| pathology | Benefit (demonstrated or suggested) and harm | | | |
|---|
| atrial fibrillation | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| ACTIVE I, 2009 | vs placebo | hospitalization for HF 0.87 [0.78; 0.98] | | cardiovascular events + HF hospitalization 0.95 [0.89; 1.02] vascular death 1.03 [0.93; 1.13] stroke/MI/vascular death 1.00 [0.92; 1.08] stroke 0.92 [0.81; 1.05] MI 1.05 [0.84; 1.33] | | Madrid, 2002 | vs placebo | AF recurrence 0.39 [0.19; 0.79] | | |
| Trial | Treatments | Patients | Method |
|---|
| ACTIVE I, 2009 | irbesartan 300mg once daily (n=4518) vs. placebo (n=4498) | patients with atrial fibrillation and with a systolic blood pressure of at least 110 mmHg associated with at least one major risk of vascular events these patients were drawn from two parallel trials (ACTIVE-A and ACTIVE-W) utilizing a partial factorial design | double blind Factorial plan Sample size: 4518/4498 Primary endpoint: coprimary MACE, HF events FU duration: 4.1 years | | Madrid, 2002 | irbesartan (n=79) vs. control (n=75) | atrial fibrillation | open Parallel groups Sample size: 79/75 Primary endpoint: FU duration: 254 d (range 60-710) |
|
| diabetes type 2 | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| IPDM (150mg), 2001 | vs placebo | microvascular events 0.30 [0.14; 0.64] | | | | IDNT (irbesartan vs pbo), 2001 | vs placebo | microvascular events 0.80 [0.66; 0.97] renal death 0.84 [0.72; 0.98] | | All deaths 0.92 [0.69; 1.23] Cardiovascular events 0.91 [0.72; 1.15] | | IDNT (irbesartan vs amlodipine), 2001 | vs placebo | microvascular events 0.77 [0.63; 0.94] renal death 0.79 [0.68; 0.93] | | All deaths 1.04 [0.77; 1.40] Cardiovascular events 1.03 [0.81; 1.31] |
| Trial | Treatments | Patients | Method |
|---|
| IPDM (150mg), 2001 | irbesartan 150 mg daily (n=195) vs. placebo (n=201) 3 arms trial: irbesartan 150 and 300 mg daily, placebo | hypertensive patients with type 2 diabetes and microalbuminuria | double-blind Parallel groups Sample size: 195/201 Primary endpoint: diabetic nephropathy FU duration: 2 years | | IDNT (irbesartan vs pbo), 2001 | Irbesartan 300 mg daily (n=579) vs. placebo (n=569)
| hypertensive patients with nephropathy due to type 2 diabetes
| double blind Parallel groups Sample size: 579/569 Primary endpoint: renal death FU duration: 2.6 years
| | IDNT (irbesartan vs amlodipine), 2001 | Irbesartan 300 mg daily (n=579) vs. amlodipine 10 mg daily (n=567)
| hypertensive patients with nephropathy due to type 2 diabetes
| double blind Parallel groups Sample size: 579/567 Primary endpoint: renal death FU duration: 2.6 years
|
|
| diabetic kidney disease | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| IPDM (150mg), 2001 | vs placebo | microvascular events 0.30 [0.14; 0.64] | | | | IDNT (irbesartan vs pbo), 2001 | vs placebo | microvascular events 0.80 [0.66; 0.97] renal death 0.84 [0.72; 0.98] | | All deaths 0.92 [0.69; 1.23] Cardiovascular events 0.91 [0.72; 1.15] | | IDNT (irbesartan vs amlodipine), 2001 | vs placebo | microvascular events 0.77 [0.63; 0.94] renal death 0.79 [0.68; 0.93] | | All deaths 1.04 [0.77; 1.40] Cardiovascular events 1.03 [0.81; 1.31] |
| Trial | Treatments | Patients | Method |
|---|
