Why the study?
What are the population pharmacokinetics of fondaparinux 2.5 mg in everyday practice after major orthopaedic surgery?
What are the population pharmacokinetics of fondaparinux 2.5 mg in everyday practice after major orthopaedic surgery?
In everyday practice, fondaparinux pharmacokinetics are influenced by body weight, age, and renal function, with increased exposure in patients weighing <50 kg or with moderate renal failure.
May warrant dosing caution in patients <50 kg or with moderate renal failure; leaves open prospective validation in orthopaedic cohorts.
Fondaparinux is a synthetic antithrombotic agent with specific anti-factor Xa activity. A population pharmacokinetic model of fondaparinux, based on data obtained in patients included in phase II/III trials, has been described. However, the validity of this model in everyday practice needed to be confirmed. This study was a multicenter, prospective cohort study in consecutive orthopaedic patients treated with 2.5 mg of fondaparinux. Anti-Xa activities were recorded in 809 patients. Population parameters and inter-individual variability were estimated using NONMEM VI software. A two-compartment model with first-order absorption best described fondaparinux pharmacokinetics. Covariates partly explaining inter-individual variability were body weight, age and creatinine clearance estimated by the simplified Modification of Diet in Renal Disease formula (MDRD). A body weight less than 50 kg and moderate renal failure increased drug exposure. Although the population pharmacokinetic model of fondaparinux was described, this one requires to be validated in everyday practice.
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Zufferey et al. (2010) studied this question.
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