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FDA Approves Aggrenox For Patients With Previous Strokes RIDGEFIELD, CT -- November 23, 1999 -- Boehringer Ingelheim Pharmaceuticals, Inc. announced Food and Drug Administration (FDA) approval of Aggrenox(TM) (aspirin/extended-release dipyridamole) 25 mg/200 mg capsules dosed twice daily for the prevention of stroke in patients who have experienced a previous stroke or a transient ischemic attack (a TIA or mini-stroke). The FDA approval was based on the results of the European Stroke Prevention Study 2 (ESPS2), the largest recurrent stroke prevention trial ever conducted. 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 (50mg/day) alone. "The efficacy of Aggrenox was convincingly shown in a very large stroke study. Aggrenox was better than aspirin alone by about 22 percent in preventing the risk of a recurrent stroke," said Dr. Ralph Sacco, Associate Professor of Neurology and Public Health (Epidemiology), College of Physicians and Surgeons, Columbia University. Treatment-related adverse events reported by the Aggrenox group in ESPS2 included headache, bleeding, and gastrointestinal (GI) complaints. "I was constantly afraid that I would have another stroke. I didn't know at what moment it was going to strike again," said Phyllis Dennett, a stroke survivor. In the United States, 730,000 people have a stroke each year. The third leading cause of death, stroke kills an estimated 160,000 Americans annually, 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. Aggrenox acts as an antiplatelet, preventing blood platelets from aggregating, or clumping, to form the blood clots that lead to stroke. Several mechanisms contribute to platelet clumping and the combination of agents in Aggrenox acts on distinct factors. Aggrenox acts in multiple ways to prevent this from happening. According to the Supplement to the Guidelines for the Management of Transient Ischemic Attacks published in the November 1999 issue of Stroke, the Journal of the American Heart Association, the combination of extended-release dipyridamole and aspirin found in Aggrenox may also be a more favorable treatment option for the prevention of secondary stroke than other antiplatelet agents. Related Link: Boehringer Ingelheim Pharmaceuticals, Inc. E-mail this page to a friend or colleague! To print, use this version