Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), Bhubaneswar, Odisha, India.
Department of Pharmacology, All India Institute of Medical Sciences (AIIMS), New Delhi, India.
J Clin Pharmacol. 2021 Dec;61(12):1534-1544. doi: 10.1002/jcph.1962. Epub 2021 Nov 12.
Monotherapy with triptans in acute migraine is ineffective in many patients and contraindicated in certain cardiovascular diseases where alternative therapeutic options are necessary to explore. This meta-analysis has evaluated the efficacy and safety of lasmiditan for the treatment of acute migraine in adults. After performing a literature search on MEDLINE/PubMed, Scopus, Cochrane databases, and International Clinical Trial Registry Platform, reviewers assessed eligibility and extracted data from 4 relevant articles. Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines were followed in the selection, analysis, and reporting of findings. A random-effects model was used to estimate effect size. Quality assessment was done using the risk of bias assessment tool and meta-regression for probable variables affecting effect size. Subgroup analysis was done depending on the dose of lasmiditan. Lasmiditan use was associated with a significantly higher percentage of patients with pain freedom (odds ratio [OR], 2.02; 95% confidence interval [CI], 1.72-2.39; P < .00001), sustained pain freedom (OR, 1.93; 95%CI, 1.55-2.39; P <.00001), headache response (OR, 2.05; 95%CI, 1.77-2.36; P < .00001), clinical disability level (OR, 1.36; 95%CI, 1.20-1.55; P < .00001), patients' global impression (OR, 1.88; 95%CI, 1.69-2.10; P < .00001), and significantly lower use of rescue medication (OR, 0.49; 95%CI, 0.38-0.63; P < .00001) compared to placebo. Lasmiditan use was also associated with a higher likelihood of adverse effects like dizziness (OR, 6.54; 95%CI, 4.24-10.07; P < .00001), paresthesia (OR, 4.28; 95%CI, 2.97-6.17; P < .00001), and fatigue (OR, 5.67; 95%CI, 3.78-8.52; P < .00001) compared to placebo. Subgroup analysis showed a dose-dependent effect of lasmiditan on pain freedom, sustained pain freedom, patient's global impression, and occurrence of adverse drug reactions. Prediction probability for effect estimate favoring placebo was calculated to be 0.0017%. Lasmiditan has shown a favorable effect in terms of efficacy and safety in the treatment of an acute attack of migraine in comparison to placebo. Further studies are needed to evaluate long-term safety, efficacy, and use in specific subgroups of patients. PROSPERO Registration Number: CRD42020177838.
在许多患者中，曲坦类药物单药治疗急性偏头痛无效，并且在某些心血管疾病中禁忌使用，因为需要探索替代的治疗选择。本荟萃分析评估了拉米替坦治疗成人急性偏头痛的疗效和安全性。在对 MEDLINE/PubMed、Scopus、Cochrane 数据库和国际临床试验注册平台进行文献检索后，审查员评估了纳入标准，并从 4 篇相关文章中提取了数据。研究结果的选择、分析和报告遵循了系统评价和荟萃分析的首选报告项目指南。使用随机效应模型估计效应大小。使用偏倚风险评估工具和可能影响效应大小的 meta 回归进行质量评估。根据拉米替坦的剂量进行了亚组分析。与安慰剂相比，拉米替坦的使用与更高比例的疼痛缓解患者（比值比 [OR]，2.02；95%置信区间 [CI]，1.72-2.39；P<0.00001）、持续疼痛缓解患者（OR，1.93；95%CI，1.55-2.39；P<0.00001）、头痛缓解患者（OR，2.05；95%CI，1.77-2.36；P<0.00001）、临床残疾程度（OR，1.36；95%CI，1.20-1.55；P<0.00001）、患者总体印象（OR，1.88；95%CI，1.69-2.10；P<0.00001）和使用救援药物的可能性显著降低（OR，0.49；95%CI，0.38-0.63；P<0.00001）。与安慰剂相比，拉米替坦的使用还与头晕（OR，6.54；95%CI，4.24-10.07；P<0.00001）、感觉异常（OR，4.28；95%CI，2.97-6.17；P<0.00001）和疲劳（OR，5.67；95%CI，3.78-8.52；P<0.00001）等不良反应的发生几率更高相关。亚组分析显示，拉米替坦对疼痛缓解、持续疼痛缓解、患者总体印象和药物不良反应发生的影响呈剂量依赖性。计算预测效应估计值有利于安慰剂的概率为 0.0017%。与安慰剂相比，拉米替坦在治疗偏头痛急性发作方面具有较好的疗效和安全性。需要进一步研究来评估长期安全性、疗效以及在特定患者亚组中的应用。PROSPERO 注册号：CRD42020177838。
