Long-term safety of atogepant as migraine prophylaxis

Daily oral atogepant (60 mg) for the preventive treatment of migraine showed no considerable safety or tolerability issues. Common treatment-emergent adverse events were upper respiratory tract infection, constipation, nausea, and urinary tract infection. Most constipation cases were mild to moderate in severity. There were no hepatic safety issues.

Prof. Messoud Ashina (University of Copenhagen, Denmark) discussed the results of the randomised, multicentre, open-label safety trial that followed 744 adult migraine patients for 1 year [1]. Participants were randomised with a 5:2 ratio to atogepant 60 mg/day or standard-of-care (SOC) to assess safety and tolerability of atogepant. Visitations were scheduled every 4 weeks. The intention-to-treat analysis included 739 participants.

In the atogepant group (n=543), 67% of patients experienced treatment-emergent adverse events. Of these, 31 (5.7%) discontinued the study. Treatment-related adverse events were reported by 98 patients (18.0%), serious adverse events by 24 patients (4.4%). Importantly, no serious adverse event occurred in more than 1 patient and none of them were considered related to atogepant treatment. Upper respiratory tract infection (10.3%), constipation (7.2%), nausea (6.3%), and urinary tract infection (5.2%) were the most frequently reported adverse events. Only 1 case of obstipation was rated severe; it was resolved before the end of the study. In the SOC group (n=196), treatment-emergent adverse events were reported by 154 (78.6%) of patients. Treatment-related adverse events were reported by 71 patients (36.2%).

1. Ashina M, et al. Long-term Safety and Tolerability of Atogepant 60 mg Following Once Daily Dosing Over 1 Year for the Preventive Treatment of Migraine. S5.001, AAN 2021 Virtual Congress, 17-22 April.

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Posted on 16 June 2021