The Janssen Pharmaceutical Companies of Johnson & Johnson has revealed the results from the MARINER and COMMANDER HF (heart failure) trials.
MARINER was a Phase lll trial that evaluated Xarelto (rivaroxaban) for the treatment of acute medically ill patients.
The randomised, double-blind, placebo-controlled trial enrolled 12,019 patients at 671 centres in 36 countries.
During the trial, the patients were randomised in a 1:1 ratio to receive Xarelto and placebo. The trial started at the time of hospital discharge and continued for 45 days.
Newly published results from the trial have shown that Xarelto failed to reduce the composite endpoint of venous thromboembolism (VTE), or blood clots, and VTE-related death in acute medically ill patients, who were discharged from hospital.
Xarelto, however, significantly reduced VTE with consistent safety, thereby supporting the medicine’s positive benefit-risk profile.
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During the COMMANDER HF trial, Xarelto was unable to impact overall mortality outcomes compared to standard of care.
However, the trial showed that Xarelto reduced the number of heart attacks and strokes in patients with significant coronary artery disease (CAD).
Xarelto has also been able to reduce left ventricular ejection fraction (LVEF) in patients who experienced a recent episode of acute decompensated heart failure (ADHF).
The results from the COMMANDER HF trial indicate that the high death rate in the enrolled patients is primarily caused by poor heart function, not thrombotic events.
COMMANDER HF trial was a Phase lll study designed to examine the potential of Xarelto in reducing the risk of heart attack, stroke and death after an episode of ADHF in patients who have had symptomatic HF for a minimum of three months.
The global, prospective, multi-centre, randomised, double-blind, placebo-controlled, event-driven trial evaluated Xarelto plus standard of care compared to standard of care alone in approximately 5,022 patients after they were hospitalised for ADHF.
Both the MARINER and COMMANDER HF trials were sponsored by Janssen.