Retrospective study evaluating safety, clinical effect, and dosing of dalteparin for the treatment of venous thromboembolism in term neonates.

Autor: Sherman N; Pfizer Inc., Collegeville, Pennsylvania, USA., Younus M; Pfizer Inc., Collegeville, Pennsylvania, USA., Wolter K; Pfizer Inc., Collegeville, Pennsylvania, USA., Victor S; King's College London and Guy's and St Thomas' NHS Foundation Trust, London, UK., Kairamkonda V; University Hospitals of Leicester NHS Trust, Leicester, UK., Adams E; Oxford University Hospitals NHS Foundation Trust, Leicester, UK., Brotherton H; Victoria Hospital Kirkcaldy, NHS Fife, Kirkcaldy, UK., Boyle EM; University Hospitals of Leicester NHS Trust, Leicester, UK.; University of Leicester, Leicester, UK.
Jazyk: angličtina
Zdroj: Pediatric blood & cancer [Pediatr Blood Cancer] 2024 Oct; Vol. 71 (10), pp. e31215. Date of Electronic Publication: 2024 Jul 25.
DOI: 10.1002/pbc.31215
Abstrakt: Background: There is an increased risk of venous thromboembolism (VTE) among neonates due to their unique hemostatic system. However, there is lack of approved treatment options for VTE in neonatal population. Importantly, dalteparin, a low molecular weight heparin approved for pediatric VTE in children ≥1 month of age, has also been used for the treatment of neonatal VTE. Based on the request from the Food and Drug Administration, this retrospective study aimed to characterize the safety, clinical effects, and dosing of dalteparin for treatment of VTE among neonates.
Procedure: Data from electronic medical records for neonates (born ≥35 weeks of gestation) treated with dalteparin for VTE between January 2010 and December 2021 were collected. The data assessed included bleeding and deterioration in hematological biomarkers among other adverse events, changes in relevant factor antifactor Xa (anti-Xa) levels and VTE status, and dosing of dalteparin and corresponding anti-Xa assay levels.
Results: Sixteen neonates from five participating sites in the United Kingdom were included. There were no bleeding events or deaths. Only one serious adverse event of hypoglycemic brain injury (unrelated to dalteparin) was documented in a patient with a history of hyperinsulinism. Median (range) daily dose of dalteparin at initiation was 309 (297-314) IU/kg. Eight of 16 neonates achieved therapeutic anti-Xa level, including two patients who did so after the first dose.
Conclusions: Dalteparin treatment in neonates raised no major safety concerns. Larger cohort studies may help provide further insights on clinical effects of dalteparin for neonatal VTE.
(© 2024 The Author(s). Pediatric Blood & Cancer published by Wiley Periodicals LLC.)
Databáze: MEDLINE
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