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Clinical Question
Is ubrogepant a safe and effective abortive treatment for acute migraine headache in adults?
Bottom line
Similar to another recently marketed "-gepant," this one, ubrogepant, is an effective acute migraine treatment in adults compared with placebo, and I'm sure this one is just as expensive. It's interesting that both of these drugs had studies published within a few months of each other in corresponding major US impact journals. I've seen TV commercials already touting the value of each one. 1b
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Industry
Setting: Outpatient (specialty)
Synopsis
Ubrogepant is another in the new class of "-gepants" for the management of acute migraine pain. The design of this study and the design of a recent study on rimegepant (see link above) are remarkably alike. For both studies, the trial design and conduct, data collection, management, analysis, medical writing, and editorial support were all provided by the manufacturer. In this study, 1686 adults with the onset of migraine before age 50, at least a one-year history of migraine, and 2 to 8 moderate or severe migraines per month randomly received (concealed allocation assignment) 1 of 2 dosages of ubrogepant (25 mg or 50 mg) or matching placebo. The mean age of participants was 41.5 years, 90% were women, and 82% were white. Complete follow-up occurred for 85% of participants. Using intention-to-treat analysis, the primary outcome—freedom from pain at 2 hours—occurred significantly more often in the treatment group than in the placebo group (21.8% in the 50-mg group, 20.7% in the 25-mg group, and 14.3% in the placebo group; number needed to treat [NNT] = 13.3; 95% CI 8.0 - 39.3). A secondary outcome of freedom from the most bothersome symptom (most commonly photophobia) occurred significantly more often in the 50-mg ubrogepant group compared with placebo (38.9% vs 27.4%; NNT = 8.7; 5.7 - 18.6). The need for rescue medication was also better with active treatment. Adverse events were uncommon.
Reviewer
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Comments
no comparison with anything but placebo?
Once again.
No comparison with other (out of patent) treatments .... or even with NSAIDS or Acetaminophen?
Come on, pharma.
Scepticism
I love the scepticism of the reviewer. It is both warranted and humorous. I agree with the above comment.