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  • 40 No difference in the incidence of hearing loss after introducing a vancomycin loading dose in neonates: A single center analysis of a tertiary NICU

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40 No difference in the incidence of hearing loss after introducing a vancomycin loading dose in neonates: A single center analysis of a tertiary NICU
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  1. Shannon L van der Zeeuw1,
  2. Anne Smits2,3,
  3. Karel Allegaert3,4,
  4. Catherijne AJ Knibbe1,5,
  5. Swantje Völler1
  1. 1Department of Systems Pharmacology and Pharmacy, Leiden Academic Centre for Drug Research, Leiden, the Netherlands
  2. 2Neonatal Intensive Care Unit, University Hospitals UZ Leuven, Leuven, Belgium
  3. 3Department of Development and Regeneration, KU Leuven, Leuven, Belgium
  4. 4Department of Pharmaceutical and Pharmacological Sciences, KU Leuven, 3000 Leuven, Belgium
  5. 5Department of Clinical Pharmacy, St. Antonius Hospital, Nieuwegein, the Netherlands

Abstract

Introduction While many studies have reported on the pharmacokinetics (PK) of vancomycin in neonates, data on the pharmacodynamics or safety (PD) are scarce. The recently published NeoVanc study indicated that a vancomycin loading dose might be associated with an increased incidence of hearing loss, as a secondary safety analysis.1 The aim of the current retrospective study was to examine the difference in the incidence of hearing loss in two cohorts from the same NICU that were treated either with or without a loading dose to evaluate this loading dose safety signal. Furthermore, we aimed to investigate the relationship between vancomycin treatment duration, cumulative dose and cumulative AUC and hearing loss.

Methodology Clinical data, vancomycin routine care therapy data and available BERA (Brainstem Evoked Response Audiometry) hearing tests were retrospectively collected for cohort 1 (June 2011-December 2012, without a loading dose) and cohort 2 (November 2017-June 2019, with a loading dose). Hearing loss was described as a failed BERA test at least unilateral after the first failed screening. The difference in the incidence in hearing loss between both cohorts was compared using an unconditional Z-pooled exact test and a Fisher exact test to determine the differences in treatment duration, cumulative dose and cumulative AUC (both tests p-value < 0.05 significant). AUC was calculated using a validated PK-model.2

Results In total, 102 neonates without a vancomycin loading dose and 56 with a loading dose were included. There was no difference in the incidence of hearing loss between both cohorts (cohort 1 11.76% hearing loss vs cohort 2 12.00%, p-value 1). Furthermore, treatment duration (p-value 0.656), cumulative dose (mg/kg) (p-value 0.992) and cumulative AUC (p-value 0.497) did not differ significantly between patients with normal and abnormal hearing when pooling both cohorts.

Conclusion In this single-center study, a vancomycin loading dose was not associated with increased hearing loss. Even a detailed AUC based assessment was not associated with hearing impairment. Due to remaining knowledge gaps, assessment of safety, both on short- and long-term outcome, after drug exposure in the neonatal period remains important.

References

  1. Hill, et al. Lanct Child Adolesc Heal 2022.

  2. Janssen, et al. AAC 2016.

https://doi.org/10.1136/bmjpo-2024-ESDPPP.40

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