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Biotech / Medical : Indications -- cardiovascular

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To: scaram(o)uche who started this subject10/30/2003 2:44:58 PM
From: nigel bates   of 214
 
Albumin Reduces Mortality in Coronary Artery Bypass Graft (CABG) Surgery

Is type of blood volume expander a variable that might not have been controlled in other CABG trials ?

RESEARCH TRIANGLE PARK, N.C., Oct. 30 /PRNewswire/ -- According to a recently published study, albumin, used as a blood volume expander in coronary artery bypass graft (CABG) surgery, is associated with a significantly lower incidence of mortality compared to non-protein expanders. The study of 19,578 patients published in CHEST (June 2003) reported the mortality rate for patients given albumin during CABG surgery was 25 percent lower than for those receiving other types of blood volume expanders, specifically non-protein colloids (hetastarch [6% hydroxyethyl starch] or dextran). As a result, use of albumin was found to save five to six additional lives per 1,000 patients. Further, albumin therapy was shown to be an extremely cost-effective alternative to other blood volume expanders. The study, supported by Bayer HealthCare LLC, was conducted by researchers at Yale University in New Haven, Conn.

Although CABG surgery has become relatively commonplace, the procedure is expensive and carries risks normally associated with open-heart surgery. "A 25 percent reduction in mortality is a very significant finding," said Dr. John Elefteriades, professor of surgery, Yale University School of Medicine, one of the study authors. "This can save five or six lives for every 1,000 patients we operate on. We have always felt, on clinical grounds, that albumin expands the circulating blood volume very efficiently, without risk of promoting bleeding. Now, we have concrete evidence in a huge number of patients that this is so."

Dr. James Russell, professor of medicine at the University of British Columbia and a research investigator of the McDonald/iCAPTURE Research Laboratories in Vancouver, commented on the findings. "The results from this study bolster the scientific literature in this area and seem to corroborate a recent pilot, randomized, controlled trial we conducted in Canada comparing Plasbumin®-5 (Bayer BP's albumin product) to a non-protein volume expander (pentastarch) in patients who had cardiac surgery. The results of our study demonstrate favorable effects of albumin compared to pentastarch on platelet count and red blood cell transfusion. Also, fewer patients who received albumin had excessive blood vessel relaxation (vasodilation)."

According to Dr. Curtis Tribble, professor of surgery at the University of Virginia's Division of Thoracic and Cardiovascular Surgery, "There has been some controversy regarding comparative safety and efficacy of non-protein blood volume expanders. We have shown some of these non-protein products can increase bleeding in the cardiac surgical patient. I am happy to see this new study demonstrating that albumin's protective benefits in CABG surgery are significant and, therefore, should be carefully considered by physicians caring for cardiac surgical patients when choosing blood volume expanders for these critical procedures."

With an estimated 600,000 CABG surgeries performed in the United States each year, the cost savings using albumin are significant. The projected savings are supported by an earlier study published in The Journal of Thoracic and Cardiovascular Surgery (1998) that found poorer CABG surgical outcomes, especially higher morbidity rates, are directly linked to higher hospital costs. The average cost of CABG surgical procedures in patients with serious morbidity is $60,335, and this escalates to $74,466 for patients who do not survive.

Bayer BP's albumin product, Plasbumin®-5, Albumin (Human), 5%, is a sterile 5% albumin solution. The main clinical indications are for blood volume expansion, including cardiopulmonary bypass, hypovolemic shock, and burn therapy. It must be administered intravenously.

Plasbumin®-5, Albumin (Human), 5%, is contraindicated in patients with a history of allergic reactions to albumin. Adverse reactions to albumin are rare. Such reactions may be allergic in nature or be due to high plasma protein levels from excessive albumin administration. Allergic manifestations include urticaria, chills, fever, and changes in respiration, pulse, and blood pressure. For additional information on Plasbumin®, see Full Prescribing Information at www.bayeralbumin.com.
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