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Kidney Transplant patients may benefit from going off of
certain Immunosuppressive Drugs
Newswise — Withdrawing
certain immunosuppressive drugs following
kidney transplantation prolongs survival and
saves money compared with keeping patients
on these medications for life, according to
a study appearing in the September 2008
issue of the Journal of the American Society
Nephrology (JASN).
In this study, a lifetime
Markov model was created to compare the
cost-effectiveness of a sirolimus-based
calcineurin inhibitor (CNI) withdrawal
regimen (sirolimus plus steroids) with other
common CNI-containing regimens in adult de
novo renal transplantation patients.
The
findings indicate that in the long-run, the
risks of the medications potentially
outweigh their benefits.
Immunosuppressive drugs such
as calcineurin inhibitors are critical after
kidney transplantation to prevent organ
rejection, particularly during the first
year. However, a trade-off exists, because
calcineurin inhibitors are associated with
serious adverse effects, including renal
dysfunction, infections, cancer, diabetes
mellitus and cardiovascular-related events.
Therefore, regimens need to be optimized
over time so that patients can benefit from
the drugs’ short-term benefits but not be
harmed by their long-term risks.
Head-to-head analyses of the
short-term benefits and long-term risks of
calcineurin inhibitors are limited. To
compare the two, Dr. Stephanie Earnshaw of
RTI Health Solutions in Research Triangle
Park, NC, and her colleagues examined data
from published studies and from the United
States transplant registry.
The
investigators developed a decision-analytic
model to assess long-term donor kidney
survival, short- and long-term patient
outcomes, and costs.
Sirolimus, in combination
with steroids, is currently the only
immunosuppressive treatment regimen that is
approved for use when calcineurin inhibitors
are withdrawn.
Therefore, Dr. Earnshaw’s
group compared treatments containing
sirolimus plus steroids versus treatments
that maintained the use of calcineurin
inhibitors.
The researchers’
decision-analytic model, using data
published in the literature and reported by
the US transplant registry, assumed that
within the first 12 months following
transplant surgery, sirolimus plus steroid
therapy is associated with a greater risk of
kidney allograft rejection than regimens
that continue to use calcineurin inhibitors.
Other commonly used regimens include a calcineurin inhibitor such as cyclosporine
or tacrolimus, plus mycophenolate mofetil
and steroids.
In this particular study, it
was assumed that in the absence of induction
therapy a total of 21.8% of patients taking sirolimus plus steroids experienced acute
rejection within one year of
transplantation, compared with 19.0% of
patients taking cyclosporine plus
mycophenolate mofetil and steroids, and
17.1% of patients taking tacrolimus plus
mycophenolate mofetil and steroids.
However, it was revealed that
overall, treatment with sirolimus plus
steroids may be more efficacious and less
costly than regimens that continued to use
calcineurin inhibitors.
Specifically,
withdrawal of calcineurin inhibitors may
prolong patients’ lives and improve their
kidney function.
It was estimated that the
average number of grafts lost per patient
over their remaining lifetime after initial
kidney transplantation (patients can have
more than one transplant) was 0.90 for
patients taking sirolimus plus steroids,
compared with 0.94 for patients in the
cyclosporine group and 0.92 for patients in
the tacrolimus group.
Sirolimus plus
steroids also may increase patient survival
(11.43 years, compared with 11.37 years in
the cyclosporine group and 11.13 years in
the tacrolimus group.) Total lifetime costs
per patient in the three groups were
$472,799; $484,020; and $505,420,
respectively.
According to the authors,
these findings indicate “calcineurin
inhibitor withdrawal not only shows
potential for long-term clinical benefits,
but also is expected to be cost-saving over
a patient’s life compared with the most
commonly prescribed calcineurin
inhibitor–containing regimens.”
They note
that withdrawal of CNIs is an important
option because clinicians consider the
lifetime of the patient to be more important
than the year that follows transplantation.
It is important to note that this analysis
relied on certain assumptions (such as the
incidence of acute rejection per treatment
arm and measures of renal function) due to
limited availability of data.
As such,
additional research will be necessary to
support these results.
Funding for this analysis was
provided by Wyeth Pharmaceuticals in
Collegeville, PA.
The article, entitled
“Cost-Utility of Calcineurin Inhibitor
Withdrawal After de Novo Renal
Transplantation,” authored by Stephanie R.
Earnshaw1, Christopher N. Graham1, William
D. Irish1, Reiko Sato2, and Mark A.
Schnitzler3 (1RTI Health Solutions, 2Wyeth
Research, 3St. Louis University) will be
available online at
http://jasn.asnjournals.org/ beginning
on Wednesday, June 18, 2008 and in the
September 2008 print issue of JASN.
ASN is a not-for-profit
organization of 11,000 physicians and
scientists dedicated to the study of
nephrology and committed to providing a
forum for the promulgation of information
regarding the latest research and clinical
findings on kidney diseases. ASN publishes
JASN, the Clinical Journal of the American
Society of Nephrology (CJASN), and the
Nephrology Self-Assessment Program (NephSAP).
In January 2009, ASN will launch a
newsmagazine.
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