Publication
Title
Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH
Author
Abstract
Objective: Changes observed during adult GH deficiency (GHD) are most often reversed with the administration of recombinant human GH (rhGH). To avoid daily injections, a long-acting GH molecule has been obtained by covalent binding of polyethylene glycol (PEG) with rhGH (PEGGH), allowing weekly s.c. injections. This study was designed to assess its efficacy and safety, in adult GHD subjects. Design and methods: This was a randomized, double-blind, placebo-controlled, multiple-dose, parallel group study. Subjects were recruited from 34 centers. A total of 105 subjects with GHD were assigned a treatment. They received 6 weekly injections of either PEGGH or placebo. Subjects were randomized into one out of four treatment groups (Groups AD) or placebo (Group E). Groups A, B, and C received 1, 3, and 4 mg PEGGH respectively, for the first 3 weeks followed by 2, 6, and 8 mg PEGGH respectively, for the remaining 3 weeks. Group D received 4 mg PEGGH for 6 weeks. Group E received placebo. The study was suspended because of the development of lipoatrophy in certain subjects and restarted with an injection rotation plan, before being terminated due to further subjects developing lipoatrophy. Results: A total of 13 cases of injection-site lipoatrophy were reported, of which ten were in females and three occurred after the first injection; all cases were independent of PEGGH dose or IGF1 levels, either basal or under treatment. Conclusion: The unpredictable occurrence of injection-site lipoatrophy with weekly long-acting pegylated GH molecules may be a limiting factor for their development.
Language
English
Source (journal)
European journal of endocrinology. - Copenhagen
Publication
Copenhagen : 2009
ISSN
0804-4643
Volume/pages
161:4(2009), p. 533-540
ISI
000271728000003
Full text (Publishers DOI)
UAntwerpen
Faculty/Department
Research group
Publication type
Subject
Affiliation
Publications with a UAntwerp address
External links
Web of Science
Record
Identification
Creation 19.01.2010
Last edited 19.05.2017
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