Levi Campbell, Kristin Huseman, Kaytlin Krutsch, Palika Datta
{"title":"阿托伐他汀及其代谢物在母乳中的最小转移:一个案例系列。","authors":"Levi Campbell, Kristin Huseman, Kaytlin Krutsch, Palika Datta","doi":"10.1089/bfm.2024.0258","DOIUrl":null,"url":null,"abstract":"<p><p><b><i>Background:</i></b> Statins are historically contraindicated during breastfeeding due to theoretical concerns of disruptions in infant development from drug exposure and nutritional changes in milk. Breastfeeding mothers requiring statins often discontinue statins or postpone treatment until breastfeeding cessation, contributing to delays in treatment up to 14 years. This study aims to determine the transfer of atorvastatin and its active metabolites into human milk and evaluate the infant's risk of drug exposure. <b><i>Materials and Methods:</i></b> Milk samples and health information were released from the InfantRisk Human Milk Biorepository for three women taking 20 mg, 40 mg, and 80 mg of atorvastatin daily at steady state conditions. The concentration of atorvastatin (AT) and its active metabolites, ortho-hydroxy AT (2OH AT) and para-hydroxy AT (4OH AT), was quantified in timed milk samples using liquid chromatography-mass spectrometry. <b><i>Results:</i></b> The highest absolute infant dose of AT was 0.00027 mg/kg/day, and the highest weight-adjusted relative infant dose of the combined analytes was 0.09%, far below established thresholds for infant safety. Milk cholesterol levels were within previously established norms in the range of 10 mg/dL. The mothers reported no adverse outcomes in the two exposed infants. <b><i>Conclusions:</i></b> The transfer of atorvastatin and its metabolites was exceedingly low. While the impact on milk composition in states of hyperlipidemia (whether treated or untreated) is not well understood, it is unlikely that the drug in the milk would be present in clinically significant levels to adversely affect a breastfed infant.</p>","PeriodicalId":9142,"journal":{"name":"Breastfeeding Medicine","volume":null,"pages":null},"PeriodicalIF":2.1000,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Minimal Transfer of Atorvastatin and Its Metabolites in Human Milk: A Case Series.\",\"authors\":\"Levi Campbell, Kristin Huseman, Kaytlin Krutsch, Palika Datta\",\"doi\":\"10.1089/bfm.2024.0258\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><b><i>Background:</i></b> Statins are historically contraindicated during breastfeeding due to theoretical concerns of disruptions in infant development from drug exposure and nutritional changes in milk. Breastfeeding mothers requiring statins often discontinue statins or postpone treatment until breastfeeding cessation, contributing to delays in treatment up to 14 years. This study aims to determine the transfer of atorvastatin and its active metabolites into human milk and evaluate the infant's risk of drug exposure. <b><i>Materials and Methods:</i></b> Milk samples and health information were released from the InfantRisk Human Milk Biorepository for three women taking 20 mg, 40 mg, and 80 mg of atorvastatin daily at steady state conditions. The concentration of atorvastatin (AT) and its active metabolites, ortho-hydroxy AT (2OH AT) and para-hydroxy AT (4OH AT), was quantified in timed milk samples using liquid chromatography-mass spectrometry. <b><i>Results:</i></b> The highest absolute infant dose of AT was 0.00027 mg/kg/day, and the highest weight-adjusted relative infant dose of the combined analytes was 0.09%, far below established thresholds for infant safety. Milk cholesterol levels were within previously established norms in the range of 10 mg/dL. The mothers reported no adverse outcomes in the two exposed infants. <b><i>Conclusions:</i></b> The transfer of atorvastatin and its metabolites was exceedingly low. While the impact on milk composition in states of hyperlipidemia (whether treated or untreated) is not well understood, it is unlikely that the drug in the milk would be present in clinically significant levels to adversely affect a breastfed infant.</p>\",\"PeriodicalId\":9142,\"journal\":{\"name\":\"Breastfeeding Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2024-09-13\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Breastfeeding Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1089/bfm.2024.0258\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"OBSTETRICS & GYNECOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Breastfeeding Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1089/bfm.2024.0258","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"OBSTETRICS & GYNECOLOGY","Score":null,"Total":0}
Minimal Transfer of Atorvastatin and Its Metabolites in Human Milk: A Case Series.
Background: Statins are historically contraindicated during breastfeeding due to theoretical concerns of disruptions in infant development from drug exposure and nutritional changes in milk. Breastfeeding mothers requiring statins often discontinue statins or postpone treatment until breastfeeding cessation, contributing to delays in treatment up to 14 years. This study aims to determine the transfer of atorvastatin and its active metabolites into human milk and evaluate the infant's risk of drug exposure. Materials and Methods: Milk samples and health information were released from the InfantRisk Human Milk Biorepository for three women taking 20 mg, 40 mg, and 80 mg of atorvastatin daily at steady state conditions. The concentration of atorvastatin (AT) and its active metabolites, ortho-hydroxy AT (2OH AT) and para-hydroxy AT (4OH AT), was quantified in timed milk samples using liquid chromatography-mass spectrometry. Results: The highest absolute infant dose of AT was 0.00027 mg/kg/day, and the highest weight-adjusted relative infant dose of the combined analytes was 0.09%, far below established thresholds for infant safety. Milk cholesterol levels were within previously established norms in the range of 10 mg/dL. The mothers reported no adverse outcomes in the two exposed infants. Conclusions: The transfer of atorvastatin and its metabolites was exceedingly low. While the impact on milk composition in states of hyperlipidemia (whether treated or untreated) is not well understood, it is unlikely that the drug in the milk would be present in clinically significant levels to adversely affect a breastfed infant.
期刊介绍:
Breastfeeding Medicine provides unparalleled peer-reviewed research, protocols, and clinical applications to ensure optimal care for mother and infant. The Journal answers the growing demand for evidence-based research and explores the immediate and long-term outcomes of breastfeeding, including its epidemiologic, physiologic, and psychological benefits. It is the exclusive source of the Academy of Breastfeeding Medicine protocols.
Breastfeeding Medicine coverage includes:
Breastfeeding recommendations and protocols
Health consequences of artificial feeding
Physiology of lactation and biochemistry of breast milk
Optimal nutrition for the breastfeeding mother
Breastfeeding indications and contraindications
Managing breastfeeding discomfort, pain, and other complications
Breastfeeding the premature or sick infant
Breastfeeding in the chronically ill mother
Management of the breastfeeding mother on medication
Infectious disease transmission through breast milk and breastfeeding
The collection and storage of human milk and human milk banking
Measuring the impact of being a “baby-friendly” hospital
Cultural competence and cultural sensitivity
International public health issues including social and economic issues.