RALES

Randomized Aldactone Evaluation Study

Paziente / Popolazione Intervento / Esposizione Confronto Esito

In 1,663 patients with severe HFrEF on ACEi, spironolactone 25 mg reduced all-cause mortality compared with placebo.

1663

Disegno

Double-blind RCT, terminated early

Esito

All-cause mortality

Rilevanza

Risultato35% vs 46% mortality; RR 0.70 (95% CI 0.60–0.82), p<0.001 (30% RRR). Gynaecomastia 10%.

Pitt B, et al. N Engl J Med. 1999;341(10):709-717. 10.1056/NEJM199909023411001

Discussione e critica

Pre-eplerenone era. Real-world hyperkalaemia rose sharply after publication (Juurlink BMJ 2004) — underscoring the gap between trial protocol and practice monitoring.