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Relative risk of new-onset diabetes during the first year after renal transplantation in patients receiving tacrolimus or cyclosporine immunosuppression


Prof Dr Andries J Hoitsma, Division of Nephrology, Radboud University Nijmegen, Medical Centre, Geert Grooteplein 8, 6525 GA Nijmegen, The Netherlands.
Tel.: +31 243 61 4761; fax: +31 243 54 0022;


Abstract:  Clinical trials have consistently shown a higher incidence of new-onset diabetes mellitus with tacrolimus than cyclosporine. However, in protocol-driven studies steroid doses are comparable in both treatment arms, while in clinical practice steroid dose used in conjunction with tacrolimus or cyclosporine may differ. This retrospective study analysed renal transplant recipients without pre-existing diabetes receiving tacrolimus (n = 100) or cyclosporine (n = 100) for whom one-year follow-up data were available. Diabetes was defined as use of insulin or oral hypoglycemic agents; fasting glucose >6.9 mmol/L; or non-fasting glucose >11 mmol/L on three consecutive occasions. Tacrolimus-treated patients were significantly older than cyclosporine-treated patients (49 ± 14 vs. 44 ± 13 yr, p < 0.05) and received a significantly lower cumulative dose of corticosteroids over the first three months post-transplant (1284 ± 379 vs. 1714 ± 486 mg, p < 0.0001). At 3, 6, 9 and 12 months significantly more tacrolimus-treated patients had new-onset diabetes than cyclosporine- treated patients. At 12 months, 18 patients receiving tacrolimus and two receiving cyclosporine had diabetes (p < 0.0001). There was a clear relationship between age and incidence of new-onset diabetes at three months in the tacrolimus cohort. After stratifying patients by age group, the frequency of diabetes was significantly higher with tacrolimus than with cyclosporine in patients aged 40–60 yr [8/46 (17.4%) vs. 2/48 (4.2%), p < 0.05] and >60 yr [9/28 (32.1%) vs. 0/14 (0%), p < 0.05]. The mean tacrolimus trough level during the first three months was similar in patients with diabetes (13.1 ± 2.3 ng/mL) or without diabetes (13.0 ± 2.8 ng/mL, n.s.). These results indicate that new-onset diabetes is strongly and significantly associated with tacrolimus vs. cyclosporine in renal transplant recipients, even when steroid dosing is lower with tacrolimus.