Bayer HealthCare has decided to end three ongoing clinical studies
investigating the safety and efficacy of Trasylol(R) (aprotinin injection)
on transfusion requirements and blood loss in adults undergoing: elective
spinal fusion surgery, pneumonectomy or esophagectomy for cancer, and
radical or total cystectomy in bladder cancer.
The Trasylol labelling that was recently approved in the U.S. and is in
the approval process in the European Union and other countries, includes a
recommendation that in order to manage possible anaphylactic reactions,
Trasylol should be administered only in surgical settings where
cardiopulmonary bypass (CPB) can be rapidly initiated. The use of CPB is
not practical in non-cardiac surgical settings.
Bayer's decision to discontinue these trials was not made based on any
safety findings in these non-CABG studies. On November 18, 2006 an
independent Data Monitoring Committee (DMC) reviewed safety data on these
three studies, examining data for the first 120 patients randomized. Based
on their review of these safety data, the DMC concluded that " ... these
three clinical trials could continue as planned without modification."
Trasylol is the only drug approved by the FDA and several other
regulatory authorities to reduce blood loss and the need for blood
transfusion in patients undergoing cardiopulmonary bypass in the course of
coronary artery bypass graft surgery in patients who are at an increased
risk for blood loss and blood transfusion. Dr. Paul Mac Carthy, Vice
President, Medical Affairs Bayer Pharmaceuticals Corporation said, "We
believe that Trasylol can continue to provide important benefits for CABG
surgery patients and, therefore, fills an important role for their cardiac
surgeons."
About Trasylol
Trasylol(R) is indicated for prophylactic use to reduce perioperative
blood loss and the need for blood transfusion in patients undergoing
cardiopulmonary bypass in the course of coronary artery bypass graft
surgery who are at an increased risk for blood loss and blood transfusion.
The effects of Trasylol use in CPB involve a reduction in systemic
inflammatory response to surgery, which translates into a decreased need
for allogeneic (blood donated from another individual) blood transfusions
reduced bleeding and decreased mediastinal re-exploration for bleeding.
Trasylol(R) administration may cause fatal anaphylactic or
anaphylactoid reactions. Fatal reactions have occurred with an initial
(test) dose as well as with any of the components of the dose regimen.
Fatal reactions have also occurred in situations where the initial (test)
dose was tolerated. The risk for anaphylactic or anaphylactoid reactions is
increased among patients with prior aprotinin exposure and a history of any
prior aprotinin exposure must be sought prior to Trasylol(R)
administration. The risk for a fatal reaction appears to be greater upon
re-exposure within 12 months of the most recent prior aprotinin exposure.
Trasylol(R) should be administered only in operative settings where
cardio-pulmonary bypass can be rapidly initiated. The benefit of
Trasylol(R) to patients undergoing primary CABG surgery should be weighed
against the risk of anaphylaxis associated with any subsequent exposure to
aprotinin. (See CONTRAINDICATIONS, WARNINGS and PRECAUTIONS in the
prescribing information.)
Safety Considerations
Trasylol is contraindicated in patients with a known or suspected
aprotinin exposure during the last 12 months. Aprotinin may also be a
component of some fibrin sealant products.
-- In clinical studies, hypersensitivity and anaphylactic reactions were
rare (0.5 mg/dL above pre-
treatment levels was statistically higher in the high-dose aprotinin
group (9.0%) compared with placebo (6.6%).
In clinical trials Trasylol did not increase the risk of the following
perioperative events: myocardial infarction, hepatic dysfunction and
mortality.
About Bayer HealthCare
Bayer HealthCare, a subsidiary of Bayer AG, is one of the world's
leading, innovative companies in the healthcare and medical products
industry and is based in Leverkusen, Germany. The company combines the
global activities of the Animal Health, Consumer Care, Diabetes Care, and
Pharmaceuticals divisions. The Pharmaceuticals division comprises the
following business units: Women's Healthcare, Diagnostic Imaging,
Specialized Therapeutics, Hematology/Cardiology, Primary Care, and
Oncology. Bayer HealthCare's aim is to discover and manufacture products
that will improve human and animal health worldwide. The products enhance
well-being and quality of life by diagnosing, preventing and treating
diseases.
Forward-Looking Statements
This news release contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group management. Various known and
unknown risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation,
development or performance of the company and the estimates given here.
These factors include those discussed in our public reports file with the
Frankfurt Stock Exchange and with the U.S. Securities and Exchange
Commission (including our Form 20-F). The company assumes no liability
whatsoever to update these forward-looking statements or to conform them to
future events or developments.
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