Janssen and Bayer announced the first results from their comprehensive research program, CALLISTO, which evaluated rivaroxaban (Xarelto) for the treatment and prevention of venous thromboembolism (VTE) in patients with active cancer in 9 studies. Findings were presented at the 2015 American Society of Hematology (ASH) Annual Meeting.
The current standard of care for treating VTE in this population is low-molecular-weight heparin (LMWH). The study, funded by Janssen and conducted at Memorial Sloan Kettering Cancer Center, evaluated rivaroxaban for the treatment of VTE in cancer patients. It followed 200 patients with cancer who were diagnosed with VTE and treated with rivaroxaban for 6 months. Primary endpoints included recurrent VTE, major bleeding, clinically relevant non-major bleeding leading to discontinuation of the medicine, and death.
Study researchers found that the efficacy and safety of rivaroxaban were generally consistent with findings of prior research with injectable anticoagulants. In the study, 4.4% of patients receiving rivaroxaban experienced recurrent VTE within 6 months. Major bleeding, clinically relevant non-major bleeding leading to drug discontinuation, and all-cause mortality were observed in 1.6%, 3.8%, and 18.2% of patients, respectively. No deaths were found due to bleeding.
Researchers concluded that the rates for rivaroxaban were generally consistent with those observed in two published studies, CLOT and DALTECAN, which examined LMWH in the treatment of cancer-associated VTE. The rates for recurrent VTE after 6 months of LMWH treatment were 9% and 8.7%, respectively. Major bleeding was observed in 6% and 10.2%, respectively, and all-cause mortality in 39% and approximately 30%, respectively.
Xarelto is a Factor Xa inhibitor currently approved for the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE), for the prophylaxis of DVT/PE post hip or knee replacement surgery, for the reduction in the risk of recurrent DVT/PE after initial 6-month treatment, and for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
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