From CoLucid Pharmaceuticals (B.K.), Inc, Cambridge, MA; Thomas Jefferson University (S.D.S.), Philadelphia, PA; Eli Lilly and Company (L.W., P.H.B.), Indianapolis, IN; IQVIA (G.D.), Durham, NC; and Montefiore Headache Center (R.B.L.), Bronx, NY.
Neurology. 2018 Dec 11;91(24):e2222-e2232. doi: 10.1212/WNL.0000000000006641. Epub 2018 Nov 16.
To assess the efficacy and safety of lasmiditan in the acute treatment of migraine.
Adult patients with migraine were randomized (1:1:1) to a double-blind dose of oral lasmiditan 200 mg, lasmiditan 100 mg, or placebo and were asked to treat their next migraine attack within 4 hours of onset. Over 48 hours after dosing, patients used an electronic diary to record headache pain and the presence of nausea, phonophobia, and photophobia, one of which was designated their most bothersome symptom (MBS).
Of the 1,856 patients who treated an attack, 77.9% had ≥1 cardiovascular risk factors in addition to migraine. Compared with placebo, more patients dosed with lasmiditan 200 mg were free of headache pain at 2 hours after dosing (32.2% vs 15.3%; odds ratio [OR] 2.6, 95% confidence interval [CI] 2.0-3.6, < 0.001), similar to those dosed with lasmiditan 100 mg (28.2%; OR 2.2, 95% CI 1.6-3.0, < 0.001). Furthermore, compared with those dosed with placebo, more patients dosed with lasmiditan 200 mg (40.7% vs 29.5%; OR 1.6, 95% CI 1.3-2.1, < 0.001) and lasmiditan 100 mg (40.9%; OR 1.7, 95% CI, 1.3-2.2, < 0.001) were free of their MBS at 2 hours after dosing. Adverse events were mostly mild or moderate in intensity.
Lasmiditan dosed at 200 and 100 mg was efficacious and well tolerated in the treatment of acute migraine among patients with a high level of cardiovascular risk factors.
NCT02439320.
This study provides Class I evidence that for adult patients with migraine, lasmiditan increases the proportion of subjects who are headache pain free at 2 hours after treating a migraine attack.
评估拉米替坦在偏头痛急性治疗中的疗效和安全性。
将偏头痛成年患者随机（1:1:1）分为三组，分别接受双盲剂量的口服拉米替坦 200mg、拉米替坦 100mg 或安慰剂治疗，并在发作后 4 小时内治疗下一次偏头痛发作。在给药后 48 小时内，患者使用电子日记记录头痛疼痛和恶心、恐音症和畏光的存在情况，其中之一被指定为最困扰的症状（MBS）。
在 1856 名接受治疗的患者中，77.9%的患者除偏头痛外还有≥1 种心血管危险因素。与安慰剂相比，更多接受拉米替坦 200mg 治疗的患者在给药后 2 小时无头痛（32.2%比 15.3%；比值比[OR]2.6，95%置信区间[CI]2.0-3.6，<0.001），与接受拉米替坦 100mg 治疗的患者相似（28.2%；OR 2.2，95%CI 1.6-3.0，<0.001）。此外，与接受安慰剂治疗的患者相比，更多接受拉米替坦 200mg 治疗（40.7%比 29.5%；OR 1.6，95%CI 1.3-2.1，<0.001）和拉米替坦 100mg 治疗（40.9%；OR 1.7，95%CI，1.3-2.2，<0.001）的患者在给药后 2 小时内无 MBS。不良事件大多为轻度或中度。
拉米替坦 200mg 和 100mg 剂量在治疗心血管风险因素水平较高的偏头痛急性发作患者中有效且耐受良好。
临床试验.gov 标识符：NCT02439320。
本研究提供了 I 级证据，表明对于偏头痛成年患者，拉米替坦可增加在治疗偏头痛发作后 2 小时头痛无缓解的患者比例。
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