Spierings E L, Gomez-Mancilla B, Grosz D E, Rowland C R, Whaley F S, Jirgens K J
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Arch Neurol. 2001 Jun;58(6):944-50. doi: 10.1001/archneur.58.6.944.
Almotriptan malate is a novel, selective serotonin(1B/D) agonist, or triptan, developed for the abortive treatment of migraine. In double-blind, placebo-controlled studies, it has been shown to be effective, well tolerated, and safe.
To compare the efficacy, tolerability, and safety of almotriptan with that of the "standard triptan," sumatriptan succinate. The power calculation of the study was based on 24-hour headache recurrence, an efficacy measure in the abortive treatment of migraine, and on the occurrence of adverse events.
Subjects, aged between18 and 65 years, with migraine with or without aura but otherwise healthy, were randomized to take orally either almotriptan malate, 12.5 mg, or sumatriptan succinate, 50 mg. The medications were provided in identical-looking capsules to ensure blinding and were taken for the treatment of moderate or severe headache. Efficacy was determined in terms of (1) headache relief-a decrease in pain intensity to mild or no pain; (2) headache freedom-a decrease to no pain; (3) use of rescue medications, allowed after 2 hours; and (4) headache recurrence-moderate or severe pain returning within 24 hours after headache relief at 2 hours. Adverse events were collected for 96 hours after treatment and for safety evaluation, vital signs, blood tests, and electrocardiograms were performed at the screening and exit visits.
Seventy-five investigators enrolled 1255 subjects of whom 1173 were treated (591 with almotriptan and 582 with sumatriptan). At 2 hours, almotriptan treatment provided headache relief in 58.0% of the subjects and sumatriptan treatment in 57.3%; headache freedom was provided by the medications in 17.9% and 24.6%, respectively (P =.005). Rescue medications were taken by 36.7% of the subjects in the almotriptan-treated group and by 33.2% in the sumatriptan-treated group; headaches returned to moderate or severe intensity in 27.4% and 24.0%, respectively. Treatment-emergent adverse events occurred in 15.2% of the subjects in the almotriptan-treated group and in 19.4% in the sumatriptan-treated group (P =.06); treatment-related adverse events occurred in 9.1% and 15.5% of the subjects, respectively (P =.001), including chest pain, which occurred in 0.3% and 2.2%, respectively (P =.004).
Almotriptan and sumatriptan are similarly effective in the abortive treatment of moderate or severe migraine headache; they are also similarly well tolerated and safe.
苹果酸阿莫曲坦是一种新型的选择性5-羟色胺（1B/D）激动剂，即曲坦类药物，用于偏头痛的发作期治疗。在双盲、安慰剂对照研究中，已证明其有效、耐受性良好且安全。
比较苹果酸阿莫曲坦与“标准曲坦类药物”琥珀酸舒马曲坦的疗效、耐受性和安全性。该研究的功效计算基于24小时头痛复发情况（偏头痛发作期治疗的一项疗效指标）以及不良事件的发生情况。
年龄在18至65岁之间、患有或不患有先兆的偏头痛但其他方面健康的受试者被随机分为口服12.5毫克苹果酸阿莫曲坦或50毫克琥珀酸舒马曲坦两组。药物装在外观相同的胶囊中以确保盲法，用于治疗中度或重度头痛。疗效通过以下方面确定：（1）头痛缓解——疼痛强度减轻至轻度或无痛；（2）头痛消失——疼痛减轻至无痛；（3）2小时后允许使用急救药物；（4）头痛复发——头痛缓解2小时后24小时内再次出现中度或重度疼痛。治疗后96小时收集不良事件，为进行安全性评估，在筛查和退出访视时测量生命体征、进行血液检查和心电图检查。
75名研究者招募了1255名受试者，其中1173名接受了治疗（591名服用苹果酸阿莫曲坦，582名服用琥珀酸舒马曲坦）。2小时时，苹果酸阿莫曲坦治疗组58.0%的受试者头痛得到缓解，琥珀酸舒马曲坦治疗组为57.3%；药物使头痛消失的比例分别为17.9%和24.6%（P = 0.0 05）。苹果酸阿莫曲坦治疗组36.7%的受试者使用了急救药物，琥珀酸舒马曲坦治疗组为33.2%；头痛分别在27.4%和24.0%的受试者中恢复到中度或重度强度。苹果酸阿莫曲坦治疗组15.2%的受试者出现治疗中出现的不良事件，琥珀酸舒马曲坦治疗组为19.4%（P = 0.06）；与治疗相关的不良事件分别发生在9.1%和15.5%的受试者中（P = 0.0 01），包括胸痛，分别发生在0.3%和2.2%的受试者中（P = 0.0 04）。
苹果酸阿莫曲坦和琥珀酸舒马曲坦在中度或重度偏头痛发作期治疗中的疗效相似；它们的耐受性和安全性也相似。
