01 January 2008
Comparison of tacrolimus levels obtained with twice-daily administration formulation (Prograf®) and with once-daily formulation (Advagraf®)
M. T. Rabuñal Ãlvarez, E. Fernández Gabriel, M. Outeda MacÃas, I. MartÃn HerranzAnn Transplant 2008; 13(1): 38-38 :: ID: 880199
Abstract
Background: To compare tacrolimus levels before and after change from conventional formulation (Prograf[sup]®)[/sup] to extend-release formulation (Advagraf[sup]®[/sup]).
Material/Methods: 100% of transplanted patients were treated with Prograf[sup]® [/sup]and change to Advagraf[sup]®[/sup] during January-May/2008. Data that was taken into account was: sex, age, type and date of transplantation (computer application Gestión Documental®), pharmacokinetic data (computer program Openlab[sup]®)[/sup]. C[sub]min[/sub] determinations by whole-blood enzyme immunoassay on IM[sub]X [/sub]analyzer (Abbott). Concentrations comparison was done by the Wilcoxon's test.
Results: There were 31patients (20 males), of an average age of 53.8±14.4 years, who were transplanted between August/1999-March/2008 (22/kidney, 6/liver, 2/lung). Before the change, Prograf[sup]®'[/sup]s average dose was 4.53±3.3 mg/day and average C[sub]min[/sub] =8.597±4.99 ng/mL. In 13 patients, with a C[sub]min-Prograf®[/sub] =7.438 ng/mL, clinicians kept the same dose when they change to new formulation, obtaining a [sub]Cmin-Advagraf®[/sub] =5.054±1.42 ng/mL; it suppose a decrease of 30,68% (p=0.001). In the rest of patients the dose does not remain during conversion: in 10 patients, with a Cmin Prograf® =6.09±2.59 ng/mL, they increased dose and a C[sub]min-Advagraf®[/sub] = 5.92±2.88 ng/mL was reached, and in 8 patients, with a C[sub]min Prograf®[/sub] =13.61±7.19 ng/mL, they diminished dose and a C[sub]min-Advagraf®[/sub] =6.56±3.47 ng/mL was obtained. C[sub]min-Advagraf®[/sub] were minor than C[sub]min-Prograf®[/sub] in all cases.
Conclusions: Clinicians do 1:1 dosage conversion, because the same behavior is expected for both formulations. They only change dose to try to modify previous concentrations. By blood levels monitoring, we observed that, in all cases, concentrations obtained with Advagraf[sup]®[/sup] were minor than with Prograf[sup]®[/sup]. This decrease, notably superior to what it is described in bibliography, presents a clinical relevancy which does necessary a confirmation by the AUC profiles comparison for both formulations.
Keywords: Barrett’s Oesophagus, Columnar mucosa, Cytocheratin 7, p53, CDX2, Tacrolimus, Columnar mucosa
In Press
Original article
Outcomes of Combined Liver-Kidney Transplantation in Polycystic Liver and Kidney DiseaseAnn Transplant In Press; DOI: 10.12659/AOT.947639
Most Viewed Current Articles
03 Jan 2023 : Original article 6,885
Impact of Autologous Stem Cell Transplantation on Primary Central Nervous System Lymphoma in First-Line and...DOI :10.12659/AOT.938467
Ann Transplant 2023; 28:e938467
15 Aug 2023 : Review article 6,837
Free-Circulating Nucleic Acids as Biomarkers in Patients After Solid Organ TransplantationDOI :10.12659/AOT.939750
Ann Transplant 2023; 28:e939750
16 May 2023 : Original article 6,584
Breaking Antimicrobial Resistance: High-Dose Amoxicillin with Clavulanic Acid for Urinary Tract Infections ...DOI :10.12659/AOT.939258
Ann Transplant 2023; 28:e939258
28 May 2024 : Original article 5,940
Effect of Dexmedetomidine Combined with Remifentanil on Emergence Agitation During Awakening from Sevoflura...DOI :10.12659/AOT.943281
Ann Transplant 2024; 29:e943281