Bayer responds to Aprotinin study

Bayer has responded to a study published in the Journal of the American Medical Association (Jama) investigating mortality associated with the administration of aprotinin.

The report, presented in Jama this week, analysed long-term mortality rates in patients that have undergone coronary artery bypass graft surgery, including those patients administered with aprotinin.

Bayer believes that the methodological and analytical approach to the original study upon which this latest research is based, is unreliable and does not support the findings reported.

In an editorial, Dr T Bruce Ferguson from the East Carolina University, said: “Aprotinin use in cardiac surgery has never been uniformly standardised, but generally has been reserved for patients in whom the surgical team anticipated a higher risk for intraoperative blood loss.”

He added that medical staff based this anticipation on factors including the technical complexity of surgery or the increased risk of an adverse result for the patient.

Bayer claims that this inherent bias in the trial is not sufficiently addressed by the authors of the report.

In October 2006, Bayer announced the appointment of an independent counsel for the review and examination of its actions regarding the disclosure of preliminary results to the US Food and Drug Authority following a study of Trasylol (aprotinin).