title: Therapeutic drug monitoring of mycophenolic acid can be used as predictor of clinical events for kidney transplant recipients treated with mycophenolate mofetil.
abstract: OBJECTIVE
  This study was designed to investigate the relationship between clinical events and the pharmacokinetics of mycophenolic acid (MPA) in adult renal transplant patients.
  
  
  METHODS
  Thirty-seven adult kidney transplant recipients received a cyclosporine, mycophenolate mofetil, and steroids. MPA-AUC(0-12) was obtained before and 12 days after grafting by RP-HPLC. Predose blood samples were measured for MPA-C(0) were gathered from all the recipients at 4, 12, and 21 days as well as 1, 1.5, 2, 2.5, 3, and 6 months after grafting. The clinical events at corresponding time points were recorded to correlate with each MPA-C(0) value.
  
  
  RESULTS
  In addition to single-dose and multidose MPA-AUC(0-12), 357 MPA-C(0) values were obtained from 37 patients. The 357 units were divided into three subgroups: group A patients, including 239 units (66.9%), experienced uneventful outcomes; group B of 100 units (28.0%) showed MPA-related side effects, and group C, 18 units (5.0%) of acute rejection episodes. MPA-C(0) for groups A, B, and C were 0.8416 +/- 0.1373 mg/L, 1.5903 +/- 0.3741 mg/L and 0.6057 +/- 0.2338 mg/L, respectively (P < .001 between groups A and B, groups B and C, and P = .021 between groups A and C). The three groups were also divided into an initial phase (< or =1 month, 251 units) and a stable phase (>1 month, 106 units). The relationship between MPA-C(0) and associated clinical events was also investigated.
  
  
  CONCLUSIONS
  Our results suggested a relationship between MPA pharmacokinetics and clinical events. The MPA-C(0) might be an appropriate pharmacokinetic monitoring parameter for kidney transplantation.
authors.affiliation: Transplantation Institute, West China Hospital, Sichuan University, Guoxuexiang 37, Chengdu, China 610041. yipinglu@163.com
authors.forename: Y P
authors.initials: YP
authors.lastname: Lu
authors.forename: Y C
authors.initials: YC
authors.lastname: Zhu
authors.forename: M Z
authors.initials: MZ
authors.lastname: Liang
authors.forename: F
authors.initials: F
authors.lastname: Nan
authors.forename: Q
authors.initials: Q
authors.lastname: Yu
authors.forename: L
authors.initials: L
authors.lastname: Wang
authors.forename: J
authors.initials: J
authors.lastname: Wang
authors.forename: Y P
authors.initials: YP
authors.lastname: Li
mesh_terms: D000293:Adolescent; D000328:Adult; D002102:Cadaver; D016903:Drug Monitoring / Q000379:methods*; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents / Q000097:blood / Q000493:pharmacokinetics / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000276:immunology / Q000502:physiology*; D008297:Male; D008875:Middle Aged; D009173:Mycophenolic Acid / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics* / Q000627:therapeutic use / Q000633:toxicity; D012372:ROC Curve; D014019:Tissue Donors
chemical_list: D007166:Immunosuppressive Agents; D009173:Mycophenolic Acid