Stroke

New Hope on Horizon for Treatment of Deadliest Form of Stroke; New Drug May Be First Effective Medical Treatment for Hemorrhagic Stroke To: National Desk Contact: Diane Mulligan-Fairfield of the National Stroke Association, 720-841-1114 ENGLEWOOD, Colo., Jan. 11 /U.S. Newswire/ -- Israeli Prime Minister Ariel Sharon continues to show improvement from his hemorrhagic stroke, but it is clear that doctors had a difficult time getting the bleeding in his brain under control. Now there may be new hope in treating hemorrhagic stroke. Currently in phase three of a worldwide clinical trial, recombinant factor VII (NovoSeven(r)) has shown positive results in significantly reducing the amount of blood that collects in the brain after a hemorrhagic stroke. Hemorrhagic Stroke occurs when a blood vessel in the brain bursts and blood collects, putting pressure on the brain and causing brain-cell death. NovoSeven(r), approved to treat hemophilia, is proving to possibly be the first effective medical treatment to stop the amount of blood the brain collects. "Every drop of blood that gathers counts when we are talking about something as delicate as the brain", said Dr. Stephan Mayer, National Stroke Association spokesperson, Associate Professor of Clinical Neurology & Neurosurgery and Director of Neurological Intensive Care Unit of Columbia University "NovoSeven(r) has the capability of preventing nearly a teaspoon of bleeding in hemorrhagic stroke patients." During the trial period, NovoSeven(r) has been seen to create a thirty-eight percent reduction in the mortality rate of the stroke patients that were studied. The trial is expected to be completed in late 2006. If the study yields positive results, NovoSeven(r) can easily be recognized as one of the biggest breakthroughs in stroke treatment to date. "We are in a golden period of discovery when it comes to stroke treatment," said Dr. Mayer who is also the principal investigator for this trial. Time is extremely important in treating hemorrhagic stroke because brain cells are dying every second the brain is being compressed. Recognizing stroke symptoms, calling 911 and treating stroke as an emergency will always be critical to surviving a stroke. "Hopefully the day will come where all hospitals are fully equipped to treat stroke patients", said Jim Baranski, National Stroke Association CEO "If NovoSeven(r) proves to be as successful as early results are indicating, seeing it in stroke centers across the country would seem like a step in the right direction." About NSA:

National Stroke Association is a leading national non-profit organization devoting its efforts and resources to stroke. Contact the NSA at 1-800-STROKES or visit http://www.stroke.org. http://www.usnewswire.com/ -0/© 2006 U.S. Newswire 202-347-2770/ Hemophiliac drug may help stroke victims Thursday, January 12, 2006 BY ANGELA STEWART Star-Ledger Staff People who experience the deadliest and most crippling type of stroke, like the one suffered by Israeli leader Ariel Sharon, may benefit from a drug that stops blood from collecting in the brain, increasing their chances of survival and reducing disability, doctors said yesterday. The clot-forming drug already has been approved as a treatment for hemophiliacs, to prevent them from bleeding to death. Called recombinant activated factor VIIa or NovoSeven, the drug is made by Princeton-based Novo Nordisk and is in Phase III clinical trials as a treatment for cerebral hemorrhage. This type of stroke occurs when a blood vessel in the brain bursts and bleeds into the surrounding tissue. When given intravenously within four hours of stroke symptoms, the drug has been found to accelerate the clotting process, reducing damage to brain

In a Phase II study, reported last February in the New England Journal of Medicine, the drug was responsible for a 38 percent reduction in mortality. Patients also were three times more likely to survive without severe disability. "Every drop of blood that gathers counts when we are talking about something as delicate as the brain," said lead trial investigator Stephan Mayer, associate professor of neurology & neurosurgery and director of the Neurological Intensive Care Unit at Columbia University Medical Center in New York. "NovoSeven has the capability of preventing nearly a teaspoon of bleeding in hemorrhagic stroke patients," added Mayer. Results of the Phase III portion of the trial, which involves about 150 sites worldwide, are expected next year, he said. "This would be a huge breakthrough if approved (by the Food and Drug Administration)," Mayer said. Although hemorrhagic strokes account for about 15 percent of all strokes, they are responsible for more than 30 percent of all stroke deaths, according to the National Stroke Association. "We recently confirmed that up to 40 percent of brain hemorrhage patients have ongoing bleeding after they reach the hospital. This drug appears to stop that bleeding," said Daniel Hanley, vice

