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Results of an international, randomized trial comparing glucose metabolism disorders and outcome with cyclosporine versus tacrolimus.
Am J Transplant 2007; 7(6):1506-14AJ

Abstract

DIRECT (Diabetes Incidence after Renal Transplantation: Neoral C(2) Monitoring 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 novo renal transplant patients were randomized to cyclosporine microemulsion (CsA-ME, using C(2) monitoring) 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 m(2) in the CsA-ME cohort and 65.9 +/- 23.1 mL/min/1.73 m(2) with tacrolimus (p = 0.285); mean serum creatinine was 139 +/- 58 and 133 +/- 57 mumol/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.

Authors+Show Affiliations

University of California San Francisco Kidney Transplant Service, San Francisco, CA, USA. VincentiF@surgery.ucsf.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17359512

Citation

Vincenti, F, et al. "Results of an International, Randomized Trial Comparing Glucose Metabolism Disorders and Outcome With Cyclosporine Versus Tacrolimus." American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons, vol. 7, no. 6, 2007, pp. 1506-14.
Vincenti F, Friman S, Scheuermann E, et al. Results of an international, randomized trial comparing glucose metabolism disorders and outcome with cyclosporine versus tacrolimus. Am J Transplant. 2007;7(6):1506-14.
Vincenti, F., Friman, S., Scheuermann, E., Rostaing, L., Jenssen, T., Campistol, J. M., ... Goto, N. (2007). Results of an international, randomized trial comparing glucose metabolism disorders and outcome with cyclosporine versus tacrolimus. American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons, 7(6), pp. 1506-14.
Vincenti F, et al. Results of an International, Randomized Trial Comparing Glucose Metabolism Disorders and Outcome With Cyclosporine Versus Tacrolimus. Am J Transplant. 2007;7(6):1506-14. PubMed PMID: 17359512.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Results of an international, randomized trial comparing glucose metabolism disorders and outcome with cyclosporine versus tacrolimus. AU - Vincenti,F, AU - Friman,S, AU - Scheuermann,E, AU - Rostaing,L, AU - Jenssen,T, AU - Campistol,J M, AU - Uchida,K, AU - Pescovitz,M D, AU - Marchetti,P, AU - Tuncer,M, AU - Citterio,F, AU - Wiecek,A, AU - Chadban,S, AU - El-Shahawy,M, AU - Budde,K, AU - Goto,N, AU - ,, Y1 - 2007/03/12/ PY - 2007/3/16/pubmed PY - 2007/9/18/medline PY - 2007/3/16/entrez SP - 1506 EP - 14 JF - American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons JO - Am. J. Transplant. VL - 7 IS - 6 N2 - DIRECT (Diabetes Incidence after Renal Transplantation: Neoral C(2) Monitoring 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 novo renal transplant patients were randomized to cyclosporine microemulsion (CsA-ME, using C(2) monitoring) 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 m(2) in the CsA-ME cohort and 65.9 +/- 23.1 mL/min/1.73 m(2) with tacrolimus (p = 0.285); mean serum creatinine was 139 +/- 58 and 133 +/- 57 mumol/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. SN - 1600-6135 UR - https://www.unboundmedicine.com/medline/citation/17359512/Results_of_an_international_randomized_trial_comparing_glucose_metabolism_disorders_and_outcome_with_cyclosporine_versus_tacrolimus_ L2 - https://doi.org/10.1111/j.1600-6143.2007.01749.x DB - PRIME DP - Unbound Medicine ER -