Paige Weaver1,2, Tsz Hin Ng3,4, Thomas Breeden1, Stephanie B Edwin4, Bradley Haan1, Christopher Giuliano4,5. 1. Department of Pharmacy, Ascension Genesys Hospital, Grand Blanc, MI, USA. 2. Department of Pharmacy, Maine Medical Center, Portland, ME, USA. 3. Department of Pharmacy, Detroit Receiving Hospital, Detroit, MI, USA. 4. Department of Pharmacy, Ascension St. John Hospital, Detroit, MI, USA. 5. Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, MI, USA.
Abstract
BACKGROUND: Rivaroxaban is a first-line option for the management of venous thromboembolism (VTE). However, limited data are available regarding its effectiveness in morbidly obese patients. OBJECTIVE: To evaluate rates of thrombosis and bleeding in morbidly obese patients receiving rivaroxaban or warfarin for VTE. METHODS: A multicenter, retrospective cohort study was conducted to compare rates of bleeding and thrombosis in patients receiving rivaroxaban versus warfarin for acute VTE. Patients were included if they were older than 18 years and had a body mass index (BMI) greater than 40 kg/m2 or weight greater than 120 kg. The primary effectiveness outcome was hazard of VTE recurrence; the primary safety outcome was hazard of major bleeding. Patients were followed for up to 12 months. RESULTS: A total of 1281 patients were identified for acute VTE and were included in this study with 487 patients receiving rivaroxaban and 785 receiving warfarin. The average cohort age was 57.6 ± 14.6 years, and the average weight was 136.4 ± 27.2 kg. After controlling for confounding factors, the use of rivaroxaban was not associated with an increased hazard of VTE events when compared with warfarin (hazard ratio [HR] = 0.69, 95% confidence interval [CI]: 0.42-1.08, P = 0.12) or major bleeding (HR = 1.29, 95% CI: 0.66-2.30, P = 0.52). CONCLUSION AND RELEVANCE: No difference was observed in obese patients with weight >120 kg or BMI >40 kg/m2 receiving rivaroxaban or warfarin for VTE treatment in hazard of VTE or major bleeding. Either agent may be considered an appropriate treatment option in this population.
BACKGROUND: Rivaroxaban is a first-line option for the management of venous thromboembolism (VTE). However, limited data are available regarding its effectiveness in morbidly obese patients. OBJECTIVE: To evaluate rates of thrombosis and bleeding in morbidly obese patients receiving rivaroxaban or warfarin for VTE. METHODS: A multicenter, retrospective cohort study was conducted to compare rates of bleeding and thrombosis in patients receiving rivaroxaban versus warfarin for acute VTE. Patients were included if they were older than 18 years and had a body mass index (BMI) greater than 40 kg/m2 or weight greater than 120 kg. The primary effectiveness outcome was hazard of VTE recurrence; the primary safety outcome was hazard of major bleeding. Patients were followed for up to 12 months. RESULTS: A total of 1281 patients were identified for acute VTE and were included in this study with 487 patients receiving rivaroxaban and 785 receiving warfarin. The average cohort age was 57.6 ± 14.6 years, and the average weight was 136.4 ± 27.2 kg. After controlling for confounding factors, the use of rivaroxaban was not associated with an increased hazard of VTE events when compared with warfarin (hazard ratio [HR] = 0.69, 95% confidence interval [CI]: 0.42-1.08, P = 0.12) or major bleeding (HR = 1.29, 95% CI: 0.66-2.30, P = 0.52). CONCLUSION AND RELEVANCE: No difference was observed in obese patients with weight >120 kg or BMI >40 kg/m2 receiving rivaroxaban or warfarin for VTE treatment in hazard of VTE or major bleeding. Either agent may be considered an appropriate treatment option in this population.