FDA Approves Vorapaxar to Reduce Heart Attack and Stroke Risks in High-Risk Patients

The U.S. Food and Drug Administration (FDA) has approved vorapaxar (Zontivity) to reduce the risk for MI, stroke, cardiovascular-related death and coronary revascularization among patients who have previously experienced MI or peripheral artery disease. Vorapaxar is the first in a new class protease-activated receptor-1 (PAR-1) antagonist drugs and is designed to target thrombin-induced platelet activation.

"In patients who have had a heart attack or who have peripheral arterial disease, this drug will lower the risk of heart attack, stroke, and cardiovascular death. In the study that supported the drug’s approval, Zontivity lowered this risk from 9.5 percent to 7.9 percent over a 3-year period – about 0.5 percent per year,” said Ellis Unger, M.D., director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research.

According to the FDA, health care professionals should inform patients that they may bleed and bruise more easily when taking vorapaxar and patients should report to their health care professional any unanticipated, prolonged or excessive bleeding, or blood in their stool or urine. The FDA also notes that the drug will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information.

A 2011 clinical trial showed vorapraxar, added to other anti-platelet agents (generally aspirin and clopidogrel), reduced the rate of a combined endpoint of heart attack, stroke, cardiovascular death, and coronary revascularization when compared to placebo.

Clinical Topics: Dyslipidemia, Vascular Medicine, Lipid Metabolism, Novel Agents

Keywords: Aspirin, Contusions, Drug Evaluation, Hemorrhage, Lactones, Myocardial Infarction, Peripheral Arterial Disease, Platelet Activation, Pyridines, Receptor, PAR-1, Receptors, Proteinase-Activated, Stroke, Thrombin, Ticlopidine, United States Food and Drug Administration, Aspirin, Contusions, Drug Evaluation, Hemorrhage, Lactones, Myocardial Infarction, Peripheral Arterial Disease, Platelet Activation, Pyridines, Receptor, PAR-1, Receptors, Proteinase-Activated, Stroke, Thrombin, Ticlopidine, United States Food and Drug Administration


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