Bisoprolol, a once‐a‐day beta‐blocking agent for patients with mild to moderate hypertension

Abstract The 24‐h blood pressure control of bisoprolol, a new beta 1 ‐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≤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 patients 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 welltolerated 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.