HDCN Article Review/Hyperlink

Ratcliffe PJ, Dudley CRK, Higgins RM, Firth JK, Smith B, Morris PJ

Randomised controlled trial of steroid withdrawal in renal transplant recipients receiving triple immunosuppression

Lancet (Sep) 348:643-648 1996

The paper by Ratcliffe et al describes a randomized controlled trial of steroid withdrawal in selected transplant recipients. Patients were selected if they were 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 pressure.

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)