Home > Long-term safety of atogepant as preventive treatment of migraine

Long-term safety of atogepant as preventive treatment of migraine

Presented by
Prof. Messoud Ashina, University of Copenhagen, Denmark
Conference
AAN 2021
Daily oral intake of atogepant for the preventive treatment of migraine showed no considerable safety or tolerability issues. Prof. Messoud Ashina (University of Copenhagen, Denmark) discussed the results of the randomised, multicentre, open-label safety trial (NCT03700320) that followed 739 adult migraine patients for 1 year [1].

Atogepant, an oral, small molecule, calcitonin gene-related peptide (CGRP) receptor antagonist, has shown efficacy in the prevention of migraine in 2 double-blind placebo-controlled trials. Long-term safety and tolerability needed to be evaluated. The presented study randomised 739 adult migraine patients with or without aura (4-14 migraine days/month) with a 5:2 ratio to daily atogepant (60 mg) or standard-of-care (SOC) to assess safety and tolerability of atogepant over a 1-year period. Visitations were scheduled every 4 weeks.

In the intention-to-treat population, 67.0% of the atogepant group experienced treatment-emergent adverse events (AEs). Treatment-related AEs were reported in 18.0% of the participants and 4.4% reported serious AEs. Importantly, no serious AE 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 AEs in this group. The cases of constipation were predominantly mild or moderate. There were no hepatic safety issues identified.

In the SOC group, AEs occurred in 78.6% of the participants; treatment-related AEs appeared in 36.2% and serious AEs were reported in 3.6%. Upper respiratory tract infection, dizziness, nausea, fatigue, and paraesthesia were the most commonly described AEs.

In conclusion, daily oral intake of 60mg atogepant demonstrated to be safe and well tolerated in adult migraine patients over a one-year period.

  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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