Bayer HealthCare Response: The Risk Associated with Aprotinin in Cardiac Surgery
January 23, 2006 West Haven, CT, USA. Bayer HealthCare has become aware of an article to be published in the upcoming, January 26th edition of the New England Journal of Medicine, entitled “The Risk Associated with Aprotinin in Cardiac Surgery, ” (Mangano et al.) Bayer has only just become aware of this observational study and we have not yet had an opportunity to receive and review the data from which the authors derived their conclusions. Therefore we cannot address their assertions in comprehensive detail. We can, however, clearly state that the results they have reported in terms of increases in renal failure, myocardial infarction, congestive heart failure and stroke or encephalopathy associated with use of aprotinin in patients undergoing coronary-artery surgery are not consistent with the more than 15 years of clinical data and experience Bayer has amassed on this drug.
Bayer has studied aprotinin in a series of prospective, randomized, double-blind, placebo-controlled clinical trials encompassing almost 6,500 open heart surgery patients worldwide (aprotinin N= 3817, placebo N= 2682). This study population is larger than the patient population in the study by Mangano et al. Bayer’s randomized trials examined results from 3,817 aprotinin patients in comparison to the 1,295 aprotinin patients in the Mangano et al. observational study. Double-blind, randomized controlled trials are the accepted standard for the assessment of the efficacy and safety of drugs and serve as the basis for approval of all new drugs. Such trials do not suffer from the limitations that can exist in observational studies.
Bayer plans to contact the study authors to discuss the details of their data, study methodology, and analysis. We have also alerted regulatory authorities about this publication. Patient safety is Bayer’s highest priority and, as always we take publications of this naturevery seriously. Bayer believes that Trasylol is a safe and effective treatment when used in accordance with the product labeling.
For more information contact:
- Meredith Fischer, [email protected] (203) 812-6485
- Helmut Schaefers, [email protected] +1 49 214 305 8308
- Dr. Michael Diehl, [email protected] +1 49 214 305 8532
