Bayer Launches Phase III Clinical Study of Trasylol® in Elective Spinal Fusion Surgery
Study Examines Effects of Trasylol in Reducing Bleeding and Need for Blood Transfusions for Spinal Fusion Patients.
12/08/05, WEST HAVEN, Conn. – Bayer Pharmaceuticals Corporation (NYSE: BAY) today announced the initiation of a Phase III clinical trial to evaluate the safety and efficacy of Trasylol® (aprotinin injection) in reducing blood loss and the need for transfusion in adult patients undergoing elective spinal fusion surgery.
Spinal fusion surgery involves ‘fusing’ together one or more of the small bones of the spine with bone grafts and devices. This fusion limits the motion between the vertebrae allowing surgeons to treat injuries to the spine, repair broken vertebra, correct deformities, adjust abnormal curvatures, stabilize weakness and remedy slipped or herniated disks. Approximately 300,000 spinal fusion surgeries take place each year in the United States, a figure that has doubled in the last decadei.
Patients undergoing spinal fusion surgery are subject to a blood transfusion rate that may be six times greater than that of patients undergoing spinal surgery without fusionii. Spine fusion surgery is also associated with more complications (such as infection, chronic pain and neural injuries) as it requires more extensive dissection and longer operative timeiii.
“Blood loss can be a significant complication of spine surgery. Combined with the potential health risks associated with transfusions and the rising cost of blood products, there is a great need to reduce bleeding in this surgical setting,” said Michael Neuwirth, MD, lead investigator of the study and director of the Spine Institute at Beth Israel Medical Center. “Trasylol has been proven safe and effective in reducing blood loss and transfusion requirements in coronary artery bypass surgery, and we are studying the drug to determine if it may play a similar role in spinal fusion surgery.”
The multi-center, randomized, double-blind, placebo-controlled trial will assess the ability of Trasylol to reduce bleeding and the need for blood transfusions in elective spinal fusion surgery involving three to seven vertebral levels. Over 450 adult patients will be randomly assigned to receive 200 mL of intravenous Trasylol or placebo at the start of the operation, followed by 50 mL/hour of either agent until the surgery is complete. Close to 40 investigational centers in North America will participate in the study.
Trasylol is currently approved for use in more than 60 countries. In the United States, Trasylol is indicated for prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass (CPB) in the course of coronary artery bypass graft (CABG) surgery.
“Studies have continued to provide evidence supporting the hemostatic effects of Trasylol in orthopedic surgery,” said Dr. Paul MacCarthy, Vice President of Medical Affairs at Bayer. “We are hopeful that this clinical trial will validate those findings and establish the safety and efficacy of Trasylol therapy in the setting of spinal fusion surgery.”
In April 2005, Bayer had announced the initiation of a Phase III study to evaluate the safety and efficacy of Trasylol in reducing blood loss and the need for transfusion in patients undergoing elective primary total hip replacement surgery.
Previous Study Results
A recent evidence-based review of previously published prospective, randomized studies evaluating aprotinin therapy in spine surgery demonstrated a significant reduction in blood loss and the amount of blood transfused.iv
Approximately 200 adult patients undergoing spinal fusion have been included in previous Bayer sponsored and independently published controlled studies with Trasylol.v,vi,vii In these trials, the incidence of adverse events was comparable to placebo, including the occurrence of deep vein thrombosis. For additional safety information associated with the use of Trasylol, see Important Safety Considerations below.
About Spinal Fusion
Spinal fusion is a surgical technique in which one or more of the vertebrae of the spine are united together so that motion no longer occurs between them. Bone grafts are placed around the spine during surgery, and the body then heals the grafts over several months, joining the vertebrae together.
The ultimate goal of spinal fusion is to obtain a solid union between two or more vertebrae. The procedure may involve use of supplemental hardware (instrumentation) such as plates, screws and cages. Instrumentation is sometimes used to correct a deformity, but usually is just used as an internal splint to hold the vertebrae together while the bone grafts heal. The immediate discomfort following spinal fusion is generally greater than with other types of spinal surgeries. Patients typically stay in the hospital for three or four days; however, a longer stay after more extensive surgery is not uncommon. A short stay in a rehabilitation unit after release from the hospital is often recommended for patients who had extensive surgery, or for elderly or debilitated patients. viii
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. ix
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 Corporation’s 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
- within 6 months, the incidence was 5 percent
- after 6 months, the incidence was 0.9 percent
Trasylol is generally well tolerated. In clinical trials, graft patency, myocardial infarction, renal or hepatic dysfunction and mortality were comparable to placebo.
About Bayer Pharmaceuticals Corporation
Bayer Pharmaceuticals Corporation (www.bayerpharma.com) is part of the worldwide operations of Bayer HealthCare AG, a subsidiary of Bayer AG.
Bayer HealthCare, with sales of approximately 8.5 billion Euro in 2004, is one of the world’s leading, innovative companies in the health care and medical products industry. The company combines the global activities of the divisions: Animal Health, Biological Products, Consumer Care, Diagnostics and Pharmaceuticals. 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. Our products enhance well-being and quality of life by diagnosing, preventing and treating disease.
Forward Looking Statement
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 Bayer’s public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission (including our Form 20-F). Bayer assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
i Agency for Healthcare Research and Quality. Healthcare Cost and Utilization Project, HCUPnet. Accessed on November 9, 2005. Available at: http://www.ahrq.gov/data/hcup/.
ii Deyo RA, et al. Lumbar spinal fusion: a cohort study of complications, reoperations, and resource use in the Medicare population. Spine 1993;18:1463-1470.
iv Kokoszka A, et al. Evidence-based review of the role of aprotinin in blood conservation during orthopaedic surgery. J Bone Joint Surg Am 2005;87:1129-36.
v Lentschener, C., et al. “Reduction of blood loss and transfusion requirement by aprotinin in posterior lumbar spine fusion.” Anesth Analg 89: 590-7, 1999.
vi Urban, MK., et al. “The efficacy of antifibrinolytics in the reduction of blood loss during complex adult reconstructive spine surgery.” Spine 2001; 26(10): 1152-56.
vii Bayer, S. “A parallel, randomized double-blind, placebo controlled evaluation of the influence of high dose aprotinin in spinal fusion surgery on intra-operative blood loss.” Report No. PH31776/1; 2002.
viii North American Spine Society. Spinal Fusion Surgery. What is it? How is it done? Accessed on October 11, 2005. Available at: http://www.spine.org/articles/spinalfusion.cfm.
ix Trasylol Prescribing Information. Accessed on November 15, 2005. Available at: http://www.trasylol.com.
- Contact Information
- Staci Gouveia
- Manager, Media Relations, Bayer Healthcare Pharmaceuticals
- Bayer Pharmaceuticals Corporation
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