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Question clinique
Is rimegepant a safe and effective abortive treatment for migraine headache?
L’Essentiel
In patients with frequent moderate or severe migraines, rimegepant will result in one more patient being pain free at 2 hours for every 13 patients treated. By comparison, a Cochrane Review reported a number needed to treat (NNT) of 5 for zolmitriptan for the same outcome (https://www.cochrane.org/CD008616). Of course, the manufacturer chose to compare its drug with placebo, not a triptan. Rimegepant will certainly be more expensive than the triptans, which are now available in generic form, but could be considered for patients with a contraindication to triptans, such as cardiovascular disease. 1b
Référence
Plan de l'etude: Randomized controlled trial (double-blinded)
Financement: Industry
Cadre: Outpatient (any)
Sommaire
Rimegepant belongs to a new class of "gepants" that target a peptide thought to play a role in the pathogenesis of migraine pain. The authors play up the many harms and deficiencies of triptans in their introduction and the need for an alternative (the manufacturer has even started a public relations campaign called "Demand More" in advance of expected FDA approval). I recall being told that triptans were a veritable miracle cure when they were first introduced. Oh, how things change. In this study, 1186 adults with at least a one-year history of migraine, the onset of migraines before age 50, and 2 to 8 moderate/severe migraines per month were randomized to receive a single dose of rimegepant 75 mg or matching placebo. The manufacturer funded and designed the study, collected the data, did the data management and analysis, and even wrote the manuscript. Patients with substance use disorder or any "unstable medical condition" were excluded. The mean age of participants was 41 years, 89% were women, 74% were white, and they had a mean of 4.6 migraines per month. Groups were balanced at the start of the study, and analysis was by intention to treat. The primary outcome was freedom from pain at 2 hours, and was more likely in the treatment group (19.6% vs 12.0%; P < .001; NNT = 13). A second primary outcome of freedom from the most bothersome symptom (most commonly photophobia) was also more likely with active treatment (37.6% vs 25.2%; P < .001; NNT = 8). Sustained pain relief at 24 hours and the need for rescue medications were also better with active treatment. Adverse events were uncommon.
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA
Commentaires
Migraine
Migraine