Data from two clinical trials presented Monday at the European Society of Cardiology Congress suggest that Eisai's experimental anticoagulant atopaxar may reduce the risk of heart attacks, strokes and cardiovascular deaths without increasing the risk of serious bleeding.
The Phase II trials randomised 241 patients with acute coronary syndrome and 263 patients with high-risk coronary artery disease to receive atopaxar or placebo. In addition, more than 90 percent of patients in the first trial also received standard therapy of aspirin and a thienopyridine, and in the second study all patients received aspirin and about 40 percent also took a thienopyridine.
Data showed that in both trials, patients treated with atopaxar demonstrated a "numerically lower incidence" of cardiovascular events compared with those on placebo. While increased bleeding was observed as the dose of atopaxar increased, serious bleeding risks were not higher and the episodes of bleeding reported were "nuisance" bleeding, lead researcher Shinya Goto said.
The researcher added, "we need further adequately powered trials to determine the efficacy and safety," of atopaxar.
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