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Bayer AG’s (ADR) (BAYRY) subgroup Bayer HealthCare announced positive results from the second Phase-III X-VeRT study of its “oral anticoagulant” Xarelto (Rivaroxaban) today. The results revealed that a daily dosage of Xarelto is an “effective and well-tolerated alternative” to Vitamin K Antagonists (VKAs) for patients suffering from non-Valvular Atrial Fibrillation and undergoing cardioversion.
X-VeRT, the first prospective trial of a novel oral anticoagulant, showed that compared with the use of VKA, rivaroxaban was associated with a numerical reduction in the risk of cardiovascular events of 50 per cent in the composite primary efficacy outcome of stroke, transient ischemic attack, peripheral embolism, myocardial infarction and cardiovascular death, with a numerically lower risk of major bleeding of 24 per cent in the primary safety outcome.
The practical advantage of using rivaroxaban was demonstrated by the shorter time to cardioversion compared to VKA. The trial was designed to support previous findings of rivaroxaban in the setting of cardioversion from ROCKET AF and was not powered for statistical significance.
Cardioversion is a common medical procedure undertaken in patients with atrial fibrillation in order to reset the heartbeat back to a regular sinus rhythm.
The X-VeRT study contributes to the extensive ongoing evaluation of rivaroxaban that would include over 275,000 patients in both clinical trials and real world settings.
Agencies/Canadajournal
