Gustavo Adolfo Centeno Soto1, Belén Ruiz-Antorán2, Rosalía Laporta3, Arantxa Sancho1, María Teresa Lázaro3, Concepción Payares Herrera1, Isabel Salcedo1, Maria Angeles Cos4, Ferrán Torres5, Piedad Usetti3, Cristina Avendaño-Sola1. 1. Clinical Pharmacology Department, Puerta de Hierro-Majadahonda University Hospital, Calle Manuel de Falla, 1, 28222, Majadahonda, Spain. 2. Clinical Pharmacology Department, Puerta de Hierro-Majadahonda University Hospital, Calle Manuel de Falla, 1, 28222, Majadahonda, Spain. mariabelen.ruiz@salud.madrid.org. 3. Pneumology Department, Puerta de Hierro-Majadahonda University Hospital, Madrid, Spain. 4. Clinical Pharmacology Unit, Marques de Valdecilla Hospital, Santander, Spain. 5. Biostatistics and Data Management Core Facility, IDIBAPS, Hospital Clinic Barcelona; Biostatistics Unit, School of Medicine, Universitat Autònoma de Barcelona, Barcelona, Spain.
Abstract
AIM: The aim of this pharmacokinetic (PK) study was to evaluate tacrolimus (TAC) exposure in stable cystic fibrosis (CF) lung transplant (LT) recipients, converted from TAC twice daily to TAC once daily in an open-label, prospective, single-centre study. METHODS: Eligible patients were post-transplant CF patients (18-65 years) with stable lung function, on stable doses of TAC twice daily and who were candidates to switch to TAC once daily. Twelve consecutive patients were included in the study. Patients had their first PK analysis on day 1, still under the stable TAC twice-daily regimen, and were converted to TAC once daily from day 2 onwards. The doses were adjusted according to clinical judgement to achieve target levels, and a second 24-h PK period profile was obtained once the patient was on a stable dosage on the therapeutic range. RESULTS: The mean total (SD) daily dose of TAC twice daily at baseline upon enrolment was 0.17 (0.10) mg/kg/day. The mean (SD) daily dose of TAC once daily after adjustments was 0.22 (0.12) mg/kg/day. In order to achieve target C min levels with a similar AUC0-24, 82% of subjects who were converted to TAC once daily required an increase of dose, in a range of 0-66.7%, with a mean dose increase of 28%. CONCLUSIONS: Our study results indicate that the switch for conversion from TAC twice daily to TAC once daily in patients with CF may need dose adjustment in order to reach levels within the therapeutic target.
AIM: The aim of this pharmacokinetic (PK) study was to evaluate tacrolimus (TAC) exposure in stable cystic fibrosis (CF) lung transplant (LT) recipients, converted from TAC twice daily to TAC once daily in an open-label, prospective, single-centre study. METHODS: Eligible patients were post-transplant CFpatients (18-65 years) with stable lung function, on stable doses of TAC twice daily and who were candidates to switch to TAC once daily. Twelve consecutive patients were included in the study. Patients had their first PK analysis on day 1, still under the stable TAC twice-daily regimen, and were converted to TAC once daily from day 2 onwards. The doses were adjusted according to clinical judgement to achieve target levels, and a second 24-h PK period profile was obtained once the patient was on a stable dosage on the therapeutic range. RESULTS: The mean total (SD) daily dose of TAC twice daily at baseline upon enrolment was 0.17 (0.10) mg/kg/day. The mean (SD) daily dose of TAC once daily after adjustments was 0.22 (0.12) mg/kg/day. In order to achieve target C min levels with a similar AUC0-24, 82% of subjects who were converted to TAC once daily required an increase of dose, in a range of 0-66.7%, with a mean dose increase of 28%. CONCLUSIONS: Our study results indicate that the switch for conversion from TAC twice daily to TAC once daily in patients with CF may need dose adjustment in order to reach levels within the therapeutic target.
Authors: Pierre Wallemacq; Victor W Armstrong; Merce Brunet; Vincent Haufroid; David W Holt; Atholl Johnston; Dirk Kuypers; Yannick Le Meur; Pierre Marquet; Michael Oellerich; Eric Thervet; Burkhand Toenshoff; Nas Undre; Lutz T Weber; Ian S Westley; Michel Mourad Journal: Ther Drug Monit Date: 2009-04 Impact factor: 3.681
Authors: Jason D Christie; Leah B Edwards; Anna Y Kucheryavaya; Christian Benden; Anne I Dipchand; Fabienne Dobbels; Richard Kirk; Axel O Rahmel; Josef Stehlik; Marshall I Hertz Journal: J Heart Lung Transplant Date: 2012-10 Impact factor: 10.247
Authors: Katherine A Barraclough; Nicole M Isbel; David W Johnson; Scott B Campbell; Christine E Staatz Journal: Drugs Date: 2011-08-20 Impact factor: 9.546
Authors: R Venkataramanan; A Swaminathan; T Prasad; A Jain; S Zuckerman; V Warty; J McMichael; J Lever; G Burckart; T Starzl Journal: Clin Pharmacokinet Date: 1995-12 Impact factor: 6.447