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According to the findings of new research, the controversial anticoagulant Xarelto fails to help prevent death from heart failure or coronary artery disease.
In a study known as COMMANDER HF, which was published this month in the New England Journal of Medicine on October 4, researchers found that individuals with heart failure or heart disease given Xarelto had o better outcomes.
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, there have been thousands of reports involving serious and uncontrollable bleeding problems from Xarelto, often resulting in severe injury or death.
In this study, researchers conducted a double-blind, randomized trial involving more than 5,000 patients with chronic heart failure, a left ventricular ejection fraction of 40% or less, coronary artery disease, and elevated plasma concentrations of natriuretic peptides. None of the subjects had atrial fibrillation. The patients were prescribed either a twice daily dose of 2.5mg of Xarelto or a placebo. Both groups were also given standard care for the treatment of worsening heart failure.
According to the findings, following a median follow-up period of 21.1 months, there was no significant difference in all-cause mortality between the Xarelto group and the placebo group.
“Rivaroxaban at a dose of 2.5 mg twice daily was not associated with a significantly lower rate of death, myocardial infarction, or stroke than placebo among patients with worsening chronic heart failure, reduced left ventricular ejection fraction, coronary artery disease, and no atrial fibrillation,” the researchers concluded.
In August, a similar study resulted in similar findings, suggesting that Xarelto was ineffective at preventing blood clot events among individuals who had been recently hospitalized. Both studies were sponsored by Janssen Pharmaceuticals, one of Xarelto’s manufacturers.
Both studies come 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.