Ubrogepant modestly effective for acute migraine, but safety and a lack of comparison with triptans are concerning

Référence

Dodick DW, Lipton RB, Ailani J, et al. Ubrogepant for the treatment of migraine. N Engl J Med 2019;381:2230-2241.

Sommaire

Ubrogepant is a calcitonin gene-related peptide antagonist. In this industry-funded trial, 1672 adults with a one-year history of migraine with or without aura who had 2 to 8 moderate to severe migraines per month were identified. Their mean age was 41 years, 89% were women, 85% were white, and approximately 25% were using prophylactic medication for migraine. The participants were randomized to receive ubrogepant 50 mg, ubrogepant 100 mg, or matching placebo. Medication was to be taken at the onset of acute migraine, and a second dose could be taken 2 to 48 hours later; the second dose was also randomized as either placebo or the prescribed dose for the 50 mg and 100 mg groups. Only patients who had a migraine, took an initial dose of medication, and recorded baseline and at least one subsequent symptom rating were included in the modified intention-to-treat analysis (n = 1327), while the safety analysis included all patients taking at least one dose of study medication or placebo (n = 1436). For the primary outcome of freedom from pain 2 hours after the initial dose, both ubrogepant 50 mg (19.2% vs 11.8%; NNT = 14) and ubrogepant 100 mg (21.2% vs 11.8%; NNT = 11) were significantly more effective than placebo. Regarding secondary outcomes, "at least some pain relief at 2 hours" and "absence of the most bothersome symptom at 2 hours" were improved to a similar degree (NNT ~ 9). Nausea, somnolence, and dry mouth were more common in the 100-mg group than in the 50-mg and placebo groups (number needed to treat to harm ~ 50). There were a total of 5 serious adverse events occuring in the active treatment groups within 30 days of enrollment (2 episodes of appendicitis and one each of pericardial effusion, seizure, and spontaneous abortion) compared with none in the placebo group.