Title
Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH
Author
Faculty/Department
Faculty of Medicine and Health Sciences
Publication type
article
Publication
Copenhagen ,
Subject
Human medicine
Source (journal)
European journal of endocrinology. - Copenhagen
Volume/pages
161(2009) :4 , p. 533-540
ISSN
0804-4643
ISI
000271728000003
Carrier
E
Target language
English (eng)
Full text (Publishers DOI)
Affiliation
University of Antwerp
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.
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