LATE PREDNISONE WITHDRAWAL IN CYCLOSPORINE-TREATED KIDNEY-TRANSPLANT PATIENTS - A RANDOMIZED STUDY

Prednisone in combination with cyclosporine and/or azathioprine is com monly used after kidney transplantation to prevent graft rejection. Lo ng-term use of prednisone can give rise to multiple side effects and m orbidity. This randomized study was conducted to find out If prednison e could be withdrawn in recipients at least 1 yr after kidney transpla ntation. Eighty-four such recipients of a cadaveric kidney with stable renal function on cyclosporine and prednisone were randomized to cont inue prednisone (N = 42) or to withdraw prednisone in a 2-month period (N = 42). The main end point was the percentage of successful prednis one withdrawal. Both groups were compared for the incidence of infecti ons and cardiovascular risk factors and for the incidence and cause of deterioration of renal function. All patients had a 14-month follow-u p. In 67% (N = 28) of the patients, prednisone could be withdrawn succ essfully. Acute rejection was the main cause of withdrawal failure (N = 11, 26%). No grafts were lost due to rejection. In the prednisone wi thdrawal group, a tendency was noted for a lower incidence of infectio ns (difference: 17%; 95% confidence interval [CI]: -4% to 37%). After withdrawal, less antihypertensive drugs were necessary to control hype rtension (difference: 0.5 drugs/patient; 95% CI: -0.9 to -0.1) and 35% less patients (23 of 41 versus nine of 42) needed cholesterol-lowerin g drugs (95% CI: -54% to -15%). A reduction of the frequency of patien ts with Type II diabetes mellitus was found (difference 10%; 95% CI: - 24% to 5%) with a decrease of glycosylated hemoglobin (difference: 0.4 mmol/L; 95% CI: 0.1 to 0.8). Disappearance of moonface was found in 2 5% of the patients. Elective withdrawal of prednisone >1 yr after post mortal kidney transplantation can be accomplished safely provided that patients are controlled frequently. Beneficial effects were found reg arding hypertension, hypercholesterolemia, hyperglycemia, and appearan ce.