Does Spironolactone Benefit Patients with HF and Preserved Systolic Function? — Physician’s First Watch
Does Spironolactone Benefit Patients with HF and Preserved Systolic Function?
By Harlan M. Krumholz, MD, SM
Spironolactone showed no significant advantage over placebo among patients with heart failure and preserved systolic function in a New England Journal of Medicine study, but the case may not be closed.
Some 3500 adults with symptomatic heart failure and a left ventricular ejection fraction of 45% or above were randomized to receive spironolactone or placebo in addition to their existing treatments for HF and any comorbidities. The primary endpoint — a composite of cardiovascular death, aborted cardiac arrest, and HF hospitalization — did not differ significantly between the spironolactone and placebo groups (18.6% and 20.4%, respectively).
The failure of an inexpensive drug to show a significant benefit in patients with a condition for which effective therapies are lacking is disappointing. Nonetheless, I find it hard to dismiss the possibility that this drug is beneficial based on these results. The trial was powered for a number needed to treat (NNT) of about 30. The observed NNT of 56, although nonsignificant, is of a magnitude that could be meaningful for this disorder. However, all we have for now is another negative study for patients with HF and preserved systolic function.
Dr. Krumholz is Editor-in-Chief of NEJM Journal Watch Cardiology, from which this story is adapted.