MedicalResearch.com Interview with:
Paul Burton MD, PhD, FACC
Vice President, Medical Affairs
Janssen Scientific Affairs, LLC.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: More than 900,000 Americans experience a venous thromboembolism (VTE) each year, with about one-third of these occurrences being fatal. Once a person experiences a VTE, they are at increased risk of a repeat occurrence. Guidelines currently recommend standard anticoagulant therapy with a Factor Xa inhibitor, like XARELTO® (rivaroxaban), for three months or longer. For those people who have had a VTE and stop anticoagulant therapy, as many as 10 percent of them will experience another VTE within one year and 20 percent within three years.
This study examined extended use of XARELTO® after the recommended three-month treatment period in patients who experienced an initial VTE, showing XARELTO® was associated with a decreased risk of recurrent VTE with no increase in major bleeding during this time period.
MedicalResearch.com: What should readers take away from your report?
Response: XARELTO® is an effective and safe option for protecting patients from experiencing another VTE. In fact, this past October, the U.S. Food and Drug Administration (FDA) approved an update to the prescribing information for XARELTO® to add a 10 mg dose to reduce patients’ risk of recurrent VTE after at least six months of standard anticoagulation therapy. Health care professionals who are managing patients with VTE are now able to prescribe either XARELTO® 10 mg (once daily) or the currently-approved 20 mg dose (once daily) after patients have received at least six months of standard anticoagulation therapy.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: We believe real-world research is an important complement to clinical trials, as it helps to build a bridge between what we observed in clinical trials and what we are seeing in routine clinical practice. In addition, we are committed to generating important clinical evidence on the safety and efficacy of XARELTO® and its potential role in addressing a wide range of critical medical needs through our EXPLORER clinical research program. As part of EXPLORER, we are examining the use of XARELTO® in preventing VTE in certain pediatric patients in our EINSTEIN Junior and UNIVERSE studies.
MedicalResearch.com: Is there anything else you would like to add?
Response: XARELTO® is the most studied oral Factor Xa inhibitor in the world today. More than 200,000 people have been evaluated in published real-world research since the approval of XARELTO® across all approved indications in the U.S. Post-marketing studies and registries continue to confirm the safety and efficacy of XARELTO® in routine clinical use across a broad spectrum of patients.
Saturday, December 1, 2018, 6:15 PM-8:15 PM
Craig I. Coleman, PharmD1*, Alexander G. Turpie, MD2*, Thomas J. Bunz, PharmD, PhD3*, Jan Beyer-Westendorf, MD4and William L Baker, PharmD5*
1School of Pharmacy, University of Connecticut School of Pharmacy, Suffield, CT
2Department of Medicine, Hamilton Health Sciences, Hamilton, Canada
3New England Health Analytics, LLC, Granby, CT
4King’s Thrombosis Service, Department of Haematology, King’s College London, Dresden, Germany
5School of Pharmacy, University of Connecticut, Storrs, CT
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