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ARS Home » Plains Area » Houston, Texas » Children's Nutrition Research Center » Research » Publications at this Location » Publication #330094
Title: Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations

Author
item CHRISTIANSEN, JENS - Aarhus University
item BACKELJAUW, PHILIPPE - Cincinnati Children'S Research Hospital
item BIDLINGMAIER, MARTIN - Universitat Munchen
item BILLER, BEVERLY - Massachusetts General Hospital
item BOGUSZEWSKI, MARGARET - Federal University Of Parana Polytechnic Center
item HAYMOND, MOREY - Children'S Nutrition Research Center (CNRC)
item YUEN, KEVIN - Swedish Medical Center

Submitted to: European Journal of Endocrinology
Publication Type: Review Article
Publication Acceptance Date: 3/23/2016
Publication Date: 6/1/2016
Citation: Christiansen, J.S., Backeljauw, P.F., Bidlingmaier, M., Biller, B.M., Boguszewski, M.C., Casanueva, F.F., Chanson, P., Chatelain, P., Choong, C.S., Clemmons, D.R., Cohen, L.E., Cohen, P., Frystyk, J., Grimberg, A., Hasegawa, Y., Haymond, M.W., Ho, K., Hoffman, A.R., Holly, J.M., Horikawa, R., Höybye, C., Jorgensen, J.O., Johannsson, G., Juul, A., Katznelson, L., Kopchick, J.J., Lee, K.O., Lee, K.W., Luo, X., Melmed, S., Miller, B.S., Misra, M., Popovic, V., Rosenfeld, R.G., Ross, J., Ross, R.J., Saenger, P., Strasburger, C.J., Thorner, M.O., Werner, H., Yuen, K. 2016. Growth Hormone Research Society perspective on the development of long-acting growth hormone preparations. European Journal of Endocrinology. 174(6):1-8. doi: 10.1530/EJE-16-0111.

Interpretive Summary:

Technical Abstract: The Growth Hormone (GH) Research Society (GRS) convened a workshop to address important issues regarding trial design, efficacy, and safety of long-acting growth hormone preparations (LAGH). A closed meeting of 55 international scientists with expertise in GH, including pediatric and adult endocrinologists, basic scientists, regulatory scientists, and participants from the pharmaceutical industry. Current literature was reviewed for gaps in knowledge. Expert opinion was used to suggest studies required to address potential safety and efficacy issues. Following plenary presentations summarizing the literature, breakout groups discussed questions framed by the planning committee. Attendees reconvened 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. 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.