Guidance for the treatment of adult growth hormone deficiency with somapacitan, a long-acting growth hormone preparation

Frontiers in Endocrinology

Endocrinology

Yutaka Takahashi¹  Jens Otto L. Jørgensen²  Hiroshi Nishioka³  David Clemmons⁴  Martin Bidlingmaier⁵  Beverly M.K. Biller⁶ 

[1] Department of Diabetes and Endocrinology, Nara Medical University, Kashihara, Japan;Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan;Department of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, Denmark;Department of Hypothalamic and Pituitary Surgery, Toranomon Hospital, Tokyo, Japan;Department of Medicine, University of North Carolina, Chapel Hill, NC, United States;Endocrine Laboratory, Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, Munich, Germany;Neuroendocrine & Pituitary Tumor Clinical Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States;

关键词: somapacitan;    growth hormone;    adult growth hormone deficiency;    insulin-like growth factor I;    treatment recommendations;    pharmacokinetic/pharmacodynamic modelling;    long-acting growth hormone;   

DOI  :  10.3389/fendo.2022.1040046

 received in 2022-09-08, accepted in 2022-12-12,  发布年份 2022

来源: Frontiers

【 摘 要 】

Adult growth hormone deficiency (AGHD) is a rare endocrine disorder characterized by an abnormal body composition, metabolic abnormalities associated with increased cardiovascular diseases, bone loss, and impaired quality of life. Daily subcutaneous injections with recombinant growth hormone (GH) can alleviate the abnormalities associated with AGHD. Several long-acting GH (LAGH) preparations are currently in development that aim to reduce treatment burden for patients receiving daily GH injections. Somapacitan (Sogroya®; Novo Nordisk, Denmark) is the first LAGH preparation that has been approved for treatment of AGHD in the United States, Europe, and Japan. The recent approval of somapacitan and anticipated approval of other LAGH molecules presents new questions for physicians planning to treat AGHD with LAGH in the future. Differences in the technologies used to prolong the half-life of recombinant GH are expected to result in variations in pharmacokinetic and pharmacodynamic profiles between preparations. Therefore, it is essential that physicians understand and consider such variations when treating patients with these novel GH replacement therapies. Here, we present a set of treatment recommendations that have been created to guide physicians initiating therapy with somapacitan in patients with AGHD who are eligible for GH replacement. Furthermore, we will review the published data that underlie these recommendations to explain the rationale for the treatment and monitoring advice provided.

【 授权许可】

Unknown   
Copyright © 2022 Bidlingmaier, Biller, Clemmons, Jørgensen, Nishioka and Takahashi