Mathew Ninan T
Houston Headache Clinic, Texas 77004, USA.
Clin Ther. 2002 Apr;24(4):520-9. doi: 10.1016/s0149-2918(02)85128-1.
Almotriptan malate is a recently marketed triptan for the treatment of acute migraine. Results from controlled clinical trials demonstrate efficacy superior to placebo and an adverse event rate comparable to that with placebo.
The goal of this study was to assess the effect of oral almotriptan on the use of rescue medication in the treatment of acute migraine attacks.
Three Phase II and III, placebo-controlled, randomized, double-blind studies of almotriptan used as the basis for regulatory approval of the drug were included in the analysis. Two studies (1 single dose, 1 multiple dose) assessed almotriptan 6.25 mg and 12.5 mg and a third compared almotriptan 12.5 mg and sumatriptan 100 mg. Primary results from all 3 trials were previously published. Rescue medication was permitted if migraine pain had not decreased to mild severity or to no pain at 2 hours after study medication. The primary end point of this analysis was use of rescue medication.
A total of 1777 patients were included in the analysis. Mean patient age ranged from 39.4 to 44.0 years; approximately 87% were women, and >98% were white. Patients were well matched for demographic characteristics. Overall, use of rescue medication was significantly lower with almotriptan 6.25 mg and 12.5 mg compared with placebo (P < or = 0.05 for each group). No significant difference was noted between the almotriptan 12.5-mg and sumatriptan 100-mg groups. In 2 of the studies, patients with moderate or severe baseline pain used significantly less rescue medication in the almotriptan groups compared with placebo.
Oral almotriptan 6.25 mg or 12.5 mg significantly reduced use of rescue medication compared with placebo among patients with acute migraine. Use of rescue medication was comparable with almotriptan 12.5 mg and sumatriptan 100 mg.
苹果酸阿莫曲坦是一种近期上市的用于治疗急性偏头痛的曲坦类药物。对照临床试验结果显示其疗效优于安慰剂，且不良事件发生率与安慰剂相当。
本研究旨在评估口服苹果酸阿莫曲坦在急性偏头痛发作治疗中对急救药物使用的影响。
三项作为该药物监管批准依据的Ⅱ期和Ⅲ期、安慰剂对照、随机、双盲研究纳入了分析。两项研究（一项单剂量，一项多剂量）评估了6.25毫克和12.5毫克的苹果酸阿莫曲坦，第三项研究比较了12.5毫克的苹果酸阿莫曲坦和100毫克的舒马曲坦。所有三项试验的主要结果此前已发表。如果在服用研究药物2小时后偏头痛疼痛未减轻至轻度或无痛，则允许使用急救药物。本分析的主要终点是急救药物的使用情况。
共有1777例患者纳入分析。患者平均年龄在39.4岁至44.0岁之间；约87%为女性，超过98%为白人。患者在人口统计学特征方面匹配良好。总体而言，与安慰剂相比，6.25毫克和12.5毫克的苹果酸阿莫曲坦组急救药物的使用显著更低（每组P≤0.05）。12.5毫克的苹果酸阿莫曲坦组和100毫克的舒马曲坦组之间未观察到显著差异。在两项研究中，与安慰剂相比，基线疼痛为中度或重度的患者在苹果酸阿莫曲坦组中使用的急救药物显著更少。
与安慰剂相比，口服6.25毫克或12.5毫克的苹果酸阿莫曲坦可显著减少急性偏头痛患者急救药物的使用。12.5毫克的苹果酸阿莫曲坦和100毫克的舒马曲坦在急救药物使用方面相当。
