Hypertension
Conditions
Brief summary
It is a national, retrospective , observational study in hypertensive patients treated for at least 8 weeks with the fixed dose combination of telmisartan 80 mg and hydrochlorothiazide 25 mg. The primary objective is to assess the control rate (systolic and diastolic blood pressure). Key secondary objectives are to assess the blood pressure reduction after at least 8 weeks of treatment, describe the population treated with this new fixed dose combination
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Hypertensives * Treated for at least 8 weeks with the fixed dose combination of telmisartan 80 mg and hydrochlorothiazide 25 mg
Exclusion criteria
\- Treated with the combination less than 8 weeks
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of BP Control in Hypertensive Patients | Baseline to a minimum of 8 weeks of treatment | Percentage of controlled Patients at the Study End. Control rate of hypertension in general practice and in cardiology defined as systolic blood pressure (SBP) and diastolic blood pressure (DBP) \<140/90 mmHg for unselected hypertensive patients and SBP and DBP \<130/80 mmHg for hypertensive patients at high cardiovascular risk (patients with diabetes and patients with impaired renal function) as defined in the recommendations of the French National Health Authority (HAS) 2005 guidelines. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population | baseline to a minimum of 8 weeks of treatment | Mean SBP measured at the Study End |
| Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population | baseline to a minimum of 8 weeks of treatment | Mean DBP measured at the Study End |
| Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk | baseline to a minimum of 8 weeks of treatment | Mean SBP measured at the Study End |
| Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk | baseline to a minimum of 8 weeks of treatment | Mean DBP measured at the Study End |
| Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007 | Baseline to a minimum of 8 weeks of treatment | The proportion of patients with blood pressure (BP) control, per risk factor. High risk factors determined according to the recommendations of the ESH/ESC 2007. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg Patients treated at least 8 weeks with Fixed Dose Combination (FDC) | 1,994 |
| Total | 1,994 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Non-evaluable Subjects | 230 |
| Overall Study | Protocol Violation | 187 |
Baseline characteristics
| Characteristic | Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg |
|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 10.6 |
| Cardiovascular risk factors (including the existence of a metabolic syndrome) Age (male>50 or female>60) | 82.0 Percentage of participants |
| Cardiovascular risk factors (including the existence of a metabolic syndrome) Diabetes | 54.3 Percentage of participants |
| Cardiovascular risk factors (including the existence of a metabolic syndrome) Family History | 28.9 Percentage of participants |
| Cardiovascular risk factors (including the existence of a metabolic syndrome) HDL-Cholesterol ≤ 0.4 g/L | 20.5 Percentage of participants |
| Cardiovascular risk factors (including the existence of a metabolic syndrome) LDL-Cholesterol ≥ 1.6 g/L | 72.4 Percentage of participants |
| Cardiovascular risk factors (including the existence of a metabolic syndrome) Smoking | 23.9 Percentage of participants |
| Conditions for prescribing 80 mg telmisartan in fixed combination with 25 mg HCTZ Lack of efficacy | 53.8 Percentage of participants |
| Conditions for prescribing 80 mg telmisartan in fixed combination with 25 mg HCTZ To decrease the number of treatment | 33.1 Percentage of participants |
| Hypertension treatments prescribed prior to initiation of treatment Angiotensin II antagonist | 71.8 Percentage of participants |
| Hypertension treatments prescribed prior to initiation of treatment Beta-blocker | 20.5 Percentage of participants |
| Hypertension treatments prescribed prior to initiation of treatment Calcium channel blocker | 23.3 Percentage of participants |
| Hypertension treatments prescribed prior to initiation of treatment Diuretic | 64.3 Percentage of participants |
| Sex: Female, Male Female | 835 Participants |
| Sex: Female, Male Male | 1159 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 1,994 |
| serious Total, serious adverse events | 0 / 1,994 |
Outcome results
Primary
Rate of BP Control in Hypertensive Patients
Percentage of controlled Patients at the Study End. Control rate of hypertension in general practice and in cardiology defined as systolic blood pressure (SBP) and diastolic blood pressure (DBP) \<140/90 mmHg for unselected hypertensive patients and SBP and DBP \<130/80 mmHg for hypertensive patients at high cardiovascular risk (patients with diabetes and patients with impaired renal function) as defined in the recommendations of the French National Health Authority (HAS) 2005 guidelines.
Time frame: Baseline to a minimum of 8 weeks of treatment
Population: Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg | Rate of BP Control in Hypertensive Patients | 51.3 Percentage of Participants |
Secondary
Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population
Mean DBP measured at the Study End
Time frame: baseline to a minimum of 8 weeks of treatment
Population: Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg | Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Overall Study Population | 80.1 mm Hg | Standard Deviation 7.2 |
Secondary
Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk
Mean DBP measured at the Study End
Time frame: baseline to a minimum of 8 weeks of treatment
Population: Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg | Diastolic Blood Pressure (DBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk | 82.9 mmHg | Standard Deviation 7.2 |
Secondary
Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007
The proportion of patients with blood pressure (BP) control, per risk factor. High risk factors determined according to the recommendations of the ESH/ESC 2007.
Time frame: Baseline to a minimum of 8 weeks of treatment
Population: Per protocol set (PPS)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg | Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007 | Age >60 years | 51.9 percentage of patients |
| Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg | Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007 | Diabetes | 5.0 percentage of patients |
| Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg | Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007 | Renal Failure | 3.8 percentage of patients |
| Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg | Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007 | History of TIA/CVA | 3.9 percentage of patients |
| Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg | Rate of BP Control by Risk Factor According to the Recommendations ESH/ESC 2007 | Coronary Chronic Disease | 8.3 percentage of patients |
Secondary
Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population
Mean SBP measured at the Study End
Time frame: baseline to a minimum of 8 weeks of treatment
Population: Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg | Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Overall Study Population | 137.3 mm Hg | Standard Deviation 9.6 |
Secondary
Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk
Mean SBP measured at the Study End
Time frame: baseline to a minimum of 8 weeks of treatment
Population: Descriptive statistical analysis was performed for the entire study population on the FAS in intention-to-treat (ITT) as well as on the Per protocol set (PPS) in per protocol (PP). The difference between the numbers of patients was inferior than 10% ; the results of the primary objective was presented in PPS.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg | Systolic Blood Pressure (SBP) After at Least 8 Weeks of Treatment in Population at High Cardiovascular Risk | 144.3 mmHg | Standard Deviation 7.9 |