Late prednisone withdrawal in cyclosporine-treated kidney transplant patients: a randomized study.

Prednisone in combination with cyclosporine and/or azathioprine is commonly used after kidney transplantation to prevent graft rejection. Long-term use of prednisone can give rise to multiple side effects and morbidity. This randomized study was conducted to find out if prednisone could be withdrawn in recipients at least 1 yr after kidney transplantation. Eighty-four such recipients of a cadaveric kidney with stable renal function on cyclosporine and prednisone were randomized to continue prednisone (N = 42) or to withdraw prednisone in a 2-month period (N = 42). The main end point was the percentage of successful prednisone withdrawal. Both groups were compared for the incidence of infections and cardiovascular risk factors and for the incidence and cause of deterioration of renal function. All patients had a 14-month follow-up. In 67% (N = 28) of the patients, prednisone could be withdrawn successfully. Acute rejection was the main cause of withdrawal failure (N = 11, 26%). No grafts were lost due to rejection. In the prednisone withdrawal group, a tendency was noted for a lower incidence of infections (difference: 17%; 95% confidence interval [CI]: -4% to 37%). After withdrawal, less antihypertensive drugs were necessary to control hypertension (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-lowering drugs (95% CI: -54% to -15%). A reduction of the frequency of patients 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 25% of the patients. Elective withdrawal of prednisone >; 1 yr after postmortal kidney transplantation can be accomplished safely provided that patients are controlled frequently. Beneficial effects were found regarding hypertension, hypercholesterolemia, hyperglycemia, and appearance.

RCT Entities:   Population Interventions Outcomes