Newswise – DURHAM, NC – A new type of anti-clotting drug caused fewer bleeding incidents in patients with atrial fibrillation than commonly prescribed apixaban, according to results from a head-to-head comparison of the two.
The study, conducted by a cardiologist from Duke Clinical Research Institutewas reported April 3 at the American College of Cardiology Annual Scientific Sessions meeting and simultaneously published in The Lancet.
“Anticoagulant therapy is a lifesaver for people who develop atrial fibrillation, which can increase the risk of stroke fivefold,” said the presenter and lead author. Manesh PatelMD, head of Division of Cardiology at Duke University School of Medicine and a Fellow of the Duke Clinical Research Institute. “But a serious complication associated with anticoagulant therapies is bleeding, which leads many patients to reduce or stop taking their medications. As a result, there is great interest in alternatives that reduce this risk.
Asundexian is a new class of anti-clotting drugs that is being studied. It works by inhibiting a blood protein called factor XI, which contributes to the development of blood clots but is not involved in the healing process of blood vessels.
In the PACIFIC-AF trial — a Phase 2 study funded by Bayer AG, which makes the investigational therapy — researchers focused on bleeding outcomes from two different doses in patients with atrial fibrillation.
The two once-daily doses of asundexian, 20 mg and 50 mg, were tested against similar doses of apixaban, which is one of several commonly prescribed anticoagulant therapies that affect a different blood clotting protein. .
The trial included 755 patients with an average age of around 74 years. At both doses, patients taking asundexian had a 67% lower risk of bleeding than patients taking apixaban.
“The reduction in bleeding risk for patients with atrial fibrillation is encouraging,” said the lead author. Jonathan Picini, MD, clinical cardiac electrophysiologist at Duke University School of Medicine. “One in four people will develop atrial fibrillation – it’s the leading cause of cardiac arrhythmia and a risk factor for stroke – so it’s important we have safe and effective therapies. We can’t wait to see the research move to phase 3 studies.
Besides Piccini and Patel, study authors include Valeria Caso, Stuart J. Connolly, Keith AA Fox, Jonas Oldgren, W. Schuyler Jones, Diana A. Gorog, Václav Durdil, Thomas Viethen, Christoph Neumann, Hardi Mundl, au name of the PACIFIC-AF investigators.