[Clinical trial of the month. The CIBIS-II study].
CIBIS-II was a multicentre bouble-blind randomized placebo-controlled trial which enrolled 2,647 class III-IV heart failure patients, with a left ventricular ejection fraction < or = 35%, receiving standard therapy with a diuretic and ACEI and randomly assigned to placebo (n = 1,320) or to bisoprolol (n = 1,327) 1.25 mg/day, progressively increased to a maximum of 10 mg/day. Mean follow-up was 1.3 years. The study was stopped early because the 2nd interim analysis showed a significant mortality benefit in the treated group. All cause mortality was significantly lower in the bisoprolol group (156 [11.8%] vs 228 [17.3%]; p < 0.0001). Sudden deaths were fewer among patients on bisoprolol and treatment effects were independent on severity and aetiology of heart failure.
Kulbertus
H
H
Service de Cardiologie, Université de Liège.
D000293:Adolescent; D000319:Adrenergic beta-Antagonists / Q000008:administration & dosage / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000806:Angiotensin-Converting Enzyme Inhibitors / Q000627:therapeutic use; D017298:Bisoprolol / Q000008:administration & dosage / Q000627:therapeutic use*; D004232:Diuretics / Q000627:therapeutic use; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006333:Heart Failure / Q000188:drug therapy*; D006801:Humans; D008875:Middle Aged; D010919:Placebos; D015996:Survival Rate; D016896:Treatment Outcome
D000319:Adrenergic beta-Antagonists; D000806:Angiotensin-Converting Enzyme Inhibitors; D004232:Diuretics; D010919:Placebos; D017298:Bisoprolol