Evaluation of the Inappropriate Prescribing Practices of Rivaroxaban and Their Association with Bleeding in Tertiary Care Hospitals in Saudi Arabia

Abstract

Background: Rivaroxaban use continues to accounts for a significant number of serious injuries, primarily bleeding, and deaths as reported by ISMP. There’s limited evidence on the associated factors with bleeding development among Saudi population. Objectives: We aimed to evaluate the association of bleeding with comorbidities and certain inappropriate prescribing practices in patients receiving rivaroxaban in Saudi Arabia. Materials and Methods: This is a two-center retrospective cohort study. Incidence of bleeding and its association with comorbidities and the most common inappropriate prescribing practices, such as unapproved indication, inappropriate dosing or drug combination, were evaluated. Results: A total of 446 patients were included; 82 (18.4%) patients receiving rivaroxaban developed bleeding, 7% had major bleeding, and 11% had nonmajor bleeding. Rivaroxaban was used for approved indication in 90.1% of the patients. Regression analysis did not identify significant association between off-label prescriptions and bleeding. However, a significant association was identified with the number of comorbidities (>3 comorbidities, 24.2%; odds ratio: 1.32; 95% confidence interval: 1.16–1.51; P ≤ 0.001) in the univariate analysis. Certain comorbidities were found to be independent risk factors for bleeding including hypertension, prior thrombosis, and myocardial infarction. Patients who developed bleeding had lower body mass index (BMI) (P = 0.004). A higher average risk score of CHA2DS2-VASc (4.0 ± 1.7) and HAS-BLED (2.0 ± 1.1) in patients with nonvalvular atrial fibrillation was observed than that reported in literature. Conclusion: We report a slightly higher rivaroxaban-bleeding incidence across multiple clinical indications than that in previously published studies. The risk of bleeding in our population was associated with the number of comorbidities, lower BMI, and a high HAS-BLED score. Future prospective controlled studies are warranted to define the bleeding risk in patients with lower BMI. Safe prescribing and use of rivaroxaban are recommended to avoid additional risks.