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Abstract：
BACKGROUND: Migraine has a great impact on public health. Current acute therapies do not satisfy all migraineurs. The novel serotonin 5-HT1F receptor agonist appears more promising for aborting migraine attacks.
OBJECTIVE: To evaluate the clinical efficacy and safety of lasmiditan in treating acute migraine attacks.
METHODS: The literature search was performed in PubMed, Embase, and the Cochrane Central Register of Controlled Trials for randomized controlled trials (RCTs) which assessed the effect and safety of lasmiditan on migraine. The risk of bias was assessed using the Cochrane Collaboration\'s risk of bias tool. Results were extracted and pooled as risk ratios (RRs) with a fixed or random-effects model.
RESULTS: Based on the four included RCTs, pooled estimates showed that lasmiditan with the 50 mg, 100 mg, and 200 mg doses was superior to placebo at 2 h after the first dose in terms of pain freedom, absence of migraine-associated symptoms, headache relief, no/mild disability, and global impression of change (very much/much better) (RRs ranged from 1.13 to 1.96), except for nausea-free and vomiting-free. Both lasmiditan 100 mg and 200 mg resulted in significantly fewer patients using rescue medication (100 mg: RR = 0.75, 95% CI (0.61, 0.92), P = 0.007; 200 mg: RR = 0.81, 95% CI (0.66, 0.99), P = 0.04) at 2-24 h postdose, compared with placebo. Safety data showed that the proportion of patients reporting at least one treatment-emergent adverse event (TEAE) and the incidence of most common TEAEs such as dizziness, paresthesia, fatigue, somnolence, and nausea was higher in the lasmiditan groups (50 mg, 100 mg, and 200 mg), compared with placebo. There was no significant difference between lasmiditan and placebo in terms of cardiovascular-related TEAEs (RR = 2.75, 95% CI (0.81, 9.37), P = 0.11). Compared with lasmiditan 100 mg, lasmiditan 200 mg was more effective in pain freedom at 2 h after the first dose (RR = 0.83, 95% CI (0.74, 0.94), P = 0.004) but associated with a higher risk of reporting at least one TEAE (RR = 0.88, 95% CI (0.81, 0.96), P = 0.006).
CONCLUSIONS: Lasmiditan with the 50 mg, 100 mg, and 200 mg doses are effective and safe in acute migraine treatment. Lasmiditan 200 mg is more effective than lasmiditan 100 mg in pain freedom, while lasmiditan 100 mg is better tolerated in the short-term follow-up. Further larger sample-size RCTs are required to verify the applicability and tolerability in the long term.
OBJECTIVE: To evaluate the clinical efficacy and safety of lasmiditan in treating acute migraine attacks.
METHODS: The literature search was performed in PubMed, Embase, and the Cochrane Central Register of Controlled Trials for randomized controlled trials (RCTs) which assessed the effect and safety of lasmiditan on migraine. The risk of bias was assessed using the Cochrane Collaboration\'s risk of bias tool. Results were extracted and pooled as risk ratios (RRs) with a fixed or random-effects model.
RESULTS: Based on the four included RCTs, pooled estimates showed that lasmiditan with the 50 mg, 100 mg, and 200 mg doses was superior to placebo at 2 h after the first dose in terms of pain freedom, absence of migraine-associated symptoms, headache relief, no/mild disability, and global impression of change (very much/much better) (RRs ranged from 1.13 to 1.96), except for nausea-free and vomiting-free. Both lasmiditan 100 mg and 200 mg resulted in significantly fewer patients using rescue medication (100 mg: RR = 0.75, 95% CI (0.61, 0.92), P = 0.007; 200 mg: RR = 0.81, 95% CI (0.66, 0.99), P = 0.04) at 2-24 h postdose, compared with placebo. Safety data showed that the proportion of patients reporting at least one treatment-emergent adverse event (TEAE) and the incidence of most common TEAEs such as dizziness, paresthesia, fatigue, somnolence, and nausea was higher in the lasmiditan groups (50 mg, 100 mg, and 200 mg), compared with placebo. There was no significant difference between lasmiditan and placebo in terms of cardiovascular-related TEAEs (RR = 2.75, 95% CI (0.81, 9.37), P = 0.11). Compared with lasmiditan 100 mg, lasmiditan 200 mg was more effective in pain freedom at 2 h after the first dose (RR = 0.83, 95% CI (0.74, 0.94), P = 0.004) but associated with a higher risk of reporting at least one TEAE (RR = 0.88, 95% CI (0.81, 0.96), P = 0.006).
