The blockbuster blood thinner Xarelto, prescribed to millions of patients worldwide, may have a higher bleeding risk than its competitor Pradaxa, according to a study based on real-world data published in JAMA Internal Medicine.
The study involved records on 118,000 Medicare patients with atrial fibrillation who were treated with either Pradaxa or Xarelto for the prevention of strokes associated with the heart ailment. When compared to patients treated with Pradaxa, the Xarelto group had significant increases in intracerebral hemorrhage, major extracranial bleeding, and gastrointestinal bleeding.
Pharmaceuticals are approved for marketing in the U.S. after undergoing a series of clinical trials showing the drug’s safety and efficacy in specific populations of patients or compared with placebo or other treatments. But real-world data, also called real-world evidence, is an increasingly important component to biopharmaceutical product development and can help researchers better understand the impact of a new product in a real-world setting. In the case of Xarelto, researchers relied on Medicare data.
“While clinical trials remain the gold standard for drug approval, more information is needed on how specific drugs perform within different age groups, such as the elderly, and different genders, races and ethnicities, as well as differences in disease severity and unstudied co-morbid conditions for use of products in the real world,” said the authors of an article on Real-World Evidence Studies in Applied Clinical Trials.
In 2014, Boehringer Ingelheim, maker of Pradaxa, paid $600 million to settle about 4,000 lawsuits alleging the company did not adequately warn of bleeding risks associated with use of the blood thinner. Johnson & Johnson’s Janssen Pharmaceuticals and Bayer, makers of Xarelto, now face a similar lot of lawsuits. The first Xarelto lawsuits are soon to be heard, but its makers have yet to offer any settlements. The question is, will the real-world data sway the company to reconsider?