1. In adults with migraines unsuitable for triptans, rimegepant (Nurtec ODT) can provide rapid-onset and lasting symptom relief.
Evidence Rating Level: 1 (Excellent)
While triptans are a cornerstone of the acute treatment of migraine, there are numerous instances when their use is unsuitable, for example, when there is inadequate response, intolerability, or a contraindication. Calcitonin gene-related peptide receptor antagonists have been shown to be efficacious and safe in acute migraine management, with a recently randomized, placebo-controlled trial (NCT05509400) showing rimegepant to have significantly increased migraine pain relief. However, the full time course of rimegepant’s effect is unknown but important to establish, as quick onset of effect is commonly preferred by patients with migraine. The objective of the present study was to evaluate the full time course of rimegepant effect from 15 min to 48 hours post-dose based on data from NCT05509400. NCT05509400 was a phase 4, multinational, randomized, double-blind, placebo-controlled study that included adults 18 years and older with ≥ 1-year history of migraine attacks, migraine attacks lasting an average of 4–72 h if untreated, an average of 4–14 migraine days per month, and unsuitable for triptan use (intolerance (30.5%) and/or lack of efficacy (84.9%) to at least 2 triptans or the documented presence of a contraindication (9.1%)). 570 participants were randomized to rimegepant 75 mg (n = 286; mean [SD] age, 43.1 [11.8] years; 88.5% female) one dose or placebo (n = 284; mean [SD] age, 42.6 [11.5] years; 90.1% female). Participants recorded migraine headache pain intensity prior to dosing and at 15 min, 30 min, 45 min, 1 h, 1.5 h, 2 h, 3 h, 4 h, 6 h, 8 h, 24 h, and 48 h post-dose. Improvements of ≥ 5% for rimegepant over placebo with p ≤ 0.05 [difference (95% CI)] were first observed at 1 h for pain relief [8.6% (1.3%, 15.8%); p = 0.0201], and 1.5 h for pain freedom [6.2% (1.5%, 11.0%); p = 0.0103] and return to normal function [7.1% (1.1%, 13.1%); p = 0.0210]. Rimegepant significantly improved pain relief, pain freedom, and return to normal function at all subsequent time points, with significance remaining at 48 hours. These results suggest that in patients with migraines unsuitable for triptans, rimegepant can provide symptom relief within 1-2 hours that remains for up to 48 hours.
Click here to read this study in Neurology and Therapy
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