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Limited-Sampling Strategy for Mycophenolic Acid in Renal Transplant Recipients Reciving Enteric-Coated Mycophenolate Sodium and Tacrolimus

2012; Lippincott Williams & Wilkins; Volume: 34; Issue: 3 Linguagem: Inglês

10.1097/ftd.0b013e318255cc15

1536-3694

Ana Sánchez‐Fructuoso, Isabel Pérez-Flores, Natividad Calvo, Rosalía Valero, Elisa Matilla, M Heredia, Maria A. Del Dedo, Cristina Fernández, Alberto Barrientos,

HIV/AIDS drug development and treatment

Background: Substantial research has been conducted to develop limited-sampling strategies (LSS) to estimate the area under the curve (AUC0-12h) in patients treated with mycophenolate mofetil. However, no LSS has been validated for enteric-coated mycophenolate sodium (EC-MPS). Our aim was to develop an LSS to measure the AUC0–12h of mycophenolic acid in kidney recipients treated with tacrolimus and EC-MPS. Study Design: Thirteen serial blood samples were collected over 12 hours from 71 patients treated with tacrolimus and EC-MPS. Mycophenolic acid was measured in plasma using the enzyme-multiplied immunoassay. LSSs were developed and validated by multiple regression analysis using a 2-group method (test, n = 47; validation, n = 24). Results: The best LSS obtained in the test group were for 3 and 4 time points AUC0–12h (mg·h−1·L−1) = 15.99 + 0.87C1 h + 0.68C2 h + 7.85C4 h and AUC0–12h (mg·h−1·L−1) =11.15 + 0.68C1 h + 0.45C1.5 h + 0.57C2 h + 8.16C4 h, respectively. When these LSS were tested in the validation group, the results were acceptable (adjusted r2 = 0.71, bias =−0.214 [95% confidence interval (CI): −7.91 to 7.48], precision = 7.48 (95% CI: 3.69–19.39) for 3 time points and adjusted r2 = 0.76, bias = −1.48 (95% CI: −8.23 to 5.27), precision = 7.68 (95% CI: 4.23–13.50) for 4 time points). Conclusions: An LSS using time points at C1h-C2h-C4h or C1h-C1.5h-C2h-C4h provides the most reliable and accurate estimation of the AUC0–12h of mycophenolic acid in stable renal transplant recipients treated with EC-MPS and tacrolimus.