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Rimegepant is an antagonist of peptides associated with the calcitonin gene, which shows efficacy and safety in acute treatment of migraines.
study aims to compare the effects of Rimegepant and placebo prevention on migraines.
the study was a randomized, double-blind, placebo-controlled phase 2/3 trial at 92 centers in USA that recruited adults with a history of migraines for at least a year.
after a four-week observation period, eligible patients were randomly assigned to the Rimegepant group (75 mg, oral, 1 time/2 days) or placebo group for 12 weeks of continuous treatment.
end of treatment is the number of days of migraines in the last month of treatment (weeks 9-12).
November 14, 2018 - August 30, 2019, 1,591 patients were recruited, of whom 747 were randomly assigned to the Rimegepant group (373) or the placebo group (374).
695 people were included in the efficacy analysis, 348 of whom belonged to the Rimegepant group and 347 to the placebo group.
9th to 12th weeks, the main endpoint effect of the Rimegepant group was significantly better than that of the placebo group.
the average number of days of migraines decreased by 4.3 days compared to the observation period (4 weeks) before the random group, while the placebo group had an average reduction of 3.5 days (average difference of 0.8 days, 95% CI -1.46 to -0.20, p-0.0099).
741 subjects were subject to the study intervention and were included in the safety analysis.
133 (36%) of the 370 patients in the Rimegepant group reported adverse reactions, while 133 (36%) of the 371 subjects in the placebo group reported adverse reactions.
7 (2%) subjects in the Rimegepant group and 4 (1%) in the placebo group interrupted the study intervention due to adverse reaction events;
in summary, taking it once the next day, Rimegepant is effective in preventing migraines, and the tolerance is comparable to that of a placebo, with unexpected or severe safety events.
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