One year follow-up of first head to head comparison of tacrolimus and microemulsified cyclosporin shows excellent safety and efficacy with tacrolimus: :: No sig

LISBON (Portugal) Oct 9 (PROTEXT/PRNewswire) - The firstlarge head-to-head, European, multicentre study of 557 renaltransplant patients compared the efficacy and safety oftacrolimus triple therapy with cyclosporin-microemulsion (CyA-ME)-based triple therapy.The study revealed a significantly lower rate of acute rejectionin the tacrolimus arm (19.6% vs. 37.3%, p<0.001) and a lowerincidence of steroid-resistant acute rejection (9.4% vs. 21.0%, p<0.001) within the first 6 month following transplantation.Even at six-months the results show a trend in graft survival(94.6% vs. 91.9%) in favour of the tacrolimus regimen. Tacrolimustherapy was associated with a superior cardiovascular profile,such as total cholesterol which was significantly lower in thetacrolimus group.At 10th congress of the European Society for OrganTransplantation (ESOT), held in Lisbon, Professor B Kraemer,Regensburg, Germany, presented the 1 year follow-up data of thisfirst head-to-head comparison of the cornerstoneimmunosuppressants tacrolimus and cyclosporin microemulsion. The1-year results confirm the initial 6-month follow-up. Theincidence of acute rejections in the second follow-up period was2.1% in the tacrolimus group and 7.1% in the CyA-ME group.Professor Kraemer highlighted some extremely interesting safetyfeatures of these two regimens: with tacrolimus, the use ofanti-hyperlipidemic drugs was only 11.1% compared to 25.1% in theCyA-ME group, the difference in the use of diuretics was alsostriking, 9.4% in the tacrolimus group and 17.5% in the CyA-MEgroup.With regards to glucose metabolism, the study confirmed that nosignificant differences exist between tacrolimus and CyA-MEregarding diabetogenicity.During the initial 6months, the incidence of new onset insulin-dependent diabetes mellitus (IDDM) was not significantlydifferent between both treatment arms - 4.5% in the tacrolimusgroup and 2.0% in the CyA-ME group. There was only one additionalpatient in the tacrolimus group and 2 in the CyA-ME group thatdeveloped diabetes between months 7-12. However, at one year, theuse of overall use of insulin was again similar (8.1% vs. 7.6%).This low incidence of IDDM under tacrolimus has been a commonfeature of recent studies. One of the largest studies everconducted involving 838 renal transplant patients treated withtacrolimus was presented by Professor Y. Vanrenterghem, Leuven,Belgium. The overall incidence of IDDM in patients receivingtacrolimus therapy was 4.5%. In one of the treatment arms of thestudy, where steroids were withdrawn, the incidence of IDDM waseven lower (3.2%), highlighting the diabetogenic potential oflong-term steroid therapy.Thus, the 1 year follow-up evaluation showed that tacrolimus-based therapy is significantly more efficacious than cyclosporinmicroemulsion in the prevention of acute rejection, and is alsoassociated with a superior safety profile with no significantdifference in the incidence of post-transplant diabetes mellitus.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( in Japan in 1993, the first in the world,Fujisawa has become one of the world's leading transplant andimmunosuppression 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( is currently available in nearly 50 countriesand forms the centrepiece of Fujisawa's continuing growth.Additional information on Fujisawa GmbH can be found on theCompany's Web site at http://www.fujisawaeurope.com.:: References1. Vianello A, McKenna M, Tiffany T. A cost-effectivenessanalysis of tacrolimus versus cyclosporin-microemulsion followingkidney transplantation. Presented at the 10th European Societyfor Organ Transplantation, Lisbon, 6-11 October 2001.2. Sperschneider H, for the European Renal Transplantation StudyGroup. A large, multicentre trial to compare the efficacy andsafety of tacrolimus with cyclosporine microemulsion followingrenal transplantation. Transplant Proc 2001;33:1279-81.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