| pathology | Benefit (demonstrated or suggested) and harm | | | |
|---|
| heart failure | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| REPLACE, 2001 | vs enalapril | | | |
| Trial | Treatments | Patients | Method |
|---|
| REPLACE, 2001 | Telmisartan, 10 mg, 20mg, 40mg, 80mg daily (n=301) vs. Enalapril, 10 mg twice daily (n=77) | ambulatory patients at least 21 years of age, in sinus rhythm, with chronic moderatesymptomatic heart failure (New York Heart Associatality.tion class II–III) and a left ventricular ejection fraction of 40% or lower | Double blind Parallel groups Sample size: 301/77 Primary endpoint: exercise test durationge FU duration: 12 wk |
|
| hypertension | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ONTARGET/Tel, 2008 | vs Ramipril | | | all-cause mortality 0.98 [0.90; 1.06] cardiovascular mortality 1.00 [0.89; 1.11] stroke 0.91 [0.80; 1.05] MI 1.07 [0.94; 1.22] | | DETAIL, 2004 | vs Ramipril | | | all-cause mortality 1.08 [0.36; 3.27] cardiovascular mortality 1.63 [0.28; 9.56] stroke 1.08 [0.36; 3.27] MI 1.63 [0.60; 4.43] | | PROPHESS, 2008 | vs Ramipril | | | cardiovascular death 0.85 [0.71; 1.02] cancer occurence 0.96 [0.83; 1.12] all cause death 1.02 [0.93; 1.13] Cardiovascular death 0.85 [0.71; 1.02] cancer 0.96 [0.83; 1.12] stroke (fatal and non fatal) 0.95 [0.87; 1.03] Myocardial infarction ( fatal and non fatal) 1.00 [0.81; 1.23] cardiovascular event 0.94 [0.88; 1.01] New onset diabetes 0.83 [0.66; 1.05] lung cancer 1.24 [0.77; 2.00] | | Cice et al, 2006 | vs Ramipril | all cause mortality 0.71 [0.53; 0.95] | | Cardiovascular mortality 0.79 [0.61; 1.02] cardiovascular event 0.79 [0.61; 1.02] |
| Trial | Treatments | Patients | Method |
|---|
| ONTARGET/Tel, 2008 | Telmisartan 80 mg daily (n=8542) vs. Ramipril 10 mg daily (n=8576) | patients with vascular disease or high-risk diabetes | double-blind Parallel groups Sample size: 8542/8576 Primary endpoint: Cv events or hospitalization FU duration: 4.7 y | | DETAIL, 2004 | Telmisartan 80 mg daily (n=120) vs. Enalapril 20 mg daily (n=130) | pateintspatients with type 2 diabetes and early nephropathy | double-blind Parallel groups Sample size: 120/130 Primary endpoint: glomerular filtration rate FU duration: 5 y | | PROPHESS, 2008 | telmisartan 80 mg daily (n=10146) vs. placebo (n=10186) | patients who recently had an ischemic stroke | double blind Factorial plan Sample size: 10146/10186 Primary endpoint: recurrent stroke FU duration: 2.5 y | | Cice et al, 2006 | Telmisartan 80 mg/day (n=151) vs. matched placebo (n=152) | | Sample size: 151/152 Primary endpoint: FU duration: |
|
| miscellaneous | All results are NS for efficacy inferior to ramipril in terms of hypotension in ONTARGET (telmisartan alone), 2008 | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ONTARGET (telmisartan alone), 2008 | vs ramipril | Toux 0.26 [0.21; 0.33] Arrêt pour effet secondaire 0.94 [0.89; 0.99] Angiodème 0.40 [0.19; 0.84] | hypotension 1.54 [1.26; 1.89] | Crit principaux 1.01 [0.95; 1.08] nouveau diabète 1.09 [0.95; 1.26] Insuffisance rénale 1.14 [0.81; 1.61] Mortalité totale 0.98 [0.90; 1.06] Ev. coronariens 1.07 [0.94; 1.22] Décès cardiovasculaires 1.00 [0.89; 1.11] revascularisation 1.02 [0.95; 1.10] AVC mortels et non mortels 0.91 [0.80; 1.05] Ev. cardiovasculaires 0.99 [0.92; 1.06] | | TRANSCEND, 2008 | vs ramipril | Ev. cardiovasculaires 0.88 [0.77; 1.00] HOPE endpoint 0.88 [0.77; 1.00] | | cancer occurence 1.16 [0.97; 1.39] cancer occurence (as prespecified endpoint) 1.16 [0.97; 1.39] Crit principaux 0.93 [0.83; 1.04] Insuffisance rénale 1.86 [0.95; 3.64] Mortalité totale 1.05 [0.91; 1.20] Ev. coronariens 0.79 [0.63; 1.01] Décès cardiovasculaires 1.02 [0.86; 1.22] revascularisation 0.90 [0.79; 1.03] AVC mortels et non mortels 0.83 [0.65; 1.06] Toux 0.84 [0.42; 1.66] hypotension 1.82 [0.99; 3.35] Arrêt pour effet secondaire 0.91 [0.83; 1.00] Angiodème 0.67 [0.11; 4.01] | | PROPHESS, 2008 | vs ramipril | | | cardiovascular death 0.85 [0.71; 1.02] cancer occurence 0.96 [0.83; 1.12] all cause death 1.02 [0.93; 1.13] Cardiovascular death 0.85 [0.71; 1.02] cancer 0.96 [0.83; 1.12] stroke (fatal and non fatal) 0.95 [0.87; 1.03] Myocardial infarction ( fatal and non fatal) 1.00 [0.81; 1.23] cardiovascular event 0.94 [0.88; 1.01] New onset diabetes 0.83 [0.66; 1.05] lung cancer 1.24 [0.77; 2.00] |
