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Pharmacotherapy: Pharmacokinetics and Pharmacodynamics (including: ADE, TDM, DUE)
TDM and stabilisation of paediatric patients in liver and kidney transplantation
  1. H. Baudet,
  2. V. McLin,
  3. P. Parvex,
  4. H. Chehade,
  5. C. Combescure,
  6. C. Samer,
  7. P. Bonnabry,
  8. C. Fonzo-Christe,
  9. K. Posfay-Barbe
  1. 1Geneva University Hospitals, Pharmacy, Geneva, Switzerland
  2. 2Geneva University Hospitals, Pediatric Gastroenterology, Geneva, Switzerland
  3. 3Geneva University Hospitals, Pediatric Nephrology, Geneva, Switzerland
  4. 4University Hospital Center of Vaud, Pediatric Nephrology, Lausanne, Switzerland
  5. 5Geneva University Hospitals, Division of Clinical Epidemiology, Geneva, Switzerland
  6. 6Geneva University Hospitals, Clinical Pharmacology and Toxicology, Geneva, Switzerland
  7. 7Geneva University Hospitals, Pediatric Infectiology, Geneva, Switzerland

Abstract

Background Immunosuppressants must be guided by therapeutic drug monitoring (TDM) to prevent rejection. Understanding and prevention of blood level variability is essential.

Purpose To evaluate TDM practice and factors associated with stabilisation.

Materials and methods Retrospective study of paediatric patients with liver (LT; since 2007) or kidney transplant (KT; since 2002) in two university hospitals. First-month % of tacrolimus (FK) and ciclosporin (CyA) therapeutic trough levels (FK: LT 10-15 ng/mL; KT 8-12 ng/mL / CyA KT 250-350 mcg/L). 30-day survival analysis (median survival in days (d) (CI 95%)) of stabilisation (discharge from intensive care or hospital / 3 consecutive therapeutic levels) and univariate analysis of associated factors in LT with stabilisation (log-rank test).

Results 46 patients included: 27 LT, 19 KT; mean age: 2.8 ±4.0 vs. 11.9 ±6.2 years. 100% of LT patients received FK; KT: 53% FK, 47% CyA. Only 32% (LT) and 41% (KT) of FK levels, and 22% (KT) of CyA levels were in the range. Discharge from intensive care and hospital occurred significantly later for LT (8d (6;12) versus 3 d (3;5) / 28 d (25; not available) versus 11.5 d (10;15) (p<0.001)), but stabilisation of levels earlier (18 d (15;27) vs not reached, p=0.04). Compared to FK levels, CyA levels were not stabilised in KT patients after one month (not reached vs 20.5 d (10; not available), p=0.02), but no difference was seen on discharge. Living donor transplant was significantly associated with an earlier discharge from intensive care (p=0.02), age <30 years and transplant weight ≥ 291 g with a trend to earlier discharge from hospital (p=0.048; p=0.06). Metabolic disease and weight-ratio transplant/patient ≥0.03 were associated with an earlier stabilisation of FK levels (p=0.01; p=0.05).

Conclusions Variability of immunosuppressant trough levels was high in the first month after liver transplantation and in kidney patients receiving ciclosporin. Factors associated with earlier stabilisation have to be confirmed in a larger study.

https://doi.org/10.1136/ejhpharm-2012-000074.287

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