Compared to Aspirin Alone, Taking Plavix with Aspirin Increases Risk of Bleeding, Death and Does Not Help Prevent Second Stroke, Study Says
Rresearchers found that the dual antiplatelet with Plavix therapy was associated with a higher rate of hemorrhaging and death.Aug 31, 2012 | Parker Waichman LLP
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective drugs, is informing the public about a new study published in the August 30th issue of the New England Journal of Medicine (NEJM). In analyzing the effects of the Plavix with aspirin versus aspirin alone, the study found that the combination, referred to “dual antiplatelet therapy” did not significantly reduce the occurrence of a second stroke among patients with a history of lacunar stroke. The study also suggested that taking Plavix with aspirin increased the risk of bleeding and death.
The study involved 3,020 patients who have had a lacunar stroke, a type of stroke that affects the small blood vessels in the brain. The participants were randomly assigned into two groups; one group would receive 75 mg of Plavix daily while the other received a placebo. All of the patients received 325 mg of aspirin a day. At an average follow-up period of 3.4 years, the dual-therapy group did not have a significantly lower rate of recurrent stroke, with a rate of 2.5 percent per year compared to 2.7 percent in the Aspirin only group. Those who took Plavix with Aspirin did, however, exhibit a higher rate of bleeding and death. Researchers found that the risk of major hemorrhage was nearly doubled in the dual therapy group with a rate of 2.1 percent per year. Patients who took Aspirin with a placebo had a rate of 1.1 percent per year. The Plavix-Aspirin combination was also associated with a higher incidence of mortality, with 113 deaths versus 77 among the Aspirin patients. The cause behind the deaths is not known.
Dr. Kirk Garratt, the director of interventional cardiovascular research at Lenox Hill Hospital in New York City, discusses the implications of the results. "It's another disappointing finding for antiplatelet drugs. The lesson here is we shouldn't start writing prescriptions for Plavix to those patients with lacunar strokes. Practitioners have to pay attention to these negative trials," he said to HealthDay.
The U.S. National Institutes of Health (NIH), who funded the research, stopped the trials last August due to the results.
The findings also support past research suggesting that there is no benefit to taking Plavix plus aspirin compared to aspirin only. In 2006, NEJM published a study showing that dual therapy with Aspirin and Plavix was not more effective at reducing the rate of atherosclerotic events compared to Aspirin alone.
Plavix is the subject of a number of lawsuits alleging that the blood thinner caused serious bleeding events. Parker Waichman LLP filed one such lawsuit in July on behalf of a man who suffered from an epidural hematoma, allegedly due to the use of Plavix.
Parker Waichman LLP continues to offer free legal consultations to victims of alleged Plavix side effects, including:
- Cerebral hemorrhage
- Thrombotic Thrombocytopenic Purpura (TTP)
- Gastrointestinal bleeding
- Internal bleeding
- Bone marrow damage
- Heart attack
If you or a loved experienced serious, life-threatening internal bleeding, heart attacks, strokes, or a blood disorder, and you believe Plavix is to blame, please contact their office by visiting the firm's Plavix side effects page at yourlawyer.com. Free case evaluations are also available by calling 1-800-YOURLAWYER (1-800-968-7529).
Parker Waichman LLP
Gary Falkowitz, Managing Attorney