Overview: For patients with a history of stroke, taking Plavix with aspirin is not more effective than taking aspirin alone, according to a new study. In fact, data indicates that the combination can actually raise the risk of major bleeding and death. The new study, which was published in the New England Journal of Medicine (NEJM) only fuels lawsuits alleging that Plavix is defective and causes hemorrhaging.
- NEJM study says that taking dual therapy with aspirin and Plavix in patients who have had a lacunar stroke is not more effective than aspirin alone for preventing a second stroke
- Compared to the group that took only aspirin, the Plavix plus aspirin group had twice the rate of major hemorrhaging events and a higher incidence of death
- The latest findings support previous research showing that Plavix with aspirin is not more effective than aspirin alone; Plavix is also associated with an increased risk of hemorrhaging
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
The study, which was published today in the New England Journal of Medicine, aimed to determine whether or not taking Plavix with aspirin in “dual antiplatelet therapy”, would reduce the chances of a second stroke among patients who had a recent lacunar stroke. A lacunar stroke is a stroke that occurs in the small blood vessels of the brain. Not only did the combination not prove to be significantly more effective, but the data suggests that taking Plavix with aspirin actually increases the risk of serious bleeding events and death. Dr. Robert Hart, who co-authored the study, told HealthDay that, “We were disappointed that the combination of aspirin plus clopidogrel only showed a non-significant trend in reducing stroke…On the other side, the two together caused more bleeding and higher mortality. The higher mortality was completely unexpected.”
Using an MRI scan, the researchers had identified 3,020 people who had a recent lacunar infarction. While all of these participants received aspirin, some were randomly assigned Plavix while the others were given a placebo. At follow-up, the rate of a second stroke between the two groups was comparable; the incidence of a second stroke was 2.5 percent per year for the dual therapy group compared to 2.7 percent for those taking aspirin. There was a difference, however, when it came to negative events. The patients taking Plavix and aspirin had nearly double the risk of major hemorrhaging compared to those taking only aspirin, with an incidence rate of 2.1 percent and 1.1 percent per year, respectively. The group taking Plavix with aspirin also exhibited a higher mortality rate, with 113 deaths compared to the 77 among patients who had only taken aspirin.
This is not the first study suggesting that aspirin alone may be a better option than Plavix. In 2006, NEJM published a study showing that dual antiplatelet therapy was not more effective at preventing blood clot, stroke and heart attack compared to aspirin as a monotherapy.
As a blood thinner, Plavix has been linked to an increased risk of bleeding events such as gastrointestinal and cerebral hemorrhaging. These conditions can be fatal, and have been the subject of many lawsuits.