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Randomized ALdactone Evaluation Study (RALES)

Study characteristics: 1) 36 month study, N = 1663, age: 65 +/- 12 years 2) class III heart failure 70%; class IV 30% 3) LVEF 25% 4) ischemic & non-ischemic cardiomyopathy 5) mean dose of ACE inhibitor a) captopril 62 mg QD b) enalapril 15 mg QD c) lisinopril 15 mg QD 6) exclusion a) operative valvular heart disease b) serum creatinine > 2.5 mg/dL c) serum K+ > 5.0 meq/L 7) standard diet 8) 10% taking beta blockers Conclusions: 1) 27% reduction in mortality with dose of 25 mg spironolactone QD 2) benefits in patients regardless of age 3) benefit in combination with conventional therapy 4) benefit diminished without digoxin or ACE inhibitor 5) little risk of hyperkalemia (2% serious hyperkalemia) Spironolactone reduced mortality in patients with congestive heart failure by 30%

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spironolactone (Aldactone)

General

clinical trial

References

  1. Watson K, in: UCLA Intensive Course in Geriatric Medicine & Board Review, Marina Del Ray, CA, Sept 12-15, 2001
  2. Natterson B, in UCLA Intensive Course in Geriatric Medicine & Board Review, Marina Del Ray, CA, Sept 25-28, 2002
  3. Pit B et al, N Eng J Med 341:709, 1999
  4. Kayser SR, in UCLA Intensive Course in Geriatric Medicine & Board Review, Marina Del Ray, CA, Sept 25-28, 2002