Hypertension
Conditions
Keywords
Quinapril non-interventional/observational study safety
Brief summary
This is a prospective, non-interventional, non comparative drug study. The efficacy of Quinapril in Asian population has been evaluated, but specifically in Indian patients the data is sparse. Data in a real world setting in a large population of Indian patients would shed more light on the safety, tolerability and effectiveness of Quinapril in the Indian population.
Interventions
DRUGquinapril
per label as non interventional study
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients already on therapy with Acupil® for a minimum period of 4 weeks, Evidence of a personally signed and dated informed consent document
Exclusion criteria
* Patients having a Week 0 visit blood pressure reading of more than 180/110 mm of Hg will not be eligible to participate in the study. * Women of child bearing age, not willing to use contraceptives, will not be eligible for the study * Women using oral contraceptives will also not be included in the study * Patients who have received any drug other than Acupil® as the first prescribed antihypertensive would not be eligible for enrollment into the trial * Patients having any complication at Week 0 visit which would require more thorough investigations or who required more than one anti-hypertensive drug at the time of initiation of their therapy will not be included in the study * Patients having any contraindications as per the LPD of Acupil®
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline to Week 52 | Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12 | Baseline and Week 12 | Value at week 12 minus value at baseline. |
| Change From Baseline in SBP at Week 52 | Baseline and Week 52 | Value at week 52 minus value at baseline. |
| Change From Baseline in DBP at Week 52 | Baseline and Week 52 | Value at week 52 minus value at baseline. |
| Change From Pre-treatment in SBP at Week 0 | Pre-treatment and Week 0 | Value at Week 0 minus value at pre-treatment. Pre-treatment BP was the last BP recorded before taking study medication from retrospective data. If no such value was available, the earliest retrospective BP value from medical records was considered. |
| Change From Pre-treatment in DBP at Week 0 | Pre-treatment and Week 0 | Value at Week 0 minus value at pre-treatment. Pre-treatment BP was the last BP recorded before taking study medication from retrospective data. If no such value was available, the earliest retrospective BP value from medical records was considered. |
| Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 | Baseline and Week 12 | Value at week 12 minus value at baseline. |
| Number of Participants With Achievement of BP Goal at Week 52 | Week 52 | The status of achieving a participant's goal BP at week 52 was yes (at goal) or no (not at goal). The BP goal also depended on the participant's status of DM or renal disease. To be considered at goal, SBP/DBP must be less than 140/90 mmHg for participants without DM or renal disease and SBP/DBP must be less than 130/80 mmHg for participants with DM or renal disease. |
| Duration of Monotherapy With Quinapril | Baseline up to week 52 or early termination | Time in weeks to the first taking additional antihypertensive medication since Quinapril therapy began. |
| Mean Daily Dose of Study Medication | Baseline up to week 52 or early termination | The mean daily dose of the study medication was calculated by dividing the total dose (sum of the daily doses) in the study by the treatment duration. |
| Number of Participants With Preference for add-on Anti-hypertensive Therapy | Baseline up to week 52 or early termination | The first add-on antihypertensive therapy for each participant was the first additional antihypertensive medication since initiation of Quinapril. If the participant did not require any such add-on medication, the first add-on antihypertensive therapy was None. |
| Number of Participants Achieving BP Goal at Week 12 | Week 12 | The status of achieving a participant's goal BP at Week 12 was yes (at goal) or no (not at goal). The BP goal also depended on the participant's status of Diabetes Mellitus (DM) or renal disease. To be considered at goal, SBP/DBP must be less than 140/90 mmHg for participants without DM or renal disease and SBP/DBP must be less than 130/80 mmHg for participants with DM or renal disease. |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Quinapril Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks. | 329 |
| Total | 329 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 16 |
| Overall Study | No longer willing to participate | 9 |
| Overall Study | Study terminated by sponsor | 2 |
Baseline characteristics
| Characteristic | Quinapril |
|---|---|
| Age Continuous | 52.5 Years STANDARD_DEVIATION 10.7 |
| Sex: Female, Male Female | 145 Participants |
| Sex: Female, Male Male | 184 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 329 |
| serious Total, serious adverse events | 0 / 329 |
Outcome results
Primary
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any untoward medical occurrence in a participant who received study drug was considered an AE, without regard to possibility of causal relationship. Treatment-emergent adverse events (TEAE): those which occurred or worsened after baseline. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: Baseline to Week 52
Population: Full analysis set (FAS) included participants who received at least 1 dose of study medication including those who took it before enrollment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quinapril | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Serious adverse events | 0 Participants |
| Quinapril | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Adverse events | 1 Participants |
Secondary
Change From Baseline in DBP at Week 52
Value at week 52 minus value at baseline.
Time frame: Baseline and Week 52
Population: The FAS-FU included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Unknown | Change From Baseline in DBP at Week 52 | Baseline | — mmHg |
| Unknown | Change From Baseline in DBP at Week 52 | Change at week 52 | — mmHg |
Secondary
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12
Value at week 12 minus value at baseline.
