The only patients even modestly helped, the study found, were those with established heart disease but even their risk of heart attack, stroke or death was about 7% versus 8% with aspirin alone.
In addition to finding no significant benefit with the combination, Plavix plus aspirin for patients with multiple risk factors was associated with increased risk for moderate and serious bleeding, the researchers reported. The analysis of adverse events showed that patients taking the combination of drugs had a severe bleeding rate of 1.7 %, compared to 1.3% for the aspirin only group.
And finally, there is no guarantee that a life-long regimen of Plavix plus aspirin will solve the problem. The data from Berne and Rotterdam-registries that include 3,875 Cypher patients and 4,271 patients implanted with Taxus stents found that 23% of late thrombosis occurred in patients who were already on dual antiplatelet therapy.
Dr Sidney Smith Jr, of the University of North Carolina at Chapel Hill, and chairman of the American College of Cardiology/American Heart Association Percutaneous Coronary Intervention Guideline Committee, points out that the guidelines already recommend that dual antiplatelet therapy be continued for a year in patients who have no excess bleeding risk and says there is no evidence that extending the aspirin plus Plavix therapy beyond a year will reduce the late thrombosis risk.
For its part, at its usual slow as molasses pace, on September 18, 2006, the FDA said it plans to convene a public panel meeting of outside scientific experts in the near future to assist in a review of all the data and make recommendations about what actions may be appropriate, such as possible labeling changes or additional studies.
More information for injured parties can be found at Lawyers and Settlements.com
http://www.lawyersandsettlements.com/
Evelyn Pringle
evelyn.pringle@sbcglobal.net
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