The efficacy and safety of atogepant for the prophylactic treatment of migraine: evidence from randomized controlled trials

Background: Migraine is a common neurovascular disorder that has a severe impact on the individual daily life. Atogepant (AGN-241689) is an orally ingested, small-molecule drugs belonging to calcitonin gene-related peptide receptor antagonist, which has been initiated for the prophylactic treatment of migraine. However, there is no comprehensive literature to study the efficacy and safety of atogepant for the treatment of migraine. In this article, we present a meta-analysis of the available studies. Methods: MEDLINE, Embase, Cochrane Library and ClinicalTrials.gov were searched before October 20, 2021 for any relevant literature. Eventually, three randomized clinical trials (RCTs) with 2,466 patients were included in our study. Results: We pooled 2,466 patients from 3 RCTs and primary outcome was mean monthly migraine days, the secondary endpoints were monthly headache days, acute medication use days per month and >= 50% reduction in monthly migraine days, baseline to end of trials. It was found that atogepant (10 mg, 30 mg, 60 mg once a day) led to a significant reduction in monthly migraine days (P< 0.00001, P< 0.00001, P=0.007), monthly headache days (P< 0.00001, P< 0.00001, P=0.001), and monthly medication use days (P< 0.00001, P<0.00001, P=0.0001), and an increase in the proportion of people with >= 50% reduction in monthly migraine days (P= 0.0008, P= 0.02, P= 0.04) in comparison with placebo. Moreover, there were no significant differences (P> 0.05) in outcomes of adverse events between atogepant and placebo. Conclusions: Atogepant has shown good efficacy and safety in the prophylactic treatment of migraine, and further studies are expected.

Automated summary

Atogepant has demonstrated good efficacy and safety in the prophylactic treatment of migraine, effectively reducing monthly migraine days, headache days, and medication use days, while increasing the proportion of patients with >= 50% reduction in monthly migraine days.