Vienna, Austria (ots/PRNewswire) -
- Prograf(R)-sirolimus Combination is Effective in Kidney
- Clinical Benefits With Prograf(R) for Heart Transplant Patients
Six-month data from a new European study, presented today by Dr
Stefan Vitko (IKEM, Prague, Czech Republic) at the XX International
Congress of the Transplantation Society, demonstrated that
cornerstone immunosuppressive therapy with Prograf(R) (tacrolimus) in
combination with sirolimus is effective for the prevention of
rejection following kidney transplantation.(1) This multicentre,
randomised study compared the efficacy and safety of Prograf(R) in
combination with either sirolimus at 0.5mg/day (n=325) or 2mg/day
(n=325), or mycophenolate mofetil (MMF) 1g/day (n=327). All patients
also received corticosteroids.
The 6-month results revealed that Prograf(R) in combination with
the higher dose of sirolimus (2mg) was associated with a
significantly lower incidence of biopsy-proven acute rejection
(15.7%) when compared with Prograf(R)/sirolimus 0.5mg (25.2%,
p=0.003) and Prograf(R)/MMF (22.3%, p=0.036). There were also
significant differences between groups (p<0.05) in terms of adverse
events. Notably, the incidence of hyperlipidaemia, a key
cardiovascular risk factor, was significantly (p<0.05) higher with
sirolimus adjunctive therapy at both doses evaluated (2mg: 24.0%;
0.5mg: 19.4%) compared with MMF (11.0%). Adverse events were the main
reason for premature study withdrawal in the sirolimus 2mg treatment
Although combination therapy with sirolimus was superior to MMF in
preventing acute rejection, this increase in efficacy needs to be
weighed against the dyslipidaemia and increased rate of adverse
events associated with sirolimus.
In addition to these data, Nizar A. Yonan of Wythenshawe Hospital,
Manchester, UK, showed that cornerstone immunosuppression with
Prograf(R) provides efficacy and safety benefits in heart transplant
patients.(2) These data add to the growing body of evidence that
supports the use of Prograf(R) as primary therapy in heart and other
forms of solid-organ transplantation.
This European, multicentre, phase III study randomly assigned 314
heart transplant patients to Prograf(R) or ciclosporin microemulsion.
Patients in both treatment groups also received adjunctive therapy
with azathioprine and corticosteroids in addition to antibody
At 18 months post-transplantation, both treatment regimens were
found to be associated with excellent patient/graft survival rates.
Importantly, Prograf(R) treatment was associated with a significantly
lower incidence of biopsy-proven acute rejection of ISHLT grades ³1B
and ³3 compared with ciclosporin microemulsion (54.0% vs 66.4%,
respectively, p=0.029; and 28.0% vs 42.0%, p=0.009).
One of the most pertinent findings from this study concerned
cardiovascular co-morbidity: significantly fewer patients receiving
Prograf(R) versus ciclosporin microemulsion-based therapy experienced
post-transplant arterial hypertension (65.6% vs. 77.7%, respectively)
and hyperlipidaemia (28.7% vs. 40.1%), whereas tacrolimus patients
experienced more new onset diabetes mellitus (20.3% vs 10.5%).
These differences between the two treatment groups are important
clinically because favourable rejection and cardiovascular risk
profiles, as seen with the Prograf(R) based regimen, may translate
into improved long-term outcomes.
Notes to Editors:
Prograf(R) is a cornerstone immunosuppressant for the prevention
of graft rejection in kidney and liver transplantation. Prograf(R) is
currently available in nearly 70 countries and currently forms the
centrepiece of Fujisawa's continuing growth. Prograf(R) is approved
for first-line use in the prevention of heart transplant rejection in
Belgium and Luxembourg only. In a number of other European countries
it is indicated for rescue therapy following heart transplantation.
Acute rejection of the graft can occur at any time after
transplantation, but the risk is highest in the first few months
post-transplant. Immunosuppressants are used to suppress the immune
system and thereby prevent acute rejection. Maximising patient health
through minimising the risk of adverse events associated with
immunosuppressive agents is an additional key challenge in
transplantation. Events such as hyperlipidaemia increase the risk of
cardiovascular disease, which is one of the main causes of late graft
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
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 centerpiece of Fujisawa's continuing growth. Additional
information on Fujisawa GmbH can be found on the Company's Web site
1. Vitko S, Wlodarczyk Z, Salmela K, Czajkowski Z, Margreiter R.
Tacrolimus in combination with two different sirolimus doses versus a
tacrolimus/MMF-based regimen: a large, randomised clinical study in
renal transplantation. Abstract no. O286.
2. Yonan NA, Grimm M, Rinaldi M, et al. The advantage of
tacrolimus versus ciclosporin-based therapy after heart
transplantation - a large European phase III study. Abstract no.O410.
Both abstracts presented at the XX International Congress of the
Transplantation Society, 5-10 September 2004, Vienna, Austria.
ots Originaltext: Fujisawa GmbH
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