chairman of the stroke association and a professor of neurology at Johns Hopkins Medical Institutions. Exercise can significantly reduce stroke risk BY JEFF DAVIS KEEP IT FIT Witnessing Dick Clark's triumphant return to TV on New Year's Eve was as painful for me as it was courageous of him. Millions of people around the world cringed and cried as they listened to the man with one of the most recognizable voices in the world struggle through simple sentences and wrestle with phrases that would have been simple for him a short time ago. Whatever the motivation behind his return, Clark demonstrated the damage caused by a stroke and the amazing results of several months of rehabilitative training and the body's ability to almost completely relearn tasks we often take for granted. A stroke is caused when blood flow is prevented from reaching part of the brain. A stroke can lead to damaged or destroyed brain cells, which causes the loss of whatever function controlled by that area. While strokes may vary in severity, they are among the top causes of death and adult disability. Stroke strikes about 700,000 Americans each year, but the vast majority of people survive. Close to 5 million stroke survivors are managing their health today, according to WebMD. There generally are two types of strokes: ischemic and hemorrhagic. During an ischemic stroke, the blood flow to the brain is decreased and a portion of the brain may be completely cut off from the flow of blood. This decreased flow is caused by a clot in an artery. About 80 percent of strokes are ischemic. A hemorrhagic stroke occurs when an artery in the brain leaks or bursts. The results of both types are very similar. After about four minutes without blood, the affected tissue becomes damaged and may die. The body tries to restore blood and oxygen flow to the brain by enlarging other blood vessels near the starving area. If the blockage is in a large blood vessel, the body may not be able to supply enough blood and permanent brain damage may occur. There are many risk factors associated with a stroke. You can reduce many of them through enlightenment, diligence and discipline High blood pressure is the second most important risk factor following age. Having diabetes also greatly increases your chances of stroke because of circulation problems associated with the disease. High cholesterol has a domino effect. It can lead to coronary artery disease that can cause a heart attack, which, because of decreased circulation, can lead to stroke. There also are other heart conditions that can lead to stroke. Smoking and secondhand smoke has been shown to increase the chances of stroke. In fact, daily cigarette smoking can increase the risk of stroke by 21/2 times. Also, heavy use of alcohol or binge drinking greatly increases the risk.

Physical inactivity and obesity, which sometimes go hand in hand, are serious risk factors as well. Some medications such as anticoagulants, birth control pills, steroids or hormone replacement therapy may slightly heighten your susceptibility to stroke. The key to avoiding a stroke is to get regular medical exams, especially if you embody one or more of the above preventable risk factors and get moving. Moderate exercise for at least 30 minutes, five days a week can greatly decrease your chances of stroke. Make this year one of discipline and diligence. I'll keep supplying the enlightenment. NEUROLOGY 2005;65:1914-1918 © 2005 American Academy of Neurology Cerebral microbleeds are common in ischemic stroke but rare in TIA D. J. Werring, PhD, L. J. Coward, MRCP, N. A. Losseff, MD, H. R. Jäger, MD and M. M. Brown, FRCP From the Stroke Research Group, Institute of Neurology, University College London, National Hospital for Neurology and Neurosurgery, London, UK. Address correspondence and reprint requests to Dr Brown, Stroke Research Group, Institute of Neurology, University College London, National Hospital for Neurology and Neurosurgery, Queen Square, London WC1N 3BG, UK; e-mail: [email protected] Background: In patients with stroke, gradient-echo MRI commonly detects microbleeds, indicating small artery disease with increased risk of macroscopic intracranial bleeding. Antithrombotic treatments are frequently prescribed after TIA and stroke, but there have been no previous studies of microbleeds in TIA. Because microbleeds may predict the hemorrhagic risk of antithrombotic treatments, we studied the prevalence of microbleeds, risk factors, and pathophysiologic mechanisms in patients with ischemic stroke and TIA. Methods: One hundred twenty-nine consecutive patients with ischemic stroke or TIA were studied with MRI including T2, fluid-attenuated inversion recovery, and gradient-echo MRI sequences. Blinded observers counted microbleeds and graded white matter T2 hyperintensities throughout the brain. TIA patients with previous ischemic stroke were excluded. Results: Sixty-seven percent of patients had ischemic stroke; 33% had TIA. Microbleeds were found in 23% of ischemic stroke patients but only 2% of TIA patients (p < 0.001). There were no significant differences in conventional risk factors or the severity of white matter disease on T2 MRI between stroke and TIA patients. Patients with microbleeds were more often hypertensive (81 vs 59%; p = 0.04) and had more severe MRI white matter disease on T2 MRI (p = 0.003). Conclusions: Microbleeds are common in ischemic stroke but rare in TIA, an observation not explained by differences in vascular risk factors or severity of white matter disease seen on T2 MRI. This finding has implications for the safety of antithrombotic therapy and clinical trial design in the two groups. Microbleeds may also be a new marker for severe microvascular pathology with increased risk of permanent cerebral infarction.

Supported by the Sir Jules Thorn Trust and the Stroke Association (D.J.W.); the Reta Lila Weston Trust for Medical Research (Chair in Stroke Medicine; M.M.B.); and the Stroke Association and a grant from Sanofi-Synthelabo (L.J.C.). Disclosure: The authors report no conflicts of interest. Received April 19, 2005. Accepted in final form September 1, 2005.

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