1. Patients with migraine treated with rimegepant during an acute event had resolution of pain and their most bothersome symptoms 2 hours after onset more frequently than patients treated with placebo.
2. Incidence of adverse events were similar for patients treated with either rimegepant or placebo.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Migraine is a common and debilitating headache condition. Treatment with triptans for acute episodes are often either not effective or can be contraindicated in certain patients. Calcitonin gene–related peptide (CGRP) has been associated with migraine pathology, and prior studies have shown inhibition of CGRP can effectively treat migraine. This phase 3 randomized controlled trial compared the CGRP small molecule inhibitor rimegepant to placebo for acute migraine treatment. The primary outcome of pain 2 hours after treatment administration showed more patients were pain free and free of their most bothersome symptoms when treated with rimegepant compared to placebo. Nausea and urinary tract infections were the most common adverse events and reported at similar rates in the treatment and placebo groups.
This large randomized study provides clinically meaningful, patient-centric data to suggest rimegepant as an efficacious treatment of acute migraine. The study is significantly limited by its lack of comparison to a triptan, or other active drug treatment.
Relevant Reading: New therapeutic approaches for the prevention and treatment of migraine
In-Depth [randomized controlled trial]: This multicenter, phase 3, double-blind, randomized controlled trial enrolled patients from 2017 to 2018. Eligible patients had migraine (with or without aura) history of over 1 year, had 2 to 8 migraine attacks of moderate or severe intensity each month, and if receiving preventative migraine treatment had to be on a stable regimen for over 3 months. Patients with any significant history of drug or alcohol use disorder were ineligible. Patients were randomized to receive 75mg of rimegepant (n=537) or placebo (n=535) for acute migraine of moderate or severe intensity. Before and after taking treatment, they recorded information about the migraine and their symptoms. The primary outcome of being pain-free 2 hours after migraine onset occurred in 19.6% vs 12.0% of patients in the rimegepant and placebo groups, respectively (absolute difference, 7.6 percentage points; 95% confidence interval [CI], 3.3 to 11.9; P<0.001). Patients free from their most bothersome symptoms 2 hours after treatment, a coprimary end point, occurred in 37.6% compared with 25.2% of patients in the rimegepant and placebo groups, respectfully (absolute difference, 12.4 percentage points; 95% CI, 6.9 to 17.9; P<0.001). Patients were more likely to be free of photophobia and phonophobia symptoms 2 hours migraine onset if in the treatment group. Incidence of adverse events was 17.1% and 14.2% in the rimegepant and placebo groups, respectfully. The most common adverse events were nausea and urinary tract infection, occurring at between 1-2% in the treatment and placebo groups for each event.
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