Abstract
Background and objective
Lowering BP to normal levels without quality of life deterioration is the most important means of reducing cardiovascular risk. Recent studies have challenged the position of β-adrenoceptor antagonists (β-blockers) as first-line antihypertensive drugs. Nebivolol is a third-generation, highly selective β1-blocker that causes vasodilation through nitric oxide (NO) release. This meta-analysis investigates the efficacy and tolerability of nebivolol compared with other antihypertensive drugs and placebo in patients with hypertension.
Methods
Twelve randomized controlled studies were included in which nebivolol 5 mg once daily was compared with the recommended clinical doses of other antihypertensive drugs (n = 9), placebo (n = 2), and both (n = 1). The clinical studies were selected after a MEDLINE search up to 2007 using the key words ‘nebivolol’ and ‘hypertension.’
Results
Antihypertensive response rates (the percentage of patients achieving target BP levels or a defined DBP reduction) were higher with nebivolol than with ACE inhibitors (odds ratio [OR] 1.92; p = 0.001) and all antihypertensive drugs combined (OR 1.41; p = 0.001) and similar to β-blockers, calcium channel antagonists (CCAs) and the angiotensin receptor antagonist (ARA) losartan. Moreover, a higher percentage of patients receiving nebivolol achieved target BP levels compared with patients treated with losartan (OR 1.98; p = 0.004), CCAs (OR 1.44; p = 0.024), and all antihypertensive drugs combined (OR 1.35; p = 0.012). The percentage of patients experiencing adverse events did not differ between nebivolol and placebo; adverse event rates were significantly lower with nebivolol than losartan (OR 0.52; p = 0.016), other β-blockers (OR 0.56; p = 0.007), nifedipine (OR 0.49; p < 0.001), and all antihypertensive drugs combined (OR 0.59; p < 0.001).
Conclusion
Results of previous pharmacokinetic studies suggest that nebivolol 5 mg may not conform completely to the definition of a classic β-blocker demonstrating additional antihypertensive effect due to endothelial NO release-mediated vasodilation. This meta-analysis showed that nebivolol 5 mg achieved similar or better rates of treatment response and BP normalization than other drug classes and other antihypertensive drugs combined, with similar tolerability to placebo and significantly better tolerability than losartan, CCAs, other β-blockers, and all antihypertensive drugs combined. Although not definitive, this meta-analysis suggests that nebivolol 5 mg is likely to have advantages over existing antihypertensives and may have a role in the first-line treatment of hypertension.
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Acknowledgments
Editorial assistance was provided by Wolters Kluwer Health. No sources of funding were used to assist in the preparation of this study. Professor Van Bortel has received honoraria from Menarini for presentations on nebivolol and nitric oxide at scientific meetings. Dr Mascagni has provided statistical expertise to Menarini for nebivolol.
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Van Bortel, L.M., Fici, F. & Mascagni, F. Efficacy and Tolerability of Nebivolol Compared with Other Antihypertensive Drugs. Am J Cardiovasc Drugs 8, 35–44 (2008). https://doi.org/10.2165/00129784-200808010-00005
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DOI: https://doi.org/10.2165/00129784-200808010-00005