“The efficacy and safety of Atogepant for migraine prophylaxis: a systematic review and meta-analysis of randomized controlled trials”

Abstract Background Migraine is a complex neurological disorder characterized by recurrent, disabling headaches and various sensory symptoms, affecting about 15% of the global population annually. It is the second most common neurological condition worldwide, causing significant disability. While cu...

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Main Authors: Ayesha Shaukat, Laiba Shakeel, Rumaisa Riaz, Saad Ashraf, Aymar Akilimali
Format: Article
Language:English
Published: BMC 2025-08-01
Series:BMC Neurology
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Online Access:https://doi.org/10.1186/s12883-025-04350-x
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Summary:Abstract Background Migraine is a complex neurological disorder characterized by recurrent, disabling headaches and various sensory symptoms, affecting about 15% of the global population annually. It is the second most common neurological condition worldwide, causing significant disability. While current prophylactic treatments include beta-blockers, tricyclic antidepressants, anticonvulsants, and monoclonal antibodies targeting the CGRP pathway, not all patients respond adequately. Atogepant, an oral CGRP receptor antagonist, has emerged as a promising option for migraine prevention with improved tolerability. Methods This meta-analysis follows PRISMA guidelines, involving a comprehensive search of Cochrane CENTRAL, PubMed/MEDLINE, and Google Scholar databases up to July 2024. Efficacy outcomes included mean monthly migraine days (MMDs), mean monthly headache days (MHDs), monthly acute medication use days and the percentage of patients with a ≥ 50% reduction in MMDs. Safety outcomes were measured by adverse events (AEs). Statistical analysis employed the Inverse Variance and Mantel-Haenszel random-effects models, with heterogeneity assessed using the I² index. Results Six RCTs with 4325 patients (3054 on Atogepant, 1271 on placebo) met the inclusion criteria. The combined analysis indicated a significant reduction in MMDs favoring Atogepant over placebo (SMD − 0.39, 95% CI: -0.45 to -0.33; p < 0.00001; I²=0%). Similarly, significant reductions were observed in MHDs, monthly acute medication use days, and the proportion of patients achieving a ≥ 50% reduction in MMDs. Conclusion Atogepant is an effective and safe option for migraine prophylaxis, showing significant reductions in MMDs. Further extensive trials are recommended to assess the long-term efficacy, safety, and cost efficiency of Atogepant compared to other preventive medications.
ISSN:1471-2377