Patients With Acute STEMI Without Heart Failure Benefit From Inspra® (Eplerenone) Within First 24 Hours, Study Shows
Date: Mar-20-2013Primary composite efficacy endpoint met in REMINDER trial
Pfizer has announced results from the REMINDER[i] trial (Role of Eplerenone in acute Myocardial INfarction - Double-blind, Early treatment initiation, Randomised, placebo-controlled, multi-centre study) showing statistically significant risk reductions in the primary composite efficacy endpoint. This is the first randomised trial to test a mineralocorticoid receptor antagonist during the acute phase of heart attack.
Eplerenone is not approved for use in the patient population studied in the REMINDER trial in any market.
The composite endpoint was defined as the time to first event of cardiovascular (CV) mortality, re-hospitalisation 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.
After a mean follow-up of 10.5 months, the primary composite endpoint occurred in 18.4% of patients in the eplerenone group as compared with 29.6% in the placebo group. This represented a statistically significant 42.9% relative risk reduction in the primary endpoint, with p About Inspra® (eplerenone)
Eplerenone is a selective aldosterone antagonist/ mineralocorticoid receptor antagonist (MRA). It is indicated in addition to standard therapy including beta-blockers, to reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (LVEF £40%) and clinical evidence of heart failure after recent myocardial infarction.[iv]
Eplerenone is also indicated in addition to standard optimal therapy, to reduce the risk of cardiovascular mortality and morbidity in adult patients with NYHA class II (chronic) heart failure and left ventricular systolic dysfunction (LVEF ≤30%).
Health economic analysis of eplerenone in patients with CHF (NYHA class II) have shown that eplerenone as an add-on to standard optimal therapy is cost-effective compared to standard therapy alone, with a cost per Quality Adjusted Life Year (QALY) gained of £3,534,[v] providing a good economic as well as a clinical case for the use of eplerenone.
Please note that eplerenone is not licensed for the treatment of patients with ST-segment elevation myocardial infarction (STEMI) without a history of heart failure.
UK prescribing information is available here.
Courtesy: Medical News Today
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