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A major Canadian study solidifies evidence that the now-withdrawn arthritis drug Vioxx® increases the risk of heart attack, and shows that higher doses are associated with a greater risk.
"This is consistent with what most of the other studies have found," said study author Dr. James A. Brophy, an associate professor of medicine at McGill University in Montreal. "But it included many more cases than other studies, so we were able to have more precision. And other studies have not demonstrated dose-dependency."
The findings appear in the February 1 online edition of the Annals of Internal Medicine.
The study included 113,927 older residents of Quebec who took painkillers between January 1999 and June 2002. The incidence of heart attacks increased 21 percent among those who took low doses of Vioxx® and by 73 percent in those who took high doses (more than 25 milligrams a day), the study found.
Taking aspirin decreased the risk for people who took lower doses of Vioxx®, but not for those who took the higher doses, according to the study.
"The importance of the new study is that it separates Vioxx® from other Cox-2 inhibitors," said Dr. Todd Schlifstein, an assistant professor of rehabilitation medicine at New York University School of Medicine. He called it "an impressive study because of its vast size and the number of years over which it was done."
The fact that aspirin did not moderate the increased risk of high-dose Vioxx® is "a pretty impressive sign that there is an increase in risk," he said.
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