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According to the findings of new research, the new-generation anticoagulant Xarelto fared poorly at preventing venous thromboembolism events among individuals who had recently been hospitalized.
In a study sponsored by the drug manufacturer, Janssen Pharmaceuticals, researchers looked at whether Xarelto worked as a prophylactic in preventing blood clot-related problems, such as deep vein thrombosis and pulmonary embolism. However, there appeared to be no significant benefit when compared to a placebo, according to a report published on August 26 in the New England Journal of Medicine.
Xarelto (rivaroxaban) is the leading member of a new generation of direct oral anticoagulants, which are marketed as superior alternatives for prevention of blood clots with atrial fibrillation and other conditions. However, the drug has been linked to thousands of reports involving severe and fatal bleeding events, after doctors were unable to reverse the blood thinning effects.
In this study, researchers conducted a double-blind trial of more than 12,000 medically ill patients who were deemed to be at risk of venous thromboembolism-related adverse events. They were assigned either a once-daily dose of Xarelto 10 mg or given a placebo for 45 days. The researchers looked for venous thromboembolism events, death from such events, and bleeding.
According to the findings, 50 out of 6,007 patients given Xarelto suffered a venous thromboembolism event. That compares to 66 out of 6,012 patients given a placebo. Bleeding events occurred in nearly twice as many Xarelto patients, 0.28%, compared to 0.15% of those in the placebo group; an increase of nearly 88%.
“In conclusion, our trial did not show a significant benefit of this rivaroxaban regimen started at hospital discharge with regard to the composite outcome of fatal or symptomatic venous thromboembolism in medically ill patients,” the researchers concluded. “Given the relatively low incidence of events despite the enrichment strategy and the lack of effect on venous thromboembolism–related death, the usefulness of extended thromboprophylaxis remains uncertain.”
The study comes several 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.