Safety profile of rivaroxaban in first-time users treated for venous thromboembolism in four European countries

• Published in: PloS one Vol. 19; no. 3; p. e0298596
• Main Authors: Ruigómez, Ana, Schink, Tania, Voss, Annemarie, Herings, Ron M C, Smits, Elisabeth, Swart-Polinder, Karin, Balabanova, Yanina, Brobert, Gunnar, Suzart-Woischnik, Kiliana, García Rodríguez, Luis Alberto
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 07.03.2024; Public Library of Science (PLoS)
• Subjects: Anticoagulants - therapeutic use; Atrial fibrillation; Atrial Fibrillation - drug therapy; Biology and Life Sciences; Care and treatment; Complications and side effects; Diagnosis; Factor Xa Inhibitors - adverse effects; Fibrinolytic Agents - therapeutic use; Gastrointestinal Hemorrhage - chemically induced; Germany; Health aspects; Humans; Medical research; Medicine and Health Sciences; Medicine, Experimental; Middle Aged; Mortality; Netherlands; Patient outcomes; People and places; Physical sciences; Respiratory agents; Rivaroxaban; Rivaroxaban - adverse effects; Safety and security measures; Sweden; Thromboembolism; Type 2 diabetes; United Kingdom; Venous Thromboembolism - drug therapy; Venous Thromboembolism - epidemiology; Venous Thromboembolism - prevention & control; Venous thrombosis; Vitamin K; Vitamins; Europe; United Kingdom; Netherlands; Sweden; Germany
• ISSN: 1932-6203; 1932-6203
• DOI: 10.1371/journal.pone.0298596

The European rivaroxaban post-authorization safety study evaluated bleeding risk among patients initiated on rivaroxaban or vitamin K antagonists for the treatment and secondary prevention of venous thromboembolism in routine clinical practice. Cohorts were created using electronic healthcare databases from the UK, the Netherlands, Germany and Sweden. Patients with a first prescription of rivaroxaban or vitamin K antagonist during the period from December 2011 (in the UK, January 2012) to December 2017 (in Germany, December 2016) for venous thromboembolism indication, with no record of atrial fibrillation or recent cancer history, were observed until the occurrence of each safety outcome (hospitalization for intracranial, gastrointestinal, urogenital or other bleeding), death or study end (December 2018; in Germany, December 2017). Crude incidence rates of each outcome per 100 person-years were computed. Overall, 44 737 rivaroxaban and 45 842 vitamin K antagonist patients were enrolled, mean age, 59.9-63.8 years. Incidence rates were similar between rivaroxaban and vitamin K antagonist users with some exceptions, including higher incidence rates for gastrointestinal bleeding in rivaroxaban users than in vitamin K antagonist users. Among rivaroxaban users, mortality and bleeding risk generally increased with age, renal impairment and diabetes. This study provides further data from routine clinical practice that broadly support safety profile of rivaroxaban for VTE indication and complement findings from previous randomized clinical trials.