New Study to Investigate Long-Term Xarelto and Pradaxa Use

xarelto bleedingA patient-centered research institute is conducting two studies that will compare the effectiveness of Pradaxa, Xarelto and other oral blood thinners to determine what the long-term effects are.

The Patient-Centered Outcomes Research Institute (PCORI) announced the $6.5 million studies to scrutinize anticoagulants including:

  • Warfarin
  • Dabigatran (Pradaxa, made by Boehringer Ingelheim)
  • Rivaroxaban (Xarelto, made by Janssen)
  • Apixaban (Eliquis, made by Bristol-Myers Squibb)
  • Edoxaban (Savaysa, made by Daiichi Sankyo)

The drugs are used to to treat clots and are often 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 PCORI.

Federal Xarelto Litigation is consolidated before US District Judge Eldon Fallon in MDL 2592 and the state litigation is consolidated in the Philadelphia Court of Common Pleas before Judge Arnold New. In the state MDL  Judge New has elected to allow “Efficacy Claims” to be filed in that MDL in addition to claims related to uncontrolled bleeding. Judge Fallon has yet to follow suit and may not.

Uncertainty about medications

Venous thromboembolism (VTE) causes more than half 500,000 hospitalizations and more than 100,000 deaths each year in the United States. VTE is typically treated with at least three months of an anticoagulant, or “blood-thinning,” medication. Afterward, patients are often given the option to extend anticoagulant treatment for a longer period to prevent VTE recurrence. Remaining on anticoagulants, however, can lead to serious bleeding complications and can be expensive and inconvenient for patients.

At present, there is much uncertainty about which medication is the best choice for extended VTE treatment, according to PCORI. Choosing the best anticoagulant strategy is particularly difficult when treating people of older age, people who have kidney disease, or people who have high bleeding risk, due to the scant evidence available on the relative benefits and harms in these populations.

The long-term goal of the project is to compare the benefits and harms of different anticoagulant options for the extended treatment of VTE, information that will be critical in helping clinicians and patients personalize their treatment decisions. The study focuses on people who have completed at least three months of anticoagulant treatment for VTE and compares the outcomes of 1) people who stay on anticoagulants with those who stop anticoagulants, and 2) those who are treated with extended warfarin compared with NOAC treatment. PCORI will also examine whether the benefits and harms of treatment differ by age, kidney function, or bleeding risk.

The study will be based in Kaiser Permanente Northern California and Kaiser Permanente Southern California, two large, integrated healthcare delivery systems that provide comprehensive medical care for more than 7.7 million patients in California. PCORI will identify in these health systems all adults treated for VTE from years 2010 to 2015 and collect information from electronic health records on their health history, anticoagulant treatment choices, and clinical outcomes. Next, PCORI will survey patients with VTE treated in more recent years (2014–2016) and measure their self-reported health, well-being, and satisfaction with treatment.

The main outcome of the study is the net benefit of one treatment strategy compared with another, measured in terms of the number of VTE events prevented and the number of bleeding complications induced. Because the study is an observational study of actual clinical care, PCORI will then apply advanced statistical techniques to maximize the validity of the results.

 

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