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New strategies of cyclosporine monitoring in heart transplantation: initial results.

Abstract：

:The aim of this study was to evaluate cyclosporine (CyA) absorption profiles in heart transplantation to establish the most adequate monitoring strategy and determine the optimal therapeutic range for AUC(0-4) or C2 levels. A total of 22 full pharmacokinetic studies were performed at steady-state in 22 adult heart transplant recipients (18 men, 4 women). Twelve studies were performed during the first month posttransplant (group I), and 10 studies were done after 1 month (group II). In 9 outpatients we performed an abbreviated AUC(0-4). The mean age of the patients was 49+/-15 years (range, 15-72 years), and the mean weight was 70.4+/-10.8 kg (mean, 54-98 kg). The CyA dosage had been adjusted to maintain trough levels (C0) in the putative target ranges of 200 to 400 ng/mL in group I and between 100 to 300 ng/mL in group II. Blood samples were drawn prior to and at 0.5, 1, 2, 4, 6, 8, and 12 hours after the morning dose. The CyA blood levels were measured by the AxSYM cyclosporine assay. The AUC was calculated by the trapezoidal rule. Multiple linear regression was done to evaluate the predictive ability of various limited sampling strategies. The C0 correlated poorly, either with the full AUC (r2=0.64) or the AUC(0-4) (r2=0.43), while C2 seemed to be the most accurate single predictor of drug exposure (r2=0.92 for AUC(0-12); r2=0.74 for AUC(0-4)). For both AUC(0-4) and AUC(0-12), all 2- or 3-point strategies had r2 values approaching that of the C2 value. In conclusion, C2 is a simple, fast, and accurate value to predict AUC(0-4) in routine clinical practice. Its implementation must focus on ensuring the commitment of all unit staff, thus ensuring that patients are sampled on time and minimizing the impact on workload.

journal_name

Transplant Proc

journal_title

Transplantation proceedings

authors

Arizón del Prado JM,Aumente Rubio MD,Cárdenas Aranzana M,López Malo de Molina MD,Segura Saint-Gerons J,López Granados A,Rodríguez Esteban E,Ruiz Ortiz M,Romo Peñas E,Muñoz Carvajal I,González Rodríguez JR,Segura Saint-Gerons C,Va

doi

10.1016/s0041-1345(03)00657-2

subject

Has Abstract

pub_date

2003-08-01 00:00:00

pages

1984-7

issue

eissn

0041-1345

issn

1873-2623

pii

S0041134503006572

journal_volume

pub_type

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New strategies of cyclosporine monitoring in heart transplantation: initial results.