Long-term results with cyclosporine monotherapy in renal transplant patients: A multivariate analysis of risk factors

There is little information on the long-term outcome of patients initially assigned to cyclosporine (CsA) monotherapy and requiring the addition of st eroid therapy during follow-up. The aim of this report is to describe our e xperience with 143 first renal transplant recipients (120 cadaver transplan ts, 23 living donor transplants) randomized to receive CsA monotherapy as a treatment arm of three consecutive controlled clinical trials. Median foll ow-up was 86 months. Thirty-four percent of the patients remained on the or iginal CsA monotherapy, whereas the remaining 66% required the addition of steroid therapy. Cumulative patient and graft survivals at 11 years were 0. 89 (95% confidence interval [CI], 0.83 to 0.95) and 0.62 (95% CI, 0.52 to 0 .72), respectively. The Ii-year graft survival for converted patients was 0 .53 (95% CI, 0.39 to 0.67). Cumulative graft half-life was 19.9 +/- 3.47 (S E) years. According to the Cox model, variables at transplantation that cor related with a lower Ii-year graft survival were yearly increases in age (r elative risk [RR], 1.04; P = 0.039), monthly increases in hemodialysis dura tion (RR, 1.01; P = 0.029), no blood transfusion before transplantation (RR , 1.99; P = 0.043), CsA administration in a double daily dose (RR, 2.35; P = 0.008), and a cadaver donor transplant (RR, 4.76; P = 0.039). Multivariat e analysis of time-dependent variables showed that delayed graft function r ecovery (RR, 2.20 P = 0.019) and the need to add steroid and/or azathioprin e therapy (RR, 5.28; P = 0.000) were also correlated with a lower graft sur vival. Patients who added steroid therapy developed infections (P < 0.001), cataracts (P < 0.001), cardiovascular complications (P = 0.004), and arter ial hypertension (P = 0.024) more frequently than patients remaining on CsA monotherapy Patients administered CsA in a single daily dose received sign ificantly less CsA over the years (P = 0.0042) than patients administered C sA in two divided doses. They also showed a trend toward greater creatinine clearance levels, although not statistically significant. In conclusion, t his analysis showed that in patients assigned to CsA therapy alone, good lo ng-term patient and graft survival probabilities can be obtained. In approx imately one third of the patients, the use of steroids could be avoided for up to 11 years, and these patients had a better long-term outcome than tho se who required the addition of steroid therapy, Finally, in patients admin istered CsA in a single daily dose, the possibility of reducing CsA dosage probably led to better intrarenal hemodynamics with improving creatinine cl earances. (C) 2000 by the National Kidney Foundation, Inc.