Abstract：
UNASSIGNED: Some migraine treatments are contraindicated for patients with cardiovascular disease (CVD) or risk factors (CVRFs). We report safety and efficacy of lasmiditan, a new oral acute migraine treatment with no cardiovascular contraindication, in Japanese patients with CVRFs.
UNASSIGNED: MONONOFU was a multicenter, randomized, double-blind, placebo-controlled, phase 2 study of Japanese patients with migraine (met International Headache Society criteria, Migraine Disability Assessment score ≥11, disabling migraine for ≥1 year). Eligible patients were randomized (7:3:7:6) to placebo or lasmiditan 50, 100, 200 mg. This prespecified analysis described CVDs, CVRFs, and cardiovascular treatment-emergent adverse events (TEAEs). Efficacy (proportion pain-free, experienced pain relief, most bothersome symptom-free, or disability-free 2 hours post-dose) was evaluated within CVRF subgroups (≤1, ≥2).
UNASSIGNED: Of 846 randomized patients, 691 were analyzed (CVRF≤1: 375; CVRF≥2: 316). The proportion of lasmiditan-treated patients with ≥1 TEAE was not related to CVRF numbers. Eighteen (3.8%) lasmiditan-treated and three (1.4%) placebo-treated patients reported likely cardiovascular TEAEs. Lasmiditan was more effective than placebo at relieving pain, symptoms, and disability in both CVRF subgroups. There was no consistent relationship between CVRF subgroups and efficacy.
UNASSIGNED: Lasmiditan was well tolerated and effective in Japanese patients with migraine and CVRFs.
UNASSIGNED: ClinicalTrials.gov: NCT03962738.
UNASSIGNED: MONONOFU was a multicenter, randomized, double-blind, placebo-controlled, phase 2 study of Japanese patients with migraine (met International Headache Society criteria, Migraine Disability Assessment score ≥11, disabling migraine for ≥1 year). Eligible patients were randomized (7:3:7:6) to placebo or lasmiditan 50, 100, 200 mg. This prespecified analysis described CVDs, CVRFs, and cardiovascular treatment-emergent adverse events (TEAEs). Efficacy (proportion pain-free, experienced pain relief, most bothersome symptom-free, or disability-free 2 hours post-dose) was evaluated within CVRF subgroups (≤1, ≥2).
UNASSIGNED: Of 846 randomized patients, 691 were analyzed (CVRF≤1: 375; CVRF≥2: 316). The proportion of lasmiditan-treated patients with ≥1 TEAE was not related to CVRF numbers. Eighteen (3.8%) lasmiditan-treated and three (1.4%) placebo-treated patients reported likely cardiovascular TEAEs. Lasmiditan was more effective than placebo at relieving pain, symptoms, and disability in both CVRF subgroups. There was no consistent relationship between CVRF subgroups and efficacy.
UNASSIGNED: Lasmiditan was well tolerated and effective in Japanese patients with migraine and CVRFs.
UNASSIGNED: ClinicalTrials.gov: NCT03962738.
摘要：
未经证实：某些偏头痛治疗对于有心血管疾病（CVD）或危险因素（CVRF）的患者是禁忌的。我们报告了lasmiditan的安全性和有效性，一种新的口服急性偏头痛治疗，没有心血管禁忌症，日本CVRF患者。
未经批准：MONONOFU是一个多中心，随机化，双盲,安慰剂对照,日本偏头痛患者的2期研究(符合国际头痛学会标准，偏头痛残疾评估评分≥11，禁用偏头痛≥1年）。符合条件的患者被随机分配（7：3：7：6）接受安慰剂或Lasmiditan50、100、200mg。这个预设的分析描述了心血管疾病，CVRF,和心血管治疗引起的不良事件（TEAE）。功效（无痛比例，经历了疼痛缓解，最麻烦的无症状，或给药后2小时无残疾）在CVRF亚组（≤1，≥2）内进行评估。
未经证实：在846名随机患者中，分析691例(CVRF≤1:375；CVRF≥2:316)。接受lasmiditan治疗的≥1TEAE患者的比例与CVRF数无关。18例（3.8％）接受lasmiditan治疗的患者和3例（1.4％）接受安慰剂治疗的患者报告了可能的心血管TEAE。Lasmiditan在缓解疼痛方面比安慰剂更有效，症状,和残疾在两个CVRF亚组。CVRF亚组与疗效之间没有一致的关系。
UASSIGNED：Lasmiditan在日本偏头痛和CVRF患者中具有良好的耐受性和有效性。
UNASSIGNED：ClinicalTrials.gov：NCT03962738。
未经批准：MONONOFU是一个多中心，随机化，双盲,安慰剂对照,日本偏头痛患者的2期研究(符合国际头痛学会标准，偏头痛残疾评估评分≥11，禁用偏头痛≥1年）。符合条件的患者被随机分配（7：3：7：6）接受安慰剂或Lasmiditan50、100、200mg。这个预设的分析描述了心血管疾病，CVRF,和心血管治疗引起的不良事件（TEAE）。功效（无痛比例，经历了疼痛缓解，最麻烦的无症状，或给药后2小时无残疾）在CVRF亚组（≤1，≥2）内进行评估。
未经证实：在846名随机患者中，分析691例(CVRF≤1:375；CVRF≥2:316)。接受lasmiditan治疗的≥1TEAE患者的比例与CVRF数无关。18例（3.8％）接受lasmiditan治疗的患者和3例（1.4％）接受安慰剂治疗的患者报告了可能的心血管TEAE。Lasmiditan在缓解疼痛方面比安慰剂更有效，症状,和残疾在两个CVRF亚组。CVRF亚组与疗效之间没有一致的关系。
UASSIGNED：Lasmiditan在日本偏头痛和CVRF患者中具有良好的耐受性和有效性。
UNASSIGNED：ClinicalTrials.gov：NCT03962738。
