Is Aldactone Any Help to Patients with Heart Failure?

Spironolactone (Aldactone) may reduce hospitalizations for heart failure—but the popular drug doesn’t significantly lower the risk of cardiac arrest or death in heart failure patients whose hearts still contract normally or near normally, according to a recent study in the New England Journal of Medicine.

“…The study provides important insights into the potential efficacy of spironolactone in reducing the need for hospitalizations for heart failure in this population, as well as providing clues for more effectively designing future studies to reduce mortality,” study author Bertram Pitt, MD, of the University of Michigan’s School of Medicine, said in a news release.
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The findings come from the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial. Researchers from Brigham and Women’s Hospital and the University of Michigan’s School of Medicine enrolled nearly 3,500 participants from 233 medical sites in six countries for the randomized, double-blind trial.

All of the patients had symptomatic heart failure and a left ventricular ejection fraction of 45% or more. Nearly 40% of heart failure patients have a preserved left ventricular ejection fraction—and currently have no drugs available to improve their prognoses. The researchers wanted to assess the clinical effects of spironolactone in this patient population.

They randomized the patients to receive either 15 mg to 45 mg of spironolactone or an inactive placebo daily, and followed them for an average of 3.3 years. They wanted to see how many patients were either hospitalized for heart failure, survived cardiac arrest, or suffered heart-related death, whichever occurred first.

These events occurred in 18.6% of the patients who took spironolactone and in 20.4% of those who took the placebo. Spironolactone didn’t significantly reduce total deaths but patients taking the drug did show have a lower rate of hospitalization than those who took the placebo (12% vs. 14.2%).

—Colleen Mullarkey

Reference

Pitt B, Pfeffer MA, Assmann SF, Boineau R, Anand IS, Claggett B, et al. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med 2014; 370:1383-92