Department of Pharmacology and Toxicology, National Institute of Pharmaceutical Education and Research (NIPER), Raebareli, 226002, India.
Department of Regulatory Toxicology, National Institute of Pharmaceutical Education and Research (NIPER), Raebareli, 226002, India.
CNS Neurol Disord Drug Targets. 2024;23(12):1474-1487. doi: 10.2174/0118715273304677240529062909.
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.
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).
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.
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.
最近,美国食品和药物管理局 (FDA) 已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)用于偏头痛的治疗。然而,这些药物的确切安全性和疗效仍不清楚。
本研究的主要目的是确定这些药物的确切安全性和疗效概况。使用合适的模型计算风险比来评估总体估计值。还进行了亚组分析,以检查个别药物对结果的影响,同时进行敏感性分析,以检查异常值对结果的影响。所有分析均使用 RevMan 5 进行。这些药物在疗效参数(疼痛缓解、最困扰的症状、恐声症、恶心和畏光)方面显示出显著改善。
亚组分析结果表明,rimegepant 和 ubrogepant 组在所有疗效参数方面均有显著改善。ubrogepant 对安全性参数的影响无统计学意义,表明 ubrogepant 的安全性优于 lasmiditan。
敏感性分析结果表明,异常值对疗效参数没有影响。基于现有证据,最近批准的药物在偏头痛治疗中有效,但不良反应较少。