Beta-blockers in the management of hypertension: focus on nebivolol

Department of Veterans Affairs Medical Center, Georgetown University Medical Center, Washington, DC 20422, USA.
Expert Review of Cardiovascular Therapy 05/2008; 6(4):471-9. DOI: 10.1586/14779072.6.4.471
Source: PubMed

ABSTRACT Hypertension is a major cardiovascular risk factor but most patients remain asymptomatic for many years. Successful therapy not only needs to be effective, it also needs to be well tolerated. beta-blockers are well established as effective antihypertensive agents. However, one major drawback to the currently available beta-blockers, particularly the noncardioselective beta-blockers, is their side-effect profile, including sexual dysfunction, fatigue, depression and metabolic abnormalities such as impaired glucose tolerance and lipid abnormalities. Nebivolol (Bystolic), a novel, highly cardioselective, third-generation beta-blocker that recently received approval by the US FDA for the treatment of hypertension in the USA, is effective in treating blood pressure and has a favorable side-effect profile. Studies conducted in Europe, where nebivolol has been available for some time for the treatment of hypertension, have shown that nebivolol achieves blood pressure reductions comparable to other beta-blockers but with fewer side effects. Additionally, nebivolol has demonstrated similar efficacy in blood pressure reduction when compared with calcium channel blockers and inhibitors of the renin-angiotensin system. When combined with hydrochlorothiazide there was an additive antihypertensive effect. Lastly, nebivolol exhibits a vasodilatory property that is related to its effect on nitric oxide, an intrinsic vasodilator produced in the vascular endothelium. Nebivolol enhances nitric oxide bioavailability. Studies have also demonstrated nebivolol's ability to function as an antioxidant and decrease markers of oxidative stress. These effects are believed to ultimately produce a modulation of the endothelial dysfunction typically seen in hypertension.

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    ABSTRACT: Nebivolol is a novel, beta1-adrenergic receptor blocker with vasodilatory properties mediated through the activation of the L-arginine/nitric oxide pathway. Short-term randomized clinical trials have demonstrated that nebivolol has antihypertensive efficacy benefits comparable to other beta blockers but with a favorable safety and tolerability profile. The long-term safety and efficacy results of oral nebivolol (5, 10, or 20 mg) 1 time/day, as monotherapy or in combination with other antihypertensive agents, were assessed in a double-blind, multicenter, 9-month extension study of 3 phase III, double-blind, 3-month trials in patients with stage I to II hypertension (mean sitting diastolic blood pressures [BPs]>or=95 and <or=109 mm Hg). Patients were eligible for entry if they had completed 1 of 3 feeder trials of nebivolol monotherapy (1.25 to 40 mg) 1 time/day. Dose titration and use of additional antihypertensive agents were used to achieve a diastolic BP goal of <90 mm Hg. The primary efficacy end point was change in diastolic BP at trough compared with baseline of the feeder study. Of the 845 patients entering this study, 607 patients (72%) were receiving nebivolol monotherapy, 206 patients (24%) were taking nebivolol plus diuretic, 21 patients (2%) were taking nebivolol plus calcium channel blocker, and 11 patients (1%) were taking nebivolol plus other antihypertensive medication at study end. Patients receiving nebivolol monotherapy had decreases in diastolic and systolic BPs of 15.0 and 14.8 mm Hg, respectively. More than 78% of patients were responders to nebivolol monotherapy, and 65% were responders to combination with a diuretic. Overall incidence of adverse events in the extension study was comparable to that seen in the feeder studies and decreased over time. In conclusion, the results demonstrate that nebivolol is a safe and effective antihypertensive therapy that provides long-term BP-lowering effects with a favorable tolerability profile.
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