Rationale for Correct Answer
The correct answer is: Gepants used as a migraine preventative treatment were associated with a reduction in mean monthly migraine days
A phase 2/3 clinical trial evaluating rimegepant as a preventative migraine treatment in patients with migraine demonstrated a statistically significant reduction in mean migraine days by 0.8 compared with placebo.1 The efficacy of atogepant as preventative therapy was demonstrated in patients with episodic and chronic migraine in 2 separate phase 3 trials.2,3 In patients with episodic migraine, atogepant significantly reduced the mean number of migraine days by 1.2 days (10 mg), 1.4 days (30 mg), and 1.7 days (60 mg) compared with placebo.2 In chronic migraine, atogepant significantly reduced the mean number of migraine days by 2.4 days (30 mg BID) and 1.8 days (60 mg QD) compared with placebo.3 Medication discontinuations in the gepant preventative studies averaged 4% to 5% across studies versus a discontinuation rate of 1% to 4% in the placebo groups.1,2,3
In a phase 3 trial in which participants with episodic migraine were randomized to take atogepant (10 mg, 30 mg, 60 mg) or placebo once daily, across the atogepant groups, the most commonly reported adverse event was constipation (6.9% to 7.7% across doses). The incidence of constipation was higher in the atogepant groups than in the placebo group (0.5%).2 Similarly, in the phase 3 trial in patients with chronic migraine, constipation was reported in 10.4% of patients taking atogepant 30 mg BID or 60 mg QD, versus 4% of patients taking placebo.3 Constipation was not reported as an adverse event in the rimegepant trial.1
In a year-long open-label rimegepant trial, rimegepant was taken every other day, with the option to take additional doses as needed on non-scheduled days. Participants were provided with 30 rimegepant doses. Most participants (81.4%) did not exceed 16 tablets per month, indicating a decreased reliance on acute migraine treatments. Mean monthly migraine headache days also decreased over the course of a year.4,5
References:
1. Croop R, et al. Lancet. 2021;397(10268):51-60;
2. Ailani J, et al. N Engl J Med. 2021;385(8):695-706;
3. Pozo-Rosich P, et al. Lancet. 2023;402(10404):775-85;
4. Lipton RB, et al. AHS 64th Annual Scientific Meeting. Headache. 2022;62(S1):1170. Abstract IOR-09;
5. L’Italien G et al. Cephalalgia Reports. 2022;5. doi:10.1177/25158163221075596