Hypertension
Conditions
Brief summary
The primary objective of this post marketing survey is to prospectively investigate patients with hypertension treated with Micardis Tablets (hereinafter this drug) in routine clinical settings for 3 years in order to determine the following: 1. Adverse events and adverse drug reactions under long-term use 2. Blood pressure measurements during the survey period 3. Determination of the incidence of cerebrovascular and cardiovascular events under use of this drug in routine clinical settings 4. Patient's lifestyle and background factors that are considered to affect the occurrence of cerebrovascular and cardiovascular events
Interventions
DRUGTelmisartan
Oral administration
Sponsors
Boehringer Ingelheim
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Hypertension patients unadministered Micardis.
Exclusion criteria
1. Patients with a history of hypersensitivity to any ingredient of this product. 2. Pregnant woman or possibly pregnant woman 3. Patients with extremely poor bile secretion or patients with serious hepatic disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events | 3 years after initiation of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline in Diastolic Blood Pressure at 6 Months | initiation and 6 months |
| Change From Baseline in Systolic Blood Pressure at 12 Months | initiation and 12 months |
| Change From Baseline in Diastolic Blood Pressure at 12 Months | initiation and 12 months |
| Change From Baseline in Systolic Blood Pressure at 6 Months | initiation and 6 months |
| Change From Baseline in Diastolic Blood Pressure at 24 Months | initiation and 24 months |
| Change From Baseline in Systolic Blood Pressure at 36 Months | initiation and 36 months |
| Change From Baseline in Diastolic Blood Pressure at 36 Months | initiation and 36 months |
| Change From Baseline in Systolic Blood Pressure at 24 Months | initiation and 24 months |
Participant flow
Pre-assignment details
In the survey, 21,433 patients were enrolled. The data of 439 patients have not reported after the registration, and 551 patients were not observed after the registration: 38 entry violation, 24 contract violation, 493 no office visit after initial prescription and 9 undefined study medication (the numbers were overlapping).
Participants by arm
| Arm | Count |
|---|---|
| Telmisartan | 20,443 |
| Total | 20,443 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1,006 |
| Overall Study | Lack of Efficacy | 1,183 |
| Overall Study | Other | 6,393 |
Baseline characteristics
| Characteristic | Telmisartan |
|---|---|
| Age, Continuous | 64.6 years old STANDARD_DEVIATION 12 |
| Sex: Female, Male Female | 10278 Participants |
| Sex: Female, Male Male | 10165 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20,443 |
| serious Total, serious adverse events | 1,058 / 20,443 |
Outcome results
Primary
Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events
Time frame: 3 years after initiation of treatment
Population: All of observed 20,443 patients were included as intention to treat set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan | Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events | Number of patients with CeV and CaV events | 479 Number of participants |
| Telmisartan | Number of Patients With Cerebrovascular(CeV) and Cardiovascular (CaV) Events | Number of patients with no CeV and CaV events | 19964 Number of participants |
Secondary
Change From Baseline in Diastolic Blood Pressure at 12 Months
Time frame: initiation and 12 months
Population: The 4400 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 12 months were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan | Change From Baseline in Diastolic Blood Pressure at 12 Months | -11.3 mmHg | Standard Deviation 12.8 |
Secondary
Change From Baseline in Diastolic Blood Pressure at 24 Months
Time frame: initiation and 24 months
Population: The 6544 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 24 months were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan | Change From Baseline in Diastolic Blood Pressure at 24 Months | -12.3 mmHg | Standard Deviation 12.8 |
Secondary
Change From Baseline in Diastolic Blood Pressure at 36 Months
Time frame: initiation and 36 months
Population: The 8270 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 36 months were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan | Change From Baseline in Diastolic Blood Pressure at 36 Months | -13.1 mmHg | Standard Deviation 13 |
Secondary
Change From Baseline in Diastolic Blood Pressure at 6 Months
Time frame: initiation and 6 months
Population: The 2506 patients with insufficient study medication adherence, no measured diastolic blood pressure in the period, or discontinued before 6 months were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan | Change From Baseline in Diastolic Blood Pressure at 6 Months | -10.3 mmHg | Standard Deviation 12.5 |
Secondary
Change From Baseline in Systolic Blood Pressure at 12 Months
Time frame: initiation and 12 months
Population: The 4400 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 12 months were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan | Change From Baseline in Systolic Blood Pressure at 12 Months | -22.2 mmHg | Standard Deviation 19.9 |
Secondary
Change From Baseline in Systolic Blood Pressure at 24 Months
Time frame: initiation and 24 months
Population: The 6544 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 24 months were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan | Change From Baseline in Systolic Blood Pressure at 24 Months | -23.9 mmHg | Standard Deviation 20.2 |
Secondary
Change From Baseline in Systolic Blood Pressure at 36 Months
Time frame: initiation and 36 months
Population: The 8267 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 36 months were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan | Change From Baseline in Systolic Blood Pressure at 36 Months | -25.0 mmHg | Standard Deviation 19.9 |
Secondary
Change From Baseline in Systolic Blood Pressure at 6 Months
Time frame: initiation and 6 months
Population: The 2503 patients with insufficient study medication adherence, no measured systolic blood pressure in the period, or discontinued before 6 months were excluded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan | Change From Baseline in Systolic Blood Pressure at 6 Months | -20.6 mmHg | Standard Deviation 19.9 |