Betaxolol is equivalent to carvedilol in patients with heart failure NYHA II or III: Result of a randomized multicenter trial (BETACAR Trial)

Background In a recent COMET trial (Lancet 362, 2003:7–13) it could be demonstrated that carvedilol ≤ 50 mg/d was superior to metoprolol tartrate ≤ 100 mg/d in the treatment of heart failure patients NYHA II–IV. Objectives It was investigated whether the superiority of carvedilol with its β1, β2 and α-blocking potency will persist in a comparison to a highly selective β1-blocker with a long plasma half-time such as betaxolol. Methods 255 pts. with NYHA II or III heart failure were double-blind randomized and uptitrated to either carvedilol 25 mg bid (n = 131) or betaxolol 20 mg od (n = 124). Results Within 8 months left ventricular ejection fraction (LVEF) increased to the same extent from 30% to 43% (carvedilol) or 31% to 43% (betaxolol) as primary endpoint (ns). 13% of the carvedilol (CAR) patients versus 15% of the betaxolol patients (BET) suffered either from cardiac death or recurrent hospitalizations (cardiac death n = 6 (CAR), n = 2 (BET), ns). The mean increase in the 6-min walk test was 63 m with CAR and 61 m with BET and the Minnesota living with heart failure questionnaire improved in both groups (ns). Heart rate reduction was pronounced in both groups: CAR 13.1 beats/min, BET 13.6 beats/min. Conclusions The long acting highly selective β1-blocker betaxolol in an adequate dosage is not inferior to carvedilol in terms of exercise tolerance, safety and effects on left ventricular function.