Patients treated with sirolimus fare better after ciclosporin
is withdrawn
Transplant patients treated with sirolimus (Rapamune)
have improved renal function and lower blood pressure one month after
stopping ciclosporin, and these improvements continue over two years,
say researchers.
In the Rapamune Maintenance Regimen study, kidney
transplant patients were treated with sirolimus, ciclosporin and corticosteroids
after transplantation. Three months later, 430 patients were randomised
to either remain on this treatment combination or to have ciclosporin
gradually withdrawn over four to six weeks.
The researchers found that renal function at 24
months, as measured by glomerular filtration rate, was improved in patients
who had ciclosporin withdrawn (64.8 versus 54.7 ml/min, P<0.001).
Systolic blood pressure was also lower in this group of patients (133.8
versus 140.7 mmHg, P<0.001). There was no difference between
the two groups in terms of graft or patient survival, or in 24-month cumulative
acute rejection rates.
Andrea Devaney, transplant pharmacist, Churchill
Hospital, Oxford (one of the study centres involved in the trial), says
that the reduction in blood pressure associated with withdrawal of ciclosporin
has the potential to reduce the use of antihypertensive drugs “and to
reduce the patient’s pill burden”.
The researchers say that using sirolimus and gradually
withdrawing ciclosporin could reduce the number of patients requiring
a second transplant operation. Mr Bob Johnson, consultant surgeon, Manchester
Royal Infirmary, said: “One of the factors which can lead to [the need
for a second transplant] is the apparent nephrotoxicity of anti-rejection
drugs.”
The researchers add that protecting transplanted
kidneys by using drugs that are not nephrotoxic will benefit patients
waiting for their first kidney transplant, as well as those who develop
signs of nephrotoxicity caused by ciclosporin. Results from the study,
which was funded by Wyeth, manufacturer of Rapamune, were presented at
the 10th Congress of the European Society of Transplantation in Lisbon
on 10 October.
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