Bristol-Myers Squibb Co. and Pfizer Inc. said their blood thinner Eliquis showed favorable safety results in certain heart disease patients in a phase 4 trial.
The phase 4 study, called Augustus, evaluated the safety of Eliquis compared to drugs known as vitamin K antagonists in patients with non-valvular atrial fibrillation, or NVAF. The patients have recent acute coronary syndrome, or ACS, are undergoing percutaneous coronary intervention or both.
NVAF is a disorder characterized by irregular heart rhythm not caused by a fault with the heart's valves. The condition can cause blood clots leading to a stroke — a scenario that patients could prevent with anti-blood clotting therapies such as Eliquis or vitamin K antagonists.
Under the 4,614-patient Augustus study, significantly fewer patients who were given Eliquis showed major or clinically relevant non-major bleeding after six months compared to those treated with a vitamin K antagonist. Patients evaluated in the trial were receiving a P2Y12 inhibitor with or without aspirin.
The results of the study were presented March 17 at the American College of Cardiology's 68th Annual Scientific Session.
ACS is an umbrella term for situations where blood supply to the heart muscle is blocked, such as a heart attack or angina. Percutaneous coronary intervention is a procedure where a thin tube called a catheter is used to place a structure, or stent, to open up blood vessels in the heart that have been narrowed due to plaque buildup.
New York's Bristol-Myers Squibb and Pfizer teamed up to develop and commercialize Eliquis, or apixaban, in a collaboration they entered in 2007. The therapy is approved for multiple indications in the U.S.