The US Food and Drug Administration has approved the blood-thinning drug Effient tablets to reduce the risk of blood clots from forming in patients who undergo angioplasty, a common procedure to unblock a clogged coronary artery.
Reportedly, Effient was studied in a 13,608-patient trial comparing it to the blood-thinning drug, Plavix (clopidogrel), in patients with a threatened heart attack or an actual heart attack who were about to undergo angioplasty.
The fraction of patients who had subsequent non-fatal heart attacks was reduced from 9.1% in patients who received Plavix to 7.0% in patients who received Effient.
While the numbers of deaths and strokes were similar with both drugs, patients with a history of stroke were more likely to have another stroke while taking Effient. In addition, there was a greater risk of significant, sometimes fatal bleeding seen in patients who took Effient.
FDA said that, the drug should not be used in patients with active pathological bleeding, a history of mini-strokes or stroke, or urgent need for surgery, including coronary artery bypass graft surgery.
John Jenkins, director of the Office of New Drugs, in the FDA’s Center for Drug Evaluation and Research, said: “Effient offers physicians an alternative treatment for preventing dangerous blood clots from forming and causing a heart attack or stroke during or after an angioplasty procedure. Physicians must carefully weigh the potential benefits and risks of Effient as they decide which patients should receive the drug.”