| IPDM (150mg), 2001 | irbesartan 150 mg daily (n=195) vs. placebo (n=201) 3 arms trial: irbesartan 150 and 300 mg daily, placebo | hypertensive patients with type 2 diabetes and microalbuminuria | double-blind Parallel groups Sample size: 195/201 Primary endpoint: diabetic nephropathy FU duration: 2 years | | IDNT (irbesartan vs pbo), 2001 | Irbesartan 300 mg daily (n=579) vs. placebo (n=569)
| hypertensive patients with nephropathy due to type 2 diabetes
| double blind Parallel groups Sample size: 579/569 Primary endpoint: renal death FU duration: 2.6 years
| | IDNT (irbesartan vs amlodipine), 2001 | Irbesartan 300 mg daily (n=579) vs. amlodipine 10 mg daily (n=567)
| hypertensive patients with nephropathy due to type 2 diabetes
| double blind Parallel groups Sample size: 579/567 Primary endpoint: renal death FU duration: 2.6 years
|
|
| heart failure | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| Tonkon et al., 2000 | vs ACE inhibitor only | | | | | I-PRESERVE (McMurray), 2008 | vs ACE inhibitor only | | | Death from Any Cause, Cardiac Arrest with Resuscitation, Hospitalization for Worsening Heart Failure, or Therapy with Intravenous Inotropes or Vasodilators 0.97 [0.89; 1.05] all cause death 1.02 [0.91; 1.14] Cardiovascular death 1.03 [0.89; 1.19] hospital admission for heart failure 0.96 [0.84; 1.11] hospital admission for any reason 1.02 [0.97; 1.08] death or CV hospitalization 0.97 [0.89; 1.05] Cardiovascular death or hospital admission for CHF 0.97 [0.87; 1.10] |
| Trial | Treatments | Patients | Method |
|---|
| Tonkon et al., 2000 | Irbesartan, 150 mg daily (plus ACE inhibitor) (n=57) vs. Placebo (plus ACE inhibitor) (n=52) | patients with heart failure (New York Heart Association functional class II and III) and left ventricular ejection fraction (LVEF) < or = 40% received stable doses of ACE inhibitors and diuretics | double blind Parallel groups Sample size: 57/52 Primary endpoint: Exercise tolerance FU duration: 12 wk | | I-PRESERVE (McMurray), 2008 | ibersatan 300mg daily (n=2067) vs. placebo (n=2061) | patients with NYHA
II, III, or IV heart failure and an ejection fraction of at least 45% | double blind Parallel groups Sample size: 2067/2061 Primary endpoint: FU duration: 49.5 months |
|
| heart failure with preserved LVEF | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| I-PRESERVE (McMurray), 2008 | vs placebo | | | Death from Any Cause, Cardiac Arrest with Resuscitation, Hospitalization for Worsening Heart Failure, or Therapy with Intravenous Inotropes or Vasodilators 0.97 [0.89; 1.05] all cause death 1.02 [0.91; 1.14] Cardiovascular death 1.03 [0.89; 1.19] hospital admission for heart failure 0.96 [0.84; 1.11] hospital admission for any reason 1.02 [0.97; 1.08] death or CV hospitalization 0.97 [0.89; 1.05] Cardiovascular death or hospital admission for CHF 0.97 [0.87; 1.10] |
| Trial | Treatments | Patients | Method |
|---|
| I-PRESERVE (McMurray), 2008 | ibersatan 300mg daily (n=2067) vs. placebo (n=2061) | patients with NYHA
II, III, or IV heart failure and an ejection fraction of at least 45% | double blind Parallel groups Sample size: 2067/2061 Primary endpoint: FU duration: 49.5 months |
|
