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| |  Once-Daily Enoxaparin Feasible in Some Children at Risk of Venous Thromboembolism: Presented at ASH By Ed Susman NEW ORLEANS -- December 10, 2009 -- Once-daily dosing of enoxaparin for children at risk of venous thromboembolism appears to be feasible, researchers said here at the American Society of Hematology Annual Scientific Meeting 2009. Using data from 126 children -- including neonates, infants, and children -- who were administered enoxaparin off-label, researchers performed pharmacokinetic analyses and modelling to determine that blood levels of the low molecular weight heparin remained in the therapeutic range for both once-daily and twice-daily dosing of the anti-coagulant, said Mirjam Trame, Westfälische-Wilhelms-Universität Münster, Münster, Germany. “According to these results, a once-daily enoxaparin dosing regimen seems to be feasible for at least 50% of this population,” she said. “Enoxaparin has been extensively studied in adults on its safety and efficacy during the prevention of symptomatic thromboembolism when acute anticoagulation is required due to venous thrombosis or stroke,” noted Trame during her poster presentation on December 5, Although used in children off-label when they are at risk of thromboembolism due to a variety of conditions including cancers and some haematological malignancies, the optimal dosing in children is not well studied. Therefore, the researchers aimed to determine if once-daily or twice-daily dosing was feasible in this paediatric population. While once-daily dosing was found to be feasible, “The high inter-individual variety in clearance and central volume of distribution in our population underlined the need for monitoring the anti-Factor Xa activity and individualising the dose,” Trame noted. By pharmacokinetic modelling, the median enoxaparin trough levels of the population were predicted to be 0.095 IU/ml anti Factor Xa activity for the once-daily dosing regimen and 0.27 IU/ml anti-Factor Xa activity for the twice-daily dosing, she explained. However, in clinical practice, she found that the 12-hour enoxaparin levels for the once-daily dosing regimen resulted with 0.27 IU/ml anti-Factor Xa activity -- in the same anti-Factor Xa activity as the trough levels of the twice-daily dosing, leading the researchers to conclude that once-daily dosing is feasible. In her study population, children aged less than 1 year received a starting dose of enoxaparin 1.5 mg/kg and those aged older than 12 months were started on 1.0 mg/kg. The maintenance dose for children aged less than 1 year was reduced to 1.3 mg/kg; it remained the same for children aged older than 1 year. Patients were dosed at 12 or 24-hour intervals and blood samples were drawn after patients reached steady-state on their maintenance dose at baseline prior to the next dose, and at 2, 4, 8 and 12 hours after administration.
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