Limited-Sampling Strategy for Mycophenolic Acid in Renal Transplant Recipients Reciving Enteric-Coated Mycophenolate Sodium and Tacrolimus
| Autor: | R. Valero, Isabel Pérez-Flores, Cristina Fernández-Pérez, Dolores Ortega, Ana I. Sánchez Fructuoso, Elisa Matilla, Alberto Barrientos, N. Calvo, Maria A. Del Dedo |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
Male medicine.medical_specialty Urology Mycophenolate Tacrolimus Mycophenolic acid medicine Humans Pharmacology (medical) Pharmacology Blood Specimen Collection Kidney business.industry Area under the curve Mycophenolate Sodium Middle Aged Mycophenolic Acid Kidney Transplantation Confidence interval medicine.anatomical_structure Renal transplant Area Under Curve Female Tablets Enteric-Coated business medicine.drug |
| Zdroj: | Therapeutic Drug Monitoring. 34:298-305 |
| ISSN: | 0163-4356 |
| DOI: | 10.1097/ftd.0b013e318255cc15 |
| Popis: | Background Substantial research has been conducted to develop limited-sampling strategies (LSS) to estimate the area under the curve (AUC(0-12h)) 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 AUC(0-12h) 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 AUC(0-12h) (mg·h(-1)·L(-1)) = 15.99 + 0.87C1 h + 0.68C2 h + 7.85C4 h and AUC(0-12h) (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 r(2) = 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 r(2) = 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 C(1h)-C(2h)-C(4h) or C(1h)-C(1.5h)-C(2h)-C(4h) provides the most reliable and accurate estimation of the AUC(0-12h) of mycophenolic acid in stable renal transplant recipients treated with EC-MPS and tacrolimus. |
| Databáze: | OpenAIRE |
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