C2 (2-h) levels are not superior to trough levels as estimates of the area under the curve in tacrolimus-treated renal-transplant patients

Abstract

Two-hour levels are not superior to trough levels in tacrolimus-treated renal transplant patients. Despite good correlation between trough level and AUC, some patients may still receive nephrotoxic doses despite trough levels in the desired range. Sampling 3-6 h after oral intake may be at least as good as trough levels.

Prediction of the tacrolimus population pharmacokinetic parameters according to CYP3A5 genotype and clinical factors using NONMEM in adult kidney transplant recipients

“…Nevertheless, as previously reported in antecedent studies where tacrolimus trough blood concentrations sufficiently predicted the area under the time-concentration curve from time 0 to 12 days (AUC 0-12 ), the four parameters share sufficient correlations for trough blood concentrations to be good indices of patient exposure to tacrolimus [37]. Through the population PK analysis approach, this study showed that genetic polymorphisms of CYP3A5, Hct level, body weight, and POD were significant factors that affected the PK parameters of tacrolimus in Korean adult kidney transplant recipients.…”

Untreated Rejection in 6-Month Protocol Biopsies Is Not Associated with Fibrosis in Serial Biopsies or with Loss of Graft Function

“…Trough levels of both CsA and tacrolimus are not closely correlated with drug exposure (17,18,(32)(33)(34), the risk for allograft rejection (35,36), or their adverse effects (37,38). The AUC 0-12h and derived parameters, such as absorption profiles, have been shown to correlate more closely with clinical outcome also in patients who received prophylaxis with basiliximab (39).…”

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“…On the one hand, it has been demonstrated that tacrolimus C0 are well correlated with the area under the time-concentration curves from time 0 to 12 hours and could subsequently be considered as a good index of patient exposure to tacrolimus. 21 On the other hand, both prospective and retrospective clinical studies showed that there was a good relationship between tacrolimus C0 and clinical outcomes. 10,11 In fact, a significant correlation between high trough levels and toxicity was found in both kidney and liver transplant patients.…”