Prograf for steroid-free and cost-effective immunosuppression

VENICE (Italy) September 24 (PROTEXT/PRNewswire) - The results of several trials reported at the 11th Congress of the European Society for Organ Transplantation in Venice suggest that the use of the cornerstone immunosuppressant Prograf(r) (tacrolimus) not only enables the successful management of transplant recipients without the need for corticosteroid therapy - an all-important goal in transplantation - but also that it can be more cost-effective than ciclosporin microemulsion. Corticosteroids have been a key component of post-transplant immunosuppressive regimens since the early days of transplantation, but their use is associated with a myriad of potentially harmful side effects, including bone demineralisation, diabetes mellitus and hyperlipidaemia. As a result, many transplant centres are investigating the feasibility of withdrawing or omitting corticosteroids from immunosuppressive regimens. Several studies presented at the ESOT congress demonstrated that immunosuppression with Prograf(r) permits the successful withdrawal or avoidance of corticosteroids, providing a number of health-related benefits and without placing the transplant recipient at increased risk of graft rejection. Indeed, the 3- year follow-up results of a European, multicentre study, presented by Professor Johannes van Hooff (Department of Internal Medicine, University Hospital Maastricht, Maastricht, the Netherlands), revealed that steroid-free immunosuppression with Prograf(r) plus mycophenolate mofetil (MMF) is feasible over the long term. (1) To achieve maximum effectiveness in terms of steroid avoidance after kidney or liver transplantation, Prograf(r) can be combined with the anti-interleukin-2-receptor monoclonal antibody agents basiliximab and daclizumab, induction agents administered in the early post-transplantation period. (2-4) The 6-month results of a randomised comparative study in 538 renal transplant recipients showed important health benefits associated with a steroid-free regimen of daclizumab induction followed by Prograf(r)/MMF dual therapy. Good renal function was maintained without any increase in acute rejection and the incidence of new- onset diabetes mellitus was less than 1%. (3) In liver transplantation, a steroid-free immunosuppressive regimen of Prograf(r) monotherapy after daclizumab induction was associated with a lower incidence of diabetes mellitus and cytomegalovirus infection compared with the same regimen but containing steroids. (4) "There is a growing body of evidence that using Prograf(r) as the primary immunosuppressant plus monoclonal antibody induction therapy does mean physicians can potentially avoid or withdraw steroids," said Mr David Mayer (The Liver and Hepatobiliary Unit, Queen Elizabeth Hospital, Birmingham, UK). He added that this is potentially very good news for patients, not just because of the important safety advantages, but also because anything that improves tolerability is likely to improve patient compliance - critical in preventing organ rejection. Data were also presented that demonstrated that the costs associated with kidney transplantation can be reduced (savings per patient ranged from 583 to 9,919) by using Prograf(r) based therapy. A pharmacoeconomic analysis of a European, multicentre, direct, head-to-head comparison (557 patients) of Prograf(r) and ciclosporin microemulsion-based regimens was conducted from a hospital perspective. To gain a reliable pan-European picture, the costs of treatment were calculated independently using local cost data from three countries - Italy, Spain and Germany. In all three countries the cost advantages of Prograf(r) were due to lower hospitalisation costs, lower costs for concomitant immunosuppressive medication, and a lower incidence of dialysis. (5) Taken together, these data reinforce the position of Prograf (r) at the centre of successful immunosuppressive regimens in both kidney and liver transplantation. Fujisawa GmbH is a subsidiary of Fujisawa Pharmaceutical Co., Ltd., based in Osaka, Japan. Fujisawa Pharmaceutical Co., Ltd. is among the world's top 30 pharmaceutical companies and employs over 8000 people in Japan, Europe, North America and Asia. Since its launch of Prograf(r) in Japan in 1993, the first in the world, Fujisawa has become one of the world's leading transplant and immunosuppression companies. Fujisawa plans to maintain its commitment to transplantation, and is dedicated both to improving the results of solid-organ transplantation and to ensuring the health and quality of life of patients. Prograf(r) is currently available in nearly 70 countries and forms the centrepiece of Fujisawa's continuing growth. Additional information on Fujisawa GmbH can be found on the Company's Web site at www.fujisawaeurope.com. References 1. Van Hoof JP, et al. Long-term efficacy and safety of steroid-withdrawal in tacrolimus-treated patients: results of a long-term follow-up study in renal transplant patients. Presented at the 11th Congress of the European Society for Organ Transplantation, 20-24 September 2003, Venice, Italy. Abstract 99. 2. Salmela K, et al. Steroid-free immunosuppression with tacrolimus/basiliximab and tacrolimus/MMF in renal transplantation: a large, prospective, randomised, 6-month study. Presented at the 11th Congress of the European Society for Organ Transplantation, 20-24 September 2003, Venice, Italy. Abstract 287. 3. Mourad G, et al. Immunosuppression without steroids: daclizumab/tacrolimus/MMF vs tacrolimus/MMF/steroids in renal transplantation. Presented at the 11th Congress of the European Society for Organ Transplantation, 20-24 September 2003, Venice, Italy. Abstract 12. 4. Mayer AD, et al. Steroid-free immunosuppression with tacrolimus after daclizumab induction: a multicentre, comparative, randomised study. Presented at the 11th Congress of the European Society for Organ Transplantation, 20-24 September 2003, Venice, Italy. Abstract 97. 5. Vianello A, et al. Analysis of cost effectiveness of immunosuppression following kidney transplantation in three European countries. Presented at the 11th Congress of the European Society for Organ Transplantation, 20-24 September 2003, Venice, Italy. Abstract 168. Abstract numbers obtained from http://www.keycongress.com/congressi/esot2003/esot.htm Contact: Marité Ode Fujisawa GmbH, Munich, Germany T: +49 89 45442249 F: +49 89 434129 media@fujisawa.de Subscribers please note that material bearing the slug "PROTEXT" is not part of CTK's news service and is not to be published under the "CTK" slug. Protext is a commercial service providing distribution of press releases from clients, who are identified in the text of Protext reports and who bear full responsibility for their contents. PROTEXT