Rimegepant, an innovative oral calcitonin gene-related peptide (CGRP) receptor antagonist, has recently gained approval for acute migraine care.
Rimegepant (75 mg) effectively relieves migraine in real-world settings, with 44.7% achieving pain freedom at 2 hours, and is well-tolerated with mostly mild adverse events.
Rimegepant, an innovative oral calcitonin gene-related peptide (CGRP) receptor antagonist, has recently gained approval for acute migraine care. While its usefulness has been portrayed in randomized clinical trials (RCTs), its real-world effectiveness and tolerability remain unexplored. The GAINER study—a prospective, multicenter investigation—sought to bridge this gap by investigating rimegepant in routine clinical practice.
Volunteers were directed to manage a single migraine episode using a 75 mg orally disintegrating tablet of rimegepant. Using a dedicated diary, they recorded migraine characteristics at baseline and at 30-minute intervals up to 2 hours post-dose, with a follow-up at 24 hours. Conducted across 16 headache centers, the study assessed two key outcomes: (i) pain freedom at 2 hours post-dose, and (ii) the occurrence of treatment-emergent adverse events.
In this real-world study, 103 migraine sufferers (74.8% female, mean age 44.4 years) were enrolled, including 24.3% with chronic migraine, of whom 44.0% had a concurrent diagnosis of medication overuse headache. The cohort had failed an average of 2.7 prior preventive treatments and experienced a mean of 9.6 migraine days per month. At the time of rimegepant intake, 40.8% reported severe migraine intensity.
Pain freedom at 2 hours was attained by 44.7% (46/103) of volunteers. Baseline pain severity did not markedly impact this outcome (p = 0.316), but earlier administration (within 1 hour of onset) was linked with a higher response rate (p = 0.032). Mild adverse events occurred in 15.5% of cases (16/103), primarily fatigue (n = 6), gastrointestinal distress (n = 6), excess sleepiness (n = 4), and transient cognitive challenges (n = 3). In 85.4% of cases (88/103), tolerability was rated as good to excellent.
The findings supported rimegepant's potential for acute migraine care in real-world settings, including those with episodic or chronic migraine, medication overuse, and multiple prior preventive treatment failures.
The Journal of Headache and Pain
Effectiveness and tolerability of rimegepant in the acute treatment of migraine: a real-world, prospective, multicentric study (GAINER study)
Luigi Francesco Iannone et al.
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