Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA.
MedStar Georgetown University Hospital, Washington D.C., USA.
J Headache Pain. 2019 Jul 24;20(1):84. doi: 10.1186/s10194-019-1032-x.
To study the efficacy and safety of lasmiditan for acute treatment of migraine in patients using migraine preventive medications.
While lasmiditan has been proven to be an effective acute treatment for migraine, its effectiveness has not been examined when used concurrently with migraine preventives.
SAMURAI 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.
In 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.
Lasmiditan 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.
SAMURAI (NCT02439320) and SPARTAN (NCT02605174). Registered 18 March 2015.
研究拉米替坦治疗使用偏头痛预防性药物的偏头痛急性发作的疗效和安全性。
虽然拉米替坦已被证明是一种有效的偏头痛急性治疗药物，但尚未研究其在与偏头痛预防性药物同时使用时的有效性。
SAMURAI 和 SPARTAN 是两项设计相同、双盲、安慰剂对照的 3 期临床试验，纳入年龄 18 岁及以上、每月偏头痛发作 3 至 8 次的患者。患者随机接受口服拉米替坦 50mg（仅 SPARTAN）、100mg、200mg 或安慰剂治疗偏头痛发作。允许使用偏头痛预防性药物，但前提是在筛选前 3 个月内剂量稳定且在研究期间不变。根据美国神经病学学会、美国头痛学会和欧洲头痛联合会的建议，包括具有明确或可能疗效的预防性药物，外加肉毒杆菌毒素 A 和坎地沙坦。纳入预防治疗药物包括正在使用和未使用预防性治疗药物的患者亚组，对拉米替坦和安慰剂组的 2 小时无疼痛和其他疗效结局进行分析。比较正在使用和未使用预防性治疗药物的患者亚组，并计算安全性和疗效结局的交互 p 值。
在这两项试验中，3981 例患者中有 698 例（17.5%）使用偏头痛预防性治疗药物。在使用预防性药物的患者中，与安慰剂相比，所有拉米替坦剂量在 2 小时时无疼痛的患者比例均显著更高（p<0.05）。主要疗效结局（2 小时无疼痛）、关键次要结局（2 小时时最困扰症状无疼痛）和所有其他疗效结局在使用或未使用偏头痛预防性药物的患者之间无显著差异（所有交互 p 值≥0.1）。正在使用和未使用预防性药物的患者的不良反应发生率相似。
与安慰剂相比，拉米替坦在同时使用偏头痛预防性药物的偏头痛急性发作患者中更有效。拉米替坦的疗效和安全性措施在使用和未使用预防性药物的患者中相似。
SAMURAI（NCT02439320）和 SPARTAN（NCT02605174）。注册于 2015 年 3 月 18 日。
