| pathology | Demonstrated benefit and harm | k | | | |
|---|
| acute myocardial infarction | versus No demonstrated result for efficacy Losartan inferior to Captopril in terms of Cardiovascular death in OPTIMAAL, 2002 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| OPTIMAAL, 2002 | Losartan vs Captopril | Angioedema 0.28 [0.09; 0.86] | Cardiovascular death 1.15 [1.01; 1.31] | cancer death 1.00 [0.65; 1.52] Hypotension 0.77 [0.53; 1.12] |
| Trial | Treatments | Patients | Method |
|---|
| OPTIMAAL, 2002 | Losartan, target dose of 50 mg daily (n=2744) vs. Captopril, traget dose of 50 mg 3 times daily (n=2733) | patients within 10 days of a confirmed acute myocardial
infarction and heart failure during the acute phase or a new
Q-wave anterior infarction or reinfarction | Double blind Parallel groups Sample size: 2744/2733 Primary endpoint: all-cause mortality FU duration: 2.7 y |
|
| atrial fibrillation | versus beta-blockers No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| LIFE (AF ancillary study), 2005 | losartan vs atenolol | AF 0.66 [0.54; 0.81] | | |
| Trial | Treatments | Patients | Method |
|---|
| LIFE (AF ancillary study), 2005 | losartan (n=4298) vs. atenolol (n=4182) | hypertension | Sample size: 4298/4182 Primary endpoint: FU duration: 4.8 y |
|
| diabetes type 2 | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| RENAAL, 2001 | losartan vs placebo | microvascular events 0.79 [0.66; 0.95] | | All deaths 1.02 [0.80; 1.30] |
| Trial | Treatments | Patients | Method |
|---|
| RENAAL, 2001 | losartan 50 to 100 mg once daily (n=751) vs. placebo (n=762) | patients with type 2 diabetes and nephropathy | double-blind Parallel groups Sample size: 751/762 Primary endpoint: doubling of the creatinine, end-stage renal disease, death FU duration: 3.4 y |
|
| diabetes type 2 | versus beta-blockers No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| LIFE (diabetic subgroup), 2002 | losartan vs atenolol | All deaths 0.61 [0.45; 0.83] Cardiovascular death 0.65 [0.44; 0.96] Cardiovascular events 0.76 [0.58; 0.99] | | Stroke 0.82 [0.58; 1.16] Fatal and nonfatal MI 0.85 [0.57; 1.27] |
| Trial | Treatments | Patients | Method |
|---|
| LIFE (diabetic subgroup), 2002 | losartan 50mg daily at step 1 (n=586) vs. atenolol 50mg daily at step 1 (n=609) | patients with diabetes (subgroup) , hypertension, and signs of left-ventricular hypertrophy on electrocardiograms of all 9193 patients included in the trial, 1195 had diabetes | double-blind Parallel groups Sample size: 586/609 Primary endpoint: CV events FU duration: 4.7 years |
|
| diabetic kidney disease | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| RENAAL, 2001 | losartan vs placebo | microvascular events 0.79 [0.66; 0.95] | | All deaths 1.02 [0.80; 1.30] |
| Trial | Treatments | Patients | Method |
|---|
| RENAAL, 2001 | losartan 50 to 100 mg once daily (n=751) vs. placebo (n=762) | patients with type 2 diabetes and nephropathy | double-blind Parallel groups Sample size: 751/762 Primary endpoint: doubling of the creatinine, end-stage renal disease, death FU duration: 3.4 y |
|
| heart failure | versus angiotensin receptor blocker No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| HEAAL, 2009 | losartan 150mg vs losartan 50mg | all cause death or hospital admission 0.90 [0.82; 0.99] hospital admission for heart failure 0.87 [0.77; 0.99] | | all cause death 0.94 [0.84; 1.05] Adverse effect leading to treatment discontinuation 1.11 [0.88; 1.39] Hypotension 1.18 [0.61; 2.29] Angioedema ∞ [NaN; ∞] Hyperkalaemia 2.24 [0.69; 7.26] death or CV hospitalization 0.92 [0.84; 1.00] Increase in creatinine 1.33 [0.87; 2.04] |
