Neoral monitoring by limited sampling area under the concentration time curve in stable indian renal transplant recipients

Abstract 

The optimization of cyclosporine (CsA) immunosuppression remains a challenge because of the narrow therapeutic window and highly variable pharmacokinetics (PK). The highly variable PK were improved by the introduction of the current microemulsion preparation Neoral. However, the best clinical benefit of this CsA microemulsion can only be obtained by regular PK monitoring. During the past decade, various PK strategies have been proposed, such as C₀, C₂, level monitoring, abbreviated or limited sampling approach, and various prediction algorithms to replace the conventional area under the curve (AUC). In this study we evaluated the Neoral PK in stable Indian renal transplant recipients using a limited sampling approach. The C₀ (mean ± SE) was 175 ± 15 ng. mL⁻¹; C_max 970 ± 101 ng. mL⁻¹, and the AUC ₀₋₄ 2734 ± 258 ng. h. mL⁻¹. The C₀ showed a poor relationship to AUC ₀₋₄ (r = .65) but high correlations were obtained with C₂ (r = 0.93) and C₃ (r = .96). Our finding suggest that stable Indian renal transplant recipients should either be monitored using C₂ or C₃.