BAYER DISCONTINUES THREE TRASYLOL STUDIES

Bayer HealthCare has decided to end three ongoing Phase III 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.

The new Trasylol labeling that was recently approved by the FDA includes a recommendation that Trasylol should only be given to patients who have an increased risk for blood loss and the possible need for blood transfusions while undergoing a cardiopulmonary bypass.

Bayer's decision to discontinue these trials was not made based on any safety findings in these non-cardiopulmonary bypass studies. In November 2006 an independent data monitoring committee (DMC) reviewed safety data on these three studies. 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 cardiopulmonary bypass surgery in patients who are at an increased risk for blood loss and blood transfusion, according to Bayer.