Schellenberg Rudiger, Lichtenthal Albert, Wöhling Heike, Graf Christine, Brixius Klara
Medical Institute for Health and Science, Hüttenberg, Germany.
Headache. 2008 Jan;48(1):118-25. doi: 10.1111/j.1526-4610.2007.00785.x.
To evaluate the efficacy of oral treatment with nebivolol and metoprolol in the prophylaxis of migraine attacks.
Beta-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.
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.
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.
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 beta-blockers.
评估口服奈必洛尔和美托洛尔预防偏头痛发作的疗效。
已知普萘洛尔和美托洛尔等β受体阻滞剂在预防偏头痛发作方面有效。在早期观察到少数伴有偏头痛的高血压患者使用奈必洛尔成功后,我们进行了一项前瞻性研究,以确定在方法严格、随机且双盲的情况下,奈必洛尔是否有效且耐受性更好。
对30例确诊偏头痛的患者进行随机、双盲研究,这些患者至少有1年病史,发病年龄在50岁之前,有前3个月发作的书面记录,且每月至少发作2次。主要终点是在14周全剂量美托洛尔和奈必洛尔治疗的最后4周内发作频率(预防偏头痛发作)。次要终点包括治疗起效时间、发作持续时间、头痛强度、镇痛药使用情况、伴随症状评估、偏头痛残疾评估、临床总体印象、生活质量和缓解率。对所有随机分组的患者进行了前瞻性计划和统计分析。
美托洛尔和奈必洛尔在主要终点(预防偏头痛发作)以及次要终点方面同样有效,且两者起效迅速,通常在开始治疗后4周内,缓解率在最初4周后随时间增加相对较少。两种药物使用的急性止痛药物以及伴随症状均减少。患者和医生对残疾和疾病状态的评估对两种治疗同样有利。在安全性方面,就所有报告事件、治疗相关事件和事件严重程度而言,奈必洛尔的耐受性明显优于美托洛尔。
我们的结果表明,奈必洛尔在预防偏头痛发作方面与美托洛尔同样有效,具有耐受性更好且无需滴定至治疗水平的优点。应进一步开展更大规模的试验研究奈必洛尔预防偏头痛发作的效果,因为它可能会改善目前β受体阻滞剂预防偏头痛的效果。