Hypertension
Conditions
Brief summary
This study was carried out in the context of daily medical practice to compare the effectiveness of telmisartan in the treatment of hypertension complicated or not with the presence of protein in the urine, which is called albuminuria. Hypertension is a chronic, treatable but not curable disease and is defined as a combination of a systolic blood pressure of 140 mmHg or more and a diastolic pressure of 90 mmHg or more. The kidneys are often the first organs damaged by hypertension; renal damage could easily be diagnosed using a urine dipstick and should be part of a routine examination in hypertensive patient. The aim of the study is to see if the decrease of blood pressure (both systolic and diastolic) after approximately 12 weeks of treatment with telmisartan in patients with albuminuria is the same or different to that in patients without albuminuria. Every patient participating should have two visits, approximately 12 weeks apart where his/her blood pressure was checked and a few questions about is concomitant disease and drugs were asked.
Interventions
None listed
Sponsors
Boehringer Ingelheim
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Age above or equal to 18, no upper limit Patient has been treated and followed up for more than 6 months by the same general practitioner (GP) Hypertension treated for at least 3 months and not under control at the time of inclusion in the study \[systolic blood pressure (SBP) above or equal to 140 mmHg and diastolic blood pressure (DBP) above or equal to 90 mmHg, or SBP above or equal to 130 mmHg and DBP above or equal to 80 mmHg if patient has chronic renal insufficiency or diabetes\] Results available from at least two tests of albuminuria Antihypertensive treatment remained unchanged during the month prior data collection Decision by the GP to introduce telmisartan (either in combination with hydrochlorthiazide \[HCTZ\] or not) in the antihypertensive treatment (normal prescription) Written informed consent of the patient to collect his/her data
Exclusion criteria
Blood pressure under control \[SBP below 140 mmHg and DBP below 90 mmHg or SBP below 130 mmHg and DBP below 80 mmHg if patient has chronic renal insufficiency or diabetes\] The patient refuse to allow his/her data to be collected Women of childbearing potential not using an effective contraception method, as well as women who are breastfeeding Patients with proteinuria above or equal to 1g/l or with glomerular filtration rate (GFR) below 15 ml/min/1.73 m² Current or prior use of telmisartan within the last 12 months Change in the antihypertensive treatment during the month prior to collection of the data
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Controlled Blood Pressure | approximately 12 weeks (10 to 14 weeks) after baseline | Systolic blood pressure (SBP) \< 140 mmHg and diastolic blood pressure (DBP) \< 90 mmHg if the patient has: * no chronic renal insufficiency or macroalbuminuria-dipsticks negative, * albuminuria is \< 300 mg/24h or \< 200 mg albumin per gram of creatinine * no diabetes or SBP \< 130 mmHg and DBP \< 80 mmHg if the patient has: * chronic renal insufficiency or macroalbuminuria-dipsticks are positive, albuminuria ≥ 300 mg/24h or ≥ 200 mg albumin per gram of creatinine * diabetes (type 1 or 2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference in Systolic Blood Pressure | baseline and approximately 12 weeks | The fall in systolic blood pressure (SBP) after approximately 12 weeks of treatment including telmisartan defined as SBP (baseline) - SBP (12 weeks) expressed in mmHg |
| Mean Difference in Diastolic Blood Pressure | baseline and approximately 12 weeks | The fall in diastolic blood pressure (DBP) after approximately 12 weeks of treatment including telmisartan defined as DBP (baseline) - DBP (12 weeks) expressed in mmHg |
| Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders) | approximately 12 weeks (10 to 14 weeks) after baseline | The response in SBP after approximately 12 weeks of treatment including telmisartan defined as a fall in SBP (SBP (baseline) - SBP (12 weeks) ≥ 10 mmHg |
| Percentage of Patients Presenting an Adverse Event (AE) | baseline to the end of study period | Percentage of patients with any adverse events during the study period, related or not to investigational drug |
| Percentage of Patients With Positive to Negative Shift in Albuminuria | Approximately 12 weeks (10 to 14 weeks) after baseline | Percentage of patients shifting from with (positive) albuminuria at baseline to without (negative) albuminuria after approximately 12 weeks |
Countries
Belgium
Participant flow
Pre-assignment details
163 patients without information on albuminuria at baseline were enrolled to the study in addition. However, for these patients information on study completion is not available.
