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- Title
Tacrolimus vs. Cyclosporin A Microemulsion in Renal Transplantation: 3-Year Follow-Up of a Large, Randomized, European Multicentre Trial.
- Authors
Krämer, B. K.; Krüger, B.; Olbricht, C.; Sperschneider, H.; Dietl, K. -H.; Köhler, H.; Arias, M.; Pascual, J.; Montagnino, G.; Margreiter, R.; Mühlbacher, F.; Kunzendorf, U.
- Abstract
Objective: This is a follow-up study of a large, multicentre study that compared tacrolimus and microemulsified cyclosporin A after renal transplantation. A total of 557 patients for primary renal transplantation or retransplantation with low immunological risk (PRA < 50%) had been recruited into the original 6-month study with 286 patients randomized to tacrolimus (Tac) and 271 patients to cyclosporin microemulsion (CyA), concomitantly with steroids and azathioprine. After 6 months, there was a significant difference (p < 0.001) in the incidence of biopsy-proven acute rejection with 19.6% (Tac) and 37.3% (CyA), and biopsy-proven steroid-resistant acute rejection with 9.4% (Tac) and 21.0% (CyA) (Margreiter R, Lancet 359: 741-746, 2003). Methods: All 50 centres were asked to provide follow-up information of all patients whether withdrawn during the main study or not at 1, 2, and 3 years post transplant. Data were entered and analysed by an independent clinical research organisation. Results: At the 3-year follow-up, data were available for 217 (Tac) and 203 (CyA) patients (76.2% of total cohort). Up to the 3-year follow-up 9 patients had died in each group, in the Tac group 25 grafts and in the CyA group 32 grafts were lost since transplantation. Median calculated creatinine clearance was 64.5 mL/min in the Tac group compared with 60.3 mL/min in the CyA group. The incidence of acute rejection between 6 months and 3 years was low in both groups (Tac 15 vs. CyA 17), preserving the difference observed after 6 months. The mean Tac dose was 0.08 mg/kg/day and the mean trough level was 8.5 ng/mL. The mean CyA dose was 2.9 mg/kg/day and the mean trough level was 137.3 ng/mL. Mean blood pressure was similar in both groups (SBP 135.5 vs.138.4 mmHg, DBP 83.2 vs. 83.1 mmHg), however, the use of antihypertensive medication was higher in the CyA group (73.7% vs. 80.7%, p = ns). Despite the significantly higher use of lipid lowering medication (17.5% vs. 32.7%, p < 0.01), the mean cholesterol level was significantly higher (5.13 mmol/L vs. 5.47 mmol/L, p < 0.05) in the CyA group. Use of insulin or of oral antihyperglycaemics was not different between groups at 3-year followup. The administration of MMF differed between the groups (Tac 8.8% vs. CyA 15.8%, p < 0.05). In the Tac group 2.8% and in the CyA group 18.2% of patients had switched their baseline immunosuppressant (p < 0.01). More patients in the CyA group (67.7% vs. 79.3%, p < 0.01) received steroids, the mean doses were 4.9 mg/day (Tac) and 5.5 mg/day (CyA). The overall side effect profile was comparable between groups, however cosmetic adverse effects, and bone disorders were less frequent with tacrolimus treatment. Conclusions: At 3 years post transplantation the advantages of Tac therapy seen in the first 6 months were preserved. There was a tendency towards better graft survival and better renal function in the tacrolimus group. Concomitant medication load, both with regard to immunosuppressive drugs and cardiovascular drugs, was lower in tacrolimus treated patients.
- Subjects
KIDNEY transplantation; CYCLOSPORINE; TRANSPLANTATION of organs, tissues, etc.; STEROIDS; IMMUNOSUPPRESSION
- Publication
Kidney & Blood Pressure Research, 2004, Vol 27, Issue 5/6, p305
- ISSN
1420-4096
- Publication type
Article