1. Oral atogepant was shown to be effective at reducing the number of migraine and headache days compared to the placebo group.
2. The main adverse events from atogepant treatment were constipation and nausea.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Frequent or severe migraine can prove to be a debilitating condition. Calcitonin gene-related peptides (CGRP) are included in the pathophysiology of migraines, leading to the use of injectable monoclonal anti-CGRP antibodies as preventive therapy. Atogepant, an oral small-molecule CGRP-receptor antagonist, is approved for migraine attacks treatment but not for preventive purposes. As such, this study aimed to demonstrate the efficacy of atogepant in preventing migraine attacks. At 12 weeks, atogepant resulted in a lower number of migraine days compared to the placebo. Also, the experimental treatment reduced the number of headache days, while improving impairment and quality of life measures. Common adverse events from atogepant were nausea and constipation. The limitation of this study was the short follow-up period and small study size. Nonetheless, the study results provided favorable evidence for the use of oral atogepant in preventing migraine attacks.
Click here to read the study in NEJM
Relevant Reading: Safety, tolerability, and efficacy of orally administered atogepant for the prevention of episodic migraine in adults: a double-blind, randomised phase 2b/3 trial
In-Depth [randomized controlled trial]: This randomized controlled trial enrolled 910 adults at 128 sites in the United States. Patients between 18 to 80 years of age experiencing 4-14 migraine days per month in the 3 months preceding the study and the 28-day baseline period were included in the study. Patients with chronic migraine, painful cranial neuropathy, and inadequate responses to oral migraine prevention medications were excluded from the study. Participants were randomized in a 1:1:1:1 ratio to receive either atogepant, 10 mg; atogepant, 30 mg; atogepant, 60 mg; or placebo, respectively. The primary outcome was the change from baseline in the mean number of migraine days per month during the 12-week treatment. The change from baseline during the treatment period was -2.5 days with placebo, -3.7 days with 10mg atogepant, -3.9 days with 30mg atogepant, and -4.2 days with 60mg atogepant. Accordingly, the mean difference from placebo was -1.2 days with 10mg atogepant (95% confidence interval [CI], -1.8 to -0.6), -1.4 days with 30mg atogepant (95% CI, -1.9 to -0.8), and -1.7 days with 60mg atogepant (95% CI, -2.3 to -1.2) (P<0.001 for all comparisons). The adverse events more common with atogepant, compared to placebo, were constipation (7.7% to 6.9%) and nausea (6.1% to 4.4%). Overall, this study provided evidence supporting the use of atogepant as a preventive therapy for migraines.
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