Ratcliffe PJ, Dudley CRK, Higgins RM, Firth JK, Smith B,
Randomised controlled trial of steroid withdrawal in renal
transplant recipients receiving triple immunosuppression
(Sep) 348:643-648 1996
The paper by Ratcliffe et al describes a randomized controlled trial of
withdrawal in selected transplant recipients. Patients were selected if they
on triple therapy (Cy A, Aza, steroids) one to six years after transplant,
without any history of steroid-resistant rejection or rejection after the
first year, and if they had good renal function (creatinine < 250 mM).
Steroids were tapered by 1 mg weekly till 5 mg daily, then switched to 10
mg every other day and tapered by 1 mg a week.
Steroid withdrawal was achieved in 86% of the 49 patients allocated to
this arm. No episode of acute rejection was seen, but a significant rise in
serum creatinine was observed (from 138 to 150 mM) that persisted over time.
On the long term, significant reduction in plasma cholesterol, but not
triglycerides, was seen in the steroid withdrawal group, together with a
slight reduction in body weight, with no significant change in blood
The authors conclude that steroid withdrawal is possible in selected
patients without major immediate risk for the graft, is accompanied by
reductions in body weight and serum cholesterol, but is associated with a
definite rise in serum creatinine of uncertain long-term prognosis.
Comment: This is an interesting, well done study that raises
concerns about the
long-term effect of steroid withdrawal. The only criticism is that the
group of patient selected is not that homogenous (between 1 and 6 years
post-transplant), and that no analysis is done on subsets of patients, for
example, those grafted more than 2 or 3 years before entering the study. A
prolonged follow-up of those patients would yield interesting information
on the risk/benefit ratio of steroid withdrawal.
(Denis Glotz MD, Hopital Broussais, Paris, France)