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Aprotinin during Coronary-Artery Bypass Grafting and Risk of Death, N Engl J Med. 2008 Feb 21;358(8):771-783.
Bayer Pharmaceuticals, the maker of Trasylol (aprotinin), financed a study conducted at Harvard University in which the medical records of 78,000 heart surgery patients were reviewed to investigate “accumulating evidence” suggesting the use of Trasylol during coronary-artery bypass surgery increases the risk of death.
The Trasylol researchers at Harvard studied the medical records of 78,000 patients who underwent coronary-artery bypass graft (CABG) surgery between January 1, 2003 to March 31, 2006. About 33,500 of the patients were given Trasylol (aprotinin injection) and 44,482 were given a different anti-bleeding medicine.
After statistical adjustment for 41 characteristics of patients and hospitals, the Bayer-financed, Harvard University researches concluded that the risk of death was 64% higher for the patients given Trasylol compared with those given a different drug.
Bayer had the details of the Harvard study when it appeared for FDA hearings on Trasylol in September 2006, but withheld the results of the study from the FDA. As a result, Trasylol remained on the market for another 22 months.
The effect of aprotinin on outcome after coronary-artery bypass grafting, N Engl J Med. 2008 Feb 21;358(8):784-93.
In 2006, a study published in the New England Journal of Medicine linked Trasylol use during heart surgery with an increased the risk of heart attack, stroke, kidney damage, renal failure, and death.
In response, researchers at Duke University reviewed the cases of over 10,000 patients who underwent coronary-artery bypass graft (CABG) surgery at Duke University Medical Center between January 1, 1996 and December 31, 2005. The purpose of the study was to look for an association between Trasylol (aprotinin) use and adverse outcomes including those reported in the 2006 study (heart attack, stroke, kidney damage, renal failure, and death.)
The Duke Study found that the 30-day death rate of patients given Trasylol during coronary-artery bypass grafting (CABG) surgery is nearly 250% higher than CABG patients given another anti-bleeding drug or no drug at all. The study also linked Trasylol with an increased risk of kidney damage and impaired kidney function.
“We’re not surprised by the results,” says Dr. Andrew Shaw, Associate Professor of Medicine at Duke and lead author of the study. “It’s what we expected to find.”