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| |  ReoPro Improves Clinical Function Up To 24 Hours After Stroke Symptoms VENICE, ITALY -- April 12, 1999 -- Results from a Phase II clinical study of patients with acute ischemic stroke, presented April 10, 1999 at the eighth annual European Stroke Meeting, show that Centocor, Inc.’s and Eli Lilly and Co.’s antiplatelet drug ReoPro(R) (abciximab) improved patients' clinical function even when administered up to 24 hours after first symptoms, with no increased risk of major intracranial bleeding. The international, multi-centre Phase II trial involved 74 patients with acute ischemic stroke, who were followed for three months. At study entry, approximately 50 percent of the patients were in the midst of a severe stroke as defined by the National Institutes of Health Stroke Scale. A preliminary analysis showed that three months after treatment, 35 percent of patients treated with any dose of abciximab had minimal or no residual disability, compared with 20 percent who received placebo. In addition, 50 percent of patients treated with abciximab showed improved function in carrying out daily activities compared with 40 percent given placebo. There also was a trend toward improved neurological functioning with abciximab therapy. This degree of improvement was seen despite the fact that half of the patients were treated more than 12 hours after stroke onset -- nearly all were treated more than three hours after onset. Currently, the only acute stroke treatment available must be administered within the first three hours of stroke onset to show optimal benefit compared to risks. "These data are promising, considering that stroke patients currently have limited treatment options," said Harold Adams, M.D., a principal investigator of the study and professor and director of cardiovascular diseases at the University of Iowa Hospitals and Clinics in Iowa City, IA. "Most patients do not recognise stroke symptoms until three or more hours after they occur. Therefore, the possibility of using a therapy such as abciximab well beyond the current three-hour treatment window holds great promise." The high rates of response in the placebo group also are in line with expectations because not all stroke patients experience debilitating effects of a stroke, regardless of medical treatment, Dr. Adams explained. Although abciximab is a potent antiplatelet drug and therefore can increase the risk of bleeding, none of the patients in the stroke trial suffered from symptomatic intracranial bleeding (ICH), a potentially fatal side effect of current therapy. "The ICH data with abciximab are encouraging, especially because use of the current stroke therapy is limited to the first three hours following stroke onset. After that time, the risks of cerebral bleeding associated with that therapy begin to outweigh the benefits," Dr. Adams said. Patients were treated with placebo or one of the following four doses of abciximab: 0.15 milligram/kilogram (mg/kg) single bolus of abciximab; 0.20 mg/kg single bolus; 0.20 mg/kg bolus plus 0.125 microgram/kg (mcg/kg) per minute infusion; or 0.25 mg/kg bolus and 0.125 mcg/kg/minute infusion. Dr. Adams added that a larger study is planned to confirm the safety and efficacy of using abciximab in patients with acute ischemic stroke. Stroke is the third leading cause of death world-wide, resulting in approximately five million deaths every year. In the United States, approximately 400,000 Americans suffer a first stroke each year and 300,000 experience recurrent stroke. About 85 percent of all strokes are termed ischemic, caused by a blood clot or plaque that blocks a blood vessel in the brain. The remaining 15 percent of ischemic strokes result when a blood vessel in the brain bursts. Related Links: ReoPro, Eli Lilly and Co., Centocor, Inc.
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