THURSDAY, Sept. 2, 2004 (HealthDayNews) -- The benefit of using the clot-busting drug tPA to treat ischemic stroke has been reaffirmed by an independent review, says an article in the Sept. 2 issue of Stroke.
The review involved an analysis of data from a U.S. National Institute of Neurological Disorders and Stroke (NINDS) clinical trial of the use of tPA (tissue plasminogen activator) to treat ischemic stroke. That study was published in 1995.
The study found that "despite an increase in incidence of symptomatic intracerebral hemorrhage (bleeding in the brain), treatment with intravenous tPA within three hours of the onset of ischemic stroke improved clinical outcome at three months."
Based on that study and subsequent U.S. Food and Drug Administration approval of tPA use for ischemic stroke, a number of groups, including the American Heart Association and the American Academy of Neurology, recommended tPA for treatment of acute ischemic stroke within three hours of the onset of symptoms.
But some other medical groups disagreed, saying there wasn't enough evidence to make such a recommendation. Some subsequent studies found tPA to be safe, while other studies documented higher bleeding and death rates than those in the NINDS study.
Currently, only about 10 percent of ischemic stroke patients are treated with tPA, due to concerns about the safety and efficacy of tPA and the limited time window for its use.
This new review by a NINDS-commissioned independent committee of stroke physicians and biostatisticians validated the benefit of treatment with tPA for ischemic stroke, when given within three hours of symptom onset and under strict treatment protocol.
"This review should put to rest the controversy surrounding the integrity of the NINDS tPA trial and the analysis and interpretation of the study's results," Dr. Larry B. Goldstein, spokesman for the American Stroke Association, said in a prepared statement.
More information
The Cleveland Clinic Foundation has more about stroke.
