FDA approves Jansen prescription drug Xarelto (rivaroxaban) for reduced primary cardiovascular risk in CAD or PAD patients
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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chronic CAD and PAD are caused by hardening or stenosis caused by cholesterol and platelet build-up, which can disrupt blood circulation and, in severe cases, damage to limbs and vital organs such as the heart, kidneys and brainrecentdays, Janssen, a Johnson and Johnson-owned
company, announced thatFDA(theof the prescribeddrug (rivaroxaban) to help patients with coronary artery disease (CAD) or peripheral arterial disease (PAD) reduce the risk of major cardiovascular events (CVs), including death, myocardial infarction and strokeXarelto
Xarelto is an oral factor Xa anticoagulant inhibitor that has been approved as a prescription drug to help patients with atrial fibrillation caused by non-cardiac valves reduce the risk of stroke and thrombosisin addition, Xarelto can help reduce the likeness of blood clots in other parts of the body, including deep vein thrombosis (DVT) and pulmonary embolism (PE) in the legs, as well as help reduce the risk of thrombosis in patients who frequent DVT or PE after at least 6 months of thrombosis treatment, and help prevent blood clots in the legs or lungs in patients who have just undergone hip or knee replacement surgeryXarelto can also be more effective at reducing the risk of heart disease, stroke, CAD and PAD if used in combination with small doses of aspirinIt is worth noting that Xarelto is also well-targeted for the safety and efficacy of childrenthe study
this approval is based on Xarelto's Phase 3 ClinicalTrialCOMPASS is a Phase 3 trial of Xarelto clinical safety and efficacy in collaboration with Bayer, involving 27,395 patients with chronic CAD or PAD from 33 countries the trial assessed the long-term effects of Xarelto as a single drug or in combination with aspirin to prevent major cardiovascular adverse events results showed that a combination of 2.5 mg xarelto and 100 mg of aspirin twice a day compared to taking aspirin alone could help patients with CAD and/or PAD reduce their risk of major cardiovascular events by 24%, with stroke rates down 42 percent, cardiovascular deaths 22 percent lower, and heart disease rates 14 percent lower
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