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Bayer Clinical Trials on Trasylol Not Consistent with New England Journal of Medicine (NEJM) Study |
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27 Jan 2006 |
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Leverkusen, DE | Jan. 26, 2006 | In response to press reports regarding a study appearing today in the New England Journal of Medicine (NEJM) Bayer HealthCare said “The study conclusions published today by Mangano et al. are not consistent with the more than 15 years of clinical trial data and experience Bayer has amassed on Trasylol.”
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. In these trials Bayer did not see the increases in renal failure, myocardial infarction, congestive heart failure and stroke or encephalopathy associated with use of aprotinin in patients undergoing coronary-artery surgery that were reported in Mangano et al observational study.
Bayer is in the process of contacting 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 nature very seriously. Bayer believes that Trasylol is a safe and effective treatment when used in accordance with the product labeling.
About Trasylol
Trasylol, a broad-spectrum proteinase inhibitor, modulates the systemic inflammatory response associated with cardiopulmonary bypass (CPB) in the course of CABG surgery. Approved by the FDA in 1993, Trasylol is the only product indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing CPB in the course of CABG surgery.
About Bayer HealthCare AG
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro.
The company combines the global activities of the divisions Animal Health, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Since January 1, 2006 the new Pharmaceutical Division consists of the former Biological Products and Pharmaceutical Division and now comprises three business units: Hematology/Cardiology; Oncology and Primary Care.
Bayer HealthCare employed 35,300 people worldwide in 2004.
Bayer HealthCare's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
SOURCE: Bayer
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