Diener Hans-Christoph, Gendolla Astrid, Gebert Irmingard, Beneke Manfred
Department of Neurology, University Essen, Germany.
Eur Neurol. 2005;53 Suppl 1:41-8. doi: 10.1159/000085061. Epub 2005 May 3.
To investigate the efficacy and tolerability of almotriptan 12.5 mg in migraine patients who respond poorly to sumatriptan 50 mg.
Poor response to sumatriptan therapy for acute migraine attacks has been documented in the literature, but few controlled trials have investigated the efficacy of an alternative triptan in this subgroup of patients.
Patients with an International Headache Society diagnosis of migraine who self-described as experiencing at least two unsatisfactory responses to sumatriptan treated their first migraine attack with open-label sumatriptan 50 mg. Patients who did not achieve 2-hour pain relief (improvement of headache from moderate/severe to mild/no headache) were then randomized to treat their second attack with almotriptan 12.5 mg or placebo under double-blind conditions.
In the first attack, 221 of 302 participants (73%) did not achieve 2-hour pain relief with sumatriptan and were randomized to treatment of their second attack with almotriptan 12.5 mg or placebo. Of the 198 sumatriptan nonresponders who treated their second attack (99 almotriptan; 99 placebo), 70% had severe headache pain at baseline. Two-hour pain-relief rates were significantly higher with almotriptan compared to placebo (47.5 vs. 23.2%; p < 0.001). A significant treatment effect for almotriptan was also seen in pain-free rates at 2 h (33.3 vs. 14.1%; p < 0.005) and sustained freedom from pain (20.9 vs. 9.0%; p < 0.05). In the second attack, 7.1% of patients in the almotriptan group experienced adverse events compared to 5.1% in the placebo group (p = 0.77).
Almotriptan 12.5 mg is an effective and well-tolerated alternative for patients who respond poorly to sumatriptan 50 mg. A poor response to one triptan does not predict a poor response to other agents in that class.
研究12.5毫克阿莫曲坦对50毫克舒马曲坦反应不佳的偏头痛患者的疗效和耐受性。
文献中已记载急性偏头痛发作对舒马曲坦治疗反应不佳的情况，但很少有对照试验研究替代曲坦类药物在该亚组患者中的疗效。
国际头痛协会诊断为偏头痛且自述对舒马曲坦至少有两次治疗反应不佳的患者，用开放标签的50毫克舒马曲坦治疗其首次偏头痛发作。未实现2小时疼痛缓解（头痛从中度/重度改善为轻度/无头痛）的患者，随后被随机分为在双盲条件下用12.5毫克阿莫曲坦或安慰剂治疗其第二次发作。
在首次发作中，302名参与者中有221名（73%）使用舒马曲坦未实现2小时疼痛缓解，并被随机分为用12.5毫克阿莫曲坦或安慰剂治疗其第二次发作。在治疗第二次发作的198名舒马曲坦无反应者中（99名使用阿莫曲坦；99名使用安慰剂），70%在基线时有严重头痛疼痛。与安慰剂相比，阿莫曲坦的2小时疼痛缓解率显著更高（47.5%对23.2%；p<0.001）。在2小时无痛率（33.3%对14.1%；p<0.005）和持续无痛（20.9%对9.0%；p<0.05）方面，也观察到阿莫曲坦有显著的治疗效果。在第二次发作中，阿莫曲坦组7.1%的患者出现不良事件，而安慰剂组为5.1%（p = 0.77）。
12.5毫克阿莫曲坦对50毫克舒马曲坦反应不佳的患者是一种有效且耐受性良好的替代药物。对一种曲坦类药物反应不佳并不能预测对该类其他药物反应不佳。
