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Pfizer Inc. (NYSE: PFE) today announced results from the REMINDER trial showing statistically significant risk reductions in the primary composite efficacy endpoint. The composite endpoint was defined as the time to first event of cardiovascular (CV) mortality, re-hospitalization or extended initial hospital stay due to diagnosis of heart failure (HF), sustained ventricular tachycardia or fibrillation, ejection fraction (EF) ≤40% after 1 month, or an elevation of BNP/ NT-proBNP after 1 month.
The results were presented for the first time during the Late Breaker Clinical Trial session at the 62
nd Annual Scientific Session of the American College of Cardiology in San Francisco today.
The REMINDER trial was a randomized, double-blind trial, involving 1,012 patients with acute ST-segment elevation myocardial infarction (STEMI) without a history of HF or EF <40% and without signs of HF. Patients received, preferably before myocardial reperfusion, either eplerenone (25-50 mg OD) or placebo in addition to standard therapy. Treatment was initiated within the first 24 hours of symptom onset (preferably within first 12h).
trial demonstrated a statistically significant 42.9% relative risk reduction in the primary endpoint with p < 0.0001 (95% confidence interval [CI] 0.439, 0.742) in patients with acute STEMI when eplerenone was initiated within the first 24 hours of onset of symptoms. Overall, the adverse events reported in the REMINDER trial were consistent with those already known for eplerenone, primarily hyperkalemia.
Eplerenone is not approved for use in the patient population studied in the REMINDER trial in any market.
The improvement in outcome was mainly driven by a significant reduction of the BNP / NT-proBNP biomarker component at 1 month. BNP/NT-proBNP has been shown to be an important marker for short- and long-term prognosis in patients with myocardial infarction in the presence or absence of preserved ejection fraction. An elevation of BNP / NT-proBNP after 1 month was observed less frequently in the eplerenone group 81(16.0%) than in the placebo group 131(25.9%) (adjusted HR, 0.584; 95% CI 0.441-0.773; p=0.0002).