COMUNICADO DE FUJISAWA GMBH

One year follow-up of first head to head comparison of tacrolimus

and microemulsified cyclosporin shows excellent safety and efficacy

with tacrolimus

No significant differences in the incidence of post-transplant

diabetes mellitus in renal transplantation

LISBON (PORTUGAL), 9 (PRNewswire)

The first large head-to-head, European, multicentre study of 557

renal transplant patients compared the efficacy and safety of

tacrolimus triple therapy with cyclosporin-microemulsion

(CyA-ME)-based triple therapy.

The study revealed a significantly lower rate of acute rejection

in the tacrolimus arm (19.6% vs. 37.3%, pá0.001) and a lower

incidence of steroid-resistant acute rejection (9.4% vs. 21.0%,

pá0.001) 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. Tacrolimus

therapy was associated with a superior cardiovascular profile, such

as total cholesterol which was significantly lower in the tacrolimus

group.

At 10th congress of the European Society for Organ

Transplantation (ESOT), held in Lisbon, Professor B Kraemer,

Regensburg, Germany, presented the 1 year follow-up data of this

first head-to-head comparison of the cornerstone immunosuppressants

tacrolimus and cyclosporin microemulsion. The 1-year results confirm

the initial 6-month follow-up. The incidence of acute rejections in

the second follow-up period was 2.1% in the tacrolimus group and 7.1%

in the CyA-ME group.

Professor Kraemer highlighted some extremely interesting safety

features of these two regimens: with tacrolimus, the use of

anti-hyperlipidemic drugs was only 11.1% compared to 25.1% in the

CyA-ME group, the difference in the use of diuretics was also

striking, 9.4% in the tacrolimus group and 17.5% in the CyA-ME group.

With regards to glucose metabolism, the study confirmed that no

significant differences exist between tacrolimus and CyA-ME regarding

diabetogenicity.

During the initial 6months, the incidence of new onset

insulin-dependent diabetes mellitus (IDDM) was not significantly

different between both treatment arms - 4.5% in the tacrolimus group

and 2.0% in the CyA-ME group. There was only one additional patient

in the tacrolimus group and 2 in the CyA-ME group that developed

diabetes between months 7-12. However, at one year, the use of

overall use of insulin was again similar (8.1% vs. 7.6%).

This low incidence of IDDM under tacrolimus has been a common

feature of recent studies. One of the largest studies ever conducted

involving 838 renal transplant patients treated with tacrolimus was

presented by Professor Y. Vanrenterghem, Leuven, Belgium. The overall

incidence of IDDM in patients receiving tacrolimus therapy was 4.5%.

In one of the treatment arms of the study, where steroids were

withdrawn, the incidence of IDDM was even lower (3.2%), highlighting

the diabetogenic potential of long-term steroid therapy.

Thus, the 1 year follow-up evaluation showed that

tacrolimus-based therapy is significantly more efficacious than

cyclosporin microemulsion in the prevention of acute rejection, and

is also associated with a superior safety profile with no significant

difference 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. 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( 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( 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 http://www.fujisawaeurope.com.

References

1. Vianello A, McKenna M, Tiffany T. A cost-effectiveness

analysis of tacrolimus versus cyclosporin-microemulsion following

kidney transplantation. Presented at the 10th European Society for

Organ Transplantation, Lisbon, 6-11 October 2001.

2. Sperschneider H, for the European Renal Transplantation Study

Group. A large, multicentre trial to compare the efficacy and safety

of tacrolimus with cyclosporine microemulsion following renal

transplantation. Transplant Proc 2001;33:1279-81.

Source: Fujisawa GmbH

Contact: Marité Cruz, Fujisawa GmbH, Munich, Germany, tel. +49 89

4544 2249, fax +49 89 434 129, marite.cruz@fujisawa.de

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