Discontinues study of higher hematocrits in dialysis patients with cardiac disease.THOUSAND OAKS, Calif.--(BUSINESS WIRE)--June 24, 1996--Amgen (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :AMGN) Monday said that it will bring to an early conclusion a clinical trial of EPOGEN(R) (Epoetin alfa) in dialysis patients with symptomatic heart disease intended to determine whether raising the hematocrit Hematocrit Definition The hematocrit measures how much space in the blood is occupied by red blood cells. It is useful when evaluating a person for anemia. Purpose Blood is made up of red and white blood cells, and plasma. to normal (42 percent) would provide additional patient benefit. This study evaluated more than 1,200 hemodialysis patients with significant cardiac disease such as congestive heart failure congestive heart failure, inability of the heart to expel sufficient blood to keep pace with the metabolic demands of the body. In the healthy individual the heart can tolerate large increases of workload for a considerable length of time. requiring hospitalization, documented heart attack or coronary disease. Study participants were randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. to a control group targeted at a hematocrit of 30 percent or an intervention group targeted toward a hematocrit of 42 percent, the normal hematocrit level of people without kidney disease. In the 631 patient control group, 181 died compared with 221 of 634 in the intervention group. When unblinded data became available, Amgen decided along with the clinical investigators to conclude the study while the results are further examined. EPOGEN is indicated in the treatment of anemia associated with chronic renal failure chronic renal failure Chronic kidney failure Nephrology A slow decline in renal function, which may be 2º to chronic HTN, DM, CHF, SLE, or sickle cell anemia and, if extreme, leads to ESRD, mandating kidney dialysis; an abrupt decline in renal function may be in dialysis patients, and is used to increase hematocrits to a range of 30 percent to 36 percent. "Nothing in these study results suggests that any changes should be made in the treatment of dialysis patients who are receiving the currently approved treatment," said Allen Nissenson, M.D., professor of medicine, UCLA UCLA University of California at Los Angeles UCLA University Center for Learning Assistance (Illinois State University) UCLA University of Carrollton, TX and Lower Addison, TX , and a principal investigator in the study. "The safety and efficacy of this treatment has been demonstrated in numerous clinical trials and in general clinical practice over the past several years," he said. Amgen is a global biotechnology company that discovers, develops, manufactures and markets human therapeutics based on advanced cellular and molecular biology. CONTACT: Amgen, Thousand Oaks David Kaye, 805/447-6692 (media) Denise Powell, 805/447-4346 (investors) |
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