| heart failure | versus placebo or control No demonstrated result for efficacy eplerenone inferior to placebo in terms of serious hyperkalemia (¡Ý6.0 mmol per liter) in EPHESUS, 2003 eplerenone inferior to placebo in terms of serious hyperkalemia (¡Ý6.0 mmol per liter) in EMPHASIS-HF, 2010 | 2 trials | meta-analysis | | | Trial | control | p<0.05 | harm | NS |
|---|
| EPHESUS, 2003 | eplerenone vs placebo | death from any cause 0.86 [0.77; 0.96] death from cardiovascular causes 0.84 [0.74; 0.95] Sudden death 0.80 [0.66; 0.98] death from cardiovascular causes or hospitalization for cardiovascular causes 0.89 [0.82; 0.96] | serious hyperkalemia (¡Ý6.0 mmol per liter) 1.43 [1.14; 1.78] | Adverse events 0.99 [0.97; 1.02] hospitalisation for cardiovascular causes 0.93 [0.84; 1.03] | | EMPHASIS-HF, 2010 | eplerenone vs placebo | death from any cause 0.81 [0.67; 0.97] death from cardiovascular causes 0.80 [0.65; 0.98] Death from any cause or hospitalization for
any reason 0.82 [0.74; 0.90] Hospitalization for heart failure 0.65 [0.54; 0.78] Hospitalization for any reason 0.84 [0.75; 0.93] Death from any cause or hospitalization for
heart failure 0.72 [0.63; 0.83] | serious hyperkalemia (¡Ý6.0 mmol per liter) 2.19 [1.58; 3.04] | Death from worsening heart failure 0.74 [0.51; 1.08] Adverse events 0.98 [0.93; 1.02] Sudden death 0.79 [0.57; 1.11] |
| Trial | Treatments | Patients | Method |
|---|
| EPHESUS, 2003 | eplerenone 25 mg per day initially, titrated to amaximum of 50 mg per day (n=3319) vs. placebo (n=3313) | patients with acute myocardial infarction complicated by left ventricular dysfunction and heart failure | Double blind Parallel groups Sample size: 3319/3313 Primary endpoint: all cause death AND cardiovascular death or hospitalization for a CV event FU duration: 16 mo (mean, range 0 to 33) | | EMPHASIS-HF, 2010 | eplerenone (n=1364) vs. placebo (n=1373) | patients with
New York Heart Association class II heart failure and an ejection fraction of no
more than 35% | double blind Parallel groups Sample size: 1364/1373 Primary endpoint: CV death, hospitalization for HF FU duration: 21 months |
|
