The FDA is reviewing a clinical trial that found 30 months of dual antiplatelet blood-thinning therapy reduced the risk of heart attack and clot formation in stents, but increased the rate of non-cardiovascular death compared with 12 months of treatment.
The FDA currently believes the benefits of clopidogrel (Plavix) and prasugrel (Effient) therapy outweigh the potential risks.
"Patients should not stop taking these drugs because doing so may result in an increased risk of heart attacks, blood clots, strokes, and other major cardiovascular problems. Health care professionals should not change the way they prescribe these drugs at this time," the FDA stated.
In the clinical trial researchers compared 30 and 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient) in about 1,000 patients following the implantation of a drug-eluting coronary stent. Stents are tiny medicine-coated tubes that are inserted into narrowed arteries to keep them from collapsing and blocking blood flow to the heart.
The study suggests the higher rate of death in the 30-month patients were primarily caused by cancer and trauma. The increased risk of death was seen in patients given clopidogrel, but not those given prasugrel.
"It should be noted that increases in non-cardiovascular death have not been reported in previous large trials examining clopidogrel for other cardiovascular diseases," the FDA stated.
The FDA has not yet reviewed the trial results or made any findings on its accuracy.
"We are communicating this safety information while we continue to evaluate the results from this trial and other available data. We will communicate our final conclusions and recommendations when our evaluation is complete," the FDA stated.
The Dual Antiplatelet Therapy (DAPT) trial was published in the New England Journal of Medicine on Nov. 16.
