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The side effects of Xarelto increase the risk of bleeding and are no better than aspirin at preventing a second stroke among patients who have already suffered one, according to the findings of a new study.
Canadian researchers report that Xarelto failed to show superiority to aspirin in the prevention of recurrent stroke, but carried a higher bleeding risk. Their findings were published in the New England Journal of Medicine on May 16, indicating that the study was cancelled due to the high risk of Xarelto bleeding events.
Xarelto (rivaroxaban) is the leading member of a new generation of direct oral anticoagulants, which are marketed as superior alternatives to warfarin for prevention of blood clots with atrial fibrillation and other conditions. However, while warfarin’s blood thinning effects can be quickly reversed with vitamin K and plasma, Xarelto and similar new blood thinners, such Pradaxa and Eliquis, were not released with a reversal agent, and have been linked to thousands of reported injuries and deaths stemming from bleeding events that could not be stopped.
The study looked at the effectiveness and safety of Xarelto in a clinical trial involving 7,213 patients; 3,609 of whom were given a 15 mg daily dose of Xarelto, with 3,604 given a 100 mg daily dose of aspirin. Patients were followed for a median of 11 months before the study had to be cancelled due to both the lack of effectiveness of Xarelto and the bleeding risks.
The study was stopped following recommendations of an Independent Data Monitoring Committee, which noticed the Xarelto bleeding rates and determined the trial may be dangerous to participants.
The rate of recurrent stroke in patients receiving the two drugs was the same, at 4.7%. However, 62 patients given Xarelto, or 1.8%, suffered major bleeding events. That compared with only 23 patients, 0.7%, in the aspirin group.
“In conclusion, there was no benefit with rivaroxaban at a daily dose of 15 mg, as compared with aspirin at a daily dose of 100 mg, for the prevention of stroke recurrence in patients with embolic stroke of undetermined source,” the researchers determined. “Patients with ischemic stroke who met the eligibility criteria for this trial had a risk of stroke recurrence of approximately 5% per year with either treatment. Ongoing randomized trials are testing alternative anticoagulants versus aspirin in similar groups of patients.”
The study comes three months after another group of Canadian researchers found that Xarelto also did no better than aspirin at preventing blood clots following hip or knee surgery. That study was also published in the New England Journal of Medicine.
Incidents of unstoppable bleeding have resulted in thousands of reports involving injury or death for patients using the new drugs. Currently, there are about 20,000 Xarelto lawsuits pending as part of a federal multidistrict litigation (MDL), which is centralized before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana.
Each of the claims raise similar allegations that users and the medical community were not adequately warned about the risk of uncontrollable bleeding on Xarelto.
Following a handful of early bellwether trials, which were held before Judge Fallon to help gauge how juries may respond to certain evidence and testimony that is likely to be repeated throughout the litigation, no progress has been made in negotiating Xarelto settlements or another resolution for the claims.
As a result, Judge Fallon recently ordered the parties to select 1,200 Xarelto cases for discovery, which may then be remanded back to U.S. District Courts nationwide for individual trial dates later this year.