| hypertension | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| IPDM (150mg), 2001 | vs placebo | microvascular events 0.30 [0.14; 0.64] | | | | IDNT (irbesartan vs pbo), 2001 | vs placebo | microvascular events 0.80 [0.66; 0.97] renal death 0.84 [0.72; 0.98] | | All deaths 0.92 [0.69; 1.23] Cardiovascular events 0.91 [0.72; 1.15] | | IDNT (irbesartan vs amlodipine), 2001 | vs placebo | microvascular events 0.77 [0.63; 0.94] renal death 0.79 [0.68; 0.93] | | All deaths 1.04 [0.77; 1.40] Cardiovascular events 1.03 [0.81; 1.31] | | IDNT (irbesartan vs pbo), 2001 | vs placebo | | | all cause death 0.92 [0.70; 1.20] coronary event 0.91 [0.72; 1.15] Cardiovascular death 1.11 [0.76; 1.62] Heart failure 0.82 [0.59; 1.13] stroke (fatal and non fatal) 1.06 [0.63; 1.78] Myocardial infarction ( fatal and non fatal) 0.94 [0.63; 1.40] | | IRMA 2, 2001 | vs placebo | | | all cause death 1.13 [0.40; 3.20] Myocardial infarction ( fatal and non fatal) 0.51 [0.15; 1.75] |
| Trial | Treatments | Patients | Method |
|---|
| IPDM (150mg), 2001 | irbesartan 150 mg daily (n=195) vs. placebo (n=201) 3 arms trial: irbesartan 150 and 300 mg daily, placebo | hypertensive patients with type 2 diabetes and microalbuminuria | double-blind Parallel groups Sample size: 195/201 Primary endpoint: diabetic nephropathy FU duration: 2 years | | IDNT (irbesartan vs pbo), 2001 | Irbesartan 300 mg daily (n=579) vs. placebo (n=569)
| hypertensive patients with nephropathy due to type 2 diabetes
| double blind Parallel groups Sample size: 579/569 Primary endpoint: renal death FU duration: 2.6 years
| | IDNT (irbesartan vs amlodipine), 2001 | Irbesartan 300 mg daily (n=579) vs. amlodipine 10 mg daily (n=567)
| hypertensive patients with nephropathy due to type 2 diabetes
| double blind Parallel groups Sample size: 579/567 Primary endpoint: renal death FU duration: 2.6 years
| | IDNT (irbesartan vs pbo), 2001 | Irbesartan 300mg/d (target 135/85) (n=579) vs. placebo (n=569) | hypertensive patients with nephropathy due to type 2 diabetes | double-blind Parallel groups Sample size: 579/569 Primary endpoint: doubling of the base-line serum creatinine concentration, end-stage renal disease, or death FU duration: 2.6 y | | IRMA 2, 2001 | irbesartan 150 mg daily or 300 mg daily (n=404) vs. placebo (n=207) | hypertensive patients with type 2 diabetes and microalbuminuria | double-blind Parallel groups Sample size: 404/207 Primary endpoint: onset of diabetic nephropathy FU duration: 2 years |
|
| miscellaneous | All results are NS for efficacy | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| IDNT (irbesartan vs pbo), 2001 | vs placebo | | | all cause death 0.92 [0.70; 1.20] coronary event 0.91 [0.72; 1.15] Cardiovascular death 1.11 [0.76; 1.62] Heart failure 0.82 [0.59; 1.13] stroke (fatal and non fatal) 1.06 [0.63; 1.78] Myocardial infarction ( fatal and non fatal) 0.94 [0.63; 1.40] | | IRMA 2, 2001 | vs placebo | | | all cause death 1.13 [0.40; 3.20] Myocardial infarction ( fatal and non fatal) 0.51 [0.15; 1.75] |
| Trial | Treatments | Patients | Method |
|---|
| IDNT (irbesartan vs pbo), 2001 | Irbesartan 300mg/d (target 135/85) (n=579) vs. placebo (n=569) | hypertensive patients with nephropathy due to type 2 diabetes | double-blind Parallel groups Sample size: 579/569 Primary endpoint: doubling of the base-line serum creatinine concentration, end-stage renal disease, or death FU duration: 2.6 y | | IRMA 2, 2001 | irbesartan 150 mg daily or 300 mg daily (n=404) vs. placebo (n=207) | hypertensive patients with type 2 diabetes and microalbuminuria | double-blind Parallel groups Sample size: 404/207 Primary endpoint: onset of diabetic nephropathy FU duration: 2 years |
|
