Studying Rivaroxaban’s Safety in Real-World Settings

Dr. Lip observed that, after adjusting the data, patients taking dabigatran had higher rates of clinically relevant nonmajor gastrointestinal bleeding (hazard ratio [HR], 1.24) and that those taking rivaroxaban were more likely to have major (HR, 3.6), clinically relevant nonmajor (HR, 1.43), or any bleeding (HR, 1.41) when compared with those taking apixaban. “Larger cohort studies and longer follow-up data of general nonvalvular atrial fibrillation populations will be needed to confirm these early observations,” he concluded.

Informing Clinical Practice

While real-world research has limitations and cannot replace clinical trial findings as a means to compare the clinical efficacy or safety profiles of various medicines, such studies can help inform clinical practice, said Dr. Camm.

“With 10 million people in Europe alone affected by atrial fibrillation, a number that is only expected to increase, real-world insights on routine anticoagulation management in everyday clinical practice are increasingly important for physicians and patients,” he said.

—Sara Freeman