More patients receiving ubrogepant 50 mg, 100 mg versus placebo report freedom from pain at two hours
WEDNESDAY, Dec. 4, 2019 (HealthDay News) — The percentage of patients with migraine reporting freedom from pain is higher for those receiving ubrogepant than those receiving placebo, according to a study published in the Dec. 5 issue of the New England Journal of Medicine.
David W. Dodick, M.D., from the Mayo Clinic in Phoenix, and colleagues randomly assigned adults with migraine, with or without aura, to receive either an initial dose of placebo (559 patients), ubrogepant 50 mg (556 patients), or ubrogepant 100 mg (557 patients) for treatment of a single migraine attack.
The researchers found that the percentage of patients with freedom from pain at two hours was 11.8, 19.2, and 21.2 percent, respectively, in the placebo, ubrogepant 50-mg, and ubrogepant 100-mg groups (P = 0.002 for ubrogepant 50 mg versus placebo; P < 0.001 for ubrogepant 100 mg versus placebo). The corresponding percentage of patients with freedom from the most bothersome symptom at two hours was 27.8, 38.6, and 37.7 percent, respectively (both P = 0.002). Within 48 hours after the initial or optional second dose, adverse events were reported in 12.8, 9.4, and 16.3 percent, respectively. Nausea, somnolence, and dry mouth were the most common adverse events; they were more frequent in the 100-mg ubrogepant group.
“Trials evaluating consistency of effect, longer-term safety data, and comparative effectiveness are needed to assess the safety and clinical utility of ubrogepant for acute migraine treatment,” the authors write.
Several authors disclosed financial ties to pharmaceutical companies, including Allergan, which manufactures ubrogepant and funded the study.
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