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%).
- 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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