Rivaroxaban, a direct oral anticoagulant (DOAC) and factor Xa inhibitor, has been widely prescribed for multiple cardiovascular indications since its approval in Europe. As part of the post-approval commitment to the European Medicines Agency (EMA), a comprehensive post-authorization safety study (PASS) program was implemented across four European countries—the Netherlands, Germany, Sweden, and the UK—leveraging rich real-world electronic health records (EHRs) and administrative data. This initiative stands among the largest pharmacoepidemiologic efforts to assess long-term safety and usage patterns of a widely used therapeutic in routine clinical care.
Research challenge
Regulatory authorities and healthcare stakeholders require robust real-world evidence (RWE) on the safety profile of medications post-market, especially for rare or long-term adverse events that clinical trials may be underpowered to detect. For rivaroxaban, it was imperative to understand how safety outcomes in everyday clinical use compared to clinical trial expectations. The PASS program aimed to address these questions across diverse European clinical populations (over 355,000 rivaroxaban users and 338,000 vitamin K antagonist users) to support regulatory, clinical, and pharmacoepidemiologic insights.
From this, our researchers documented the challenges when conducting multi-country real-world safety research with heterogeneous coding and data capture systems.
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