Growth Hormone Research Society Perspective on the Development of Long-Acting Growth Hormone Preparations

Jens Sandahl Christiansen, Philippe Backeljauw, Martin Bidlingmaier, Beverly Biller, Margaret Boguszewski, Felipe F Casanueva, Philippe Chanson, Pierre Chatelain, Catherine S Choong, David R Clemmons, Laurie Cohen, Pinchas Cohen, Jan Frystyk, Adda Grimberg, Yukihiro Hasegawa, Morey Haymond, Ken Ho, Andrew R Hoffman, Jeff Mp Holly, Reiko HorikawaCharlotte Hoybye, Jens Otto L Jorgensen, Gudmundur Johannsson, Anders Juul, Laurence Katznelson, John J Kopchick, K-O Lee, Kuk Wha Lee, Xiao-Ping Luo, Shlomo Melmed, Bs Miller, Madhusmita Misra, Vera Popović, Ron G Rosenfeld, Judith Ross, Richard J Ross, Paul Saenger, Christian J Strasburger, Michael O Thorner, Haim Werner, Kevin Cj Yuen

105 Citationer (Scopus)

Abstract

OBJECTIVE: The Growth Hormone (GH) Research Society convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting GH preparations (LAGH).

PARTICIPANTS: A closed meeting of 55 international scientists with expertise in growth hormone, including pediatric and adult endocrinologists, basic scientists, regulatory scientists, and participants from the pharmaceutical industry.

EVIDENCE: Current literature was reviewed for gaps in knowledge. Expert opinion was utilized to suggest studies required to address potential safety and efficacy issues.

CONSENSUS PROCESS: Following plenary presentations summarizing the literature, breakout groups discussed questions framed by the planning committee. Attendees re-convened after each breakout session to share group reports. A writing team compiled the breakout session reports into a draft document that was discussed and revised in an open forum on the concluding day. This was edited further and then circulated to attendees from academic institutions for review after the meeting. Participants from pharmaceutical companies did not participate in the planning, writing, or in the discussions and text revision on the final day of the workshop. Scientists from industry and regulatory agencies reviewed the manuscript to identify any factual errors.

CONCLUSIONS: LAGH compounds may represent an advance over daily GH injections because of increased convenience and differing phamacodynamic properties, providing the potential for improved adherence and outcomes. Better methods to assess adherence must be developed and validated. Long-term surveillance registries that include assessment of efficacy, cost-benefit, disease burden, quality of life, and safety are essential for understanding the impact of sustained exposure to LAGH preparations.

OriginalsprogEngelsk
TidsskriftEuropean journal of endocrinology / European Federation of Endocrine Societies
Vol/bind174
Udgave nummer6
Sider (fra-til)C1-8
Antal sider9
ISSN0804-4643
DOI
StatusUdgivet - 23 mar. 2016

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