Oral atogepant effective in reducing migraine and headache days: NEJM
USA: Once-daily oral atogepant is effective in reducing the number of headache days and migraine days over a period of 12 weeks, show results from a phase 3 trial published in the New England Journal of Medicine.
Atogepant is an oral, small-molecule, calcitonin gene-related peptide receptor antagonist which is being investigated for the preventive treatment of migraine.
To assess the effectiveness of oral atogepant for the preventive treatment of migraine, Jessica Ailani, From MedStar Georgetown University Hospital, Washington, DC, and colleagues included adults with 4 to 14 migraine days per month in a phase 3, double-blind trial. They were randomly assigned in the ratio of 1:1:1:1 to receive a once-daily dose of oral atogepant (10 mg, 30 mg, or 60 mg) or placebo for 12 weeks.
The primary endpoint was the change from baseline in the mean number of migraine days per month across the 12 weeks.
The researchers screened a total of 2270 participants, 910 were enrolled, and 873 were included in the efficacy analysis; 214 were assigned to the 10-mg atogepant group, 223 to the 30-mg atogepant group, 222 to the 60-mg atogepant group, and 214 to the placebo group.
The research yielded the following findings:
- The mean number of migraine days per month at baseline ranged from 7.5 to 7.9 in the four groups.
- The changes from baseline across 12 weeks were −3.7 days with 10-mg atogepant, −3.9 days with 30-mg atogepant, −4.2 days with 60-mg atogepant, and −2.5 days with placebo.
- The mean differences from placebo in the change from baseline were −1.2 days with 10-mg atogepant, −1.4 days with 30-mg atogepant, and −1.7 days with 60-mg atogepant.
- Results for the secondary end points favored atogepant over placebo with the exceptions of the AIM-D Performance of Daily Activities score and the AIM-D Physical Impairment score for the 10-mg dose.
- The most common adverse events were constipation (6.9 to 7.7% across atogepant doses) and nausea (4.4 to 6.1% across atogepant doses).
- Serious adverse events included one case each of asthma and optic neuritis in the 10-mg atogepant group.
"Over a period of 12 weeks, oral atogepant once daily to be effective in reducing the number of migraine days and headache days. Adverse events included constipation and nausea," wrote the authors. "Longer and larger trials are needed to determine the effect and safety of atogepant for migraine prevention."
The study titled, "Atogepant for the Preventive Treatment of Migraine," is published in the New England Journal of Medicine.