Positive Results for Blood Clot Medication XARELTO

The threat of a blood clot looms large after many an orthopedic surgery. Two new studies are showing positive results for XARELTO (rivaroxaban) in treating venous thromboembolism (VTE), or blood clots, and reducing the risk of recurrence. Janssen Pharmaceuticals, Inc. (Janssen) and its development partner, Bayer AG, made the announcement.

In one study, people with VTE taking XARELTO for longer than three months had a lower risk of VTE recurrence, without an increase in major bleeding, compared to those taking the medicine for only three months.

“This study in a broad real-world setting affirms the American College of Chest Physicians [ACCP] guidelines for the extended treatment of an unprovoked VTE, ” said Scott Kaatz, D.O., lead study investigator and hospitalist, Henry Ford Hospital, in the October 23, 2016 news release. “Extended treatment with rivaroxaban showed a decrease in recurrent VTE without an increase in major bleeding and is consistent with a previous clinical trial.”

As indicated in the news release, “The second study was the first readout from Janssen’s Post-Marketing Safety Surveillance (PMSS) study in VTE, which showed the rates and patterns of major bleeding in people taking XARELTO for VTE in routine clinical practice were consistent with those reported in clinical trials.”

“Post-marketing research is invaluable to physicians who are continually looking to understand how a medicine is performing in real-world settings in order to make informed treatment decisions for their patients, ” said PMSS study investigator W. Frank Peacock, M.D., FACEP, associate chair and research director, Emergency Medicine, Baylor College of Medicine. “We have been closely examining the use of rivaroxaban in daily clinical practice for more than three years in people with non-valvular atrial fibrillation, and are pleased to expand our work to those with VTE.”

Dr. Kaatz told OTW, “The ACCP guidelines suggest long term anticoagulation for patients with unprovoked VTE disease based on randomized clinical trials. Our study with XARELTO corroborates findings of a previous clinical trial in a real world population and further supports the ACCP guidelines.”

“Patients with a history of VTE are at high risk of developing another clot after major orthopedic surgery and require aggressive prophylaxis. In addition, nearly three out of four of the patients with unprovoked VTE in our study were on extended treatment with rivaroxaban, which requires careful peri-operative planning for anticoagulation interruption.”