U.S. Food and Drug Administration has approved Zontivity (vorapaxar) which helps in reducing deaths from Heart attack, Stroke, and Cerebrovascular accidents and also to be used in procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs. This is a very good news for patients who are at high risk of Heart attack, Stroke, and Cerebrovascular accidents.
Zontivity (vorapaxar) is the first drug in a new class called protease-activated receptor-1 (PAR-1) antagonist. By antagonistic action on PAR-1 receptors, it causes reduced aggregation of platelets i.e. reducing the tendency of platelets to clump together to form a blood clot which further helps in reducing risks of myocardial infarction (heart attack) and stroke.
just like any other drug Zontivity (vorapaxar) also has side effects which are increased the risk of bleeding including life-threatening and fatal bleeding.
FDA also recommended that Zontivity should not be used in patients who have had a stroke, transient ischemic attack (TIA), or bleeding in the head, because the risk of bleeding in the head is too great in these patients.
FDA announcement states “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. Also “In a clinical trial with over 25,000 participants, Zontivity, added to other antiplatelet agents (generally aspirin and clopidogrel), reduced the rate of a combined endpoint of heart attack, stroke, cardiovascular death, and urgent procedures to improve blood flow to the heart (coronary revascularization) when compared to an inactive pill (placebo).”
Also, doctors should inform patients that they will bleed and bruise more easily after taking this drug and patients should report to their doctor about any unanticipated, prolonged or excessive bleeding, or blood in their stool or urine.
Zontivity (vorapaxar) has been developed by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. of Whitehouse Station, N.J.
