Evidence map›Paper›PMID 38278872›Full record

ArticleClinical pharmacokinetics2024

Maternal Ezetimibe Concentrations Measured in Breast Milk and Its Use in Breastfeeding Infant Exposure Predictions.

Cindy H T Yeung, Julie Autmizguine, Pooja Dalvi, Audrey Denoncourt, Shinya Ito, Pamela Katz, Mehzabin Rahman, Yves Theoret, Andrea N Edginton

Abstract read
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In one paragraph

Article in Clinical pharmacokinetics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 4 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Lactation safety of cardiovascular medications.American heart journal plus : cardiology research and practice · 2025
    Review
  4. Article
  5. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Cindy H T YeungDivision of Clinical Pharmacology and Toxicology, Hospital for Sick Children, Toronto, ON, Canada.
Julie AutmizguineDepartment of Clinical Pharmacology Unit, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada.
Pooja DalviDivision of Clinical Pharmacology and Toxicology, Hospital for Sick Children, Toronto, ON, Canada.
Audrey DenoncourtDepartment of Clinical Pharmacology Unit, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada.
Shinya ItoDivision of Clinical Pharmacology and Toxicology, Hospital for Sick Children, Toronto, ON, Canada.
Pamela KatzDivision of Endocrinology and Metabolism, Department of Medicine, University of Manitoba, Winnipeg, MB, Canada.
Mehzabin RahmanDivision of Clinical Pharmacology and Toxicology, Hospital for Sick Children, Toronto, ON, Canada.
Yves TheoretDepartment of Clinical Pharmacology Unit, Centre Hospitalier Universitaire Sainte-Justine, Montreal, QC, Canada.
Andrea N EdgintonSchool of Pharmacy, University of Waterloo, 10 Victoria St S A, Kitchener, ON, N2G 1C5, Canada. aedginto@uwaterloo.ca.ORCID 0000-0002-9014-1653
Centre Hospitalier Universitaire Sainte-Justine · CAHospital for Sick Children · CAUniversity of Manitoba · CAUniversity of Toronto · CAUniversity of Waterloo · CA

Funding

CIHR DF2-171445CIHR PJT-159782
6 · The paper itself

Abstract

backgroundLactating mothers taking ezetimibe, an antihyperlipidemic agent, may be hesitant to breastfeed despite the known benefit of breastfeeding to both mother and infant. Currently, no data exist on the presence or concentration of ezetimibe and its main active metabolite, ezetimibe-glucuronide (EZE-glucuronide), in human breast milk.

methodsVoluntary breast milk samples containing ezetimibe and EZE-glucuronide were attained from lactating mothers taking ezetimibe as part of their treatment. An assay was developed and validated to measure ezetimibe and EZE-glucuronide concentrations in breast milk. A workflow that utilized a developed and evaluated pediatric physiologically based pharmacokinetic (PBPK) model, the measured concentrations in milk, and weight-normalized breast milk intake volumes was applied to predict infant exposures and determine the upper area under the curve ratio (UAR).

resultsFifteen breast milk samples from two maternal-infant pairs were collected. The developed liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay showed an analytical range of 0.039-5.0 ng/mL and 0.39-50.0 ng/mL for ezetimibe and EZE-glucuronide, respectively. The measured concentrations in the breast milk samples were 0.17-1.02 ng/mL and 0.42-2.65 ng/mL of ezetimibe and EZE-glucuronide, respectively. The evaluated pediatric PBPK model demonstrated minimal exposure overlap in adult therapeutic dose and breastfed infant simulated area under the concentration-time curve from time zero to 24 h (AUC

conclusionsPBPK model-predicted ezetimibe and EZE-glucuronide exposures and UAR suggest that breastfeeding infants would receive non-therapeutic exposures. Future work should involve a 'mother-infant pair study' to ascertain breastfed infant plasma ezetimibe and EZE-glucuronide concentrations to confirm the findings of this work.

Indexed as

Breast FeedingMilk, HumanAdultChildChromatography, LiquidEzetimibeFemaleGlucuronidesHumansInfantLactationTandem Mass SpectrometryEzetimibeGlucuronides

Identifiers

PMID38278872
OpenAlexW4391251185

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.