Perindopril in Breast Milk and Determination of Breastfed Infant Exposure: A Prospective Observational Study

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dc.contributor.authorLeggett, C.
dc.contributor.authorLwin, E.M.P.
dc.contributor.authorRitchie, U.
dc.contributor.authorSong, Y.
dc.contributor.authorGerber, J.P.
dc.contributor.authorTurner, S.
dc.contributor.authorHague, W.M.
dc.contributor.authorStark, M.
dc.contributor.authorUpton, R.
dc.contributor.authorGarg, S.
dc.date.issued2020
dc.description.abstractObjective: This study aimed to quantify the amount of perindopril and its active metabolite perindoprilat present in breast milk and corresponding maternal and infant plasma concentrations. Design: Prospective, longitudinal, observational. Setting: Tertiary specialist paediatric and obstetric hospital in Adelaide, South Australia. Population: Breastfeeding women actively treated with perindopril for hypertensive disorders postpartum. Methods: Eight breast milk samples and a single plasma sample were collected from each participant over a 24 hrs period, and plasma samples were taken from eligible breastfed infants. Breast milk and plasma concentrations of perindopril and perindoprilat were analysed using a validated Liquid Chromatography tandem-Mass Spectrometry (LC-MS/MS) method. Main Outcome Measures: Mean breast milk concentrations of perindopril and perindoprilat, Relative Infant Dose (RID) <10%, and Theoretical Infant Dose (TID). Results: Ten women and three infants participated in the study. The mean concentration of perindopril in breast milk for each participant ranged from 0.003 to 1.2 ng/mL and perindoprilat 0.2–36 ng/mL. RID for perindopril was 0.0005–0.2% and perindoprilat 0.03–4.6%. TID for perindopril was 0.00045–0.18 μg/kg/day and perindoprilat 0.032–5.4 μg/kg/day. Infant plasma levels for perindopril ranged from 0.44 to 1.12 ng/mL and perindoprilat undetectable – 10.14 ng/mL. Maternal reports described normal infant growth and development. Conclusion: Infant exposure to perindopril and perindoprilat through breast milk is low. However, some infants were found to have plasma perindoprilat concentrations consistent with pharmacodynamic effects. Perindopril may be used in mothers of healthy term infants, provided the infant is carefully monitored.
dc.description.statementofresponsibilityCatherine Leggett, Ei Mon Phyo Lwin, Usha Ritchie, Yunmei Song, Jacobus P Gerber, Sean Turner, William M Hague, Michael Stark, Richard Upton, Sanjay Garg
dc.identifier.citationDrug Design, Development and Therapy, 2020; 14:961-967
dc.identifier.doi10.2147/DDDT.S239704
dc.identifier.issn1177-8881
dc.identifier.issn1177-8881
dc.identifier.orcidHague, W.M. [0000-0002-5355-2955]
dc.identifier.orcidStark, M. [0000-0001-5518-1580] [0000-0003-1835-8679]
dc.identifier.orcidUpton, R. [0000-0001-9996-4886]
dc.identifier.urihttps://hdl.handle.net/2440/145878
dc.language.isoen
dc.publisherDove Medical Press
dc.rights© 2020 Leggett et al. This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms. php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php).
dc.source.urihttps://doi.org/10.2147/dddt.s239704
dc.subjectperindopril; perindoprilat; LC-MS/MS; human plasma; human milk; clinical lactation; infant drug exposure
dc.subject.meshMilk, Human
dc.subject.meshHumans
dc.subject.meshIndoles
dc.subject.meshPerindopril
dc.subject.meshAngiotensin-Converting Enzyme Inhibitors
dc.subject.meshProspective Studies
dc.subject.meshBreast Feeding
dc.subject.meshAdult
dc.subject.meshMiddle Aged
dc.subject.meshInfant
dc.subject.meshFemale
dc.subject.meshMale
dc.subject.meshYoung Adult
dc.titlePerindopril in Breast Milk and Determination of Breastfed Infant Exposure: A Prospective Observational Study
dc.typeJournal article
pubs.publication-statusPublished

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