Nebivolol in the treatment of patients with stage 1 and stage 2 hypertension: Results of a randomized, double-blind, placebo-controlled study

The purpose of this study was to establish the antihypertensive efficacy and safety of nebivolol – a novel, highly selective β1 blocker with nitric-oxide mediated vasodilatory effects – in patients with Stage 1 or 2 hypertension. In this 12-week, multicenter, double-blind study, 909 hypertensive patients (mean sitting diastolic blood pressure [siDBP] 95 to 109 mm Hg) were randomized and treated with either placebo or nebivolol 1.25 mg, 2.5 mg, 5 mg, 10 mg, 20 mg, or 40 mg once daily. Statistically significant reductions in blood pressure (BP) were evident at doses of 10, 20 and 40 mg approximately 2 to 3 hours after administering the first dose. Furthermore, treatment with nebivolol resulted in a dose-dependent reduction in both trough siDBP and trough sitting systolic blood pressure (siSBP), with a statistically significant treatment effect (vs. placebo) for all nebivolol doses at all visits from 2 to 12 weeks. At the end of the 12-week treatment period, the placebo-subtracted numerical reductions in siDBP at trough ranged from −5.1 mmHg for nebivolol 1.25mg to −8.3 mmHg for nebivolol 40 mg. The placebo-subtracted numerical reductions in siSBP at trough ranged from −6.6 mmHg for nebivolol 1.25 mg to −11.7 mmHg for nebivolol 40 mg. The placebo-subtracted trough-to-peak ratios for the reduction in SiDBP were 0.9 or above for all doses of nebivolol. Heart rate was statistically significantly reduced in the nebivolol treatment groups in a dose dependent manner. The incidence of adverse events was not statistically different from placebo for doses of nebivolol up to and including 10 mg. In summary, nebivolol reduced BP and had an adverse event profile comparable to placebo.