The Patient-Centered Outcomes Research Institute Board of Governors announced the approval of $6.5 million to fund two studies that will compare the effectiveness of novel oral anticoagulants for prevention of venous thromboembolism and pulmonary embolism, according to a press release.
In addition to warfarin, four novel oral anticoagulants — apixaban (Eliquis, Bristol-Myers Squibb), dabigatran (Pradaxa, Boehringer Ingelheim), edoxaban (Savaysa, Daiichi Sankyo) and rivaroxaban (Xarelto, Janssen) — are now available for use in the United States to treat clots. These novel oral anticoagulants are frequently used for longer than the standard 3-month treatment period to prevent formation of additional clots, but the comparative safety and effectiveness of extended use is unclear, according to information in the release.
A research team at the University of California at San Francisco will study records of patients treated with one of the four novel oral anticoagulants or warfarin for an extended period or who stopped treatment after clots were resolved. The researchers will also look at outcomes associated with each of the treatments, and whether the benefits and harms differ for patients who are older, have impaired kidney function or have a higher risk for bleeding, according to the release.
Another team of researchers based at Brigham and Women’s Hospital will study the safety and efficacy of the four novel oral anticoagulants and warfarin when used for extended periods. The researchers will evaluate outcomes experienced by patients receiving treatment for the first time for clots, according to the release.
“The research we are supporting gives the patients a vital role in finding the evidence on these newer medications that they, along with their providers, can use to make treatment decisions,” Joe Selby, MD, MPH, executive director of the Patient-Centered Outcomes Research Institute (PCORI), stated in the release.
In addition, each study will engage key stakeholders including patient organizations and professional medical societies/associations in the research design and implementation to help facilitate quicker dissemination and application of the study results and to ensure that the research addresses outcomes that are important for patients and their caregivers, according to the release. – by Cassie Homer
Disclosure: Selby is executive director of PCORI.