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Observational study
Leverkusen / January 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. Full prescribing and warning information is also available at
www.Trasylol.com. Trasylol Prescribing Information. Accessed on November 15,
2005. Available at: http://www.trasylol.com.
The effects of Trasylol use in CPB involves a reduction of inflammatory
response to surgery, reduced bleeding and decreased re-exploration for
bleeding, which translates into a decreased need for allogeneic (blood donated
from another individual) blood transfusions. An important part of Bayer
Pharmaceuticals Specialty Pharmaceuticals portfolio, Trasylol has remained a
category leader for several years. Bayer is committed to further investment in
the Trasylol franchise and is actively engaged in the research and development
of a recombinant version of the product. In anticipation of emerging needs of
this market, Bayer is also leading in next generation product development.
Important Safety Considerations
Anaphylactic or anaphylactoid reactions are possible when Trasylol is
administered. Hypersensitivity reactions are rare in patients with no prior
exposure to aprotinin. The risk of anaphylaxis is increased in patients who are
reexposed to aprotinin-containing products. The benefit of Trasylol to patients
undergoing primary CABG surgery should be weighed against the risk of
anaphylaxis should a second exposure to aprotinin be required (see WARNINGS and
PRECAUTIONS in the Trasylol prescribing information).
In clinical studies, hypersensitivity and anaphylactic reactions were:
? rare (<0.1%) in patients with no prior exposure to Trasylol
? 2.7% overall reaction rate upon re-exposure
o within 6 months, the incidence was 5 percent
o after 6 months, the incidence was 0.9 percent7
Trasylol is generally well tolerated. In clinical trials, graft patency,
myocardial infarction, renal or hepatic dysfunction and mortality were
comparable to placebo.
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.
