A new study investigating the efficacy of Xarelto suggests that the new-generation anticoagulant is no better than aspirin at preventing dangerous blood clots in patients who have undergone hip or knee replacement surgery.
The study, published this month in The New England Journal of Medicine, involved more than 3,400 hip and knee replacement patients and was the first to compare the Xarelto and baby aspirin for this indication.
All of the study participants were treated with Xarelto for the first five days after their implant surgery. Some were then randomly switched to aspirin.
The volunteers continued to take the drugs for 14 days. They were then followed for 90 days, during which time they were monitored for signs of venous thromboembolism (VTE) or serious bleeding events.
Overall, VTE occurred in less than 1% of the study subjects: 11 of the 1,707 who received a baby aspirin compared to 12 of the 1,717 were give Xarelto.
Clinically-important bleeding occurred in 1% of Xarelto patients versus 1.3% of those taking aspirin, a difference not considered significant. In every case, bleeding occurred at the site of surgery.
“The major message here is aspirin is an effective and safe alternative to rivaroxaban,” lead author Dr. David Anderson, told Reuters Health. “And it offers a choice and potential benefits of savings to patients and the healthcare system.”
Reuters noted that Xarelto costs around $425.00/month, compared to less than a dollar for aspirin.
Dr. Anderson also suggested that “there will be interest in looking at other areas of potential comparison” between Xarelto and aspirin in the wake of his study.
Xarelto is marketed jointly by Bayer and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary. The blood thinner was initially approved by the FDA in October 2011 and is currently indicated to treat:
Xarelto is currently the subject of more than 21,000 lawsuits filed on behalf of patients who suffered life-threatening episodes of internal bleeding. Among other things, they assert that sales of Xarelto were driven by misleading marketing claims that positioned the drug as a superior alternative to an older anticoagulant called warfarin.
Among other things, the lawsuits point out that bleeding associated with warfarin can be stopped relatively quickly via the administration of vitamin K. However, there is currently no approved antidote to reverse Xarelto bleeding.
The majority of Xarelto lawsuits are pending in a federal multidistrict litigation now underway in the U.S. District Court, Eastern District of Louisiana. So far three cases have gone to trial in that proceeding, all of which concluded with defense verdicts.
On December 4th, a jury in the Philadelphia Court of Common Pleas awarded $28 million ($1.8 million in actual damages and $26 million in punitive damages) to an Indiana woman who suffer gastrointestinal bleeding after taking Xarelto for a little over a year. However, the trial court recently dismissed the verdict. The plaintiff is appealing that decision.