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Comparison of the new cardioselective beta-blocker nebivolol with bisoprolol in hypertension: the Nebivolol, Bisoprolol Multicenter Study (NEBIS).

Author(s): Czuriga I, Riecansky I, Bodnar J, Fulop T, Kruzsicz V, Kristof E, Edes I, For The NEBIS Investigators, NEBIS Investigators Group

Affiliation(s): Department of Cardiology, University of Debrecen, Hungary.

Publication date & source: 2003-05, Cardiovasc Drugs Ther., 17(3):257-63.

Publication type: Clinical Trial; Comparative Study ; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVES: The aim of the present study was to evaluate the antihypertensive efficacy of the highly beta(1)-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.

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