Daiichi Sankyo Co. Ltd.'s Lixiana blood thinner showed low rates of clots and bleeding events in a late-stage clinical trial, meeting the main effectiveness and safety goals of the study.
The phase 3b trial, dubbed Eliminate-AF, included about 600 European patients with atrial fibrillation — a condition in which the heart beats irregularly, raising the risk of deadly clots and stroke. More than 6 million people in Europe have atrial fibrillation, Daiichi Sankyo said, citing research from the European Heart Journal.
Researchers looked at how much a once-daily, oral dose of Lixiana reduced the incidence of death, stroke and major bleeding compared to a vitamin K antagonist, a type of anti-coagulation medicine, in patients undergoing a minimally invasive procedure known as catheter ablation. During the procedure, small scars are made on the heart to stop the abnormal electrical signals responsible for the irregular beating from moving through the heart muscle. It is common to administer a blood thinner to reduce the risk of clotting associated with the procedure.
Of the patients receiving Lixiana from the end of the procedure to the end of treatment, 0.3% experienced a stroke or a major bleeding incident, compared with 2.0% in the vitamin K antagonist group. There were only three events reported, all major bleedings, and there were no deaths in the study, the company said.
About 2.5% of patients receiving Lixiana and 1.5% of those receiving the vitamin K antagonist experienced major bleeding from the start of medication to the end of treatment, the study results showed.
Researchers presented the data March 18 at the European Heart Rhythm Association meeting in Lisbon. The data are the first of a slew of results to be presented this year on the use of Lixiana in specific clinical situations and in real-world settings, said Hans Lanz, vice president and head of global medical affairs for the drug at the Japanese drugmaker's European unit.
The medicine, also known as edoxaban, is sold as Savaysa in the U.S. and as Lixiana elsewhere.