CLINICAL STUDY: HEART FAILURE
Complications of inappropriate use of spironolactone in heart failure: when an old medicine spirals out of new guidelines
Biykem Bozkurt, MD*,
Ildiko Agoston, MD* and
A. A. Knowlton, MD ,*
* Winters Center For Heart Failure Research, V A Medical Center, Baylor College of Medicine, Houston, Texas, USA
Cardiology Research, VA Medical Center, Baylor College of Medicine, Houston, Texas, USA
Manuscript received April 8, 2002;
revised manuscript received August 23, 2002,
accepted September 6, 2002.
* Reprint requests and correspondence: Dr. A. A. Knowlton, Cardiovascular Division, TB172, University of California, Davis, One Shields Avenue, Davis, California 95616, USA.
aaknowlton{at}ucdavis.edu
OBJECTIVES: This study was designed to investigate the appropriateness and complications of the use of spironolactone for heart failure (HF) in clinical practice.
BACKGROUND: Spironolactone was reported by one prospective randomized trial to decrease morbidity and mortality in patients with New York Heart Association (NYHA) class III and IV HF. With this report (Randomized Spironolactone Evaluation Study [RALES] trial), we noted a marked increase in widespread use of spironolactone in patients with HF. Long-term outcome data with respect to safety and utilization of this medication in HF are not available.
METHODS: To investigate the use of spironolactone for HF in a clinical setting, we analyzed the application of the RALES trial protocol to the care of 104 patients, whom we identified as being started on spironolactone for HF after prerelease of the RALES trial.
RESULTS: We found broader use, less intensive follow-up, and increased complications with spironolactone treatment compared with the RALES trial. Cardiologists provided more appropriate care than did primary care providers.
CONCLUSIONS: These data suggest that spironolactone is being used widely in HF without consideration of the NYHA class and ejection fraction, and without optimization of background treatment with angiotensin-converting enzyme inhibitors and beta-blockers. Clinical follow-up does not adhere to the RALES trial guidelines, resulting in higher complications. We conclude that long-term studies with further safety and efficacy data are needed.
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Abbreviations and Acronyms
| | ACC | | American College of Cardiology | | AHA | | American Heart Association | | BP | | blood pressure | | HF | | heart failure | | LVEF | | left ventricular ejection fraction | | NYHA | | New York Heart Association | | RALES | | Randomized Spironolactone Evaluation Study | | SBP | | systolic blood pressure |
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