Janssen Pharmaceuticals announced FDA approval of Xarelto (rivaroxaban) tablets for the prevention of deep vein thrombosis (DVT) that may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery.
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Apixaban and rivaroxaban are both factor Xa inhibitors.
A recent report highlights the importance of using rivaroxaban cautiously in morbidly obese.
Johnson & Johnson Pharmaceutical Research & Development announced that it has submitted a New Drug Application to the FDA for rivaroxaban for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF).
The researchers found that a composite outcome of symptomatic venous thromboembolism or death due to venous thromboembolism occurred in 0.83% of patients in the rivaroxaban group and in 1.10% in the placebo group (hazard ratio, 0.76; 95% confidence interval, 0.52 to 1.09; P=0.14).
A case study reports on two patients that experienced severe liver injury onset during treatment with the oral anticoagulant rivaroxaban.
The NDA submission is supported by data from the phase 3 EINSTEIN-Jr and UNIVERSE trials in pediatric patients, along with adequate and well-controlled studies in adults.
Novel oral anticoagulants, that do not require the laboratory monitoring associated with warfarin therapy, may alter the landscape of venous thromboembolism treatment and stroke prevention in atrial fibrillation, according to a study presented at the 52nd American Society of Hematology Meeting and Exposition.
The application is supported by data from the double-blind, placebo-controlled phase 3 VOYAGER PAD trial.
Oral anticoagulation with rivaroxaban for stroke prevention in atrial fibrillation (AF) patients resulted in low rates of bleeding and stroke, researchers presented at the European Society of Cardiology Congress 2015.