Betablockers in Heart Failure: Carvedilol Safety Assessment (CASA 2-Trial)

BACKGROUND: Betablockers are a cornerstone in the treatment of patients with chronic heart failure (CHF). The purpose of the present study was to assess safety and tolerability of carvedilol in CHF-patients. METHODS: 66 general practitioners, who were supervised by a local cardiologist, enrolled 151 CHF-patients. All patients were on standard therapy with ACE-inhibitors and diuretics. Carvedilol treatment was started with 3.125 mg twice daily and slowly uptitrated in 2-week intervals to 2x25 mg per day. Mean follow-up was 12 weeks. RESULTS: 145 of the 151 patients (96%) finished the study according to protocol, six patients were lost to follow-up (4%). 59 patients (41%) experienced minor and nine (6%) serious adverse events. 68 were under maximal therapy with 50 mg daily, 33 received 25 mg, and 15 12.5 mg. Overall tolerability was good and NYHA-class fell significantly from 2.2 to 1.8 (P<0.001). Mean heart rate decreased from 78 to 69 bpm (P<0.001), mean systolic blood pressure from 137 to 132 mmHg (P<0.001) and mean diastolic blood pressure from 80 to 76 mmHg (P<0.001). Quality of life significantly improved under carvedilol with a reduction in the Minnesota living with heart failure score from 1.28 to 0.88 (P<0.001). CONCLUSIONS: Carvedilol is well tolerated in CHF-patients treated by general practitioners. Serious adverse events and hospitalisations are rare. Thus, carvedilol is a safe drug in the treatment of CHF-patients and can be easily initiated and managed by the general practitioner.