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首页> 外文期刊>Clinical therapeutics >A review of the effects of almotriptan and other triptans on clinical trial outcomes that are meaningful to patients with migraine.
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A review of the effects of almotriptan and other triptans on clinical trial outcomes that are meaningful to patients with migraine.

机译：综述阿莫曲坦和其他曲普坦对偏头痛患者有意义的临床试验结果的影响。

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BACKGROUND: Traditional end points in clinical trials of migraine therapy, such as 2-hour pain response, may not fully address the outcomes patients consider most important: rapid and sustained freedom from pain over 24 hours, and a low, placebo-like incidence of adverse events. A composite efficacy measure such as the sustained pain-free rate (no pain by 2 hours after dosing, no recurrence, no use of rescue medication from 2 to 24 hours after dosing) may be more appropriate. OBJECTIVE: Clinically relevant differences between almotriptan and other triptans were reviewed in the context of the attributes of acute migraine treatment that patients consider most important. METHODS: This review was based on published reports of open-label and placebo-controlled clinical trials of almotriptan, results of a survey concerning the attributes patients consider most important in a migraine medication, and a published meta-analysis of 53 placebo-controlled clinical trials of triptans involving >24,000 patients. RESULTS: Almotriptan was effective and well tolerated in the placebo-controlled clinical trials; results of the 6- and 12-month open-label studies supported its good tolerability profile. A respective 87% and 86% of respondents to the patient survey indicated that they considered complete freedom from pain and no recurrence among the most important attributes of migraine treatment, both of which are included in the sustained pain-free rate. In the meta-analysis, almotriptan had a favorable efficacy and tolerability profile compared with other triptans, particularly with respect to sustained pain-free rate, which was significantly higher with almotriptan 12.5 mg compared with sumatriptan 100 mg (25.9% vs 20.0%, respectively; P < 0.05). In addition, the placebo-subtracted rate of adverse events was significantly lower with almotriptan compared with sumatriptan (1.8% vs 4.4%, respectively; P < 0.05). Results of a head-to-head placebo-controlled trial of almotriptan 12.5 mg and sumatriptan 100 mg supported the balance of efficacy and tolerability observed for almotriptan in the meta-analysis. CONCLUSIONS: Data from clinical trials suggest that almotriptan is effective and well tolerated in the treatment of acute migraine pain. Based on a sustained pain-free rate that is among the highest and an adverse-event rate that is among the lowest for the triptans, almotriptan represents a therapeutic option for the initial treatment of acute migraine with or without aura.
机译：背景：偏头痛治疗的临床试验中的传统终点指标（例如2小时疼痛反应）可能无法完全解决患者认为最重要的结果：24小时内快速且持续地摆脱疼痛，并且安慰剂样发生率低不良事件。诸如持续无痛率（给药后2小时内无疼痛，无复发，给药后2至24小时内不使用急救药物）等综合疗效指标可能更合适。目的：根据患者认为最重要的急性偏头痛治疗的特点，回顾了阿莫曲普坦与其他曲普坦之间的临床相关差异。方法：本综述基于阿莫曲坦的公开标签和安慰剂对照临床试验的公开报道，有关患者认为偏头痛药物最重要的属性的调查结果以及对53种安慰剂对照临床的已发表荟萃分析曲坦类药物涉及24,000多例患者的临床试验。结果：阿莫曲坦在安慰剂对照的临床试验中有效且耐受性良好。 6和12个月开放标签研究的结果支持了其良好的耐受性。分别有87％和86％的患者调查受访者表示，他们认为完全无痛苦且无复发是偏头痛治疗的最重要属性，两者均包括在持续无痛率中。在荟萃分析中，与其他曲普坦相比，阿莫曲坦具有良好的疗效和耐受性，特别是在持续无痛率方面，阿莫曲坦12.5 mg与舒马曲坦100 mg显着更高（分别为25.9％和20.0％） ; P <0.05）。此外，与舒马曲坦相比，阿莫曲坦组的安慰剂减去不良事件发生率显着降低（分别为1.8％和4.4％; P <0.05）。 12.5 mg阿莫曲普坦和100 mg舒马普坦的头对头安慰剂对照试验的结果支持荟萃分析中观察到的阿莫曲普坦功效与耐受性之间的平衡。结论：来自临床试验的数据表明，阿莫曲坦在治疗急性偏头痛方面有效且耐受性良好。基于曲普坦类药物的持续无痛发生率最高，而不良事件发生率则最低，阿莫曲坦代表了初始治疗有或没有先兆的急性偏头痛的治疗选择。

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