Overview: Extra-extended dual platelet therapy with Aspirin and Plavix is not better than Aspirin alone in patients who have a drug-eluting stent, according to a new study by Korean researchers in the DES-LATE trial. The researchers found that, compared to aspirin alone, dual therapy with Plavix and Aspirin had a higher bleeding risk with no other endpoint favoring the combination. This data is only the latest in a growing body of research showing that adding Plavix to standard Aspirin therapy offers little benefits, and can in fact be more dangerous. For those looking to file lawsuits over the blood thinning drug, the study helps confirm that Plavix is an unnecessary treatment that has been falsely touted as a superior version of Aspirin.
- Korean researchers have found that extra-extended dual-therapy with Aspirin and Plavix is not better then Aspirin alone in patients with a stent
- The researchers found that the group taking Plavix was associated with a higher bleeding risk
- Plavix lawsuits allege that manufacturers falsely touted Plavix as a superior version of Aspirin; the DOJ is currently investigating Sanofi and BMS over claims made to the FDA about the drug
Product: Plavix® (clopidogrel)
Manufacturer: Sanofi-Aventis, Bristol-Myers Squibb Co.
Side Effects & Complications
- Cerebral hemorrhage
- Thrombotic Thrombocytopenic Purpura (TTP)
- Gastrointestinal bleeding
- Internal bleeding
- Bone marrow damage
- Heart attack
According to MedPage Today, Korean researchers found in the DES-LATE trial that an extra-extended dual antiplatelet therapy won’t help boost outcomes in in patients with a drug-eluting stent. Such devices are placed inside blood vessels in order to prevent blood clots that could lead to a heart attack. Current guidelines recommend dual antiplatelet therapy, such as a combination of Aspirin and Plavix, for a minimum of 6 to 12 months in patients who have had these procedures. The researchers, however, found that the risk of heart attack, stroke and cardiac death was the same whether or not patients were taking Aspirin and Plavix for 36 months or longer or switched to Aspirin alone after 12 months. At the American College of Cardiology meeting,Cheol Whan Lee, MD and his colleagues said that there was no other endpoint favoring dual therapy, and in addition there appeared to be a higher risk for major bleeding.
Bristol-Myers Squibb and Sanofi-Aventis, the manufacturers of Plavix, are facing a number of lawsuits over injuries alleged from the blood thinner. Recently, we reported that the US Department of Justice is investigating Sanofi over claims it made about Plavix to the U.S. Food and Drug Administration (FDA) about individual responses to the drug. In March 2010, the FDA updated the Plavix label by adding a black box warning stating that about 3 percent of the population is unable to metabolize the blood thinner. Late last year, West Virginia’s attorney general filed a deceptive marketing suit alleging that the state had needlessly overpaid for the expensive medication because the company had falsely touted it as being superior to Aspirin.