Bayer Discontinues Trasylol(R) Clinical Trial Program In Non-CABG Indications

Main Category: Blood / Hematology
Also Included In: Transplants / Organ Donations;  Clinical Trials / Drug Trials
Article Date: 26 Jan 2007 - 0:00 PDT

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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 (<0.1%) in patients with no prior exposure to Trasylol.

Trasylol administration increases the risk for renal dysfunction and may increase the need for dialysis in the perioperative period.

-- This risk may be increased for patients with pre-existing renal impairment or those who receive aminoglycosides or drugs that alter renal function.

-- The incidence of serum creatinine elevations >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.

Bayer HealthCare
http://www.trasylol.com