Prograf(r) versus ciclosporin microemulsion : Pan- European clinical trial demonstrates significant clinical benefits with Prograf(r) in kidney transplantation

MUNICH, March 11 (PROTEXT/PRNewswire) - The 6-month results of an important clinical trial comparing the cornerstone immunosuppressants, Prograf(r) (tacrolimus) and the microemulsion formulation of ciclosporin, in kidney transplantation were published this week in The Lancet.[1] This is the first time these products have been compared head-to-head in a major, randomised, multicentre clinical trial. The results confirm previous findings, where Prograf(r) had shown clinically important advantages over the original formulation of ciclosporin.[2,3] In this open, parallel-group study, conducted in 50 transplant units in seven European countries, a total of 286 kidney transplant patients were given Prograf(r) to prevent rejection, whereas 271 patients were given ciclosporin microemulsion. Patients in both treatment groups received azathioprine and corticosteroids as adjunctive immunotherapy. All patients were monitored for 6 months after transplantation. The published findings demonstrate the superiority of Prograf(r) over ciclosporin microemulsion in terms of preventing renal allograft rejection. At 6 months post-transplantation, the rate of biopsy-confirmed acute rejection was significantly lower with Prograf(r) compared with ciclosporin microemulsion (19.6% vs 37.3%, respectively; p<0.0001), as were the rates of biopsy- proven corticosteroid-resistant acute rejection (9.4% vs 21.0%, p <0.0001) and recurrent acute rejection (1.1% vs 7.0%, p=0.0003). Importantly, the requirement to switch between therapies because of biopsy-confirmed acute rejection was significantly lower in the Prograf(r) treatment group (0.3% vs 10.0%, p<0.0001). Other key findings from this study that reinforce Prograf(r)'s superiority over ciclosporin microemulsion concern its cardiovascular risk profile. Not only was Prograf(r) therapy associated with a significantly lower incidence of hypercholesterolaemia compared with ciclosporin microemulsion (4.2% vs 8.9%, respectively; p=0.037), but also new-onset or worsening hypertension (15.7% vs 23.2%, p=0.032). Moreover, there was no significant difference between the two treatment groups in terms of new-onset diabetes mellitus (4.5% vs 2.0%, p=0.105). These results demonstrate that Prograf(r) is significantly more effective than ciclosporin microemulsion in preventing acute rejection after kidney transplantation, and highlights its benefits in terms of cardiovascular risk. Given that the two leading causes of late renal allograft loss (>1 year post-transplant) are chronic rejection (for which acute rejection is a significant risk factor[4]) and death with a functioning transplant (of which approximately half of all cases are a result of cardiovascular disease, usually involving hypertension or hyperlipidaemia[5]), [6] these findings may have important clinical implications in terms of long-term patient and graft survival. 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 50 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. Margreiter R, for the European Tacrolimus vs Ciclosporin Microemulsion Renal Transplantation Study Group. Efficacy and safety of tacrolimus compared with ciclosporin microemulsion in renal transplantation: a randomised multicentre study. Lancet 2002;359:741-6. 2. Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS. A comparison of tacrolimus (FK506) and cyclosporine for immunosuppression after cadaveric renal transplantation. Transplantation 1997;63:977-83. 3. Mayer AD, Dmitrewski J, Squifflet JP, et al. Multicenter randomized trial comparing tacrolimus (FK506) and cyclosporine in the prevention of renal allograft rejection: a report of the European Tacrolimus Multicenter Renal Study Group. Transplantation 1997;64:436-43. 4. Almond PS, Matas A, Gillingham K, et al. Risk factors for chronic rejection in renal allograft recipients. Transplantation 1993;55:752-7. 5. Wheeler DC, Steiger J. Evolution and etiology of cardiovascular diseases in renal transplant recipients. Transplantation 2000;70(11 Suppl):SS41-5. 6. Pascual M, Theruvath T, Kawai T, Tolkoff-Rubin N, Cosimi AB. Strategies to improve long-term outcomes after renal transplantation. N Engl J Med 2002;346:580-90. For further information, please contact: Marité Cruz Fujisawa GmbH, Munich, Germany T: +49 89 45442249 F: +49 89 434129 marite.cruz@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. 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