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Therapeutics
Spironolactone reduced mortality in severe congestive heart failure

https://doi.org/10.1136/ebm.5.1.11

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    (1999) N Engl J Med 341, 709. Pitt B, Zannad F, Remme WJ, et al. for the Randomized Aldactone Evaluation Study Investigators. . The effect of spironolactone on morbidity and mortality in patients with severe heart failure. . . Sep 2;. :. –17.
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 QUESTION: In patients with severe congestive heart failure (CHF) caused by systolic left ventricular dysfunction, does spironolactone combined with usual care reduce all-cause mortality?

    Design

    Randomised (allocation concealed*), blinded (patients, clinicians, and outcome assessors),* placebo-controlled trial with mean follow-up of 24 months. Interim analyses were done.

    Setting

    195 clinical centres in 15 countries.

    Patients

    1663 patients (mean age 65 y, 73% men, 87% white) with severe CHF who were using angiotensin-converting enzyme (ACE) inhibitors, if tolerated, and a loop diuretic and had had a recent left ventricular ejection fraction ≤35%. The major exclusion criterion was use of potassium-sparing diuretics. All patients were analysed.

    Intervention

    All patients received usual care and were allocated to spironolactone, 25 mg/day, which could be doubled after 8 weeks …

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    Footnotes

    • Source of funding: Searle.

    • For correspondence: Dr B Pitt, Division of Cardiology, University of Michigan Medical Center, 3910 Taubman, 1500 East Medical Center Drive, Ann Arbor, MI 48109-0366, USA. FAX 734-936-5256.

    • ↵* See glossary.