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Abstract：
This MONONOFU trial subgroup analysis evaluates the efficacy of lasmiditan across patient and migraine characteristics in Japanese patients with migraine.
MONONOFU trial was a multicenter, randomized, double-blind, placebo-controlled study. The patients were randomly assigned in a 3:7:6:7 ratio to receive lasmiditan 50 mg, 100 mg, 200 mg, or placebo for a single migraine attack within 4 h of pain onset. Efficacy of lasmiditan vs placebo was evaluated at 2 h post dose for proportion of patients with headache pain freedom. Efficacy was assessed across patient characteristics (age, sex, body weight, cardiovascular risk factors (CVRF), and comorbidity of tension-type headache), migraine disease characteristics (history of migraine with aura, migraine prevention therapy, triptan response, and triptan use or nonuse), and migraine attack characteristics (headache severity, aggressive headache, attack during perimenstrual period, time to dosing, time of dosing, experienced treatment-emergent adverse event (TEAE) of dizziness, and experienced TEAE of somnolence). Logistic regression was used; all subgroup analyses were not analyzed with multiplicity-adjusted statistical tests.
Treatment-by-subgroup interactions (by each arm) were not significant (p ≥ 0.05) for pain freedom at 2 h post dose across all patient subgroups and lasmiditan doses, except for CVRF (100 mg and 200 mg), migraine with aura (50 mg), triptan response (50 mg), and time to dosing (200 mg). Treatment-by-subgroup interactions (by overall) were not significant (p ≥ 0.05) for pain freedom at 2 h post dose across all patient subgroups, except for CVRFs. Higher proportions of patients were pain free at 2 h post dose when treated with lasmiditan (50 mg, 100 mg, and 200 mg) versus placebo, irrespective of most patient characteristics, migraine disease characteristics, and migraine attack characteristics.
Although few interactions were observed, lasmiditan could be a promising acute treatment option in a wide range of Japanese patients with migraine, as efficacy is not generally influenced by patient and migraine characteristics.
MONONOFU trial was a multicenter, randomized, double-blind, placebo-controlled study. The patients were randomly assigned in a 3:7:6:7 ratio to receive lasmiditan 50 mg, 100 mg, 200 mg, or placebo for a single migraine attack within 4 h of pain onset. Efficacy of lasmiditan vs placebo was evaluated at 2 h post dose for proportion of patients with headache pain freedom. Efficacy was assessed across patient characteristics (age, sex, body weight, cardiovascular risk factors (CVRF), and comorbidity of tension-type headache), migraine disease characteristics (history of migraine with aura, migraine prevention therapy, triptan response, and triptan use or nonuse), and migraine attack characteristics (headache severity, aggressive headache, attack during perimenstrual period, time to dosing, time of dosing, experienced treatment-emergent adverse event (TEAE) of dizziness, and experienced TEAE of somnolence). Logistic regression was used; all subgroup analyses were not analyzed with multiplicity-adjusted statistical tests.
Treatment-by-subgroup interactions (by each arm) were not significant (p ≥ 0.05) for pain freedom at 2 h post dose across all patient subgroups and lasmiditan doses, except for CVRF (100 mg and 200 mg), migraine with aura (50 mg), triptan response (50 mg), and time to dosing (200 mg). Treatment-by-subgroup interactions (by overall) were not significant (p ≥ 0.05) for pain freedom at 2 h post dose across all patient subgroups, except for CVRFs. Higher proportions of patients were pain free at 2 h post dose when treated with lasmiditan (50 mg, 100 mg, and 200 mg) versus placebo, irrespective of most patient characteristics, migraine disease characteristics, and migraine attack characteristics.
Although few interactions were observed, lasmiditan could be a promising acute treatment option in a wide range of Japanese patients with migraine, as efficacy is not generally influenced by patient and migraine characteristics.
摘要：
这项MONONOFU试验亚组分析评估了日本偏头痛患者中lasmiditan跨患者和偏头痛特征的疗效。
MONONOFU试验是多中心的，随机化，双盲,安慰剂对照研究。患者以3:7:6:7的比例随机分配，接受lasmiditan50毫克，100毫克，200毫克，或安慰剂用于疼痛发作后4小时内的单次偏头痛发作。在给药后2小时评估了lasmiditan与安慰剂的疗效，以缓解头痛疼痛的患者比例。通过患者特征(年龄，性别,体重,心血管危险因素（CVRF），和紧张型头痛的合并症)，偏头痛疾病特征（偏头痛有先兆，偏头痛预防治疗,Triptan反应,和曲坦使用或不使用)，和偏头痛发作特征(头痛严重程度，侵袭性头痛,在围产期攻击，给药时间，给药时间，经历过治疗引起的头晕不良事件（TEAE），并经历了TEAE的嗜睡）。使用Logistic回归；所有亚组分析均未使用多重校正统计检验进行分析。
在所有患者亚组和Lasmiditan剂量中，治疗亚组之间的相互作用（每个手臂）在剂量后2小时的疼痛自由度均无统计学意义（p≥0.05）。除CVRF（100mg和200mg）外，先兆偏头痛（50毫克），曲坦反应（50毫克），和给药时间（200毫克）。在所有患者亚组的剂量后2小时，治疗与亚组的相互作用（总体）对于疼痛自由没有统计学意义（p≥0.05）。除了CVRF。较高比例的患者在剂量后2小时无疼痛时，用Lasmiditan治疗（50mg，100毫克，和200毫克）与安慰剂相比，不管大多数患者的特征，偏头痛的疾病特点，和偏头痛发作特征。
虽然很少观察到相互作用，Lasmiditan可能是一个有希望的急性治疗选择，在广泛的日本偏头痛患者，因为疗效通常不受患者和偏头痛特征的影响。
MONONOFU试验是多中心的，随机化，双盲,安慰剂对照研究。患者以3:7:6:7的比例随机分配，接受lasmiditan50毫克，100毫克，200毫克，或安慰剂用于疼痛发作后4小时内的单次偏头痛发作。在给药后2小时评估了lasmiditan与安慰剂的疗效，以缓解头痛疼痛的患者比例。通过患者特征(年龄，性别,体重,心血管危险因素（CVRF），和紧张型头痛的合并症)，偏头痛疾病特征（偏头痛有先兆，偏头痛预防治疗,Triptan反应,和曲坦使用或不使用)，和偏头痛发作特征(头痛严重程度，侵袭性头痛,在围产期攻击，给药时间，给药时间，经历过治疗引起的头晕不良事件（TEAE），并经历了TEAE的嗜睡）。使用Logistic回归；所有亚组分析均未使用多重校正统计检验进行分析。
在所有患者亚组和Lasmiditan剂量中，治疗亚组之间的相互作用（每个手臂）在剂量后2小时的疼痛自由度均无统计学意义（p≥0.05）。除CVRF（100mg和200mg）外，先兆偏头痛（50毫克），曲坦反应（50毫克），和给药时间（200毫克）。在所有患者亚组的剂量后2小时，治疗与亚组的相互作用（总体）对于疼痛自由没有统计学意义（p≥0.05）。除了CVRF。较高比例的患者在剂量后2小时无疼痛时，用Lasmiditan治疗（50mg，100毫克，和200毫克）与安慰剂相比，不管大多数患者的特征，偏头痛的疾病特点，和偏头痛发作特征。
虽然很少观察到相互作用，Lasmiditan可能是一个有希望的急性治疗选择，在广泛的日本偏头痛患者，因为疗效通常不受患者和偏头痛特征的影响。
