Bisoprolol, A Once-A-Day Beta-Blocking Agent For Patients With Mild-To-Moderate Hypertension

The 24-h blood pressure control of bisoprolol, a new beta1- selective, beta-blocking agent, was studied in 240 mild to moderate hypertensive patients in this 4-week, randomized, double-blind, placebo-controlled trial. A once-daily dosing schedule was evaluated by comparing bisoprolol's antihypertensive effectiveness and safety at 24 h postdose and 3 h postdose, the latter time intended to correspond to peak effectiveness. Results from this trial demonstrated the antihypertensive effectiveness of once-daily bisoprolol at doses ranging from 5-20 mg. Mean reductions from baseline diastolic blood pressure, measured 24 h postdose, were 6.3, 8.8, and 10. 1 mmHg for patients receiving bisoprolol 5, 10, and 20 mg, respectively, compared with 1.6 mmHg for placebo-treated patients (p < 0.01); mean reductions from baseline systolic blood pressure for the bisoprolol groups were 8.6,8.6, and 10.9 mmHg, respectively, versus 3.3 mmHg for placebo (p less-than-or-equal-to 0.01); and mean reductions from baseline heart rate for the bisoprolol groups were 5.1, 7. 1, and 10.2 beats/min, respectively, compared with a 0.9 beats/min increase in heart rate for the placebo group (p < 0.01). The response rates for bisoprolol-treated patents ranged from 47 to 70% compared with 18% for patients on placebo (p < 0.01). Antihypertensive effects were dose-related and sustained over the 24-h dosing interval. Near maximal antihypertensive effects were achieved within 1 week of initiation of therapy with bisoprolol and were sustained over the course of the trial.The antihypertensive effects of bisoprolol were accompanied by a favorable safety profile. Furthermore, bisoprolol was well-tolerated and did not differ significantly from placebo in either the frequency or severity of reported adverse experiences. Withdrawal rates for adverse events were 1.4% for the placebo group versus 1.9% for the composite bisoprolol group. Laboratory changes generally were related to small increases within the normal range and were not clinically relevant. No bisoprolol-treated patient left the study or interrupted treatment for a clinical laboratory abnormality.