| Trial | Treatments | Patients | Method |
|---|
| ONTARGET (telmisartan alone), 2008 | telmisartan 80mg daily (n=8542) vs. ramipril 10 mg daily (n=8576) | patients patients with coronary, peripheral, or cerebrovascular disease or diabetes with end-organ damage | double blind Parallel groups Sample size: 8542/8576 Primary endpoint: cardiovascular events or hospitalization for HF FU duration: 4.7y | | TRANSCEND, 2008 | telmisartan 80 mg/day (n=2954) vs. placebo (n=2972) | high-risk patients intolerant to
angiotensin-converting enzyme inhibitors | double blind Parallel groups Sample size: 2954/2972 Primary endpoint: CV death, MI, stroke, hospitalization for HF FU duration: median 56 months (IQR 51-64) | | PROPHESS, 2008 | telmisartan 80 mg daily (n=10146) vs. placebo (n=10186) | patients who recently had an ischemic stroke | double blind Factorial plan Sample size: 10146/10186 Primary endpoint: recurrent stroke FU duration: 2.5 y |
|
| patients at high risk for cardiovascular events | All results are NS for efficacy inferior to ramipril in terms of hypotension in ONTARGET (telmisartan alone), 2008 | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ONTARGET (telmisartan alone), 2008 | vs ramipril | Toux 0.26 [0.21; 0.33] Arrêt pour effet secondaire 0.94 [0.89; 0.99] Angiodème 0.40 [0.19; 0.84] | hypotension 1.54 [1.26; 1.89] | Crit principaux 1.01 [0.95; 1.08] nouveau diabète 1.09 [0.95; 1.26] Insuffisance rénale 1.14 [0.81; 1.61] Mortalité totale 0.98 [0.90; 1.06] Ev. coronariens 1.07 [0.94; 1.22] Décès cardiovasculaires 1.00 [0.89; 1.11] revascularisation 1.02 [0.95; 1.10] AVC mortels et non mortels 0.91 [0.80; 1.05] Ev. cardiovasculaires 0.99 [0.92; 1.06] | | TRANSCEND, 2008 | vs ramipril | Ev. cardiovasculaires 0.88 [0.77; 1.00] HOPE endpoint 0.88 [0.77; 1.00] | | cancer occurence 1.16 [0.97; 1.39] cancer occurence (as prespecified endpoint) 1.16 [0.97; 1.39] Crit principaux 0.93 [0.83; 1.04] Insuffisance rénale 1.86 [0.95; 3.64] Mortalité totale 1.05 [0.91; 1.20] Ev. coronariens 0.79 [0.63; 1.01] Décès cardiovasculaires 1.02 [0.86; 1.22] revascularisation 0.90 [0.79; 1.03] AVC mortels et non mortels 0.83 [0.65; 1.06] Toux 0.84 [0.42; 1.66] hypotension 1.82 [0.99; 3.35] Arrêt pour effet secondaire 0.91 [0.83; 1.00] Angiodème 0.67 [0.11; 4.01] | | PROPHESS, 2008 | vs ramipril | | | cardiovascular death 0.85 [0.71; 1.02] cancer occurence 0.96 [0.83; 1.12] all cause death 1.02 [0.93; 1.13] Cardiovascular death 0.85 [0.71; 1.02] cancer 0.96 [0.83; 1.12] stroke (fatal and non fatal) 0.95 [0.87; 1.03] Myocardial infarction ( fatal and non fatal) 1.00 [0.81; 1.23] cardiovascular event 0.94 [0.88; 1.01] New onset diabetes 0.83 [0.66; 1.05] lung cancer 1.24 [0.77; 2.00] |
| Trial | Treatments | Patients | Method |
|---|
| ONTARGET (telmisartan alone), 2008 | telmisartan 80mg daily (n=8542) vs. ramipril 10 mg daily (n=8576) | patients patients with coronary, peripheral, or cerebrovascular disease or diabetes with end-organ damage | double blind Parallel groups Sample size: 8542/8576 Primary endpoint: cardiovascular events or hospitalization for HF FU duration: 4.7y | | TRANSCEND, 2008 | telmisartan 80 mg/day (n=2954) vs. placebo (n=2972) | high-risk patients intolerant to
angiotensin-converting enzyme inhibitors | double blind Parallel groups Sample size: 2954/2972 Primary endpoint: CV death, MI, stroke, hospitalization for HF FU duration: median 56 months (IQR 51-64) | | PROPHESS, 2008 | telmisartan 80 mg daily (n=10146) vs. placebo (n=10186) | patients who recently had an ischemic stroke | double blind Factorial plan Sample size: 10146/10186 Primary endpoint: recurrent stroke FU duration: 2.5 y |
|
| post stroke | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| PROFESS, 2008 | telmisartan 80 mg/d (n=-9) vs. placebo (n=-9) | | Sample size: -9/-9 Primary endpoint: FU duration: |
|
