Stroke Drugs May Increase Bleeding in Gut
Combination Treatment Not Advised for Stroke Prevention
July 22, 2004 -- A duo stroke prevention drug treatment -- aspirin and Plavix -- may increase the risk of serious intestinal bleeding in people who have had strokes, a new study shows.
The report, which appears in this week's issue of The Lancet, investigates the safety of the anti-clotting drug Plavix -- which is known to reduce stroke risk -- plus aspirin, which also has anti-clotting capabilities. There have been concerns about the use of these drugs and the risks of bleeding. Previous studies have shown that the two drugs effectively reduce the risk of heart attacks.
But does risk of bleeding outweigh the stroke-prevention potential that the combination may offer? That's what this newest study analyzes.
The 7,276 patients in this study all had recent strokes or transient ischemic attacks (often called mini strokes). They took either Plavix and a placebo or Plavix plus aspirin daily for 18 months. The patients had a battery of tests at regular intervals to determine whether they were developing any worsening blood vessels or any bleeding problems.
In most patients, there was a consistent reduction of transient ischemic attacks and strokes in patients taking the duo-drug treatment, reports lead researcher Christoph Diener, MD, a neurologist with the University of Essen in Germany.
In both treatment groups, similar percentages of strokes, heart attacks, hospitalization, and death occurred, with 13% of patients having one of these events.
Adding aspirin to Plavix, however, resulted in significantly more complications from bleeding. Twice as many people who took the combination therapy had either life-threatening bleeding or a major bleeding episode compared with people who took Plavix plus a placebo. The majority of these episodes were related to stomach irritation and bleeding.
The significantly higher bleeding episodes from the duo-drug treatment outweighed the small benefit, Diener reports.
While only 3% of the duo-drug group had life-threatening bleeding, that was three times the cases in the Plavix plus placebo group.
Stroke patients who are taking aspirin and Plavix should be advised of this risk, writes Peter M. Rothwell, MD, a neurologist with the Radcliffe Infirmary at Oxford, in an accompanying editorial.