CONCLUSIONS: Lasmiditan with the 50 mg, 100 mg, and 200 mg doses are effective and safe in acute migraine treatment. Lasmiditan 200 mg is more effective than lasmiditan 100 mg in pain freedom, while lasmiditan 100 mg is better tolerated in the short-term follow-up. Further larger sample-size RCTs are required to verify the applicability and tolerability in the long term.
摘要：
背景：偏头痛对公众健康有很大影响。目前的急性疗法不能满足所有的偏头痛患者。新型5-羟色胺5-HT1F受体激动剂似乎更有希望中止偏头痛发作。
目的：评价拉米替坦治疗偏头痛急性发作的临床疗效和安全性。
方法：文献检索在PubMed，Embase,和Cochrane中央对照试验注册中心的随机对照试验（RCT），该试验评估了lasmiditan对偏头痛的疗效和安全性。使用CochraneCollaboration的偏倚风险工具评估偏倚风险。提取结果并合并为固定或随机效应模型的风险比（RR）。
结果：基于包含的四个RCT，汇总估计显示，lasmiditan与50毫克，100毫克，和200毫克剂量优于安慰剂在2小时后的第一剂量在疼痛自由方面，没有偏头痛相关症状，头痛缓解,无/轻度残疾，和变化的全球印象(非常/好得多)(RR范围从1.13到1.96)，除了无恶心和无呕吐。Lasmiditan100mg和200mg均导致使用救护药物的患者明显减少（100mg：RR=0.75，95％CI（0.61，0.92），P=0.007；200mg：RR=0.81，95%CI（0.66，0.99），P=0.04）在给药后2-24小时，与安慰剂相比。安全性数据显示，报告至少一种治疗紧急不良事件（TEAE）的患者比例和最常见的TEAE（如头晕）的发生率。感觉异常,疲劳,嗜睡,恶心在lasmiditan组(50毫克，100毫克，和200毫克），与安慰剂相比。Lasmiditan和安慰剂在心血管相关TEAE方面没有显着差异（RR=2.75，95％CI（0.81，9.37），P=0.11）。与Lasmiditan100毫克相比，Lasmiditan200mg在第一次给药后2小时对疼痛自由更有效（RR=0.83，95％CI（0.74，0.94），P=0.004），但与报告至少一次TEAE的较高风险相关（RR=0.88，95％CI（0.81，0.96），P=0.006)。
结论：Lasmiditan与50毫克，100毫克，200毫克剂量在急性偏头痛治疗中是有效和安全的。Lasmiditan200毫克在疼痛自由方面比Lasmiditan100毫克更有效，而Lasmiditan100mg在短期随访中耐受性更好。需要进一步更大的样本量RCT来验证长期适用性和耐受性。
目的：评价拉米替坦治疗偏头痛急性发作的临床疗效和安全性。
方法：文献检索在PubMed，Embase,和Cochrane中央对照试验注册中心的随机对照试验（RCT），该试验评估了lasmiditan对偏头痛的疗效和安全性。使用CochraneCollaboration的偏倚风险工具评估偏倚风险。提取结果并合并为固定或随机效应模型的风险比（RR）。
结果：基于包含的四个RCT，汇总估计显示，lasmiditan与50毫克，100毫克，和200毫克剂量优于安慰剂在2小时后的第一剂量在疼痛自由方面，没有偏头痛相关症状，头痛缓解,无/轻度残疾，和变化的全球印象(非常/好得多)(RR范围从1.13到1.96)，除了无恶心和无呕吐。Lasmiditan100mg和200mg均导致使用救护药物的患者明显减少（100mg：RR=0.75，95％CI（0.61，0.92），P=0.007；200mg：RR=0.81，95%CI（0.66，0.99），P=0.04）在给药后2-24小时，与安慰剂相比。安全性数据显示，报告至少一种治疗紧急不良事件（TEAE）的患者比例和最常见的TEAE（如头晕）的发生率。感觉异常,疲劳,嗜睡,恶心在lasmiditan组(50毫克，100毫克，和200毫克），与安慰剂相比。Lasmiditan和安慰剂在心血管相关TEAE方面没有显着差异（RR=2.75，95％CI（0.81，9.37），P=0.11）。与Lasmiditan100毫克相比，Lasmiditan200mg在第一次给药后2小时对疼痛自由更有效（RR=0.83，95％CI（0.74，0.94），P=0.004），但与报告至少一次TEAE的较高风险相关（RR=0.88，95％CI（0.81，0.96），P=0.006)。
结论：Lasmiditan与50毫克，100毫克，200毫克剂量在急性偏头痛治疗中是有效和安全的。Lasmiditan200毫克在疼痛自由方面比Lasmiditan100毫克更有效，而Lasmiditan100mg在短期随访中耐受性更好。需要进一步更大的样本量RCT来验证长期适用性和耐受性。
