Nebivolol efficacy and safety in patients with stage I-II hypertension.

BACKGROUND: Nebivolol is a novel, beta(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] > or = 95 mm Hg and < or = 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 > or = 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< or =.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.