Atogepant well tolerated, effectively reduces migraine days
PHILADELPHIA — Atogepant, a novel, oral calcitonin gene-related peptide receptor in development for the prevention of migraine, achieved positive results in trials presented at the American Headache Society Annual Meeting.
Two studies evaluated data from a multicenter, randomized, double-blind, placebo-controlled trial that included 834 patients with a history of migraine with or without aura who had 4 to 14 migraine days during the baseline period. Patients in the trial were assigned placebo or one of five atogepant (Allergan) treatment arms for a 12-week treatment period.
Peter Goadsby, MD, professor of neurology and director of NIHR King’s Clinical Research Facility, King’s College, London, and professor of neurology at the University of California, San Francisco, and colleagues evaluated change in monthly migraine days among the six arms.
Goadsby and colleagues found that atogepant treatment resulted in significant changes in migraine days from the baseline (mean = 7.67) compared with those taking placebo (–2.85): atogepant 10 mg once daily (–4; P = .0236), 30 mg once daily (–3.76; P = .039), 30 mg twice daily (–4.23; P = .0034), 60 mg once daily (–3.55; P = .039), and 60 mg twice daily (–4.14; P = .0031).
David Dodick, MD, of the Mayo Clinic, and colleagues, evaluated the proportion of patients who experienced 25%, 50%, 75%, and 100% reduction in migraine days in placebo and in all five treatment arms.
Researchers found that the reduction in headache days from the baseline was 25% in 77% of patients, 50% in 57% of patients, 75% in 34% of patients, and 100% in 10% of patients.
All treatment arms had significantly higher proportions of patients with 25%, 75%, or 100% reductions in migraine days compared with placebo. The proportion of patients with a 50% reduction in migraine days was significant in atogepant 30 mg once daily, 30 mg twice daily, and 60 mg twice daily groups.
An analysis of results in 4-week intervals found that patients in all reduction groups and all atogepant doses were significantly different from placebo between 1 and 4 weeks.
Both studies reported 480 (58.2%) patients with adverse events during the treatment period, 170 (20.6%) of which were considered treatment related.
“Atogepant was generally well tolerated, with no patient experiencing a treatment-related serious [adverse event],” Dodick and colleagues wrote. – by Erin Michael
Dodick D, et al. Responder rates to atogepant in patients with episodic migraine: a post-hoc analysis of results from a phase 2b/3, randomized, double-blind, placebo-controlled trials.
Goadsby P, et al. Orally administered atogepant was efficacious, safe, and tolerable for the prevention of migraine: results from a phase 2b/3 study.
Both presented at: American Headache Society Annual Scientific Meeting; July 11-14, 2019; Philadelphia.
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