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J Am Coll Cardiol, 2003; 41:211-214
© 2003 by the American College of Cardiology Foundation
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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{dagger},*

* Winters Center For Heart Failure Research, V A Medical Center, Baylor College of Medicine, Houston, Texas, USA
{dagger} 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.

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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