Early vs. non-early intervention in acute migraine - 'Act when Mild (AwM)'. A double-blind, placebo-controlled trial of almotriptan
Early vs. non-early intervention in acute migraine - 'Act when Mild (AwM)'. A double-blind, placebo-controlled trial of almotriptan
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DOI：
10.1111/j.1468-2982.2008.01546.x
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发表时间：
2008-04-01
期刊：
影响因子：
4.9
通讯作者：
Fortea, J.
中科院分区：
文献类型：
--
作者：
Goadsby, P. J.;Zanchin, G.;Fortea, J.
该研究旨在比较偏头痛患者在发作过程中早期服用药物与在疼痛变得中度或重度后服用药物时对阿莫曲坦的反应。进行了一项随机、四臂、多中心、多国、双盲、安慰剂对照的阿莫曲坦（12.5 mg）试验，比较头痛发作1小时内疼痛强度为轻度时与中度或重度疼痛时的治疗给药。在入组的491例偏头痛患者中，403例可评价[意向治疗人群（ITT）]。他们的平均年龄为38岁，84%为女性，平均每月发作3.7次。在这些患者中，10%的患者没有根据其随机分配的基础疼痛强度（轻度或中度/重度）服用药物，随后被重新分配到该分析组-“轻度时采取行动（AwM）”组。在阿莫曲坦组中，53%的轻度基础疼痛患者和38%的中度/重度基础疼痛患者在2小时时疼痛消失（P = 0.03;主要终点）。安慰剂组的相应比例为25%和17%（与相应的阿莫曲坦组相比具有统计学显著性）。次要终点（ITT）也明显有利于早期干预阿莫曲坦，治疗组之间和治疗组之间，如持续无疼痛：45.6%对30.5%（P = 0.02）。所有组（NS）中< 5%的治疗患者报告了不良事件，无严重事件。与疼痛已达到更高严重程度时的治疗相比，偏头痛仍为轻度时用阿莫曲坦治疗提供了统计学显著和临床相关的疗效增强。
The study was designed to compare the response to almotriptan in migraine patients who take medication early in the course of the attack with that when medication is taken after pain has become moderate or severe. A randomized, four-arm, multicentre, multinational, double-blind, placebo-controlled trial of almotriptan (12.5 mg) comparing treatment administration when pain intensity was mild and within 1 h of headache onset vs. pain that had become moderate or severe was conducted. Of 491 migraineurs enrolled, 403 were evaluable [intention-to-treat population (ITT)]. Their mean age was 38 years, 84% were female and they had a mean of 3.7 attacks/month. Of these patients, 10% did not take medication according to their randomly allocated basal pain intensity (mild or moderate/severe) and were subsequently reassigned to that group for this analysis-'Act when Mild (AwM)' group. In the almotriptan arms, 53% of mild basal pain and 38% of moderate/severe basal pain patients were pain free at 2 h (P = 0.03; primary end-point). Corresponding proportions in the placebo groups were 25% and 17% (statistically significant vs. respective almotriptan arms). Secondary end-points (ITT) were also significantly in favour of early intervention with almotriptan, both between and across treatment groups, such as sustained pain free: 45.6% vs. 30.5% (P = 0.02). Adverse events were reported in < 5% of treated patients in all groups (NS), with no serious events. Treatment with almotriptan while migraine pain is still mild provides statistically significant and clinically relevant enhancements in efficacy compared with treatment when pain has reached higher severity levels.