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Results of an inter...
Results of an international, randomized trial comparing glucose metabolism disorders and outcome with cyclosporine versus tacrolimus
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Vincenti, F. (författare)
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- Friman, Styrbjörn, 1948 (författare)
- Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences
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Scheuermann, E. (författare)
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Rostaing, L. (författare)
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Jenssen, T. (författare)
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Campistol, J. M. (författare)
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Uchida, K. (författare)
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Pescovitz, M. D. (författare)
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Marchetti, P. (författare)
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Tuncer, M. (författare)
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Citterio, F. (författare)
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Wiecek, A. (författare)
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Chadban, S. (författare)
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El-Shahawy, M. (författare)
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Budde, K. (författare)
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Goto, N. (författare)
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(creator_code:org_t)
- Elsevier BV, 2007
- 2007
- Engelska.
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Ingår i: American journal of transplantation. - : Elsevier BV. - 1600-6135. ; 7:6, s. 1506-14
- Relaterad länk:
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https://onlinelibrar...
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https://gup.ub.gu.se...
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https://doi.org/10.1...
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Abstract
Ämnesord
Stäng
- 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.
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Till lärosätets databas
- Av författaren/redakt...
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Vincenti, F.
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Friman, Styrbjör ...
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Scheuermann, E.
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Rostaing, L.
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Jenssen, T.
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Campistol, J. M.
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visa fler...
-
Uchida, K.
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Pescovitz, M. D.
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Marchetti, P.
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Tuncer, M.
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Citterio, F.
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Wiecek, A.
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Chadban, S.
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El-Shahawy, M.
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Budde, K.
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Goto, N.
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visa färre...
- Artiklar i publikationen
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American journal ...
- Av lärosätet
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Göteborgs universitet