Bayer's Trasylol linked to CABG mortality risk

A study published in the February 7 on-line edition of the Journal of the American Medical Association, suggests that Bayer's Trasylol (aprotinin) is associated with an increased risk of long-term mortality following coronary artery bypass graft surgery. In the trial, patients on the drug had a 20.8% five-year mortality compared with 12.7% on the control, while neither aminocaproic acid nor tranexamic acid was associated with increased mortality.

Lead study author Denise Mangano said that "the use of aprotinin among patients undergoing CABG surgery does not appear prudent because safer and less expensive alternatives, such as aminocaproic acid and tranexamic acid, are available." In a written response, German drug major Bayer said that the methodological and analytical approaches used in the JAMA study were not reliable and do not support the authors' reported conclusions, noting that one of the limitations of the study is that doctors chose whether to administer aprotinin or another treatment based on the patient's condition, so that generally, sicker patients, already at greater risk for mortality, were treated with its drug.