1. Hypertensive men treated with beta-blockers frequently complain of erectile dysfunction. The present study investigated the effects of two beta(1)-adrenoceptor-selective antagonists, namely nebivolol and metoprolol, on erectile function in hypertensive men. 2. Male out-patients (age range 40-55 years) with newly diagnosed or existing stage 1 essential hypertension (mean seated systolic blood pressure 140-159 mmHg; diastolic blood pressure 90-99 mmHg) were enrolled in the study. All patients lived in a stable, heterosexual partnership and had no history of sexual dysfunction. After a 2-week placebo run-in period, patients were randomized double-blind to either Treatment group A (comprising nebivolol 5 mg once daily for 12 weeks, followed by placebo for 2 weeks and then metoprolol succinate 95 mg once daily for 12 weeks) or Treatment group B (comprising metoprolol succinate 95 mg for 12 weeks, placebo for 2 weeks and then nebivolol 5 mg for 12 weeks). An international index of erectile function (IIEF) questionnaire and a diary documented patients' sexual function and activity. 3. Nebivolol and metoprolol lowered blood pressure to a similar extent. Metoprolol, but not nebivolol, significantly decreased the IIEF erectile function subscore by 0.92 in the first 8 weeks after onset of beta-blocker treatment. In contrast with metoprolol, nebivolol improved secondary sexual activity scores and other IIEF subscores. 4. Despite similar antihypertensive efficacy of the cardioselective beta(1)-adrenoceptor antagonists nebivolol and metoprolol, nebivolol may offer additional benefits by avoiding erectile dysfunction in male hypertensive patients on long-term beta-adrenoceptor antagonist therapy.
Nebivolol has been adequately tested in clinical efficacy trials of patients with mild hypertension. Clinical efficacy trials or their meta-analyses did not accurately predict the outcome of subsequent large studies. The primary objective was to assess the efficacy/safety of nebivolol 5-10 mg daily in a nationwide study of patients with mild hypertension. Secondary objectives were (1) to compare efficacy/safety as monotherapy versus add-on therapy and (2) to assess the effect of nebivolol on ISH. This was an open-label, 6-week follow-up study of 6,356 patients with mild hypertension or ISH, as defined by the 1999 World Health Organization guidelines, recruited from 2,700 facilities. Previous monotherapies were continued except for beta-blockers. Results are reported as means+/-SDs. Intention-to-treat analysis is given. A total of 5,740 patients completed the study; of the withdrawals, 90% were lost for follow-up or were noncompliant, 38% were untreated before, 23% had beta-blockers. In the accumulated data, mean systolic and diastolic blood pressures fell by 24+/-14 and 13+/-9 mm Hg (both P<0.001). The differences between the blood pressure-reducing effects of nebivolol monotherapy and add-on therapy were not statistically significant: 28+/-16 and 22+/-14 mm Hg for systolic and 15+/-11 and 11+/-8 mm Hg for diastolic blood pressures. Adverse events were limited to 0.5% of the patients, no serious adverse events were observed. In the ISH patients, diastolic blood pressure fell by 4+/-6 mm Hg compared with 15+/-10 mm Hg in the no-ISH patients (P<0.01). Efficacy-safety effects of nebivolol in patients with mild hypertension can be generalized in a nationwide assessment. The efficacy of nebivolol as monotherapy and as the efficacy as add-on therapy are very similar. Nebivolol is highly efficacious in patients with ISH.
Objective.-To evaluate the efficacy of oral treatment with nebivolol and metoprolol in the prophylaxis of migraine attacks.Background.-b-Blockers such as propranolol and metoprolol are known to be effective in preventing migraine attacks. Following earlier observations of successful use of nebivolol in a few hypertensive patients with concomitant migraine, we conducted a prospective study to ascertain whether nebivolol would be effective and better tolerated, in a methodologically strict, randomized and double-blind setting.Design and Methods.-Randomized, double-blind study in 30 patients with confirmed migraine diagnosis, a minimum 1-year history, onset prior to 50 years of age, written records of attacks for the previous 3 months, and minimum 2 attacks per month. Primary endpoint was frequency of attacks (prevention of migraine attacks) in the final 4 weeks of a 14-week treatment on full dose of metoprolol and nebivolol. Secondary endpoints were time to therapeutic effect, duration of attacks, intensity of headache, consumption of analgesics, evaluation of accompanying symptoms, migraine disability assessment, clinical global impression, quality of life, and responder rates. The statistical analysis was prospectively planned and conducted for all randomized patients.Results.-Both metoprolol and nebivolol where similarly effective regarding the main endpoint (prevention of migraine attacks) as well as the secondary ones, and both had a fast onset of action, typically within 4 weeks from starting therapy, with responder rates increasing relatively little over time after the first 4 weeks. Use of acute pain medication decreased on both drugs, as well as accompanying symptoms. Both patients' and physicians' evaluations of disability and disease status were similarly favorable to the 2 treatments. Regarding safety, nebivolol was considerably better tolerated than metoprolol in terms of all reported events, treatment-related events, and event severity.Conclusions.-Our results suggest that nebivolol is as effective as metoprolol in the prophylaxis of migraine attacks, with the advantages of being better tolerated and not requiring up-titration to achieve therapeutic levels. Further and larger trials should be conducted on nebivolol in the prevention of migraine attacks as it may provide an improvement in current migraine prophylaxis with b-blockers.
The study commenced in July 2007. Results are anticipated in December 2008.
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