Time frame: Baseline and Week 12
Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were imputed by LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinapril | Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12 | Baseline | 86.31 mmHg | Standard Deviation 6.71 |
| Quinapril | Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12 | Change at Week 12 | -3.93 mmHg | Standard Deviation 6.29 |
Secondary
Change From Baseline in SBP at Week 52
Value at week 52 minus value at baseline.
Time frame: Baseline and Week 52
Population: The full analysis set - follow up (FAS-FU) included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Unknown | Change From Baseline in SBP at Week 52 | Baseline | — mmHg |
| Unknown | Change From Baseline in SBP at Week 52 | Change at week 52 | — mmHg |
Secondary
Change From Baseline in Systolic Blood Pressure (SBP) at Week 12
Value at week 12 minus value at baseline.
Time frame: Baseline and Week 12
Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were imputed by last-observation-carried forward (LOCF).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinapril | Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 | Baseline | 142.16 Millimeters of mercury (mmHg) | Standard Deviation 12.93 |
| Quinapril | Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 | Change at Week 12 | -9.40 Millimeters of mercury (mmHg) | Standard Deviation 11.18 |
Secondary
Change From Pre-treatment in DBP at Week 0
Value at Week 0 minus value at pre-treatment. Pre-treatment BP was the last BP recorded before taking study medication from retrospective data. If no such value was available, the earliest retrospective BP value from medical records was considered.
Time frame: Pre-treatment and Week 0
Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Missing values were imputed by LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinapril | Change From Pre-treatment in DBP at Week 0 | Pre-treatment | 92.82 mmHg | Standard Deviation 7.91 |
| Quinapril | Change From Pre-treatment in DBP at Week 0 | Change at Week 0 | -6.74 mmHg | Standard Deviation 8.2 |
Secondary
Change From Pre-treatment in SBP at Week 0
Value at Week 0 minus value at pre-treatment. Pre-treatment BP was the last BP recorded before taking study medication from retrospective data. If no such value was available, the earliest retrospective BP value from medical records was considered.
Time frame: Pre-treatment and Week 0
Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Missing values were imputed by LOCF.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Quinapril | Change From Pre-treatment in SBP at Week 0 | Pre-treatment | 154.06 mmHg | Standard Deviation 13.5 |
| Quinapril | Change From Pre-treatment in SBP at Week 0 | Change at Week 0 | -12.49 mmHg | Standard Deviation 11.69 |
Secondary
Duration of Monotherapy With Quinapril
Time in weeks to the first taking additional antihypertensive medication since Quinapril therapy began.
Time frame: Baseline up to week 52 or early termination
Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed. Due to limited number of participants available, the analysis could not be performed.
Secondary
Mean Daily Dose of Study Medication
The mean daily dose of the study medication was calculated by dividing the total dose (sum of the daily doses) in the study by the treatment duration.
Time frame: Baseline up to week 52 or early termination
Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quinapril | Mean Daily Dose of Study Medication | 11.28 mg | Standard Deviation 3.06 |
Secondary
Number of Participants Achieving BP Goal at Week 12
The status of achieving a participant's goal BP at Week 12 was yes (at goal) or no (not at goal). The BP goal also depended on the participant's status of Diabetes Mellitus (DM) or renal disease. To be considered at goal, SBP/DBP must be less than 140/90 mmHg for participants without DM or renal disease and SBP/DBP must be less than 130/80 mmHg for participants with DM or renal disease.
Time frame: Week 12
Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrolment. Subgroup analysis was performed for each subgroup of participants in the FAS defined by DM or renal disease status. Missing values were imputed by LOCF.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quinapril | Number of Participants Achieving BP Goal at Week 12 | 78 Participants |
Secondary
Number of Participants With Achievement of BP Goal at Week 52
The status of achieving a participant's goal BP at week 52 was yes (at goal) or no (not at goal). The BP goal also depended on the participant's status of DM or renal disease. To be considered at goal, SBP/DBP must be less than 140/90 mmHg for participants without DM or renal disease and SBP/DBP must be less than 130/80 mmHg for participants with DM or renal disease.
Time frame: Week 52
Population: The FAS-FU included the subset of participants who had at least 1 additional BP measurement. This analysis was not conducted because only 2 participants were eligible for inclusion in the FAS-FU.
Secondary
Number of Participants With Preference for add-on Anti-hypertensive Therapy
The first add-on antihypertensive therapy for each participant was the first additional antihypertensive medication since initiation of Quinapril. If the participant did not require any such add-on medication, the first add-on antihypertensive therapy was None.
Time frame: Baseline up to week 52 or early termination
Population: FAS included all participants who received at least 1 dose of study medication including those who took it before enrollment. Missing values were not imputed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Quinapril | Number of Participants With Preference for add-on Anti-hypertensive Therapy | None | 321 Participants |
| Quinapril | Number of Participants With Preference for add-on Anti-hypertensive Therapy | Metoprolol | 1 Participants |
| Quinapril | Number of Participants With Preference for add-on Anti-hypertensive Therapy | Metoprolol Succinate | 1 Participants |