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Date: Tuesday, June 18, 1996 FOR IMMEDIATE RELEASE Contact: Margo Warren/Norman Oliver (301)496-5751
Zach W. Hall, Ph.D., director of the National Institute of Neurological Disorders and Stroke (NINDS), applauded today's rapid decision by the Food and Drug Administration (FDA) to approve t-PA1 for the emergency treatment of stroke. "The FDA action means that we now have an approved emergency treatment for stroke, the leading cause of adult disability," Dr. Hall said. "This is an exemplary demonstration of careful scientific investigation and of the power of partnership between industry, academia and the Federal government."
A 5-year clinical trial funded by the NINDS demonstrated that treatment with the clot-dissolving drug t-PA was an effective emergency treatment for acute ischemic stroke despite some risk from bleeding. Results were first published in the December 14, 1995, issue of The New England Journal of Medicine. The nationwide study of more than 600 carefully selected stroke patients found that those treated with t-PA within 3 hours of their initial stroke symptoms were at least 30 percent more likely than untreated patients to recover from their stroke with little or no disability.
The next step, according to Michael D. Walker, M.D., director of the NINDS Stroke and Trauma Division, will be developing a national educational approach to reach the many members of the public who must be involved in this new treatment. "A bold three- tiered program is envisioned in which patients, their families and friends must become aware of the signs of stroke and the need for prompt action; physicians and medical personnel must become familiar with diagnosis and treatment regimens; and emergency medical systems in the field and in the hospital must become accustomed to rigid timetables, rapid scanning and the need for immediate treatment."
Each year, about 500,000 Americans suffer a stroke. As the third leading cause of death in the country after heart disease and cancer, stroke kills about 150,000 Americans each year. The overall cost of stroke to the nation is estimated to be $30 billion a year in today's dollars.
"We have a major education task ahead, but the payoff is the tens of thousands of patients who will be spared lifelong disabilities," said Dr. Hall. The NINDS is the nation's principal supporter of research on the brain and nervous system and a lead agency for the Congressionally designated Decade of the Brain. The Institute supports and conducts a broad program of basic and clinical neurological investigations and is part of the National Institutes of Health, located in Bethesda, MD.
To arrange for an interview with Dr. Hall, Dr. Walker or Dr. John Marler, please contact Margo Warren or Norman Oliver at 301-496-5751. Copies of the December news release and background information are available by calling the same number, or on the World Wide Web at www.nih.gov/ninds/)
1 t-PA = tissue plasminogen activator.
2 The National Institute of Neurological Disorders and Stroke t-PA Stroke Study Group. "Tissue Plasminogen Activator for Acute Ischemic Stroke." The New England Journal of Medicine, Vol. 333, No. 24, pp. 1581-1587,1995.