Successful pregnancy and lactation outcome in a patient with Gaucher disease receiving enzyme replacement therapy, and the subsequent distribution and excretion of imiglucerase in human breast milk.

Abstract:

BACKGROUND:Enzyme replacement therapy (ERT) with imiglucerase is a well-established, effective treatment for Gaucher disease. However, there have been no published reports regarding the excretion of imiglucerase into human breast milk and its effects on the nursing infant. OBJECTIVE:This letter reports on the successful pregnancy and lactation of a patient with Gaucher disease receiving treatment with imiglucerase, and the subsequent distribution and excretion of imiglucerase in human breast milk. METHODS:A 39-year-old Japanese female (height, 164 cm; weight, 55 kg) with Gaucher disease had 2 successful pregnancies and continued ERT through both. The study was conducted 6 months after the first delivery. She was administered a 1-hour infusion of imiglucerase 60 U/kg that coincided with her regular every-2-week regimen. Serum and breast-milk samples were obtained before and up to 24 hours after administration. Breast-milk samples were also obtained from 10 nursing mothers with galactorrhea as controls. RESULTS:The preinfusion level of breast-milk β-glucocerebrosidase was 0.008 nmol/h/mL. The peak of serum β-glucocerebrosidase activity (0.119 nmol/h/mL) was obtained at the end of the 1-hour infusion period. Slightly increased enzymatic activity (0.016 nmol/h/mL) was observed in the first breast milk sampled after imiglucerase infusion. CONCLUSIONS:We report a case of successful pregnancy and breastfeeding in a Japanese patient with Gaucher disease. A small amount of imiglucerase was found to be excreted into human breast milk, but only in the first milk produced after infusion.

journal_name

Clin Ther

journal_title

Clinical therapeutics

authors

Sekijima Y,Ohashi T,Ohira S,Kosho T,Fukushima Y

doi

10.1016/j.clinthera.2010.11.008

subject

Has Abstract

pub_date

2010-11-01 00:00:00

pages

2048-52

issue

12

eissn

0149-2918

issn

1879-114X

pii

S0149-2918(10)00370-X

journal_volume

32

pub_type

信件
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    authors: Nuijten MJ,Brignone M,Marteau F,den Boer JA,Hoencamp E

    更新日期:2012-06-01 00:00:00

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    authors: Sasaki T,Takekoshi T,Okada T

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    doi:

    authors: Shalita AR

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    abstract::To determine the cost relative to efficacy and tolerability of two antimicrobial regimens, a prospective, multicenter study compared imipenem-cilastatin (I-C) monotherapy with clindamycin+aminoglycoside (C+A) in the treatment of serious lower respiratory, intra-abdominal, gynecologic, and urinary tract infections. The...

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    pub_type: 临床试验,杂志文章,多中心研究,随机对照试验

    doi:

    authors: Kreter B

    更新日期:1992-01-01 00:00:00

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    doi:

    authors: Banwell JG

    更新日期:1990-01-01 00:00:00

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    doi:

    authors: Trotter JP,Reinhart SP,Katz RM,Glazier HS

    更新日期:1993-09-01 00:00:00

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    abstract:PURPOSE:We estimated the real-world costs of bleeding-related episodes (BREs) in adults with primary immune thrombocytopenia (ITP). METHODS:This retrospective cohort study used the MarketScan Commercial Claims and Encounters and Medicare Supplemental and Coordination of Benefits databases. We identified adult patients...

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    authors: Lin J,Zhang X,Li X,Chandler D,Altomare I,Wasser JS,Cetin K

    更新日期:2017-03-01 00:00:00

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    pub_type: 临床试验,杂志文章,随机对照试验

    doi:

    authors: Jaffe R,Altaras M,Cohen I,Ben-Aderet N

    更新日期:1985-01-01 00:00:00

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    doi:10.1016/s0149-2918(04)90177-4

    authors: Fujii Y,Tanaka H,Kawasaki T

    更新日期:2004-07-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1016/S0149-2918(00)86736-3

    authors: Burgess DS,Summers KK,Hardin TC

    更新日期:1999-11-01 00:00:00

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    abstract:BACKGROUND:Despite increasing investigation in the area of cardiovascular instability in preterm infants, huge gaps in knowledge remain. None of the current treatments for hypotension, including the use of inotropic agents, have been well studied in the preterm population, and data regarding safety and efficacy are lac...

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    doi:10.1016/j.clinthera.2006.09.006

    authors: Evans JR,Lou Short B,Van Meurs K,Cheryl Sachs H

    更新日期:2006-09-01 00:00:00

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    authors: Somwar R,Sweeney G,Ramlal T,Klip A

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    更新日期:2018-05-01 00:00:00

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    更新日期:2019-06-01 00:00:00

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    pub_type: 杂志文章,评审

    doi:

    authors: Frishman WH,Amsterdam E,Glasser SP,Thadani U

    更新日期:1994-03-01 00:00:00

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    pub_type: 杂志文章

    doi:10.1016/j.clinthera.2014.05.009

    authors: Cheen HH,Lim SH,Huang MC,Bee YM,Wee HL

    更新日期:2014-07-01 00:00:00

  • Limited Sampling Strategy for Accurate Prediction of Pharmacokinetics of Saroglitazar: A 3-point Linear Regression Model Development and Successful Prediction of Human Exposure.

    abstract:PURPOSE:Our aim was to develop and validate the extrapolative performance of a regression model using a limited sampling strategy for accurate estimation of the area under the plasma concentration versus time curve for saroglitazar. METHODS:Healthy subject pharmacokinetic data from a well-powered food-effect study (fa...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,随机对照试验

    doi:10.1016/j.clinthera.2018.01.016

    authors: Joshi SN,Srinivas NR,Parmar DV

    更新日期:2018-03-01 00:00:00

  • Effect of glucagon-like peptide-1 receptor agonists on lipid profiles among type 2 diabetes: a systematic review and network meta-analysis.

    abstract:PURPOSE:The goal of this study was to assess the effect of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) on lipid profiles in patients with type 2 diabetes. METHODS:The MEDLINE, Embase, Cochrane Library, and ClinicalTrials.gov databases were searched from inception through October 31, 2013. Randomized controll...

    journal_title:Clinical therapeutics

    pub_type: 杂志文章,meta分析,评审

    doi:10.1016/j.clinthera.2014.11.008

    authors: Sun F,Wu S,Wang J,Guo S,Chai S,Yang Z,Li L,Zhang Y,Ji L,Zhan S

    更新日期:2015-01-01 00:00:00

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    pub_type: 杂志文章,评审

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    authors: Rollins KD,Lindley C

    更新日期:2005-09-01 00:00:00