(Circulation. 2000;101:e41.)
© 2000 American Heart Association, Inc.
Circulation Electronic Pages |
FDA Approves New Drug to Reduce Risk of Stroke
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Anew drug to reduce the risk of stroke has received approval from the US Food and Drug Administration. The new drug combines aspirin and dipyridamole into one pill to reduce the risk of stroke for patients who have already had transient ischemic attacks or ischemic strokes caused by blood clots in the brain.
Approximately 500 000 people in the United States have strokes each year, and 150 000 die as a result. A total of 80% of these strokes are caused by a blood clot that blocks or reduces blood flow to the brain. Others are caused by bleeding into the brain.
In the European Stroke Prevention Study 2, which involved 6602 patients who had experienced a stroke or a transient ischemic attack within 3 months before entry into the study, the drug reduced the risk of stroke by 36.8% and the cumulative risk of stroke and death by 24.2% when compared with a placebo.
The study also proved that the combination of the 2 drugs is superior to each one used alone. The new drug is contraindicated for patients with hypersensitivity to dipyridamole, aspirin, or any of the product’s other components. Adverse events associated with the use of the drug include headache, abdominal pain, dizziness, and nausea. It will be marketed as Aggrenox by Boehringer Ingelheim Pharmaceuticals, Inc, of Ridgefield, Conn.
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