New data looking at the safety and efficacy of rivaroxaban (Xarelto, Janssen) for the prevention of venous thromboembolism (VTE) following major orthopedic surgery has been published online ahead of print in Thrombosis and Haemostasis.
New data looking at the safety and efficacy of rivaroxaban (Xarelto, Janssen) for the prevention of venous thromboembolism (VTE) following major orthopedic surgery has been published online ahead of print in Thrombosis and Haemostasis.
Data from a non-interventional phase 4 XAMOS study in 17,701 unselected patients undergoing hip or knee surgery in routine practice confirmed the favorable benefit–risk profile of rivaroxaban seen in the phase 3 RECORD trials. These data show that, in routine clinical practice, rivaroxaban improves the chances of preventing VTE in patients after major orthopedic surgery with no increased risk of major bleeding, compared to standard care-80 % low-molecular weight heparin. Data from this study were previously presented at the 54th American Society of Hematology (ASH) Annual Meeting in Atlanta in December 2012.
Turpie“VTE prophyaxis is recommended for 35 days for patients having hip replacement surgery and 10 to 35 days for knee replacement surgery,” said Alexander G.G. Turpie, MD, FRCP, FACP, FACC, FRCPC, emeritus professor of medicine at McMaster University, and an internist on the staff of Hamilton Health Sciences, Hamilton, Ontario, Canada.
“The results showed a significant 35% reduction in symptomatic VTE with rivaroxaban versus standard of care with no difference in major bleeding. Rivaroban 10 mg once daily is highly effective and safe for VTE prophylaxis in major joint replacement surgery,” Dr Trupie said.
Rivaroxaban is approved for 6 indications, including treatment of PE, treatment of DVT, and to reduce the risk of recurrence of DVT or PE following an initial 6-month treatment for acute VTE.
The study demonstrated that the data from the phase 3 RECORD study showing similar findings and can be translated in to routine practice, concluded Dr Turpie. “An effective oral agent such as rivaroxaban that does not require monitoring is very practical in this setting,” he said.