Pfizer REMINDER trial of Inspra meets primary composite efficacy endpoint

11th March 2013 (Last Updated March 11th, 2013 18:30)

Pfizer has announced that its Reminder trial of Inspra (eplerenone) demonstrated statistically significant risk reductions, meeting its primary composite efficacy endpoint.

Pfizer

Pfizer has announced that its Reminder trial of Inspra (eplerenone) demonstrated statistically significant risk reductions, meeting its primary composite efficacy endpoint.

The data supports the treatment of patients with acute acute ST-segment elevation myocardial infarction (STEMI) without heart failure with Inspra within the initial 24 hours of symptoms, as well as standard therapy.

The Reminder Steering Committee chair and Centre Hospitalier Pitié-Salpêtriere, Paris, institute of cardiology professor Gilles Montalescot said eplerenone improved the outcome of patients presenting with acute STEMI, and without concomitant heart failure.

"This benefit was obtained in a low-risk population that was well treated, without serious adverse drug effect. Adding eplerenone to standard therapy as early as within the first 24 hours of symptoms reduced heart failure-related morbidity," Pitié-Salpêtriere said.

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 one month, or an elevation of BNP/ NT-proBNP after one month is the composite endpoint.

Around 1,012 patients involved in the randomised, double-blind trial received either eplerenone (25-50 mg OD) or placebo in addition to standard therapy with in first 24 hours of symptom onset.

A statistically significant 42.9% relative risk reduction in the primary endpoint with p < 0.0001 was observed in patients with acute STEMI when eplerenone was initiated.

The improvement in outcome occurred due to reduction of the BNP / NT-proBNP biomarker component at one month.

An elevation of BNP / NT-proBNP after one month was observed less frequently in the eplerenone group 81(16.0%) than in the placebo group 131(25.9%), according to the study data.


Image: Pfizer REMINDER trial results support use of Inspra along with standard therapy in acute STEMI patients without heart failure. Photo: Courtesy of Jim.henderson.