Common heart surgery drug may be more dangerous than cheaper alternatives: study
Last Updated: Tuesday, December 2, 2008 | 2:45 PM ET
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The risk of death during cardiac surgery tended to be higher among patients who were given the drug aprotinin to control blood loss compared with less expensive alternatives, a Canadian review suggests.
In Tuesday's online issue of the Canadian Medical Association Journal, Dr. David Henry of the Institute for Clinical Evaluative Sciences (ICES) in Toronto and his colleagues reviewed 49 randomized trials comparing Bayer's aprotinin to two other anti-bleeding agents, tranexamic acid or aminocaproic acid.
The same team reviewed a number of these studies and published their findings online in 2007 in the Cochrane Review. Their latest review was an update that included new information from the Bart trial, which was published in the New England Journal of Medicine in May.
The Bart (Blood conservation using antifibrinolytics in a randomized trial) trial suggested people who received aprotinin were 53 per cent more likely to die during surgery than people who received the other anti-bleeding drugs, which are also known as lysine analogues.
The Bart trial, a cross-country study of aprotinin use in heart surgeries, was cut short last fall when it seemed the death rate was higher in patients receiving aprotinin.
"Compared with aprotinin, lysine analogues are almost as effective, are cheaper and do not appear to increase mortality," Henry and his co-authors from ICES, Toronto's St. Michael's Hospital, the University of Toronto, University of Newcastle in Australia and the Ottawa Health Research Institute concluded after reviewing the randomized trials.
"Either tranexamic acid or epsilon aminocaproic acid should be recommended to prevent bleeding after cardiac surgery," the team wrote.
The journal said the study was released early in advance of Wednesday's meeting of Health Canada's advisory panel, which is deciding on the use of aprotinin.
After the Bart trial was stopped, Bayer announced it was suspending worldwide sales of aprotinin, sold under the brand name Trasylol.
When the Bart study was published in the New England Journal of Medicine, Bayer said it planned to review the findings before making a final decision on the future of the drug.
Two of the authors of the review were involved in the Bart trial.
With files from Canadian PressShare Tools
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