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[Study of the month. The RALES study (randomized aldactone evaluation study].
Rev Med Liege 1999; 54(9):770-2RM

Abstract

RALES was a double-blind study which enrolled 1.663 patients with severe heart failure and a left ventricular ejection fraction of no more than 35 percent who were being treated with an angiotensin-converting-enzyme inhibitor, a loop diuretic and, in most cases, digoxin. A total of 822 patients were randomly assigned to receive 25 mg of spironolactone daily and 841 to receive placebo. The primary end point of the study was death from all causes. The trial was discontinued early after a mean follow-up of 24 months because an interim analysis determined that spironolactone was efficacious. There were indeed 386 deaths in the placebo group (46%) and 284 in the spironolactone group (35%) (relative risk of death: 0.70; 95% confidence interval, 0.60-0.82; p < 0.001). The reduction of mortality among patients in the spironolactone group was attributable to a lower risk of sudden cardiac death and of death from progressive heart failure. Patients treated by spironolactone had a lower hospitalization rate for worsening heart failure; they also had a significant improvement in the symptoms of heart failure as assessed by the New York Heart Association functional class. Serious hyperkalemia was minimal in both groups of patients. Gynecomastia or breast pain was reported in 10% of men who were treated with spironolactone as compared with 1% of men in the placebo group (p < 0.001).

Authors+Show Affiliations

Université de Liège, Service de Cardiologie.

Pub Type(s)

Clinical Trial
English Abstract
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

fre

PubMed ID

10589274

Citation

Kulbertus, H. "[Study of the Month. the RALES Study (randomized Aldactone Evaluation Study]." Revue Medicale De Liege, vol. 54, no. 9, 1999, pp. 770-2.
Kulbertus H. [Study of the month. The RALES study (randomized aldactone evaluation study]. Rev Med Liege. 1999;54(9):770-2.
Kulbertus, H. (1999). [Study of the month. The RALES study (randomized aldactone evaluation study]. Revue Medicale De Liege, 54(9), pp. 770-2.
Kulbertus H. [Study of the Month. the RALES Study (randomized Aldactone Evaluation Study]. Rev Med Liege. 1999;54(9):770-2. PubMed PMID: 10589274.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - [Study of the month. The RALES study (randomized aldactone evaluation study]. A1 - Kulbertus,H, PY - 1999/12/10/pubmed PY - 1999/12/10/medline PY - 1999/12/10/entrez SP - 770 EP - 2 JF - Revue medicale de Liege JO - Rev Med Liege VL - 54 IS - 9 N2 - RALES was a double-blind study which enrolled 1.663 patients with severe heart failure and a left ventricular ejection fraction of no more than 35 percent who were being treated with an angiotensin-converting-enzyme inhibitor, a loop diuretic and, in most cases, digoxin. A total of 822 patients were randomly assigned to receive 25 mg of spironolactone daily and 841 to receive placebo. The primary end point of the study was death from all causes. The trial was discontinued early after a mean follow-up of 24 months because an interim analysis determined that spironolactone was efficacious. There were indeed 386 deaths in the placebo group (46%) and 284 in the spironolactone group (35%) (relative risk of death: 0.70; 95% confidence interval, 0.60-0.82; p < 0.001). The reduction of mortality among patients in the spironolactone group was attributable to a lower risk of sudden cardiac death and of death from progressive heart failure. Patients treated by spironolactone had a lower hospitalization rate for worsening heart failure; they also had a significant improvement in the symptoms of heart failure as assessed by the New York Heart Association functional class. Serious hyperkalemia was minimal in both groups of patients. Gynecomastia or breast pain was reported in 10% of men who were treated with spironolactone as compared with 1% of men in the placebo group (p < 0.001). SN - 0370-629X UR - https://www.unboundmedicine.com/medline/citation/10589274/[Study_of_the_month__The_RALES_study__randomized_aldactone_evaluation_study]_ L2 - https://medlineplus.gov/heartfailure.html DB - PRIME DP - Unbound Medicine ER -