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FDA Advisors Back Aggrenox For Preventing Stroke Recurrence GAITHERSBURG, MD -- April 28, 1999 -- The Food and Drug Administration’s (FDA) Peripheral & Central Nervous System Drugs Advisory Committee today voted unanimously to recommend the approval of Aggrenox™ (extended-release dipyridamole 200mg/aspirin 25mg) Capsules. The recommendation was in favour of a twice daily dose of the drug for the prevention of recurrent stroke in patients with a history of transient ischemic attack (TIA or mini-stroke) or ischemic stroke. The committee’s recommendation, while not binding, will be considered by the FDA in its review of Aggrenox. Submitted by Boehringer Ingelheim Pharmaceuticals, Inc. on December 15, 1998, the application was granted priority review by the FDA. The submission was based on data from the European Stroke Prevention Study 2 (ESPS2) involving more than 6,600 patients. ESPS2 represents the largest clinical trial exclusively devoted to the prevention of recurrent stroke. Results from ESPS2 indicate that Aggrenox reduces the risk of recurrent stroke by 37 percent compared to placebo. The study also showed that Aggrenox reduces the risk of recurrent stroke by 22 percent over aspirin alone. Treatment-related adverse events reported by the Aggrenox group included headache, bleeding, and gastro-intestinal (GI) complaints. The majority of these events were not serious. "The results of the ESPS2 study demonstrate that the benefits of the two medications that are combined in Aggrenox are additive," said Greg Albers, MD, Director, Stanford Stroke Center, Associate Professor of Neurology and Neurological Sciences, Stanford University School of Medicine. Aggrenox acts as an antiplatelet agent. Antiplatelets prevent blood platelets from aggregating or combining to form the blood clots that lead to stroke. Several factors contribute to platelet aggregation. The two main ingredients in Aggrenox act on distinct factors. The 50mg daily aspirin dose in Aggrenox was recently recommended by the FDA for the prevention of recurrent stroke. Stroke is the third leading cause of death, killing an estimated 160,000 Americans every year, according to the National Stroke Association. Of the 570,000 stroke survivors, the cumulative risk of recurrence over five years ranges from 30 percent to almost 50 percent. Currently, there are more than four million Americans living with the consequences of stroke. E-mail this page to a friend or colleague! To print, use this version