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 resultsof an important clinical trial comparing the cornerstoneimmunosuppressants, Prograf(r) (tacrolimus) and the microemulsionformulation of ciclosporin, in kidney transplantation werepublished this week in The Lancet.[1] This is the first timethese products have been compared head-to-head in a major,randomised, multicentre clinical trial. The results confirmprevious findings, where Prograf(r) had shown clinicallyimportant advantages over the original formulation ofciclosporin.[2,3]In this open, parallel-group study, conducted in 50 transplantunits in seven European countries, a total of 286 kidneytransplant patients were given Prograf(r) to prevent rejection,whereas 271 patients were given ciclosporin microemulsion.Patients in both treatment groups received azathioprine andcorticosteroids as adjunctive immunotherapy. All patients weremonitored for 6 months after transplantation.The published findings demonstrate the superiority of Prograf(r)over ciclosporin microemulsion in terms of preventing renalallograft rejection. At 6 months post-transplantation, the rateof biopsy-confirmed acute rejection was significantly lower withPrograf(r) compared with ciclosporin microemulsion (19.6% vs37.3%, 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 becauseof biopsy-confirmed acute rejection was significantly lower inthe Prograf(r) treatment group (0.3% vs 10.0%, p<0.0001).Other key findings from this study that reinforce Prograf(r)'ssuperiority over ciclosporin microemulsion concern itscardiovascular risk profile. Not only was Prograf(r) therapyassociated with a significantly lower incidence ofhypercholesterolaemia compared with ciclosporin microemulsion(4.2% vs 8.9%, respectively; p=0.037), but also new-onset orworsening hypertension (15.7% vs 23.2%, p=0.032). Moreover, therewas no significant difference between the two treatment groups interms of new-onset diabetes mellitus (4.5% vs 2.0%, p=0.105).These results demonstrate that Prograf(r) is significantly moreeffective than ciclosporin microemulsion in preventing acuterejection after kidney transplantation, and highlights itsbenefits in terms of cardiovascular risk. Given that the twoleadingcauses of late renal allograft loss (>1 year post-transplant) arechronic rejection (for which acute rejection is a significantrisk factor[4]) and death with a functioning transplant (of whichapproximately half of all cases are a result of cardiovasculardisease, usually involving hypertension or hyperlipidaemia[5]),[6] these findings may have important clinical implications interms 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. isamong the world's top 30 pharmaceutical companies and employsover 8000 people in Japan, Europe, North America and Asia. Sinceits launch of Prograf(r) in Japan in 1993, the first in theworld, Fujisawa has become one of the world's leading transplantand immunosuppression companies.Fujisawa plans to maintain its commitment to transplantation, andis dedicated both to improving the results of solid-organtransplantation and to ensuring the health and quality of life ofpatients. Prograf(r) is currently available in nearly 50countries and forms the centrepiece of Fujisawa's continuinggrowth. Additional information on Fujisawa GmbH can be found onthe Company's Web site at www.fujisawaeurope.com.References1. Margreiter R, for the European Tacrolimus vs CiclosporinMicroemulsion Renal Transplantation Study Group. Efficacy andsafety of tacrolimus compared with ciclosporin microemulsion inrenal transplantation: a randomised multicentre study. Lancet2002;359:741-6.2. Pirsch JD, Miller J, Deierhoi MH, Vincenti F, Filo RS. Acomparison of tacrolimus (FK506) and cyclosporine forimmunosuppression after cadaveric renal transplantation.Transplantation 1997;63:977-83.3. Mayer AD, Dmitrewski J, Squifflet JP, et al. Multicenterrandomized trial comparing tacrolimus (FK506) and cyclosporine inthe prevention of renal allograft rejection: a report of theEuropean Tacrolimus Multicenter Renal Study Group.Transplantation 1997;64:436-43.4. Almond PS, Matas A, Gillingham K, et al. Risk factors forchronic rejection in renal allograft recipients. Transplantation1993;55:752-7.5. Wheeler DC, Steiger J. Evolution and etiology ofcardiovascular 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 renaltransplantation. N Engl J Med 2002;346:580-90.For further information,please contact:Marité CruzFujisawa GmbH, Munich, GermanyT: +49 89 45442249F: +49 89 434129marite.cruz@fujisawa.de

Subscribers please note that material bearing the slug"PROTEXT" is not part of CTK's news service and is not to bepublished under the "CTK" slug. Protext is a commercial serviceproviding distribution of press releases from clients, who areidentified in the text of Protext reports and who bear fullresponsibility for their contents.

PROTEXT