title: Prospective Randomized Trial Investigating the Influence of Pharmaceutical Care on the Intra-Individual Variability of Tacrolimus Concentrations Early After Kidney Transplant.
abstract: This study evaluated the influence of pharmaceutical care (PhC) in the intra-individual variability of dose-corrected whole blood tacrolimus (TAC) trough concentrations, adherence to immunosuppressive therapy and clinical outcomes.
  
  
  
  We randomized 128 kidney transplant recipients to receive PhC consisted of predefined instructions provided by a pharmacist (PhC group, n = 64) or standard nurse staff instructions (control group, n = 64) from day 3 to day 90 after kidney transplantation. The study was powered to detect at least 50% reduction in the coefficient of variation (%CV), calculated from 6 dose-corrected whole blood TAC trough concentrations, in the PhC group. Patient adherence was evaluated using Basel Assessment of Adherence to Immunosuppressive Medication Scale (BAASIS) questionnaire.
  
  
  
  There was no difference in the %CV comparing PhC and control group (31.4% ± 12.3% versus 32.5% ± 16.1%, P = 0.673). There were no differences in the proportion of patients showing TAC concentrations within predefined target concentrations in each study visit. There was no difference in the proportion of nonadherent patients at day 28 (17% versus 26%, P = 0.135) and day 90 (27% versus 25%, P = 0.457) based on BAASIS questionnaire answers, respectively. There were no differences in clinical outcomes.
  
  
  
  Universal PhC in addition to standard nurse staff instruction was not associated with reduced intra-individual variability of dose-corrected whole blood TAC trough concentrations or improved adherence.
authors.affiliation: Divisions of *Nephrology and †Urology, Hospital do Rim, Universidade Federal de São Paulo, Brazil.
authors.forename: Adrieli B
authors.initials: AB
authors.lastname: Bessa
authors.forename: Claudia R
authors.initials: CR
authors.lastname: Felipe
authors.forename: Pedro
authors.initials: P
authors.lastname: Hannun
authors.forename: Priscila
authors.initials: P
authors.lastname: Sayuri
authors.forename: Maria Julia
authors.initials: MJ
authors.lastname: Felix
authors.forename: Priscila
authors.initials: P
authors.lastname: Ruppel
authors.forename: Alexandra N
authors.initials: AN
authors.lastname: Ferreira
authors.forename: Marina P
authors.initials: MP
authors.lastname: Cristelli
authors.forename: Laila
authors.initials: L
authors.lastname: Viana
authors.forename: Juliana B
authors.initials: JB
authors.lastname: Mansur
authors.forename: Geovana
authors.initials: G
authors.lastname: Basso
authors.forename: Wilson Ferreira
authors.initials: WF
authors.lastname: Aguiar
authors.forename: Hélio
authors.initials: H
authors.lastname: Tedesco-Silva
authors.forename: José
authors.initials: J
authors.lastname: Medina-Pestana
mesh_terms: D000328:Adult; D004334:Drug Administration Schedule; D005260:Female; D006084:Graft Rejection / Q000517:prevention & control; D006801:Humans; D007165:Immunosuppression Therapy / Q000379:methods; D007166:Immunosuppressive Agents / Q000097:blood* / Q000627:therapeutic use; D016030:Kidney Transplantation / Q000379:methods; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D010593:Pharmaceutical Services; D011446:Prospective Studies; D016559:Tacrolimus / Q000097:blood* / Q000627:therapeutic use; D066027:Transplant Recipients
chemical_list: D007166:Immunosuppressive Agents; D016559:Tacrolimus