By Pamela Fayerman, Vancouver Sun
Treatment of patients at risk of stroke will be transformed by results of an international drug trial, a University of Alberta researcher told delegates to the Canadian Cardiovascular Congress in Vancouver Wednesday.
“We have a drug that can increase reductions in death and stroke and it is safer in terms of bleeding,” said cardiologist Dr. Justin Ezekowitz, who with a University of Toronto researcher, led the Canadian arm in the study of the new anticoagulant drug apixaban.
The drug is used to prevent strokes in patients with atrial fibrillation, a heart rhythm disturbance associated with a four- to five-fold increased risk of ischemic stroke.
Ezekowitz said the study, which included 1,057 Canadians, was so promising that he expects the drug will not only be approved by Health Canada next year, but that it will replace warfarin, now the main treatment for atrial fibrillation.
“Warfarin has been a terrific drug for a long time,” he said in an interview. “But there are various challenges with warfarin. It carries a risk of bleeding and requires frequent monitoring, and changes in dosing. This new drug is taken twice a day and does not require monitoring. Our trial showed that it was better than warfarin for preventing strokes and embolisms and it caused less bleeding.”
The apixaban versus warfarin study included 18,201 patients with atrial fibrillation and at least one other risk factor for stroke (such as being older than 75).
The study was randomized and double-blinded, which means half of patients got one drug and the other half got the other but neither patients nor researchers knew who was on what until the study ended. Patients were followed for up to about two years.
The rate of major bleeding was 2.13 per cent per year in the apixaban group, compared to 3.09 per cent in the warfarin group. The rates of death from any cause were 3.52 per cent and 3.94 per cent. The rate of hemorrhagic stroke was 0.24 per cent in the apixaban group compared to twice that in the warfarin group. The rate of other strokes was 0.97 per cent in the apixaban group and 1.05 per cent in the warfarin group.
Results of the 39-country study on apixaban (brand name Eliquis) were recently published in the New England Journal of Medicine.
The trial was sponsored by the drug manufacturer companies Bristol-Myers Squibb and Pfizer.
In another study on atrial fibrillation patients, apixaban was compared to Aspirin and was also found to reduce the rate of stroke or embolism while not increasing the rate of bleeding.
Ezekowitz spoke on the final day of the Congress, which drew about 3,500 cardiovascular health professionals to Vancouver.
He said it was the first time the results had been presented in North America. They were initially announced at the European Society of Cardiology meeting in Paris two months ago. Since then, numerous business journalists and other observers have been effusively commenting on the new drug. In Forbes, for example, a writer called apixaban the “golden mean of anticoagulation.”
There are two other new competitors in the warfarin replacement market — Pradax and Xarelto.
Sun Health Issues Reporterpfayerman@vancouversun.com
Notícia em canada.com
http://www.canada.com/drug+promising+patients+with+stroke+risk/5612456/story.htmlAcesso em 02 de novembro de 2011.
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