Abstract
Objective: The aim of the present study was to evaluate the antihypertensive efficacy of the highly beta1-selective adrenergic antagonist nebivolol in comparison with bisoprolol in the treatment of mild to moderate essential hypertension.
Methods: This multicenter, single-blind, randomized, parallel-group 16-week study involved a 4-week placebo run-in, followed by a 12-week treatment period (5 mg nebivolol or 5 mg bisoprolol). Patients (n = 273) eligible for the study had a sitting diastolic blood pressure (DBP) between 95 and 110 mm Hg and a systolic blood pressure (SBP) ≤180 mm Hg at the end of the placebo run-in period. The primary endpoint of the study was the percentage of responders achieving DBP normalization (≤90 mm Hg) or a DBP reduction of at least 10 mm Hg.
Results: The baseline SBP and DBP were similar in the two groups. Both SBP and DBP decreased gradually and significantly upon treatment. The two treatments had similar effects on the mean change from the baseline for both DBP (nebivolol −15.7 ± 6.4 mm Hg vs. bisoprolol −16.0 ± 6.8 mm Hg) and SBP. A high proportion of responders was noted in both groups (nebivolol 92.0% vs. bisoprolol 89.6%) and there was no significant difference between the treatments. The overall number and incidence of spontaneously reported adverse events were slightly, but not significantly lower for nebivolol (8 events; 5.8%) than for bisoprolol (12 events; 8.9%).
Conclusions: The findings of the present trial indicate that 5 mg nebivolol once daily is an effective antihypertensive agent. It can therefore be recommended as a useful alternative first-line treatment option for the management of patients with mild to moderate essential hypertension.
Similar content being viewed by others
References
Opie LH. Beta-blocking agents. In: Drugs for the Heart. Philadelphia: Saunders, 2001:1-32.
Carvedilol Prospective Randomized Survival Study Group. Effects of carvedilol on survival in severe chronic heart failure. N Engl J Med 2001;344:1651-1658.
McNeelyW, Goa KL. Nebivolol in the management of essential hypertension. Drugs 1999;57:633-651.
Bowman AJ, Chen CPLH, Ford GA. Nitric oxide mediated venodilator effects of nebivolol. Br J Clin Pharmacol 1994;38:199-204.
Edes I, Chu G, Kranias EG. Sarcoplasmic reticulum Ca2+ transport. In: Sperelakis N, ed. Heart Physiology and Pathophysiology. San Diego: Academic Press, 2001:447-460.
Prichard BNC, Graham B, Cruickshank JM. Beta-blockers in the third millennium-when are they really indicated? J Clin Basic Cardiol 2001;4:3-9.
Cleophas TJ. Experimental evidence of selective antagonistic action of nebivolol on beta1-adrenergic receptors. J Clin Med 1998;2:2-8.
Pauwels PJ, Gompel PV, Leysen JE. Human β1-and β2-adrenergic receptor binding and mediated accumulation of cAMP in transfected chinese hamster ovary cells. Biochem Pharmacol 1991;42:1683-1689.
Maack C, Tyroller S, Schnabel P, et al. Characterization of β1-selectivity, adrenoceptor-Gs-protein interaction and inverse agonism of nebivolol in human myocardium. Br J Pharmacol 2001;132:1817-1826.
Bundkirchen A, Brixius K, Bölck B, Nguyen Q, Schwinger RHG. β1-adrenoreceptor selectivity of nebivolol and bisoprolol. A comparison of [3H]CGP 12.177 and [125I]iodocyanopindolol binding studies. Eur J Pharmacol 2003;460:19-26.
Dawes M, Brett SE, Chowienczyk PJ, Mant TGK, Ritter JM. The vasodilator action of nebivolol in forearm vasculature of subjects with essential hypertension. Br J Clin Pharmacol 1999;48:460-463.
Tzemos N, Lim PO, MacDonald TM. Nebivolol reverses endothelial dysfunction in essential hypertension: A randomized double blind, crossover study. Circulation 2001;104:511-514.
Broeders MAW, Doevendans PA, Bekkers B, et al. Nebivolol: A third-generation β-blocker that augments vascular nitric oxide release. Circulation 2000;102:677-684.
Lacourciere Y, Poirier L, Lefebvre J, Archambault F, Cleroux J. Comparative assessment of antihypertensive efficacy of DL-nebivolol and D-nebivolol in patients with confirmed mild to moderate hypertension. J Cardiovasc Pharmacol 1995;25:619-624.
Uhlir O. Nebivolol versus metoprolol in the treatment of hypertension. Drug Invest 1991;3(Suppl 1):107-110.
Ikeda M, Inagaki Y, Iimura O, Kuramoto K, Takeda T. Clinical evaluation of bisoprolol in patients with hypertension: Interim report. J Cardiovasc Pharmacol 1986;8(Suppl 11):S139-S142.
The Joint National Committee on prevention, detection, evaluation and treatment of high blood pressure. JNC VI 1999.
Lacourciere Y, Lefebvre J, Poirier L, ArchambaultF, Arnott W. Treatment of ambulatory hypertensives with nebivolol or hydrochlorothiazide alone and in combination. Am J Hypertens 1994;7:137-145.
Lacourciere Y, Poirier L, Lefebvre J, Provencher P, Arnott W. Comparative effect of a new cardioselective beta-blocker nebivolol and nifedipine sustained-release on 24-hour ambulatory blood pressure and plasma lipoproteins. J Clin Pharmacol 1992;32:660-666.
Simon G, Johnson ML. Comparison of antihypertensive and β1-adrenoreceptor antagonist effect of nebivolol and atenolol in essential hypertension. Clin Exp Hyperten 1993;15:501-509.
Van Nueten L, Taylor FR, Robertson JI. Nebivolol vs. Atenolol and placebo in essential hypertension: A double blind randomised trial. J Human Hypertension 1998;12:135-140.
Van Bortel LMAB, Breed JGS, Joosten J, Kragten A, Lustermans FA, Mooij JMV. Nebivolol in hypertension: A double blind placebo controlled multicenter study assessing its antihypertensive efficacy and impact on quality of life. J Cardiovasc Pharmacol 1993;21:856-862.
Mangrella M, Rossi F, Fici F, Rossi F. Pharmacology of nebivolol. Pharm Res 1998;38:419-431.
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Czuriga, I., Riecansky, I., Bodnar, J. et al. Comparison of the New Cardioselective Beta-Blocker Nebivolol with Bisoprolol in Hypertension: The Nebivolol, Bisoprolol Multicenter Study (NEBIS). Cardiovasc Drugs Ther 17, 257–263 (2003). https://doi.org/10.1023/A:1026180325278
Issue Date:
DOI: https://doi.org/10.1023/A:1026180325278