Document Detail


Clinical effect and safety profile of recombinant human lysosomal acid lipase in patients with cholesteryl ester storage disease.
MedLine Citation:
PMID:  23348766     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
CONCLUSION: These data establish that sebelipase alfa, an investigational enzyme replacement, in patients with CESD is well tolerated, rapidly decreases serum transaminases, and that these improvements are sustained with long-term dosing and are accompanied by improvements in serum lipid profile.
Authors:
Manisha Balwani; Catherine Breen; Gregory M Enns; Patrick B Deegan; Tomas Honzík; Simon Jones; John P Kane; Vera Malinova; Reena Sharma; Eveline O Stock; Vassili Valayannopoulos; J Edmond Wraith; Jennifer Burg; Stephen Eckert; Eugene Schneider; Anthony G Quinn
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Publication Detail:
Type:  Clinical Trial, Phase I; Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, N.I.H., Extramural     Date:  2013-03-28
Journal Detail:
Title:  Hepatology (Baltimore, Md.)     Volume:  58     ISSN:  1527-3350     ISO Abbreviation:  Hepatology     Publication Date:  2013 Sep 
Date Detail:
Created Date:  2013-09-02     Completed Date:  2014-02-13     Revised Date:  2014-09-02    
Medline Journal Info:
Nlm Unique ID:  8302946     Medline TA:  Hepatology     Country:  United States    
Other Details:
Languages:  eng     Pagination:  950-7     Citation Subset:  IM    
Copyright Information:
Copyright © 2013 American Association for the Study of Liver Diseases.
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MeSH Terms
Descriptor/Qualifier:
Adult
Alanine Transaminase / metabolism
Aspartate Aminotransferases / metabolism
Cholesterol Ester Storage Disease / blood,  drug therapy*
Cholesterol, HDL / blood
Cholesterol, LDL / blood
Dose-Response Relationship, Drug
Female
Humans
Liver / metabolism
Male
Middle Aged
Recombinant Proteins / adverse effects*,  pharmacokinetics,  therapeutic use*
Sterol Esterase / adverse effects*,  pharmacokinetics,  therapeutic use*
Treatment Outcome
Triglycerides / blood
Grant Support
ID/Acronym/Agency:
T32 GM082773/GM/NIGMS NIH HHS; UL1 TR000067/TR/NCATS NIH HHS; UL1TR000067/TR/NCATS NIH HHS
Chemical
Reg. No./Substance:
0/Cholesterol, HDL; 0/Cholesterol, LDL; 0/Recombinant Proteins; 0/Triglycerides; EC 2.6.1.1/Aspartate Aminotransferases; EC 2.6.1.2/Alanine Transaminase; EC 3.1.1.13/Sterol Esterase
Comments/Corrections
Comment In:
Hepatology. 2013 Sep;58(3):850-2   [PMID:  23471861 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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