EPHESUS

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EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study:

EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study Purpose To evaluate the effects of eplerenone (a selective aldosterone blocker) on morbidity and mortality among patients with acute myocardial infarction (MI) complicated by left ventricular dysfunction and heart failure Reference Pitt B, Remme W, Zannad F et al. for the Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study Investigators. Eplerenone, a selective aldosterone blocker, in patients with left ventricular dysfunction after myocardial infarction. N Engl J Med 2003; 348 :1309–21.

EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study - TRIAL DESIGN -:

EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study - TRIAL DESIGN - Design Multicenter, multinational, randomized, double-blind, placebo-controlled Patients 6632 patients 3 – 14 days after acute MI, who had left ventricular ejection fraction < 40% and were receiving optimal treatment, which could include ACE inhibitors, angiotensin receptor blockers, diuretics (other than K + -sparing diuretics) and beta-blockers Follow up and primary endpoints Primary endpoints: all-cause mortality; death from cardiovascular cause or first hospitalization for cardiovascular event. Mean 16 months follow up. Treatment Placebo or eplerenone titrated to target dose 50 mg daily

EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study - TRIAL DESIGN continued -:

EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study - TRIAL DESIGN continued - Age (years) a Male (%) History Left ventricular ejection fraction (%) a Days from MI to randomization a Symptoms of heart failure Medications ACE inhibitor or angiotensin-receptor blocker Beta-blockers Diuretics Aspirin Statins Baseline characteristics 64 70 33 7.3 90 87 75 61 89 47 Placebo (n=3313) 64 72 33 7.3 90 86 75 60 88 47 Eplerenone (n=3319) Pitt et al. N Engl J Med 2003; 348 :1309 – 21. a Mean

EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study - RESULTS -:

EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study - RESULTS - Both primary endpoints significantly reduced in eplerenone group compared with placebo: all-cause mortality: 14.4 vs. 16.7% (RR 0.85, P=0.008) death or hospitalization due to cardiovascular event: 26.7 vs. 30.0% (RR 0.87, P=0.002) Significantly fewer hospitalizations for cardiovascular events in eplerenone group, attributable to significant reduction in hospitalizations for heart failure Incidence of gynecomastia in the two groups was similar Incidence of serious hyperkalemia significantly higher in eplerenone group; serious hypokalemia significantly lower Drug well tolerated as defined by withdrawal rate from trial: only marginally higher with eplerenone

EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study - RESULTS continued -:

EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study - RESULTS continued - Months after randomization Cumulative incidence (%) 0 0 6 12 18 24 30 36 40 30 20 10 All-cause mortality Pitt et al. N Engl J Med 2003; 348 :1309 – 21. Placebo Eplerenone RR=0.85 (95% CI=0.75 – 0.96) P=0.008

EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study - RESULTS continued -:

EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study - RESULTS continued - Primary and selected secondary endpoints Pitt et al. N Engl J Med 2003; 348 :1309 – 21. P Primary endpoints All-cause mortality Cardiovascular death or hospitalization for cardiovascular events Secondary endpoints (No.) Hospitalization for cardiovascular events Acute MI Heart failure Stroke Ventricular arrhythmia 0.85 (0.75 – 0.96) 0.87 (0.79 – 0.95) 0.008 0.002 0.03 0.96 0.002 0.11 0.69 478 (14.4) 885 (26.7) No. (%) Eplerenone (n=3319) 554 (16.7) 993 (30.0) 1004 269 618 54 63 876 268 477 73 58 0.87 0.99 0.77 1.35 0.92 No. (%) Placebo (n=3313) Relative risk (95% CI) or ratio

EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study - RESULTS continued -:

EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study - RESULTS continued - P Gynecomastia Serious hyperkalemia (serum potassium >6 mmol/L) Serious hypokalemia (serum potassium <3.5 mmol/L) Adverse events 12 180 273 No. (0.5) (5.5) (8.4) 0.70 0.002 <0.001 (%) Eplerenone (n=3307) 14 126 424 No. (0.6) (3.9) (13.1) (%) Placebo (n=3301) Pitt et al. N Engl J Med 2003; 348 :1309 – 21.

EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study - SUMMARY -:

EPHESUS: Eplerenone Post-Acute Myocardial Infarction Heart Failure Efficacy and Survival Study - SUMMARY - In patients with acute myocardial infarction (MI) complicated by left ventricular dysfunction and heart failure, eplerenone: Reduced all-cause mortality, and reduced death or hospitalization due to cardiovascular events Had no effect on the incidence of gynecomastia Increased the incidence of serious hyperkalemia but decreased serious hypokalemia

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