Showing posts with label Deep vein thrombosis. Show all posts
Showing posts with label Deep vein thrombosis. Show all posts

Tuesday, January 26, 2016

XARELTO reduces rates of major bleeding, recurrent blood clots in people with deep vein thrombosis



Rivaroxaban2DCSD.svg


In continuation of my update on rivaroxaban


Janssen Pharmaceuticals, Inc. (Janssen) and its development partner, Bayer HealthCare, today announced the results from their real-world study XALIA showing that, in people with deep vein thrombosis (DVT), the rates of major bleeding and recurrent blood clots for XARELTO® (rivaroxaban) in routine clinical practice were generally consistent with those observed in Phase 3 research. Patients taking XARELTO® also had shorter length of hospital stays than those given standard anticoagulation. The prospective study was presented at the 2015 American Society of Hematology (ASH) Annual Meeting and simultaneously published in Lancet Hematology.

"On average, every 37 seconds someone in the Western world dies from a venous blood clot, so it is important we understand the effectiveness and safety of available treatment options for these potentially life-threatening blood clots," said XALIA principal investigator Professor Alexander G. G. Turpie, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada. "The real-world insights from XALIA confirm the positive benefit-risk profile of rivaroxaban for the treatment of deep vein thrombosis that was observed in the Phase 3 EINSTEIN-DVT study, signalling that the medicine is performing as expected in patients that physicians typically see in everyday clinical practice."

XALIA – which included approximately 5,000 patients from 21 countries – evaluated the safety and effectiveness of XARELTO®, taken once daily, for the treatment of DVT in routine clinical practice as compared to standard anticoagulation. The primary outcome was the incidence of adverse events (major bleeding, recurrent blood clots and all-cause mortality). Healthcare resource utilization, including length of stay, also was evaluated. A propensity score analysis was completed to address differences in baseline characteristics and help correct any selection bias. Methodological and other differences between the studies limit the ability to directly compare results of XALIA to the pivotal Phase 3 EINSTEIN-DVT study, which was used by regulatory authorities worldwide to approve XARELTO®.

XARELTO reduces rates of major bleeding, recurrent blood clots in people with deep vein thrombosis

Wednesday, October 2, 2013

Phase III EINSTEIN trial program: XARELTO reduces risk of DVT and PE

In continuation of my update on Rivaroxaban



The EINSTEIN-PE study was an open-label, randomized, non-inferiority trial. The trial compared oral rivaroxaban – 15 mg twice daily for three weeks, followed by 20 mg once daily – with the current standard of care (enoxaparin followed by a Vitamin K Antagonist [VKA]) in subjects with acute symptomatic PE with or without symptomatic DVT. Patients received treatment for six or 12 months. EINSTEIN-PE enrolled 4,833 participants and is the largest study ever conducted in the acute treatment of PE.