To: Anthony Wong who wrote (1405 ) 2/4/1999 2:52:00 PM From: Anthony Wong Read Replies (2) | Respond to of 1722
AHA STROKE CONFERENCE: New Clot-Dissolving Drug Shows Promise In Stroke Treatment ABBOTT PARK, IL -- Feb. 4, 1999 -- A recently completed Phase III study, PROACT II, suggests Abbott Laboratories' investigational clot-dissolving drug can lessen the neurological disability associated with stroke. Data presented today at the 24th American Heart Association international conference on stroke and cerebral circulation in Nashville, TN., show that 40 percent of patients treated with r-ProUK (recombinant pro-urokinase), a clot-dissolving drug, had slight or no neurological disability 90 days after treatment, compared to 25 percent of control patients. "By opening the treatment window to six hours, r-ProUK offered hope for stroke patients in this study," said Anthony Furlan, M.D., medical director, cerebral vascular centre, department of neurology, The Cleveland Clinic Foundation, Cleveland, OH. "Further development of r-ProUK may extend hope to other stroke sufferers." Stroke is the third leading cause of death in the United States, affecting approximately 600,000 people each year. There are two types of stroke: approximately 83 percent are ischemic stroke, caused by a blood clot in the brain and 17 percent are hemorrhagic, caused by the breakage of a blood vessel in the brain. PROACT II is the first randomised, controlled study to show a statistically significant treatment effect using a clot-dissolving agent up to six hours after onset of ischemic stroke symptoms. The primary endpoint was percent of patients achieving a Modified Rankin score of less than or equal to two, meaning no symptoms to slight disability, at 90 days of follow up. The Modified Rankin Scale is an accepted measure of disability outcome for stroke survivors. Angiography was used to confirm ischemic stroke in the middle cerebral artery in the brain. There were 180 patients randomised to receive either r-ProUK 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. There was an increased risk of symptomatic intracranial bleeding with r-ProUK versus control -- 10.2 percent versus 1.8 percent, respectively within 36 hours. There was no statistically significant difference in mortality rates between treatment groups. "Patients experiencing the symptoms of stroke should seek immediate medical attention," Furlan said. "These acute symptoms include weakness, numbness or paralysis of the face, arm or leg; difficulty speaking or understanding; blurred vision; dizziness; or intense headache."