 percentage of prescriptions |
| IPCI [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6 | 0 percentage of prescriptions |
| PHARMO [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6 | 0 percentage of prescriptions |
| THIN [Part 1] | Percentage of Cabergoline Prescriptions for Dosages Greater Than 3 Milligram (mg) Per Day: Year 6 | 2 percentage of prescriptions |
Primary
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Time frame: Year 1 (Year 2006)
Population: Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aarhus [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1 | 0 percentage of prescriptions |
| HSD [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1 | 0 percentage of prescriptions |
| IPCI [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 1 | 0 percentage of prescriptions |
Primary
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Time frame: Year 2 (Year 2007)
Population: Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aarhus [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2 | 4 percentage of prescriptions |
| HSD [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2 | 10 percentage of prescriptions |
| IPCI [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 2 | 10 percentage of prescriptions |
Primary
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Time frame: Year 3 (Year 2008)
Population: Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aarhus [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3 | 20 percentage of prescriptions |
| HSD [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3 | 39 percentage of prescriptions |
| IPCI [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 3 | 23 percentage of prescriptions |
Primary
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Time frame: Year 4 (Year 2009)
Population: Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aarhus [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4 | 7 percentage of prescriptions |
| HSD [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4 | 22 percentage of prescriptions |
| IPCI [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 4 | 12 percentage of prescriptions |
Primary
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5
Changes to the Summary of Product Characteristics (SPC) included that the cabergoline should be used for Parkinson's disease only in participants who had already taken or cannot take other treatments, which was as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline was considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Time frame: Year 5 (Year 2010)
Population: Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aarhus [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5 | 18 percentage of prescriptions |
| HSD [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5 | 43 percentage of prescriptions |
| IPCI [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 5 | 21 percentage of prescriptions |
Primary
Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6
Changes to the Summary of Product Characteristics (SPC) in April 2007 included that the cabergoline should be used for Parkinson's disease only in participants who have already taken or cannot take other treatments, that is as second line therapy. Second-line use restriction did not apply to the hyperprolactinemia indication, for which cabergoline is considered a first-time therapy. Percentage of second-line prescriptions of a total number of prescriptions for cabergoline during a respective year for the neurological indication was reported.
Time frame: Year 6 (Year 2011)
Population: Study population: participants registered in one of databases and were treated with cabergoline during study period. Data not reported for IPCI and PHARMO databases because no information was retrieved for second-line prescriptions of cabergoline for Parkinson's disease. 'N' (number of participants analyzed)=participants evaluable for this measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aarhus [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6 | 11 percentage of prescriptions |
| HSD [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6 | 67 percentage of prescriptions |
| IPCI [Part 1] | Percentage of Second-line Prescriptions of Cabergoline for Parkinson's Disease Indications: Year 6 | 0 percentage of prescriptions |
Primary
Prevalence of Valvular Fibrosis
Prevalence of valvular fibrosis was calculated as number of participants with documented valvulopathy during cabergoline treatment divided by number of participants with at least 1 echocardiography examination. Percentage of participants with valvular fibrosis are reported.
Time frame: Baseline (Week 1) up to Week 339
Population: Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson's disease during the study period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aarhus [Part 1] | Prevalence of Valvular Fibrosis | 57.2 percentage of participants |
| HSD [Part 1] | Prevalence of Valvular Fibrosis | 50.0 percentage of participants |
| IPCI [Part 1] | Prevalence of Valvular Fibrosis | 55.9 percentage of participants |
Primary
Total Number of Echocardiography Examinations in Cabergoline Users
The CHMP recommended that the prescribing information for cabergoline should be updated to include: a warning stating that participant must be monitored for signs of cardiac valve fibrosis with echocardiography before treatment is started and regularly (every 6 months) during treatment. To evaluate effectiveness with the new prescription guidelines, it was assessed whether cabergoline users were monitored by echocardiography.
Time frame: Baseline (Week 1) up to Week 339
Population: Study population included all participants who were recruited from specialized clinical centers in Italy and treated with cabergoline for Parkinson's disease during the study period.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aarhus [Part 1] | Total Number of Echocardiography Examinations in Cabergoline Users | 11 echocardiography examinations |
| HSD [Part 1] | Total Number of Echocardiography Examinations in Cabergoline Users | 3 echocardiography examinations |
| IPCI [Part 1] | Total Number of Echocardiography Examinations in Cabergoline Users | 68 echocardiography examinations |