| Trial | Treatments | Patients | Method |
|---|
| HEAAL, 2009 | losartan 150mg daily (n=1921) vs. losartan 50 mg daily (n=1913) | patients with systolic heart failure who couldn't tolerate ACE inhibitors | double blind Parallel groups Sample size: 1921/1913 Primary endpoint: death, admission for heart failure FU duration: 4.7 y (median) |
|
| heart failure | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Losartan Phase III International, 1996 | losartan vs placebo | all cause death 0.17 [0.05; 0.62] | | | | Losartan Phase III U.S., 1995 | losartan vs placebo | | | all cause death 0.48 [0.12; 1.89] |
| Trial | Treatments | Patients | Method |
|---|
| Losartan Phase III International, 1996 | Losartan, 50 mg daily (n=254) vs. Placebo (n=131) | patients with heart failure who had never received ACE inibitors or who had discontinued ACE inhibitors | double blind Parallel groups Sample size: 254/131 Primary endpoint: Exercise FU duration: 12 wk | | Losartan Phase III U.S., 1995 | Losartan, 50 mg daily (n=237) vs. Placebo (n=114) | patients with heart failure who had never received ACE inibitors or who had discontinued ACE inhibitors | double blind Parallel groups Sample size: 237/114 Primary endpoint: Exercise FU duration: 12 wk |
|
| heart failure | versus angiotensin-converting enzyme inhibitors No demonstrated result for efficacy | 7 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Dickstein et al., 1995 | losartan vs enalapril | | | | | ELITE, 1997 | losartan vs captopril | | | Cardiovascular death 0.53 [0.27; 1.03] Hypotension 1.68 [0.56; 5.09] Angioedema 0.00 [0.00; NaN] Hyperkalaemia 0.35 [0.07; 1.72] Increase in creatinine 1.00 [0.65; 1.53] | | ELITE II, 2000 | losartan vs captopril | | | | | Hamroff et al., 1999 | losartan+ACE inhibitor vs ACE inhibitor only | | | | | Lang et al., 1997 | losartan vs enalapril | | | | | Losartan phase II S, 1996 | losartan vs enalapril | | | | | losartan phase II US, 1996 | losartan vs enalapril | | | |
| Trial | Treatments | Patients | Method |
|---|
| Dickstein et al., 1995 | Losartan, 25 mg, 50mg daily (n=108) vs. Enalapril, 10 mg twice daily (n=58) | patients with moderate or severe chronic heart failure in New York Heart Association functional class III or IV and an ejection fraction < or = 35% | double blind Parallel groups Sample size: 108/58 Primary endpoint: clinical status and exercise performance FU duration: 8 wk | | ELITE, 1997 | Losartan titrated to 50 mg once daily (n=352) vs. Captopril,titratedto 50 mg three times daily (n=370) | ACE inhibitor naive patients (aged 65 years or more) with New York HeartAssociation (NYHA) class II–IV heart failure and ejection fractions of 40% or less | Double blind Parallel groups Sample size: 352/370 Primary endpoint: tolerability measure of a persist ing FU duration: 48 wk | | ELITE II, 2000 | Losartan, target dose 50 mg daily (n=1578) vs. Captopril, target dose 50 mg 3 times daily (n=1574) | patients aged 60 years or older with New York Heart Association class II–IV heart failure and ejection fraction of 40% or less. | Double blind Parallel groups Sample size: 1578/1574 Primary endpoint: All-cause mortalityur=na FU duration: median 1.5y | | Hamroff et al., 1999 | Losartan, 50 mg daily (plus ACE