Results of COMMANDER HF study showed Xarelto to have no significant benefit on death from any cause, heart attack or stroke compared to placebo.- Bayer AG + Janssen Research & Development, LLC.

Bayer AG and its development partner Janssen Research & Development, LLC announced new data from an investigational study for its Factor Xa inhibitor rivaroxaban (Xarelto) at ESC Congress 2018, 25-29 August in Munich, Germany.

�Sudden worsening of the symptoms of heart failure is serious and often requires hospitalization to manage worsening breathlessness and swelling of the legs,� said Professor John Cleland, Professor of Cardiology at Imperial College London, UK. �While the COMMANDER HF study demonstrated that rivaroxaban offers no additional benefit on top of standard of care in this group of patients, rivaroxaban did numerically reduce both heart attacks and stroke, suggesting that it did have a beneficial effect on thrombosis. The composite efficacy result was driven primarily by all-cause mortality which was mostly due to worsening of the heart�s pumping function; these deaths represented about one third of all deaths in this very sick patient population.

Rivaroxaban may reduce the risk of heart attack and stroke but these do not appear to be key drivers of prognosis in the long term setting after an episode of decompensated heart failure in contrast to the large number of patients with milder and more stable heart failure.�Data from the COMMANDER HF study showed that, in patients following an acute decompensation of heart failure and concomitant coronary artery disease, there was no statistically significant difference between rivaroxaban 2.5 mg twice daily and placebo, each on top of standard of care, in reducing the composite risk of all-cause mortality, heart attack and stroke. However, there were numerically fewer events for both heart attack and stroke in patients receiving rivaroxaban. Furthermore patients receiving rivaroxaban had similar and in general low rates of severe bleeding compared to those receiving placebo.