The FDA ( Food and Drug Administration ) has approved the blood-thinning drug Effient tablets ( Prasugrel ) to reduce the risk of blood clots from forming in patients who undergo angioplasty.

During an angioplasty, a balloon is used to open the artery that has been narrowed by atherosclerotic plaque. Often, a stent is inserted into the blood vessel to help keep the artery open after the procedure. Platelets in the blood can clump around the procedure site, causing clots that can lead to myocardial infarction, stroke, and death.

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 myocardial infarction who were about to undergo angioplasty.

The fraction of patients who had subsequent non-fatal myocardial infarction was reduced from 9.1 percent in patients who received Clopidogrel to 7.0 percent in patients who received Prasugrel. 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 Prasugrel . In addition, there was a greater risk of significant, sometimes fatal bleeding seen in patients who took Prasugrel.

The drug’s labeling will include a boxed warning alerting physicians that the drug can cause significant, sometimes fatal, bleeding. The drug should not be used in patients with active pathological bleeding, a history of transient ischemic attacks ( TIA ) or stroke, or urgent need for surgery, including coronary artery bypass graft surgery ( CABG ).

Source: FDA, 2009

XagenaMedicine2009


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