inhibitor) (n=16) vs. Placebo (plus ACE inhibitor) (n=17) | patients with severe congestive heart failure (NYHA III-IV) despite treatment with maximally recommended or tolerated doses of ACE inhibitors | double blind Parallel groups Sample size: 16/17 Primary endpoint: exercise capacity FU duration: 6 mo | | Lang et al., 1997 | Losartan titrated to 25 mg ou 50 mg daily (n=78) vs. Enalapril, titrated to 10 mg twice daily (n=38) Three arms: losartan 25mg/d, losaratan 50mg/d and enalapril 20mg/d. The 2 losartan group has been pooled | patients with congestive heart failure (New York Heart Association functionalclasses II to IV) and left ventricular ejection fraction <= 45%previously treated with stable doses of ACE inhibitors and diureticagents, with or without concurrent digitalis and othervasodilators | Double blind Parallel groups Sample size: 78/38 Primary endpoint: maximal treadmill FU duration: 12 wk | | Losartan phase II S, 1996 | losartan 50 or 25 mg/d (n=108) vs. enalapril 10mg twice daily (n=58) | patient with heart failure | double blind Parallel groups Sample size: 108/58 Primary endpoint: exercise FU duration: 8 weeks | | losartan phase II US, 1996 | losartan 25 and 50 mg/d (n=78) vs. enalapril 10mg twice daily (n=38) | patients with heart failure | double blind Parallel groups Sample size: 78/38 Primary endpoint: exercise FU duration: 12 weeks |
|
| hypertension | versus placebo or control No demonstrated result for efficacy | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| RENAAL, 2001 | losartan vs placebo | microvascular events 0.79 [0.66; 0.95] | | All deaths 1.02 [0.80; 1.30] | | RENAAL, 2001 | losartan vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| RENAAL, 2001 | losartan 50 to 100 mg once daily (n=751) vs. placebo (n=762) | patients with type 2 diabetes and nephropathy | double-blind Parallel groups Sample size: 751/762 Primary endpoint: doubling of the creatinine, end-stage renal disease, death FU duration: 3.4 y | | RENAAL, 2001 | lLosartan 50 to 100 mg once daily (n=751) vs. placebo (n=762) | patients with type 2 diabetes and nephropathy | double-blind Parallel groups Sample size: 751/762 Primary endpoint: doubling of the base-line serum creatinine concentration, end-stage renal disease, or death FU duration: 3.4 years |
|
| hypertension | versus ACEIs No demonstrated result for efficacy Losartan inferior to Captopril in terms of cardiovascular mortality in OPTIMAAL, 2001 | 3 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ELITE, 1997 | Losartan vs Captopril | all-cause mortality 0.56 [0.32; 0.99] | | cardiovascular mortality 0.53 [0.27; 1.03] stroke 1.40 [0.32; 6.22] MI 0.79 [0.18; 3.50] | | ELITE-II, 2000 | Losartan vs Captopril | | | all-cause mortality 1.12 [0.96; 1.31] cardiovascular mortality 1.15 [0.97; 1.38] stroke 1.63 [0.77; 3.44] MI 1.10 [0.67; 1.83] | | OPTIMAAL, 2001 | Losartan vs Captopril | | cardiovascular mortality 1.15 [1.01; 1.31] | all-cause mortality 1.11 [0.99; 1.25] stroke 1.06 [0.84; 1.33] MI 1.01 [0.88; 1.15] |
| Trial | Treatments | Patients | Method |
|---|
