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Results of an International, Randomized Trial Comparing Glucose Metabolism Disorders and Outcome with Cyclosporine Versus Tacrolimus

2007; Elsevier BV; Volume: 7; Issue: 6 Linguagem: Inglês

10.1111/j.1600-6143.2007.01749.x

1600-6143

Flavio Vincenti, S. Friman, Ernst‐Heinrich Scheuermann, Lionel Rostaing, Trond Jenssen, Josep M. Campistol, Kazuharu Uchida, Mark D. Pescovitz, Piero Marchetti, Murat Tuncer, Franco Citterio, Andrzej Więcek, Steven J. Chadban, M. El-Shahawy, Klemens Budde, Norihiko Goto,

Neurological Complications and Syndromes

DIRECT (Diabetes Incidence after Renal Transplantation: Neoral C2Monitoring Versus Tacrolimus) was a 6-month, open-label, randomized, multicenter study which used American Diabetes Association/World Health Organization criteria to define glucose abnormalities. De novorenal transplant patients were randomized to cyclosporine microemulsion (CsA-ME, using C2monitoring) or tacrolimus, with mycophenolic acid, steroids and basiliximab. The intent-to-treat population comprised 682 patients (336 CsA-ME, 346 tacrolimus): 567 were nondiabetic at baseline. Demographics, diabetes risk factors and steroid doses were similar between treatment groups. The primary safety endpoint, new-onset diabetes after transplant (NODAT) or impaired fasting glucose (IFG) at 6 months, occurred in 73 CsA-ME patients (26.0%) and 96 tacrolimus patients (33.6%, p = 0.046). The primary efficacy endpoint, biopsy-proven acute rejection, graft loss or death at 6 months, occurred in 43 CsA-ME patients (12.8%) and 34 tacrolimus patients (9.8%, p = 0.211). Mean glomerular filtration rate (Cockcroft–Gault) was 63.6 ± 20.7 mL/min/1.73 m2in the CsA-ME cohort and 65.9 ± 23.1 mL/min/1.73 m2with tacrolimus (p = 0.285); mean serum creatinine was 139 ± 58 and 133 ± 57 μmol/L, respectively (p = 0.005). Blood pressure was similar between treatment groups at month 6, but total cholesterol, LDL-cholesterol and triglyceride levels were significantly higher with CsA than with tacrolimus (total cholesterol:HDL remained unchanged). The profile and incidence of adverse events were similar between treatments. The incidence of NODAT or IFG at 6 months post-transplant is significantly lower with CsA-ME than with tacrolimus without a significant difference in short-term outcome.In this 6-month, open-label, randomized, multicenter study in de novo renal transplant patients, the primary safety endpoint of new-onset diabetes after transplant or impaired fasting glucose was significantly less frequent with cyclosporine microemulsion than tacrolimus, with no significant differences in short-term outcome. See also editorial by Van Hooff in this issue on page 1435. DIRECT (Diabetes Incidence after Renal Transplantation: Neoral C2Monitoring Versus Tacrolimus) was a 6-month, open-label, randomized, multicenter study which used American Diabetes Association/World Health Organization criteria to define glucose abnormalities. De novorenal transplant patients were randomized to cyclosporine microemulsion (CsA-ME, using C2monitoring) or tacrolimus, with mycophenolic acid, steroids and basiliximab. The intent-to-treat population comprised 682 patients (336 CsA-ME, 346 tacrolimus): 567 were nondiabetic at baseline. Demographics, diabetes risk factors and steroid doses were similar between treatment groups. The primary safety endpoint, new-onset diabetes after transplant (NODAT) or impaired fasting glucose (IFG) at 6 months, occurred in 73 CsA-ME patients (26.0%) and 96 tacrolimus patients (33.6%, p = 0.046). The primary efficacy endpoint, biopsy-proven acute rejection, graft loss or death at 6 months, occurred in 43 CsA-ME patients (12.8%) and 34 tacrolimus patients (9.8%, p = 0.211). Mean glomerular filtration rate (Cockcroft–Gault) was 63.6 ± 20.7 mL/min/1.73 m2in the CsA-ME cohort and 65.9 ± 23.1 mL/min/1.73 m2with tacrolimus (p = 0.285); mean serum creatinine was 139 ± 58 and 133 ± 57 μmol/L, respectively (p = 0.005). Blood pressure was similar between treatment groups at month 6, but total cholesterol, LDL-cholesterol and triglyceride levels were significantly higher with CsA than with tacrolimus (total cholesterol:HDL remained unchanged). The profile and incidence of adverse events were similar between treatments. The incidence of NODAT or IFG at 6 months post-transplant is significantly lower with CsA-ME than with tacrolimus without a significant difference in short-term outcome. In this 6-month, open-label, randomized, multicenter study in de novo renal transplant patients, the primary safety endpoint of new-onset diabetes after transplant or impaired fasting glucose was significantly less frequent with cyclosporine microemulsion than tacrolimus, with no significant differences in short-term outcome. See also editorial by Van Hooff in this issue on page 1435.