Pfizer's Inspra shown to reduce AF in Ph IIIb trial

Global drugs behemoth Pfizer (NYSE: PFE) has reported results from a sub-analysis of the Phase IIIb EMPHASIS-HF trial (n=2737) showing that its already marketed Inspra (eplerenone) plus standard therapy statistically significantly reduced the incidence of new onset atrial fibrillation in patients with systolic heart failure, compared with placebo plus standard therapy (2.7% versus 4.5%, respectively; HR 0.58; 95% CI: 0.35-0.96, p=0.034).

The study was presented at the Heart Failure Congress 2011, organized by the Heart Failure Association of the European Society of Cardiology (HFA of the ESC). The analysis furthermore showed that the beneficial effects of eplerenone in reducing major CV events were similar in patients with and without AFF at the start of the study. While eplerenone is available generically in the USA, the drug is still under patent in Europe and Canada.

Eplerenone in comparison to placebo was shown to produce a 37% reduction in the primary end point of the composite of death from cardiovascular causes or hospitalization for heart failure, a 24% reduction in cardiovascular death, and a 42% reduction in hospitalization for heart failure for patients with class 2 heart failure.