According to a Patient-Centered Outcomes Research Institute (PCORI) press release from earlier this month, the PCORI Board of Governors approved $6.5 million for research to compare the potential benefits and harms of popular anticoagulant drugs.
The study will include the older anticoagulant, Coumadin (warfarin), as well as the newer “novel oral anticoagulants” (NOACs): Eliquis (apixaban), Savaysa (edoxaban), Xarelto (rivaroxaban), and Pradaxa (dabigatran).
Typically, these blood-thinning drugs are used in the treatment and prevention of blood clots in the lungs and veins. The money from PCORI will be used to fund two different studies that will compare the effectiveness of the newer, as well as the older, anticoagulants in preventing such clots.
The press release provides the following details concerning the specifics of these studies:
A research team based at the University of California at San Francisco was approved for a $3.5 million award for a study that will review thousands of records of patients who either took one of the five drugs for extended periods of time as a preventive measure or stopped taking the drugs once their clots were resolved. It also will compare outcomes associated with each of the drugs and look at whether the benefits and harms differ for patients who are older, have impaired kidney function, or a higher risk of bleeding.
Another research team based at Brigham and Women’s Hospital in Boston was approved a $2.9 million award to compare the safety and effectiveness of each of the newer anticoagulants to one another and to warfarin when used for extended periods. Researchers will examine the outcomes experienced by patients being treated for the first time for clots.
While there are benefits to taking these anticoagulant drugs, there are also substantial risks that include major bleeding events that can sometimes be fatal. The aforementioned press release from PCORI acknowledges these risks, as well, stating that “although effective treatments, these drugs also can cause serious bleeding, including in the brain.”
The Abstract from the article, “Minimizing the Risk of Bleeding with NOACs in the Elderly,” provides the following information:
Novel oral anticoagulants (NOACs) such as [Pradaxa (dabigatran)], [Xarelto (rivaroxaban)], [Eliquis (apixaban)and [Savaysa (edoxaban)] have gained a lot of popularity as alternatives to warfarin for anticoagulation in various clinical settings. However, there is conflicting opinion regarding the absolute benefit of NOAC use in elderly patients…There have been reports that NOAC use, in particular [Pradaxa (dabigatran)], is associated with a higher risk of gastrointestinal bleeding in the elderly. Diagnosis and management of NOAC-associated bleeding in the elderly is difficult due to the absence of commonly available drug-specific antidotes that can rapidly reverse the anticoagulant effects.
At this time, the only FDA-approved reversal agent is Praxbind. However, it only reverses the blood-thinning effects of Pradaxa. Unfortunately, the other NOACs — Eliquis, Savaysa, and Xarelto — still do not have any FDA-approved reversal agents for acute bleeding episodes. More information is available on this topic in the article, “Savaysa Is Safe And Effective According To Recent Study, But Doctors Still Concerned About Lack Of Antidote To Stop Bleeding.”
We will continue to monitor the medical literature for the results of these two recent studies concerning Eliquis, Savaysa, Xarelto, Pradaxa, and Coumadin.
Additionally, we are currently investigating possible drug injury lawsuits against the responsible pharmaceutical companies for patients who have taken Pradaxa, Eliquis, Savaysa, or Xarelto and been hospitalized for serious side effects such as major bleeding events and hemorrhages, among others. For more information, see our information pages on Eliquis, Savaysa, and Xarelto.
Written by: Heather Helmendach, Legal Assistant
Law Offices of Thomas J. Lamb, P.A.
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