Hypertension
Conditions
Brief summary
This Post Marketing Surveillance (PMS) study aims to review the followings by investigating the actual practice of MicardisPlus Tablet on the market: 1. Unexpected adverse drug reactions (especially, serious adverse events (SAEs)) 2. Frequency of incidence and its change in adverse events (AEs) 3. Factors on the safety profile of the study drug 4. Factors on the efficacy profile of the study drug
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
patients diagnosed with essential hypertension
Exclusion criteria
patients who took Micardis Plus before participating in this PMS study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Unexpected Adverse Events | Up to 6 years | Occurrence status of unexpected adverse events |
| Frequency of Adverse Events | Up to 6 years | — |
| Change From Baseline in SBP (Systolic Blood Pressure) at Week 2 | Baseline and End of Study | Effect on decrease in systolic blood pressure |
| Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2 | Baseline and End of Study | Effect on decrease in diastolic blood pressure |
| Effective Rate | Baseline and End of Study | Efficacy assessment (effective or not effective) based on a clinical judgement (1=Cured, 2=Improved, 3=Failed) as follows: Ⅰ. Effective (if the clinical judgement of investigator is 1 or 2=cured or improved) Ⅱ. Not effective (if the clinical judgement of investigator is 3=failed) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concomitant Disease Factors Affecting the Safety Profile | Up to 6 years | Occurrence status of adverse events by Concomitant disease of patients |
| Medical History Factors Affecting the Efficacy Profile | Baseline and End of Study | Efficacy rate by medical characteristic of patients |
| Gender Factors Affecting the Safety Profile | Up to 6 years | Occurrence status of adverse events by Gender category of patients |
| Baseline Severity of Hypertension Factors Affecting the Efficacy Profile | Baseline and End of Study | Efficacy rate by medical characteristic of patients Stage 1 (SBP 140\ 159 mmHg or DBP 90\ 99 mmHg) Stage 2 (SBP 160\ 179 mmHg or DBP 100\ 109 mmHg) Stage 3 (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg) |
| Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile | Baseline and End of Study | Efficacy rate by medical characteristic of patients 40/12.5mg \< daily dose \< 80/12.5mg - Because some physicians changed the daily dose based on patient's BP control result, this range exists |
| Previous Medication Factors Affecting the Efficacy Profile | Baseline and End of Study | Efficacy rate by medical characteristic of patients |
| Age Factors Affecting the Safety Profile | Up to 6 years | Occurrence status of adverse events by Age category of patients |
| Proportion of Geriatric Population Factor Affecting the Safety Profile | Up to 6 years | Occurrence status of adverse events by Proportion of geriatric population of patients |
| Treatment Type Factors Affecting the Safety Profile | Up to 6 years | Occurrence status of adverse events by Treatment type of patients |
| Medical History Factors Affecting the Safety Profile | Up to 6 years | Occurrence status of adverse events by medical history of patients |
Countries
South Korea
Participant flow
Recruitment details
A total of 6,901 Case Report Forms were retrieved from 281 study centers. Three thousand and nine hundred thirty two (3,932) patients were eligible for the safety assessment. As requested by KFDA to be in line with the registered indication, 2, 969 patients with mild hypertension and treatment naïve patients were excluded from analysis.
