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- W2003292256 abstract "P516 Aims: The level of cyclosporine (CsA) at 2 hours post dose (C2), correlates well with CsA absorption or AUC0-4 which correlates with rejection and adverse events. C2 monitoring is becoming an accepted method of drug monitoring because it may provide a better indication of drug exposure. The purpose of this trial was to compare the safety and efficacy of CsA monitored by C2 levels versus tacrolimus monitored by trough levels in de novo liver transplant recipients. Methods: After informed consent, de novo liver transplant recipients were randomized to received either tacrolimus (n=30; trough 6-10 ng/ml) or cyclosporine (n=30; C2 600-1200 ng/ml) and corticosteroids. Results: Both groups were similar for gender (FK=47%; CsA=17% male), race (FK=90%; CsA=87% Caucasian) and age (FK=53±7; CsA=52±9 years). Indications for transplant included viral hepatitis (FK=67%; CsA=53%), HCC (FK=3%; CsA=3%), cholestatic liver disease (FK=7%; CsA=0%) and other causes (FK=37%; CsA=30%). Mean follow-up was 10 months (range 3-18 months). Early acute rejection (as evidenced by biopsy and/or response to steroid pulse) occurred in 30% of FK treated patients and 17% of CsA treated recipients, (P=0.2). Mean C2 level was 773±209 ng/mL at 3 months and 612±169 ng/mL at 6 months after transplant. Mean FK level was 7.5± 2.6 ng/mL at 3 months and 6.4±2.0 ng/mL at 6 months after transplant. Serum creatinine levels were similar pre-transplant and at 3 and 6 months after transplant in both arms. PTDM, defined as new-onset requirement of an oral agent or insulin, developed in 2 patients in each arm. Hypertension developed in 24% of FK patients and 36% of CsA patients. Infectious complications were similar in both groups. Conclusions: This interim analysis, suggests that immunosuppression with CsA, monitored by C2 levels, is effective in liver transplant recipients and provides at least equivalent immunosuppression to tacrolimus. The safety and efficacy of this approach is being monitored with longer follow up." @default.
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- W2003292256 date "2004-07-01" @default.
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- W2003292256 title "INTERIM ANALYSIS OF A SINGLE-CENTER, PROSPECTIVE, RANDOMIZED TRIAL COMPARING TACROLIMUS VERSUS CYCLOSPORINE IMMUNOSUPPRESSION USING 2 HOUR POST DOSE (C2) MONITORING IN DE NOVO LIVER TRANSPLANT RECIPIENTS" @default.
- W2003292256 doi "https://doi.org/10.1097/00007890-200407271-01011" @default.
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