(HealthDay News) — Spironolactone did not significantly reduce a composite outcome end point in heart failure patients with a preserved ejection fraction, according to a study published in the April 10 issue of the New England Journal of Medicine.

Bertram Pitt, MD, from University of Michigan in Ann Arbor, and colleagues conducted a randomized, double-blind trial in which 3,445 patients with symptomatic heart failure and a left ventricular ejection fraction of ≥45 percent received either spironolactone (15–45 mg daily) or placebo. A composite of death from cardiovascular causes, aborted cardiac arrest, or hospitalization for the management of heart failure was the primary outcome.

The researchers found that over a mean 3.3 years of follow-up, the primary outcome occurred in 18.6% of patients in the spironolactone group and 20.4% of patients in the placebo group (hazard ratio, 0.89; P=0.14). Only hospitalization for heart failure had a significantly lower incidence in the spironolactone group versus the placebo group (12.0 vs. 14.2%; hazard ratio, 0.83; P=0.04). Increased serum creatinine levels and a doubling of the rate of hyperkalemia were seen with spironolactone, but there were no significant differences in the incidence of serious adverse events.

“In patients with heart failure and a preserved ejection fraction, treatment with spironolactone did not significantly reduce the incidence of the primary composite outcome,” the authors write.

Several authors disclosed financial ties to the pharmaceutical industry.

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