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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.