Nebivolol Efficacy and Safety in Patients with Stage I‐II Hypertension

Background Nebivolol is a novel, β 1 ‐adrenergic receptor blocker with vasodilatory properties mediated through activation of the L‐arginine/nitric oxide pathway. Hypothesis This multicenter, double‐blind, parallel‐group, placebo‐controlled study investigated the antihypertensive efficacy and safety of nebivolol in patients with stage I through stage II hypertension (sitting diastolic blood pressure [SiDBP] ≥ 95 mm Hg and ≤ 109 mm Hg). Methods A total of 811 patients were randomized to placebo or nebivolol 5 mg, 10 mg, or 20 mg once daily for 12 weeks. The primary efficacy endpoint was the reduction in mean trough SiDBP from baseline. Results At study end, the least squares mean reductions in trough SiDBP from baseline with nebivolol 5 mg, 10 mg, and 20 mg were − 7.8 mm Hg, − 8.5 mm Hg, and − 9.1 mm Hg, respectively, compared with − 4.6 mm Hg for placebo ( P = .002 for nebivolol 5 mg, P <.001 for nebivolol 10 mg and 20 mg, vs placebo). Nebivolol treatment also produced reductions in trough sitting systolic blood pressure; however, only the 20 mg dose was statistically significant compared with placebo (−6.7 mm Hg vs − 0.4 mm Hg; P <.001). Response rates (defined as an average trough SiDBP < 90 mm Hg or a decrease by ≥ 10 mm Hg from baseline at the end of the study) ranged from 66.0% to 68.9% with nebivolol 5–20 mg, compared with 49.3% with placebo ( P ≤.009). Nebivolol 5 mg and 10 mg doses were well tolerated, with an overall adverse event incidence comparable to placebo. Conclusions Once‐daily nebivolol is an effective antihypertensive agent in patients with stage I‐II hypertension. Copyright © 2010 Wiley Periodicals, Inc.