Saitama International Headache Center, Saitama Neuropsychiatric Institute, Saitama, Japan.
Department of Neurology, Tominaga Hospital, Kyoto, Japan.
Headache. 2021 May;61(5):755-765. doi: 10.1111/head.14122. Epub 2021 May 15.
To evaluate the efficacy and safety of lasmiditan in Japanese adults with migraine.
Global clinical studies have demonstrated the efficacy and safety of lasmiditan in the acute treatment of migraine.
This was a multicenter, randomized, double-blind, placebo-controlled, phase 2 study in Japan (NCT03962738), which enrolled adults with migraine with or without aura. Participants were randomized 7:3:7:6 to placebo, lasmiditan 50 mg, 100 mg, or 200 mg to be self-administered orally within 4 h of onset of a single moderate-to-severe migraine attack. Participants recorded their response to treatment prior to dosing and for 48 h postdose. The primary endpoint was headache pain freedom at 2 h postdose.
Participants (N = 846) were randomized and treated (N = 691, safety; N = 682, modified intent-to-treat). At 2 h postdose, a significantly higher proportion of participants were headache pain-free in the lasmiditan 200 mg (40.8%, 73/179; odds ratio 3.46 [95% confidence interval 2.17 to 5.54]; p < 0.001; primary objective) and 100 mg groups (32.4%, 67/207; odds ratio 2.41 [1.51 to 3.83]; p < 0.001) compared with the placebo group (16.6%, 35/211), whereas the lasmiditan 50 mg group had a numerically higher proportion of participants headache pain-free (23.5%, 20/85; odds ratio 1.55 [0.83 to 2.87]; p = 0.167) compared with placebo. A statistically significant linear dose-response relationship for pain freedom was achieved at 2 h by a Cochran-Armitage trend test (p < 0.001). Lasmiditan treatment was also associated with headache pain relief, most bothersome symptom freedom, and improvement on disability and Patient Global Impression of Change outcomes. The majority of treatment-emergent adverse events were mild and of short duration, the most common of which were dizziness (39.4%; 188/477), somnolence (19.3%; 92/477), and malaise (10.5%; 50/477) in all lasmiditan groups, with no serious adverse events reported.
Lasmiditan was well tolerated and effective for the acute treatment of Japanese patients with migraine, consistent with global phase 3 studies.
评估 lasmiditan 在日本偏头痛成人患者中的疗效和安全性。
全球临床研究已经证实了 lasmiditan 在偏头痛急性治疗中的疗效和安全性。
这是一项在日本进行的多中心、随机、双盲、安慰剂对照、2 期研究（NCT03962738），纳入了有或无先兆偏头痛的成年患者。参与者按照 7:3:7:6 的比例随机分配至安慰剂组、lasmiditan 50mg 组、100mg 组或 200mg 组，在单次中度至重度偏头痛发作后 4 小时内自行口服给药。参与者在给药前和给药后 48 小时内记录对治疗的反应。主要终点为给药后 2 小时头痛缓解率。
共有 846 名参与者被随机分组并接受治疗（安全性分析 n=691，改良意向治疗分析 n=682）。给药后 2 小时，lasmiditan 200mg 组（40.8%，73/179；优势比 3.46[95%置信区间 2.17 至 5.54]；p<0.001；主要目标）和 100mg 组（32.4%，67/207；优势比 2.41[1.51 至 3.83]；p<0.001）的头痛无缓解比例显著高于安慰剂组（16.6%，35/211），而 lasmiditan 50mg 组的头痛无缓解比例（23.5%，20/85；优势比 1.55[0.83 至 2.87]；p=0.167）与安慰剂组相比则有更高的数值。通过 Cochran-Armitage 趋势检验（p<0.001），在 2 小时时达到了疼痛缓解的统计学显著线性剂量反应关系。头痛缓解、最困扰症状缓解、残疾和患者整体变化印象的改善也与 lasmiditan 治疗相关。大多数治疗相关不良事件为轻度且持续时间短，最常见的不良事件为头晕（39.4%，188/477）、嗜睡（19.3%，92/477）和不适（10.5%，50/477），所有 lasmiditan 组均无严重不良事件报告。
Lasmiditan 治疗日本偏头痛患者的急性发作具有良好的耐受性和疗效，与全球 3 期研究一致。
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