Efficacy and safety of rimegepant 75 mg for acute treatment of migraine: a pooled analysis of four randomized, placebo-controlled trials
Abstract
OBJECTIVE: This pooled analysis of data from four randomized placebo-controlled trials summarizes the efficacy and safety of rimegepant for acute treatment of migraine.
METHODS: In all studies, participants were aged ≥18 years and had a ≥ 1-year history of migraine, two to eight migraine attacks of moderate or severe pain intensity per month, and attacks lasting 4-72 hours if untreated. Participants were provided with a single dose of rimegepant 75 mg or placebo to treat a single migraine attack of moderate or severe pain intensity within the next 45 days. Co-primary endpoints at 2 hours post-dose were pain freedom and freedom from the most bothersome symptom (MBS). Treatment comparisons utilized Mantel-Haenszel risk estimation with stratification by study and prophylactic migraine medication use randomization stratum; p values are nominal. On-treatment adverse events (AEs) were also assessed.
RESULTS: Overall, 4,895 participants received rimegepant (n = 2,439) or placebo (n = 2,456). For the co-primary endpoints, the proportion of participants with pain freedom 2 hours post-dose (20.0% vs. 11.8%; p 1% of participants was nausea (rimegepant = 1.4%, placebo = 1.3%). Severe AEs occurred in 0.3% and 0.1% of participants in the rimegepant and placebo groups, respectively. Serious AEs occurred in 0.1% of participants in both groups; none were deemed related to study treatment.
CONCLUSION: In this pooled analysis of four randomized placebo-controlled trials, a single dose of…
How strong is the evidence?
Evidence Hub reads this as a secondary / pooled analysis, done in people. Its evidence level is 3 of 5 (Moderate · trial / cohort / secondary analysis). Trials without a large randomized design, cohorts and secondary analyses give moderate evidence. Reported size: 4,895 participants or records.
Read the paper
Related studies
- Calcium Ions in the Physiology and Pathology of the Central Nervous System
- AI-powered in silico twins: redefining precision medicine through simulation, personalization, and predictive healthcare
- In silico functional, structural and pathogenicity analysis of missense single nucleotide polymorphisms in human MCM6 gene
- In Silico drug repurposing pipeline using deep learning and structure based approaches in epilepsy
- Targeting serotonin receptors with phytochemicals – an in-silico study
- In silico exploration of anti-prostate cancer compounds from differential expressed genes
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.