Dr. Lip observed that, after adjusting the data, patients taking dabigatran had higher rates of clinically relevant nonmajor gastrointestinal bleeding (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 apixaban users.
“Larger cohort studies and longer follow-up data of general nonvalvular atrial fibrillation populations will be needed to confirm these early observations,” Dr. Lip concluded.
While real-world research of course has its limitations and cannot replace clinical trial findings as a means to accurately compare the clinical efficacy or safety profiles of different medicines, such studies do provide information that can help inform clinical practice.
“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 is increasingly important for physicians and patients,” Dr. Camm noted in a media release on the XANTUS trial issued by the European Society of Cardiology.
Dr. Camm added: “These real-world insights from XANTAS complement and expand on what we already know from clinical trials, and provide physicians with reassurance to prescribe rivaroxaban as an effective and well-tolerated treatment option for the broad range of patients with atrial fibrillation seen in their everyday practice.”
The XANTUS and PMSS studies were supported by Bayer HealthCare and Janssen. The other studies mentioned were supported by Bristol-Myers Squibb and Pfizer. Dr. Camm disclosed acting as a consultant for Bayer Healthcare and other health care companies. Dr. Lip disclosed acting as a consultant for Bayer Healthcare, Bristol-Myers Squibb, and Pfizer as well as other health care companies.