Drugs Xagena
The FDA ( Food and Drug Administration ) has approved Zontivity ( Vorapaxar ) tablets to reduce the risk of myocardial infarction, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.
Zontivity is the first in a new class of drug, called a protease-activated receptor-1 ( PAR-1 ) antagonist. It is an anti-platelet agent, designed to decrease the tendency of platelets to clump together to form a blood clot. By decreasing the formation of blood clots, Zontivity decreases the risk of heart attack and stroke.
Like other drugs that inhibit blood clotting, Zontivity increases the risk of bleeding, including life-threatening and fatal bleeding. Bleeding is the most commonly reported adverse reaction in people taking Zontivity. The drug’s prescribing information includes a Boxed Warning to alert health care professionals about this risk.
Zontivity must not be used in people 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 the study that supported the drug’s approval, Zontivity lowered this risk from 9.5 to 7.9% over a 3-year period, about 0.5% per year.
Health care professionals should inform patients that they may bleed and bruise more easily when taking Zontivity. Patients should report to their health care professional any unanticipated, prolonged or excessive bleeding, or blood in their stool or urine.
Zontivity will be dispensed with an FDA-approved patient Medication Guide that provides instructions for its use and important safety information.
In a clinical trial with over 25,000 participants, Zontivity, added to other anti-platelet agents ( generally Acetylsalicylic acid [ Aspirin ] and Clopidogrel [ Plavix ] ), reduced the rate of a combined endpoint of myocardial infarction, stroke, cardiovascular death, and urgent procedures to improve blood flow to the heart ( coronary revascularization ) when compared to placebo. ( Xagena )
Source: FDA, 2014
XagenaMedicine_2014
