REMINDER Trial Shows Early Eplerenone Improves Acute STEMI
Data presented March 10 during ACC.13's Late Breaking Clinical Trials III session suggest that early use of eplerenone can improve the outcome of patients presenting with acute ST-Elevation Myocardial Infarction (STEMI). Gilles Montalescot, MD, professor at the Institute of Cardiology, Centre Hospitalier Pitié-Salpêtriére, Paris, presented the results of the REMINDER trial, a double-blind, randomized, placebo-controlled trial evaluating the safety and efficacy of early treatment with eplerenone in patients with acute MI.
Patients were identified during ER or ambulance evaluation and diagnosis of acute STEMI in the absence of heart failure. Those who agreed to participate were randomized and given an initial dose of either eplerenone or placebo within 12 to 24 hours of the initial onset of symptoms of an acute MI. Eplerenone once-daily dosing of 25 or 50 mg/day was based on serum potassium and eGFR levels. Most patients (88.6 percent) received the 50-mg dose. Patients in both arms of the trial also received standard medical care for acute STEMI. A total of 1,012 patients were randomized, 506 to each arm.
The primary endpoint was a composite of cardiovascular mortality, ventricular arrhythmia, clinical or subclinical heart failure as determined by left ventricle ejection fraction (LVEF) below 40 percent or elevated brain natriuretic peptide (BNP)/NT-proBNP one month or longer after enrollment. After a mean follow-up of 10.5 months, 93 patients (18.4 percent) in the eplerenone group had reached the primary endpoint versus 150 patients (29.6 percent) in the placebo group. Eplerenone had an overall hazard ratio of 0.57 (p<0.0001) for the primary endpoint.
After the same follow-up period, a high BNP/NT-proBNP level was seen in 18 patients (16 percent) in the eplerenone group compared to the 131 patients (25.9 percent) in the placebo group. The eplerenone hazard ratio for high BNP/NT-proBNP was 0.58 (>0.0002).
Adverse event rates were similar in both groups. Serum potassium levels exceeded 5.5 mmol/L in 5.6 percent of the eplerenone group and 3.2 percent of the placebo group (p=0.09) and were below 3.5 mmol/L in 1.4 percent of the eplerenone group and 5.6 percent of the placebo group (p=0.0002).
This is the first large study to examine the safety profile of eplerenone for early administration with no prior potassium check. Results show that adding eplerenone to standard therapy within 24 hours of the onset of MI symptoms improves the outcome of patients with acute STEMI without evidence of either heart failure or LVEF below 40 percent.
< Back to Listings