Tolerability, safety, and efficacy of atogepant versus topiramate in adults with migraine (TEMPLE): a randomised, head-to-head, phase 3b trial.
Uwe Reuter, Annelies Van Dycke, Jan Versijpt et al.
✦ AI-curated · Sources linked
In 30 seconds
The TEMPLE trial, a phase 3b randomized controlled trial, compared the tolerability, safety, and efficacy of atogepant (60 mg daily) versus topiramate in adults with migraine. Among 540 participants, atogepant demonstrated significantly lower treatment discontinuation due to adverse events (12% vs 30%, RR 0.4, p<0.0001) and greater efficacy, with 64% achieving at least a 50% reduction in migraine days compared to 39% for topiramate (RR 1.6, p<0.0001).
Key findings
- Discontinuation due to treatment-emergent adverse events was 12% for atogepant versus 30% for topiramate (RR 0.4, p<0.0001).
- 56% of atogepant participants reported treatment-related adverse events compared to 78% for topiramate.
- 64% of atogepant participants achieved at least a 50% reduction in mean monthly migraine days versus 39% for topiramate (RR 1.6, p<0.0001).
- Atogepant showed a greater reduction in mean monthly migraine days (-6.3 vs -4.5 days, treatment difference -1.8, p<0.0001).
Why it matters
This study provides direct comparative evidence on the tolerability and efficacy of atogepant versus topiramate, which may influence treatment decisions for migraine prevention, particularly in patients who struggle with the tolerability of conventional therapies.