Safety and Efficacy of Calcitonin Gene-related Peptide Receptor Antagonists and Selective Serotonin Receptor Agonist in the Management of Migraine: A Systematic Review and Meta-analysis.
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引用次数: 0
Abstract
Background: Recently, US Food and Drug Administration (FDA) has approved calcitonin gene-related peptide receptor antagonists (rimegepant, and ubrogepant), and selective serotonin receptor agonists (lasmiditan) in the management of migraine. However, the exact safety and efficacy profile of these drugs is unclear so far.
Methods: The study's primary objective was to determine the exact safety and efficacy profile. The overall estimate was calculated in terms of risk ratios using a suitable model. The subgroup analysis was also performed to check the effect of individual drugs on the outcome, whereas sensitivity analysis was performed to check the effects of outliers on the outcome. All the analyses were performed using Rev Man 5. The drugs have shown significant improvement in efficacy parameters (pain freedom, most bothersome symptoms, phonophobia, nausea, and photophobia).
Results: The subgroup analysis results have shown significant improvement in all efficacy parameters in the rimegepant and ubrogepant groups. The effect of ubrogepant on safety parameters was found to be non-significant, indicating a better safety profile of ubrogepant than lasmiditan.
Conclusion: The sensitivity analysis results have shown no effect of outliers on the efficacy parameters. Based on the available evidence, recently approved drugs are effective in the treatment of migraine, however, associated with few adverse drug reactions.
背景:最近,美国食品和药物管理局(FDA)批准降钙素基因相关肽受体拮抗剂(rimegepant和ubrogepant)和选择性5-羟色胺受体激动剂(lasmiditan)用于治疗偏头痛。然而,迄今为止,这些药物的确切安全性和疗效尚不清楚:研究的主要目的是确定确切的安全性和疗效。采用合适的模型,以风险比的形式计算总体估计值。此外,还进行了亚组分析,以检查单个药物对结果的影响,并进行了敏感性分析,以检查异常值对结果的影响。所有分析均使用 Rev Man 5 进行。这些药物在疗效参数(无痛、最令人烦恼的症状、畏音、恶心和畏光)方面均有明显改善:亚组分析结果表明,利美昔班组和乌洛格班组的所有疗效参数均有明显改善。结果:亚组分析结果显示,利美盖潘组和乌洛盖潘组的所有疗效指标均有明显改善,乌洛盖潘对安全性指标的影响不显著,表明乌洛盖潘的安全性优于拉斯米丹:敏感性分析结果表明,异常值对疗效参数没有影响。根据现有证据,最近批准的药物对治疗偏头痛有效,但与之相关的药物不良反应较少。