| ELITE, 1997 | Losartan titrated to 50 mg once daily for 48 weeks (n=352) vs. Captopril titrated to 50 mg three times daily for 48 weeks (n=370) | naive patients (aged 65 years or more) with NYHA class II-IV heart failure and ejection fractions of 40% or less | double-blind Parallel groups Sample size: 352/370 Primary endpoint: persisting increase in serum creatinine of 26.5 mumol/L or more FU duration: 1 y | | ELITE-II, 2000 | Losartan titrated to 50 mg once daily (n=1578) vs. Captopril titrated to 50 mg three times daily (n=1574) | patients aged 60 years or older with New York Heart Association class II-IV heart failure and ejection fraction of 40% or less. Patients | double-blind Parallel groups Sample size: 1578/1574 Primary endpoint: all cause death FU duration: 1.5 y | | OPTIMAAL, 2001 | losartan (titrated to 50 mg once daily) (n=2744) vs. Captopril (titrated to 50 mg three times daily) (n=2733) | patients 50 years of age or older, with confirmed acute myocardial infarction and heart failure during the acute phase or a new Q-wave anterior infarction or reinfarction | NA Parallel groups Sample size: 2744/2733 Primary endpoint: all cause death FU duration: 2.7 y |
|
| hypertension | versus beta-blockers No demonstrated result for efficacy losartan inferior to atenolol in terms of PAD inférieure à 90 in LIFE, 2002 losartan inferior to atenolol in terms of lung cancer in LIFE, 2002 | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| LIFE, 2002 | losartan vs atenolol | apparition d'un premier évènement cardiovasculaire 0.86 [0.77; 0.96] PAS inférieure à 140 1.08 [1.03; 1.12] PA inférieure à140/90 1.07 [1.02; 1.11] stroke (fatal and non fatal) 0.75 [0.63; 0.88] cardiovascular event 0.86 [0.77; 0.96] New onset diabetes 0.75 [0.64; 0.89] | PAD inférieure à 90 0.98 [0.97; 1.00] lung cancer 2.41 [1.23; 4.71] | cardiovascular death 0.87 [0.72; 1.04] cancer occurence(prespecified endpoint) 1.11 [0.96; 1.29] cancer occurence 1.11 [0.96; 1.29] all cause death 0.89 [0.78; 1.01] coronary event 1.05 [0.86; 1.28] Cardiovascular death 0.87 [0.72; 1.04] Heart failure 0.95 [0.76; 1.18] cancer 1.11 [0.96; 1.29] Myocardial infarction ( fatal and non fatal) 1.05 [0.86; 1.28] cancer death 1.03 [0.80; 1.34] | | LIFE (diabetic subgroup), 2002 | losartan vs atenolol | All deaths 0.61 [0.45; 0.83] Cardiovascular death 0.65 [0.44; 0.96] Cardiovascular events 0.76 [0.58; 0.99] | | Stroke 0.82 [0.58; 1.16] Fatal and nonfatal MI 0.85 [0.57; 1.27] |
| Trial | Treatments | Patients | Method |
|---|
| LIFE, 2002 | losartan (n=4605) vs. atenolol (n=4588) | patients aged 55–80 years, with previously treated or untreated hypertension (sitting blood pressure 160–200/95–115 mm Hg) and ECG signs of LVH. | Double blind Parallel groups Sample size: 4605/4588 Primary endpoint: Cardiovascular mortality, stroke, and myocardial infarction FU duration: 4.8 y (mean) | | LIFE (diabetic subgroup), 2002 | losartan 50mg daily at step 1 (n=586) vs. atenolol 50mg daily at step 1 (n=609) | patients with diabetes (subgroup) , hypertension, and signs of left-ventricular hypertrophy on electrocardiograms of all 9193 patients included in the trial, 1195 had diabetes | double-blind Parallel groups Sample size: 586/609 Primary endpoint: CV events FU duration: 4.7 years |
|
| miscellaneous | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| RENAAL, 2001 | losartan vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| RENAAL, 2001 | lLosartan 50 to 100 mg once daily (n=751) vs. placebo (n=762) | patients with type 2 diabetes and nephropathy | double-blind Parallel groups Sample size: 751/762 Primary endpoint: doubling of the base-line serum creatinine concentration, end-stage renal disease, or death FU duration: 3.4 years |
|
