Rimegepant safety and patient-reported outcomes among triptan-naïve, triptan-using, and triptan-failure participants: Subgroup analysis of an open-label, multicenter study.

Abstract

BackgroundRimegepant was safe and well tolerated in a multicenter, open-label, phase 2/3 trial for acute treatment of migraine administered as 75 mg every other day (EOD) and as needed (PRN; EOD + PRN) for 12 weeks or PRN for 52 weeks.MethodsPost-hoc analysis of this long-term safety study in adults was conducted according to five subgroups based on current and historical triptan use: current triptan use and no historical discontinued triptans; no current triptan use and no historical discontinued triptans (triptan-naïve); and history of =1, ≥1 and ≥2 discontinued triptans. Triptan failure was defined as discontinuation of any triptan, for any reason, including insufficient response and/or tolerability.ResultsThe proportion of participants with ≥1 on-treatment adverse event (AE) was 57.6-66.3% across triptan subgroups. Rimegepant-related AEs (17.7-23.2%), treatment discontinuations (1.6-3.8%) and the most common AE (upper respiratory tract infection, 7.7-9.5%) were consistent across subgroups. After long-term treatment, the proportion of participants who preferred rimegepant to their previous medication was >75% in all triptan subgroups.ConclusionsLong-term acute treatment of migraine with rimegepant 75 mg up to once daily was safe and well tolerated in triptan-naïve participants, current triptan users and those with single or multiple historical triptan discontinuations.Trial RegistrationNCT03266588.