Inspra eplerenone: Phase IIIb data

The double-blind, international Phase IIIb EMPHASIS-HF trial in 2,737 patients with New York Heart Association (NYHA) class II chronic systolic heart failure showed that Inspra plus standard of care (SOC) significantly reduced the incidence of CV death or heart failure hospitalization, the composite primary endpoint, vs. placebo plus SOC (18.3% vs. 25.9%, p<0.0001). On secondary endpoints, Inspra plus SOC significantly reduced all-cause mortality (12.5% vs. 15.5%, p=0.008), CV mortality (10.8% vs. 13.5%, p=0.012), all-cause hospitalization (29.9% vs. 35.8%, p<0.0001) and heart failure hospitalization vs. placebo plus SOC (12% vs. 18.4%, p<0.0001).

The incidence of hyperkalemia, defined as a serum potassium levels >5.5 mmol/L, was significantly higher for Inspra vs. placebo (11.8% vs. 7.2%, p<0.001), whereas hypokalemia, defined as serum potassium levels <3.5 mmol/L, was significantly lower for Inspra vs. placebo (7.5% vs. 11%, p=0.002). Patients received once-daily 25 mg Inspra or placebo for 4 weeks, at which point the dose could be increased to once-daily 50 mg based on serum potassium levels. SOC included an angiotensin-converting enzyme (ACE) inhibitor and/or angiotensin-receptor blocker (ARB), plus a beta blocker. The trial was designed to enroll 3,100 patients and continue until 813 primary endpoint events were reported. Data were published in the New England Journal of Medicine and were presented at the American Heart Association meeting in Chicago. ...