Atogepant is a novel oral calcitonin gene-related peptide (CGRP) receptor antagonist indicated for the preventive treatment of migraine in adults with ≥4 migraine days per month. While clinical trials have demonstrated its efficacy and tolerability, patients with significant cardiovascular (CV) or cerebrovascular (CeV) disease were excluded from those trials, leaving an important evidence gap regarding its safety in this high-risk population.
To address this, a multi-country Post-Authorization Safety Study (PASS) has been launched to evaluate utilization patterns and safety outcomes for atogepant in routine clinical practice, with particular focus on patients with migraine and CV/CeV comorbidities.
Research challenge
The challenge was to identify a rare, high-risk patient population across multiple countries, track medication utilization and switching patterns, and evaluate CV/CeV outcomes with robust adjustment for baseline risk factors.
Our approach
- Multi-country common data model: harmonized variable definitions across Denmark, Spain (Catalonia), Sweden, and the Netherlands, enabling cross-national comparison while preserving local analytic expertise
- Advanced confounding control strategies: including propensity score matching and inverse probability of treatment weighting (IPTW), with standardized difference checks to ensure balance
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