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| |  Activase Approved In Canada For Acute Management Of Stroke MISSISSAUGA, ON -- Feb. 17, 1999 -- The Therapeutic Products Directorate of Health Canada has approved Hoffmann-La Roche Ltd.’s clot-dissolving agent, Activase(R) (alteplase, recombinant), a genetically-engineered version of the naturally occurring tissue plasminogen activator (t-PA), for the treatment of eligible adult patients with acute ischemic stroke or brain attack within three hours of symptom onset. Activase, which has been available in Canada since 1987 for the treatment of heart attack, is the first therapy to be indicated for the acute management of stroke, Canada's leading cause of adult disability and the fourth-leading cause of death. The new indication for Activase is based upon data from a clinical trial conducted by the National Institute of Neurological Disorders and Stroke (NINDS) and published in The New England Journal of Medicine. This study showed that eligible patients treated with Activase within three hours of symptom onset were at least 32 percent more likely (depending on the scale) to be left with minimal or no disability compared to those treated with placebo. "This is a significant, positive development in the treatment of stroke in Canada. Prior to the availability of Activase, there was little that could be done for stroke patients. Now, for those eligible patients who can identify the symptoms of stroke and seek emergency medical treatment, there is an effective therapy available -- one that can save lives and prevent disability in some patients,'' said Dr. Philip Teal, division of neurology at Vancouver Hospital and Health Sciences Centre. The NINDS study found that out of every 100 patients treated with Activase within three hours of symptom onset, at least 11 (depending on the scale) more patients demonstrated a favourable outcome at three months, as compared to placebo. A favourable outcome was defined as minimal or no disability using the four different stroke outcome scales. These results are statistically significant in favour of those treated with Activase. The trial utilised rigorous entry criteria to carefully select patients for treatment, including the requirements that initiation of treatment occur within three hours of symptom onset and a brain CT scan be conducted to rule out hemorrhage. Not all patients with acute ischemic stroke will meet the eligibility criteria for Activase therapy. For example some of the conditions which disqualify patients from therapy include: evidence of recent or active bleeding, recent stroke, uncontrolled high blood pressure or impaired blood clotting. As with most drugs, benefits will vary among patients receiving Activase. The most common side effect from this therapy was symptomatic intracerebral hemorrhage or bleeding. There was an incidence of intracerebral hemorrhage of 6.4 percent within 36 hours of treatment among the Activase-treated population as compared to 0.6 percent in the placebo group. No significant mortality differences were observed at 90 days between Activase and placebo groups (17 and 21 percent, respectively). Stroke is the leading cause of adult disability in Canada and the fourth-leading cause of death. For every four Canadians who suffer a stroke, one will die, and two of three will survive with some degree of chronic disability. It is estimated that stroke costs the Canadian economy close to $4 billion CDN in both direct medical costs and indirect costs such as lost productivity. Related Links: Doctor's Guide to Stroke, Activase, Hoffmann-La Roche Ltd.
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