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| |  Recombinant Activated Factor VII Reduces Blood Loss, Eliminates Transfusion Requirements in Patients Undergoing Prostatectomy New clinical study data published in The Lancet (volume 361, number 9353, 18 January 2003) show that NiaStase,® a treatment currently used for hemophilia, may play a significant role in surgery. TORONTO, ON -- January 20, 2003 -- Encouraging findings from a study in this week's issue of THE LANCET indicate that NiaStase® (eptacog alfa, activated) -an agent involved in blood clotting-could be effective in reducing excessive blood loss during prostatectomy surgery. NiaStase® has been shown to promote blood clotting in patients with hemophilia. Results from the PROSE (PROstatectomy, SEven) study add to an increasing body of evidence suggesting that NiaStase® can reduce blood loss and transfusion requirements in surgical patients with normal coagulation. Open prostatectomy, the removal of the prostate through an incision in the lower abdomen above the pubic area, was chosen because the prostate lies in a highly vascularised area with complicated anatomical localization. Its removal during surgery is often associated with heavy and diffuse bleeding (800 ml- 3,500 ml) and occasionally death. Limited supply of donated blood and the risk of viral (HIV, hepatitis, parvovirus), or bacterial infection with blood transfusion are always problems surgeons have to face. The PROSE study results showed that rFVIIa significantly reduced blood loss and transfusion requirements. Dr. Marcel Levi, Department of Internal Medicine, Academic Medical Centre, University of Amsterdam, Netherlands, and colleagues also found that limiting blood loss shortened the duration of the operation, partly due to improved visibility in the operative field. For example, the operations in patients treated with NiaStase® were 54 minutes shorter than those performed in the placebo group. "Patients undergoing prostatectomy surgery can risk serious blood loss, transfusion therapy and long operating times," said Dr. Terry Smith, Department of Critical Care Medicine, Sunnybrook and Women's College Health Sciences Centre. "The PROSE study results show that NiaStase® can significantly reduce blood loss, reduce or even eliminate transfusion therapy and shorten operating times. These are all direct benefits to the patient. With further study, NiaStase® may prove to be a universal hemostatic agent," he added. Study and findings The first group received a dose of 20 mcg/kg body weight, the second group received 40 mcg/kg body weight. The third group had been scheduled to receive 80 mcg/kg body weight, but independent assessors deemed this dose increase unnecessary, as satisfactory efficacy had been achieved at the 40 mcg/kg body weight dosage. Results showed that NiaStase® reduced blood loss and transfusion requirements in a dose-dependent manner (1,235 ml and 1,089 ml in patients receiving NiaStase® at doses of 20 and 40 mcg/kg, respectively, versus 2,688 ml in the placebo group). The need for transfusion was eliminated in patients receiving NiaStase® 40 mcg/kg body weight, while only 38 per cent of patients in the 20 mcg/kg group required transfusion versus 58 per cent in the placebo group. In addition the volume of packed red blood cells transfused decreased from 1.5 units in the placebo-treated group to 0.6 units in the 20 mcg/kg body weight group. Patients undergoing prostatectomy have a two-four per cent risk of venous thromboembolis. However, no thromboembolic events or other adverse events occurred during the study period. Interpretation of the PROSE study "We conclude that treatment of patients undergoing surgery associated with significant blood loss with recombinant activated Factor VII seems to be effective and safe," said Dr. Levi. "Naturally, blood loss does not exclusively depend on the coagulation system, because type and duration of operation, individual patient characteristics, surgical skill, and postoperative patient-care are important variables that affect perioperative blood-loss and transfusion requirements. Nevertheless, promotion of hemostatic function could be a promising option that needs further exploration, in particular in situations of severe perioperative bleeding when surgical hemostasis is difficult to achieve," he added. Novo Nordisk A/S (Copenhagen, Denmark), the manufacturer of NiaStase®, provided the medicine, but was not involved in the design of the study, data collection, analysis or interpretation. Health Canada has issued a conditional marketing authorization under the Notice of Compliance with Conditions policy to reflect the promising nature of NiaStase® (eptacog alfa, activated) in the treatment of Haemophilia A/B patients with inhibitors to Factor VIII or Factor IX, respectively. It is expected that clinical experience and additional data from ongoing studies will validate which patients will benefit most from treatment with NiaStase®. Patients should be advised of the potential risks as well as the benefits of this therapy. Novo Nordisk is a focused healthcare company and a world leader in diabetes care. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs approximately 17,900 people in 68 countries and markets its products in 179 countries. Novo Nordisk's B shares are listed on the stock exchanges in Copenhagen and London. Its ADRs are listed on the New York Stock Exchange under the symbol "NVO". For further company information visit www.novonordisk.com <http://www.novonordisk.com> References Hedner U. Recombinant factor VIIa (NovoSeven®) in the control of surgical bleeding. In: Management of bleeding in cardiovascular surgery. Hanley & Belfus, Inc., Philadelphia 1999; Chpt 19:323--335. Hendricks HGD, et al. Reduced transfusion requirements by recombinant factor VIIa in orthotopic liver transplantation. Transplantation 2001; 71:402-405. Martinowitz U. The use of rFVIIa as adjunct treatment for hemorrhage control in trauma and surgery. Bloodline Reviews 2001; 1:9-11. Martinowitz U, et al. Recombinant FVIIa (rFVIIa) for salvage of surgical patients suffering uncontrolled bleeding. Blood 2000; 94 (10) abstract. Porte R. The risk of bleeding during liver surgery and liver transplantation and the effect on outcome. Bloodline Reviews 2001; 1:14-15. Vlot AJ, et al. Treatment of a severely bleeding patient without pre-existing coagulopathy with activated recombinant factor VII. Am J Med 2000; 108:421-423.
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