Minimal Transfer of Atorvastatin and Its Metabolites in Human Milk: A Case Series.

IF 2.1 3区 医学 Q2 OBSTETRICS & GYNECOLOGY
Levi Campbell, Kristin Huseman, Kaytlin Krutsch, Palika Datta
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引用次数: 0

Abstract

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.

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。
背景:他汀类药物历来是母乳喂养期间的禁忌,因为理论上担心药物暴露和乳汁营养变化会影响婴儿发育。需要服用他汀类药物的哺乳期母亲通常会停用他汀类药物或推迟治疗直至停止哺乳,这导致治疗延迟长达 14 年之久。本研究旨在确定阿托伐他汀及其活性代谢物转移到母乳中的情况,并评估婴儿接触药物的风险。材料与方法:从 InfantRisk 人乳生物库中提取了三名妇女的乳汁样本和健康信息,她们在稳定状态下每天服用 20 毫克、40 毫克和 80 毫克阿托伐他汀。采用液相色谱-质谱法对定时牛奶样本中的阿托伐他汀(AT)及其活性代谢物--正羟基AT(2OH AT)和对羟基AT(4OH AT)的浓度进行了定量分析。结果显示婴儿摄入 AT 的最高绝对剂量为 0.00027 毫克/千克/天,综合分析物的最高体重调整相对婴儿剂量为 0.09%,远低于婴儿安全的既定阈值。牛奶中的胆固醇水平在 10 毫克/分升的范围内,符合先前确定的标准。据母亲报告,两名暴露婴儿未出现不良后果。结论阿托伐他汀及其代谢物的转移量极低。虽然对高脂血症状态下(无论是否经过治疗)乳汁成分的影响尚不十分清楚,但乳汁中的药物含量不太可能达到对母乳喂养婴儿产生不利影响的临床显著水平。
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来源期刊
Breastfeeding Medicine
Breastfeeding Medicine OBSTETRICS & GYNECOLOGY-PEDIATRICS
CiteScore
4.20
自引率
11.10%
发文量
130
审稿时长
6-12 weeks
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.
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