HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) All Versions of this Article: EJE-09-0422v1 161/4/533    most recent Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Google Scholar Articles by Touraine, P. PubMed PubMed Citation Articles by Touraine, P.

Lipoatrophy in GH deficient patients treated with a long-acting pegylated GH

Department of Endocrinology and Reproductive Medicine, GH Pitié Salpêtrière, Centre de Référence des Maladies Endocriniennes Rares de la Croissance, Université Paris VI Pierre et Marie Curie, 47–83, Boulevard de l'Hôpital, 75651 Paris Cedex 13, France¹ Pfizer Limited, Sandwich, Kent, UK² Pfizer, New York, New York, USA³ Department of Endocrinology, University of Antwerp, Antwerp, Belgium⁴ Endocrinology and Nutrition, Hospital General Universitario de Alicante, Universidad Miguel Hernández, Alicante, Spain⁵ Department of Internal Medicine I, University of Granada Hospital, Granada, Spain⁶ Division of Internal Medicine, Department of Medical and Health Sciences, Linköping University, Linköping, Sweden

(Correspondence should be addressed to P Touraine; Email: philippe.touraine{at}psl.aphp.fr)

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 (PEG–GH), 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 PEG–GH or placebo. Subjects were randomized into one out of four treatment groups (Groups A–D) or placebo (Group E). Groups A, B, and C received 1, 3, and 4 mg PEG–GH respectively, for the first 3 weeks followed by 2, 6, and 8 mg PEG–GH respectively, for the remaining 3 weeks. Group D received 4 mg PEG–GH 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 PEG–GH 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.