Participants by arm
| Arm | Count |
|---|---|
| Hypertensive Patients With Micardis Plus for the First Time In Post Marketing Surveillance (PMS), there are totally three figures. The number of enrolled patients: 6,901/ The number of patients for safety assessment: 3,932/ The number of patients for efficacy assessment: 3,616. | 3,917 |
| Total | 3,917 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Inconsistent BP measuring date | 2 |
| Overall Study | No blood pressure recorded | 147 |
| Overall Study | No recorded efficacy data | 15 |
| Overall Study | 'Unable to evaluate' for the final asses | 67 |
| Overall Study | Unknown measuring date of blood pressure | 85 |
Baseline characteristics
| Characteristic | Hypertensive Patients With Micardis Plus for the First Time |
|---|---|
| Age, Continuous | 60 years STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 2057 Participants |
| Sex: Female, Male Male | 1860 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3,932 |
| serious Total, serious adverse events | 1 / 3,932 |
Outcome results
Primary
Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2
Effect on decrease in diastolic blood pressure
Time frame: Baseline and End of Study
Population: Out of 6,901 patients, 3,616 patients for the efficacy assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypertensive Patients With Micardis Plus for the First Time | Change From Baseline in DBP (Diastolic Blood Pressure) at Week 2 | -15 mmHg | Standard Deviation 11 |
p-value: <0.0001t-test for paired observations
Primary
Change From Baseline in SBP (Systolic Blood Pressure) at Week 2
Effect on decrease in systolic blood pressure
Time frame: Baseline and End of Study
Population: Out of 6,901 patients, 3,616 patients for the efficacy assessment
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Hypertensive Patients With Micardis Plus for the First Time | Change From Baseline in SBP (Systolic Blood Pressure) at Week 2 | -29 mmHg | Standard Deviation 16 |
p-value: <0.0001t-test for paired observations
Primary
Effective Rate
Efficacy assessment (effective or not effective) based on a clinical judgement (1=Cured, 2=Improved, 3=Failed) as follows: Ⅰ. Effective (if the clinical judgement of investigator is 1 or 2=cured or improved) Ⅱ. Not effective (if the clinical judgement of investigator is 3=failed)
Time frame: Baseline and End of Study
Population: Out of 6,901 patients, 3,616 patients for the efficacy assessment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypertensive Patients With Micardis Plus for the First Time | Effective Rate | 99 Percentage of patients |
Primary
Frequency of Adverse Events
Time frame: Up to 6 years
Population: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypertensive Patients With Micardis Plus for the First Time | Frequency of Adverse Events | 1.04 Percentage of patients |
Primary
Unexpected Adverse Events
Occurrence status of unexpected adverse events
Time frame: Up to 6 years
Population: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hypertensive Patients With Micardis Plus for the First Time | Unexpected Adverse Events | 0.58 Percentage of patients |
Secondary
Age Factors Affecting the Safety Profile
Occurrence status of adverse events by Age category of patients
Time frame: Up to 6 years
Population: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hypertensive Patients With Micardis Plus for the First Time | Age Factors Affecting the Safety Profile | 20 ≤ age < 30 | 0 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Age Factors Affecting the Safety Profile | 30 ≤ age < 40 | 1.32 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Age Factors Affecting the Safety Profile | 40 ≤ age < 50 | 1.20 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Age Factors Affecting the Safety Profile | 50 ≤ age < 60 | 1.13 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Age Factors Affecting the Safety Profile | 60 ≤ age < 70 | 0.88 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Age Factors Affecting the Safety Profile | ≥ 70 | 1.04 Percentage of patients |
p-value: 0.9674Chi-squared
Secondary
Baseline Severity of Hypertension Factors Affecting the Efficacy Profile
Efficacy rate by medical characteristic of patients Stage 1 (SBP 140\ 159 mmHg or DBP 90\ 99 mmHg) Stage 2 (SBP 160\ 179 mmHg or DBP 100\ 109 mmHg) Stage 3 (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg)
Time frame: Baseline and End of Study
Population: Out of 6,901 patients, 3,616 patients for the efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hypertensive Patients With Micardis Plus for the First Time | Baseline Severity of Hypertension Factors Affecting the Efficacy Profile | Stage 1 | 98.3 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Baseline Severity of Hypertension Factors Affecting the Efficacy Profile | Stage 2 | 99.2 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Baseline Severity of Hypertension Factors Affecting the Efficacy Profile | Stage 3 | 98.3 Percentage of patients |
p-value: 0.0393Chi-squared
Secondary
Concomitant Disease Factors Affecting the Safety Profile
Occurrence status of adverse events by Concomitant disease of patients
Time frame: Up to 6 years