Participants by arm
| Arm | Count |
|---|---|
| Patients Without Albuminuria Treated With Telmisartan baseline population | 2,027 |
| Patients With Albuminuria Treated With Telmisartan baseline population | 684 |
| Total | 2,711 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 86 | 0 |
| Overall Study | no respect of the 12 weeks period | 657 | 227 |
Baseline characteristics
| Characteristic | Patients Without Albuminuria Treated With Telmisartan | Patients With Albuminuria Treated With Telmisartan | Total |
|---|---|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 11.7 | 65.9 years STANDARD_DEVIATION 11.9 | 63.8 years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 966 Participants | 329 Participants | 1295 Participants |
| Sex: Female, Male Male | 1061 Participants | 355 Participants | 1416 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 2,027 | 0 / 684 | 0 / 163 |
| serious Total, serious adverse events | 1 / 2,027 | 1 / 684 | 0 / 163 |
Outcome results
Primary
Percentage of Patients With Controlled Blood Pressure
Systolic blood pressure (SBP) \< 140 mmHg and diastolic blood pressure (DBP) \< 90 mmHg if the patient has: * no chronic renal insufficiency or macroalbuminuria-dipsticks negative, * albuminuria is \< 300 mg/24h or \< 200 mg albumin per gram of creatinine * no diabetes or SBP \< 130 mmHg and DBP \< 80 mmHg if the patient has: * chronic renal insufficiency or macroalbuminuria-dipsticks are positive, albuminuria ≥ 300 mg/24h or ≥ 200 mg albumin per gram of creatinine * diabetes (type 1 or 2)
Time frame: approximately 12 weeks (10 to 14 weeks) after baseline
Population: 1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Patients Without Albuminuria Treated With Telmisartan | Percentage of Patients With Controlled Blood Pressure | 46.1 Percentage of patients | 1.39 |
| Patients With Albuminuria Treated With Telmisartan | Percentage of Patients With Controlled Blood Pressure | 24.1 Percentage of patients | 2 |
p-value: <0.0001Chi-squared
Secondary
Mean Difference in Diastolic Blood Pressure
The fall in diastolic blood pressure (DBP) after approximately 12 weeks of treatment including telmisartan defined as DBP (baseline) - DBP (12 weeks) expressed in mmHg
Time frame: baseline and approximately 12 weeks
Population: 1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Without Albuminuria Treated With Telmisartan | Mean Difference in Diastolic Blood Pressure | 11.7 mmHg | Standard Deviation 9.22 |
| Patients With Albuminuria Treated With Telmisartan | Mean Difference in Diastolic Blood Pressure | 12.5 mmHg | Standard Deviation 8.53 |
Secondary
Mean Difference in Systolic Blood Pressure
The fall in systolic blood pressure (SBP) after approximately 12 weeks of treatment including telmisartan defined as SBP (baseline) - SBP (12 weeks) expressed in mmHg
Time frame: baseline and approximately 12 weeks
Population: 1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Without Albuminuria Treated With Telmisartan | Mean Difference in Systolic Blood Pressure | 20.8 mmHg | Standard Deviation 13.3 |
| Patients With Albuminuria Treated With Telmisartan | Mean Difference in Systolic Blood Pressure | 20.5 mmHg | Standard Deviation 13 |
Secondary
Percentage of Patients Presenting an Adverse Event (AE)
Percentage of patients with any adverse events during the study period, related or not to investigational drug
Time frame: baseline to the end of study period
Population: 1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Without Albuminuria Treated With Telmisartan | Percentage of Patients Presenting an Adverse Event (AE) | 0.7 percentage of patients |
| Patients With Albuminuria Treated With Telmisartan | Percentage of Patients Presenting an Adverse Event (AE) | 0.44 percentage of patients |
Secondary
Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders)
The response in SBP after approximately 12 weeks of treatment including telmisartan defined as a fall in SBP (SBP (baseline) - SBP (12 weeks) ≥ 10 mmHg
Time frame: approximately 12 weeks (10 to 14 weeks) after baseline
Population: 1741 patients had a visit 2 between 10 and 14 weeks after baseline (1284+457)
| Arm | Measure | Value (NUMBER) | Dispersion |
|---|---|---|---|
| Patients Without Albuminuria Treated With Telmisartan | Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders) | 87.7 Percentage of patients | 0.92 |
| Patients With Albuminuria Treated With Telmisartan | Percentage of Patients With a Decrease of Systolic Blood Pressure (SBP) ≥ 10 mmHg (Responders) | 88.6 Percentage of patients | 1.49 |
Secondary
Percentage of Patients With Positive to Negative Shift in Albuminuria
Percentage of patients shifting from with (positive) albuminuria at baseline to without (negative) albuminuria after approximately 12 weeks
Time frame: Approximately 12 weeks (10 to 14 weeks) after baseline
Population: All patients with albuminuria at initial visit and for which information on albuminuria was known at visit 2, 12 weeks after the initial visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients Without Albuminuria Treated With Telmisartan | Percentage of Patients With Positive to Negative Shift in Albuminuria | 53.8 Percentage of patients |