Efficacy and safety of carvedilol in the treatment of hypertension.

In an open clinical study, long-term efficacy and safety of carvedilol were investigated in 154 patients with essential hypertension WHO I-II and diastolic blood pressure (BP) between 95 and 115 mm Hg over a period of 1 year. After a washout and a placebo phase, all patients were treated with 25 mg carvedilol b.i.d., after 4 weeks of an adaption to 25 mg o.d. or 50 mg b.i.d. was possible. Eighty-six patients had been treated according to the protocol (5 patients 25 mg o.d., 77 patients 25 mg b.i.d., and 4 patients 50 mg b.i.d.) An additional 18 patients were included to the final evaluation in spite of the fact that they had incorrect placebo phases. Ten patients had to be excluded from the final evaluation because of protocol violation. Eight patients dropped out because they were nonresponders, 8 patients dropped out because of side effects, and 15 patients dropped out because of other reasons. In all patients treated over the period of 1 year, 99 patients had a diastolic BP less than or equal to 95 and 88 of the less than or equal to 90 mm Hg. The side effects were mostly correlated to the pharmacodynamic effects of the drug; there were no serious side effects during the trial.

RCT Entities:   Population Interventions Outcomes