Population: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hypertensive Patients With Micardis Plus for the First Time | Concomitant Disease Factors Affecting the Safety Profile | With Concomitant disease | 2.30 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Concomitant Disease Factors Affecting the Safety Profile | Without Concomitant disease | 0.56 Percentage of patients |
p-value: <0.000195% CI: [1.642, 6.776]Chi-squared
Secondary
Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile
Efficacy rate by medical characteristic of patients 40/12.5mg \< daily dose \< 80/12.5mg - Because some physicians changed the daily dose based on patient's BP control result, this range exists
Time frame: Baseline and End of Study
Population: Out of 6,901 patients, 3,616 patients for the efficacy assessment and Daily dose not recorded for 26 patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hypertensive Patients With Micardis Plus for the First Time | Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile | 40/12.5mg | 98.8 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile | 40/12.5mg < daily dose < 80/12.5mg | 95.8 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Daily Dose of Micardis® Plus Factors Affecting the Efficacy Profile | 80/12.5mg | 99.4 Percentage of patients |
p-value: 0.0245Chi-squared
Secondary
Gender Factors Affecting the Safety Profile
Occurrence status of adverse events by Gender category of patients
Time frame: Up to 6 years
Population: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Gender not recorded for 15 patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hypertensive Patients With Micardis Plus for the First Time | Gender Factors Affecting the Safety Profile | Male | 1.24 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Gender Factors Affecting the Safety Profile | Female | 0.88 Percentage of patients |
p-value: 0.2669Chi-squared
Secondary
Medical History Factors Affecting the Efficacy Profile
Efficacy rate by medical characteristic of patients
Time frame: Baseline and End of Study
Population: Out of 6,901 patients, 3,616 patients for the efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hypertensive Patients With Micardis Plus for the First Time | Medical History Factors Affecting the Efficacy Profile | With Medical history | 98.1 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Medical History Factors Affecting the Efficacy Profile | Without Medical history | 99.2 Percentage of patients |
p-value: 0.0075Chi-squared
Secondary
Medical History Factors Affecting the Safety Profile
Occurrence status of adverse events by medical history of patients
Time frame: Up to 6 years
Population: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hypertensive Patients With Micardis Plus for the First Time | Medical History Factors Affecting the Safety Profile | With Medical history | 1.97 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Medical History Factors Affecting the Safety Profile | Without Medical history | 0.68 Percentage of patients |
p-value: 0.000395% CI: [1.121, 4.151]Chi-squared
Secondary
Previous Medication Factors Affecting the Efficacy Profile
Efficacy rate by medical characteristic of patients
Time frame: Baseline and End of Study
Population: Out of 6,901 patients, 3,616 patients for the efficacy assessment
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hypertensive Patients With Micardis Plus for the First Time | Previous Medication Factors Affecting the Efficacy Profile | Without Previous medication | 99.6 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Previous Medication Factors Affecting the Efficacy Profile | With Previous medication | 98.3 Percentage of patients |
p-value: 0.0007Chi-squared
Secondary
Proportion of Geriatric Population Factor Affecting the Safety Profile
Occurrence status of adverse events by Proportion of geriatric population of patients
Time frame: Up to 6 years
Population: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Date of birth not recorded for 15 patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hypertensive Patients With Micardis Plus for the First Time | Proportion of Geriatric Population Factor Affecting the Safety Profile | < 65 | 1.03 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Proportion of Geriatric Population Factor Affecting the Safety Profile | >= 65 | 1.07 Percentage of patients |
p-value: 0.9207Chi-squared
Secondary
Treatment Type Factors Affecting the Safety Profile
Occurrence status of adverse events by Treatment type of patients
Time frame: Up to 6 years
Population: Out of 6,901 patients, 3,932 patients were analyzed for the safety assessment and Treatment type not recorded for 294 patients
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Hypertensive Patients With Micardis Plus for the First Time | Treatment Type Factors Affecting the Safety Profile | In-patient | 0 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Treatment Type Factors Affecting the Safety Profile | Out-patient | 1.10 Percentage of patients |
| Hypertensive Patients With Micardis Plus for the First Time | Treatment Type Factors Affecting the Safety Profile | In-patient and outpatient alternatively | 1.40 Percentage of patients |
p-value: 0.8249Fisher Exact