FDA announced that it will review results from a clinical trial showing that long-term dual antiplatelet therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment.
FDA announced that it will review results from a clinical trialshowing that long-term dual antiplatelet therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment.
Published in the New England Journal of Medicine, the Dual Antiplatelet Therapy (DAPT) trial compared 30 months versus 12 months of treatment in approximately 10,000 patients who received aspirin plus either clot-busters clopidogrel or prasugrel, after implantation of drug-eluting coronary stents.
“The use of dual antiplatelet blood-thinning therapy, particularly clopidogrel [Plavix] and prasugrel [Effient], may prove to provide benefits versus risks when used appropriately,” according to FormularyWatch advisor Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.
The risks of stent thrombosis and heart attacks in the group receiving the 30-month treatment was reduced compared to 12 months; however, there was a higher rate of death in the 30-month treatment group. The higher rate of death was attributed to cancer and trauma deaths. The increased risk of death with longer treatment was seen in the patients given clopidogrel, but not those receiving 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 final decision of FDA is pending review of the DAPT trial but in the interim, clinicians are to use current evidence and their clinical judgment to determine whether or not patients would benefit from this combination therapy,” said Dr Farinde.
FDA said that it believes the benefits of clopidogrel and prasugrel continue to outweigh their potential risks when used for current indications. Patients should not stop taking these drugs because doing so may result in an increased risk of myocardial infarctions, blood clots, strokes, and other major cardiovascular problems.
FDA has not yet reached any conclusions based on the findings from this clinical trial. The agency is communicating this safety information while it continues to evaluate the results from this trial and other available data.