[Study of the month. The RALES study (randomized aldactone evaluation study].

Area of Science:

• Cardiology
• Pharmacology

Background:

• Severe heart failure (HF) significantly impacts mortality and morbidity.
• Current treatments, including ACE inhibitors and diuretics, are insufficient for many patients.

Purpose of the Study:

• To evaluate the efficacy of spironolactone in reducing mortality in patients with severe heart failure.
• To assess the impact of spironolactone on heart failure symptoms and hospitalizations.

Main Methods:

• The Randomized Aldactone Evaluation Study (RALES) was a double-blind, placebo-controlled trial.
• 1,663 patients with severe HF (LVEF ≤ 35%) received standard therapy plus either spironolactone (25 mg/day) or placebo.
• Primary endpoint was all-cause mortality, with secondary endpoints including HF hospitalizations and symptom assessment.

Main Results:

• Spironolactone significantly reduced the risk of death by 30% (RR 0.70; 95% CI, 0.60-0.82; p < 0.001).
• Mortality reduction was due to decreased sudden cardiac death and death from progressive HF.
• Spironolactone use led to fewer hospitalizations for worsening HF and improved New York Heart Association functional class.

Conclusions:

• Spironolactone is a highly effective adjunctive therapy for severe heart failure, significantly improving survival and quality of life.
• The benefits of spironolactone outweigh the risks, with minimal serious hyperkalemia observed.
• Gynecomastia/breast pain occurred in 10% of men on spironolactone versus 1% on placebo.