PITTSBURGH, February 4, 1999 — Data from a recently completed multi-center Phase III trial, presented today at the American Heart Association’s 24th annual International Conference on Stroke and Cerebral Circulation in Nashville, suggest an investigational clot-dissolving drug can lessen the neurological disability associated with stroke.
"For people who will have moderate-to-severe strokes, this new medication offers hope that they will be able to benefit from this treatment approach—even as long as six hours after onset," said Lawrence Wechsler, M.D., director, University of Pittsburgh Medical Center (UPMC) Stroke Institute, and professor, neurology and neurological surgery, University of Pittsburgh School of Medicine, who led the Pittsburgh component of the study. Few stroke patients receive treatment within three hours of their stroke, the treatment window for TPA, a drug previously approved for dissolving clots, according to UPMC stroke experts.
Stroke is the third leading cause of death and the most common cause of adult disability in the United States, according to the National Institutes of Health. Each year, 700,000 Americans suffer a stroke. Approximately 30 percent die, and 20–30 percent become severely and permanently disabled. There are two types of stroke: approximately 83 percent are ischemic strokes, caused by a blood clot in the brain; 17 percent are hemorrhagic, caused by the breakage of a blood vessel in the brain.
The study, led by the Cleveland Clinic, randomized 180 patients with ischemic stroke in the brain’s middle cerebral artery to receive either r-ProUK (recombinant pro-urokinase) plus intravenous heparin or intravenous heparin alone, within six hours of stroke symptom onset. R-ProUK was administered intra-arterially by guiding a catheter to the site of the clot in the brain where it was injected. For a majority of patients, treatment was initiated after five hours.
Results showed 40 percent (n=121) of patients treated with r-ProUK had slight or no neurological disability 90 days after treatment, compared with 25 percent (n=59) of control patients. There was an increased risk of symptomatic intracranial bleeding with r-ProUK versus control—10.8 percent versus 1.8 percent—within 36 hours. There was no statistically significant difference in mortality rates between the treatment groups.
The drug r-ProUK has been developed by Abbott Laboratories, Abbott Park, IL. Abbott plans to submit this data in support of an FDA New Drug Application in mid-1999.