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Abstract
This study was designed to investigate the appropriateness and complications of the
use of spironolactone for heart failure (HF) in clinical practice.
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.
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.
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.
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.