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Bayer Discontinues Trasylol® (Aprotinin Injection) Clinical Trial Program in Non-CABG Indications
Recent label changes for Trasylol® in CABG indication impact the clinical trial development in other indications
LEVERKUSEN, GERMANY -- January 25, 2007 -- Bayer HealthCare has decided to end three ongoing clinical studies investigating the safety and efficacy of Trasylol® (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.
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.
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."
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."
SOURCE: Bayer HealthCare
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