FDA Approves New Tablet to Reduce Stroke, Heart Attack Risk

The agency approves Zontivity to reduce the risk of heart attack, stroke and cardiovascular death in high risk patients

The FDA recently approved the drug Zontivity (vorapaxar) to reduce the risk of stroke, heart attack and cardiovascular death in high risk patients, the FDA reports. The tablets also reduce the need for procedures to restore blood flow to the heart. The medication is ideal for use in patients who have previously had a heart attack or blockages in the arteries to the legs.

A clinical trial with over 25,000 patients showed that when added to other anti-platelet agents such as aspirin, Zontivity reduced the rate of a combined endpoint of heart attack, stroke, cardiovascular death and urgent procedures to improve blood flow to the heart.

According to the FDA, Zontivity is “the first in a new class of drug, called a protease-activated receptor-1 (PAR-1) antagonist.” The tablets are designed to decrease the tendency of platelets to clump together and form a blood clot, which in turn decreases the risk of heart attack or stroke. The drug does increase the risk of bleeding, however, and should not be used in people who have had a stroke, transient ischemic attack or bleeding in the head because of the risk of bleeding.  

“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, in the FDA’s press release.
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