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How Is Spironolactone Being Used for Heart Failure in Practice?

A lesson about applying positive research findings carefully to the target populations studied

In line with data from the RALES randomized, placebo-controlled trial (N Engl J Med 1999; 341:709), guidelines recommend the aldosterone antagonist spironolactone for patients with severe heart failure (HF) who have left-ventricular systolic dysfunction (LVSD), recent or current symptoms at rest despite other appropriate medical therapy, a serum potassium level <5.0 mmol/L, and a pretreatment serum creatinine level <2.5 mg/dL. However, concerns about hyperkalemia due to inappropriate use of spironolactone (or inappropriate monitoring of its use) have surfaced recently (Journal Watch Cardiology Sep 17 2004).

Using the National Heart Care Project database, these researchers reviewed spironolactone prescriptions at hospital discharge among Medicare patients (age 65) with HF and LVSD before RALES was published (9758 patients) and after publication (9468 patients). The spironolactone prescription rate increased more than sevenfold after RALES was published (from 3.0% to 21.3%). Of the patients prescribed spironolactone after publication, 31% did not meet RALES enrollment criteria; many of this subgroup were at high risk for hyperkalemia.

Comment: The potential of treatments that have been proven effective in clinical trials can be undermined both by delays in applying the evidence to those who would benefit and by misapplication of the evidence to people at risk for adverse events from the proven treatment. This study illustrates the need for an evidence-based approach to clinical management in which positive research findings are applied carefully to the target populations studied. Only through such careful application can potentially serious consequences be avoided.

— William T. Abraham, MD

Published in Journal Watch Cardiology September 9, 2005

Citation(s):

Masoudi FA et al. Adoption of spironolactone therapy for older patients with heart failure and left ventricular systolic dysfunction in the United States, 1998–2001. Circulation 2005 Jul 5; 112:39-47.

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