ObjectiveTo study the efficacy and safety of lasmiditan for acute treatment of migraine in patients using migraine preventive medications.BackgroundWhile lasmiditan has been proven to be an effective acute treatment for migraine, its effectiveness has not been examined when used concurrently with migraine preventives.MethodsSAMURAI and SPARTAN were similarly designed, double-blind, phase 3, placebo-controlled studies of patients 18 years or older with 3 to 8 migraine attacks per month. Patients were randomized to treat a migraine attack with oral lasmiditan 50 mg (SPARTAN only), 100 mg, 200 mg, or placebo. Migraine preventives were allowed as long as doses were stable for 3 months prior to screening and were unchanged during the study. Preventive medications with established or probable efficacy, as recommended by the American Academy of Neurology, the American Headache Society, and the European Headache Federation, plus botulinum toxin type A and candesartan, were included. Within the subgroups of patients using and not using preventive therapies, lasmiditan and placebo groups were analyzed for the outcome of pain-free at 2 h and other efficacy outcomes. The subgroups of patients using and not using preventive therapies were compared and interaction p-values were calculated for safety and efficacy outcomes.ResultsIn these trials, 698 of 3981 patients (17.5%) used migraine preventive treatments. Among patients using preventives, all lasmiditan doses resulted in significantly more patients being pain-free at 2 h, compared to placebo (p < 0.05). Primary efficacy outcome (pain-free at 2 h), key secondary outcome (most bothersome symptom-free at 2 h) and all other efficacy outcomes were not significantly different between patients using or not using migraine preventives (all interaction p-values ≥0.1). Rates of adverse events were similar for patients using and not using preventive medications.ConclusionsLasmiditan was more effective than placebo for the acute treatment of migraine in patients concurrently using migraine preventive medications. Lasmiditan efficacy and safety measures were similar for patients using and not using preventive medications.Trial registrationSAMURAI (NCT02439320) and SPARTAN (NCT02605174). Registered 18 March 2015.

中文翻译：

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lasmiditan 在同时使用偏头痛预防药物的患者中的疗效和安全性：来自 SAMURAI 和 SPARTAN 的结果，两项随机 3 期试验

目的研究lasmiditan用于偏头痛预防药物患者急性偏头痛的疗效和安全性。背景虽然lasmiditan已被证明是一种有效的偏头痛急性治疗，但其与偏头痛预防药物同时使用时的有效性尚未得到验证。方法SAMURAI和SPARTAN是类似设计的、双盲、3 期、安慰剂对照研究，对 18 岁或以上、每月偏头痛发作 3 至 8 次的患者进行。患者随机接受口服 lasmiditan 50 mg（仅 SPARTAN）、100 mg、200 mg 或安慰剂治疗偏头痛发作。只要在筛选前 3 个月内剂量稳定并且在研究期间保持不变，就允许使用偏头痛预防剂。根据美国神经病学学会的建议，具有确定或可能有效的预防性药物，包括美国头痛协会和欧洲头痛联合会，以及 A 型肉毒杆菌毒素和坎地沙坦。在使用和不使用预防性治疗的患者亚组中，分析了 lasmiditan 和安慰剂组的 2 小时无痛结果和其他疗效结果。比较了使用和不使用预防性治疗的患者亚组，并计算了安全性和有效性结果的相互作用 p 值。结果在这些试验中，3981 名患者中有 698 名 (17.5%) 使用了偏头痛预防性治疗。在使用预防药物的患者中，与安慰剂相比，所有 lasmiditan 剂量导致更多的患者在 2 小时时无痛（p < 0.05）。主要疗效结果（2 小时无痛），使用或不使用偏头痛预防剂的患者之间的关键次要结果（最令人烦恼的 2 小时无症状）和所有其他疗效结果没有显着差异（所有相互作用 p 值≥0.1）。使用和不使用预防药物的患者的不良事件发生率相似。结论对于同时使用偏头痛预防药物的患者的偏头痛急性治疗，Lasmiditan 比安慰剂更有效。Lasmiditan 的疗效和安全措施对使用和不使用预防药物的患者相似。试验注册 SAMURAI (NCT02439320) 和 SPARTAN (NCT02605174)。2015 年 3 月 18 日注册。使用和不使用预防药物的患者的不良事件发生率相似。结论对于同时使用偏头痛预防药物的患者的偏头痛急性治疗，Lasmiditan 比安慰剂更有效。Lasmiditan 的疗效和安全措施对使用和不使用预防药物的患者相似。试验注册 SAMURAI (NCT02439320) 和 SPARTAN (NCT02605174)。2015 年 3 月 18 日注册。使用和不使用预防药物的患者的不良事件发生率相似。结论对于同时使用偏头痛预防药物的患者的偏头痛急性治疗，Lasmiditan 比安慰剂更有效。Lasmiditan 的疗效和安全措施对使用和不使用预防药物的患者相似。试验注册 SAMURAI (NCT02439320) 和 SPARTAN (NCT02605174)。2015 年 3 月 18 日注册。