| miscellaneous | versus beta-blockers No demonstrated result for efficacy losartan inferior to atenolol in terms of PAD inférieure à 90 in LIFE, 2002 losartan inferior to atenolol in terms of lung cancer in LIFE, 2002 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| LIFE, 2002 | losartan vs atenolol | apparition d'un premier évènement cardiovasculaire 0.86 [0.77; 0.96] PAS inférieure à 140 1.08 [1.03; 1.12] PA inférieure à140/90 1.07 [1.02; 1.11] stroke (fatal and non fatal) 0.75 [0.63; 0.88] cardiovascular event 0.86 [0.77; 0.96] New onset diabetes 0.75 [0.64; 0.89] | PAD inférieure à 90 0.98 [0.97; 1.00] lung cancer 2.41 [1.23; 4.71] | cardiovascular death 0.87 [0.72; 1.04] cancer occurence(prespecified endpoint) 1.11 [0.96; 1.29] cancer occurence 1.11 [0.96; 1.29] all cause death 0.89 [0.78; 1.01] coronary event 1.05 [0.86; 1.28] Cardiovascular death 0.87 [0.72; 1.04] Heart failure 0.95 [0.76; 1.18] cancer 1.11 [0.96; 1.29] Myocardial infarction ( fatal and non fatal) 1.05 [0.86; 1.28] cancer death 1.03 [0.80; 1.34] |
| Trial | Treatments | Patients | Method |
|---|
| LIFE, 2002 | losartan (n=4605) vs. atenolol (n=4588) | patients aged 55–80 years, with previously treated or untreated hypertension (sitting blood pressure 160–200/95–115 mm Hg) and ECG signs of LVH. | Double blind Parallel groups Sample size: 4605/4588 Primary endpoint: Cardiovascular mortality, stroke, and myocardial infarction FU duration: 4.8 y (mean) |
|
| patients at high risk for cardiovascular events | versus placebo or control No demonstrated result for efficacy | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| RENAAL, 2001 | losartan vs placebo | | | |
| Trial | Treatments | Patients | Method |
|---|
| RENAAL, 2001 | lLosartan 50 to 100 mg once daily (n=751) vs. placebo (n=762) | patients with type 2 diabetes and nephropathy | double-blind Parallel groups Sample size: 751/762 Primary endpoint: doubling of the base-line serum creatinine concentration, end-stage renal disease, or death FU duration: 3.4 years |
|
| patients at high risk for cardiovascular events | versus beta-blockers No demonstrated result for efficacy losartan inferior to atenolol in terms of PAD inférieure à 90 in LIFE, 2002 losartan inferior to atenolol in terms of lung cancer in LIFE, 2002 | 1 trial | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| LIFE, 2002 | losartan vs atenolol | apparition d'un premier évènement cardiovasculaire 0.86 [0.77; 0.96] PAS inférieure à 140 1.08 [1.03; 1.12] PA inférieure à140/90 1.07 [1.02; 1.11] stroke (fatal and non fatal) 0.75 [0.63; 0.88] cardiovascular event 0.86 [0.77; 0.96] New onset diabetes 0.75 [0.64; 0.89] | PAD inférieure à 90 0.98 [0.97; 1.00] lung cancer 2.41 [1.23; 4.71] | cardiovascular death 0.87 [0.72; 1.04] cancer occurence(prespecified endpoint) 1.11 [0.96; 1.29] cancer occurence 1.11 [0.96; 1.29] all cause death 0.89 [0.78; 1.01] coronary event 1.05 [0.86; 1.28] Cardiovascular death 0.87 [0.72; 1.04] Heart failure 0.95 [0.76; 1.18] cancer 1.11 [0.96; 1.29] Myocardial infarction ( fatal and non fatal) 1.05 [0.86; 1.28] cancer death 1.03 [0.80; 1.34] |
| Trial | Treatments | Patients | Method |
|---|
| LIFE, 2002 | losartan (n=4605) vs. atenolol (n=4588) | patients aged 55–80 years, with previously treated or untreated hypertension (sitting blood pressure 160–200/95–115 mm Hg) and ECG signs of LVH. | Double blind Parallel groups Sample size: 4605/4588 Primary endpoint: Cardiovascular mortality, stroke, and myocardial infarction FU duration: 4.8 y (mean) |
|
