Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available.
T99-53 Jason Brodsky: 301-827-6242 November 23, 1999 Consumer Inquiries:888-INFO-FDA
Each year, about 500,000 people in the United States have strokes, with approximately 150,000 dying as a result. Of these strokes, 400,000 are ischemic, or caused by a blood clot reducing or blocking blood flow to the brain. The rest are hemorrhagic strokes, caused by bleeding into and around the brain.
The pivotal clinical trial of the new drug, which will be marketed as Aggrenox by Boehringer Ingelheim Pharmaceuticals, Inc. of Ridgefield, Conn., was a double-blinded, placebo controlled, 24-month study, referred to as European Stroke Prevention Study 2 (ESPS2). The study included 6,602 patients who had an ischemic stroke (76%) or transient ischemic attack (TIA, 24%) within three months prior to entry. The results showed the combination reduced the risk of stroke by 36.8% and the cumulative risk of stroke and death by 24.2% compared to placebo.
The study also compared the use of the combination to the single use of each active ingredient and results showed the combination was more favorable for reducing risk of stroke than each active ingredient alone.
The new drug is contraindicated for patients with hypersensitivity to dipyridamole, aspirin or any of the productís other components. Adverse events associated with the use of the drug include headache, abdominal pain, dizziness and nausea.
Todayís action follows an April 1999 recommendation for approval of the drug by FDAís Peripheral and Central Nervous System Advisory Committee.