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

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) ca...

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Main Authors: Martin Bidlingmaier, Beverly M.K. Biller, David Clemmons, Jens Otto L. Jørgensen, Hiroshi Nishioka, Yutaka Takahashi
Format: Article
Language:English
Published: Frontiers Media S.A. 2022-12-01
Series:Frontiers in Endocrinology
Subjects:
Online Access:https://www.frontiersin.org/articles/10.3389/fendo.2022.1040046/full
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author Martin Bidlingmaier
Beverly M.K. Biller
David Clemmons
Jens Otto L. Jørgensen
Hiroshi Nishioka
Yutaka Takahashi
Yutaka Takahashi
author_facet Martin Bidlingmaier
Beverly M.K. Biller
David Clemmons
Jens Otto L. Jørgensen
Hiroshi Nishioka
Yutaka Takahashi
Yutaka Takahashi
author_sort Martin Bidlingmaier
collection DOAJ
description 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.
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spelling doaj.art-342be24d33884ae4b11fbb92d31b1fed2023-03-03T16:47:03ZengFrontiers Media S.A.Frontiers in Endocrinology1664-23922022-12-011310.3389/fendo.2022.10400461040046Guidance for the treatment of adult growth hormone deficiency with somapacitan, a long-acting growth hormone preparationMartin Bidlingmaier0Beverly M.K. Biller1David Clemmons2Jens Otto L. Jørgensen3Hiroshi Nishioka4Yutaka Takahashi5Yutaka Takahashi6Endocrine Laboratory, Medizinische Klinik und Poliklinik IV, Klinikum der Universität München, Munich, GermanyNeuroendocrine & Pituitary Tumor Clinical Center, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United StatesDepartment of Medicine, University of North Carolina, Chapel Hill, NC, United StatesDepartment of Endocrinology and Internal Medicine, Aarhus University Hospital, Aarhus, DenmarkDepartment of Hypothalamic and Pituitary Surgery, Toranomon Hospital, Tokyo, JapanDepartment of Diabetes and Endocrinology, Nara Medical University, Kashihara, JapanDivision of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, JapanAdult 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.https://www.frontiersin.org/articles/10.3389/fendo.2022.1040046/fullsomapacitangrowth hormoneadult growth hormone deficiencyinsulin-like growth factor Itreatment recommendationspharmacokinetic/pharmacodynamic modelling
spellingShingle Martin Bidlingmaier
Beverly M.K. Biller
David Clemmons
Jens Otto L. Jørgensen
Hiroshi Nishioka
Yutaka Takahashi
Yutaka Takahashi
Guidance for the treatment of adult growth hormone deficiency with somapacitan, a long-acting growth hormone preparation
Frontiers in Endocrinology
somapacitan
growth hormone
adult growth hormone deficiency
insulin-like growth factor I
treatment recommendations
pharmacokinetic/pharmacodynamic modelling
title Guidance for the treatment of adult growth hormone deficiency with somapacitan, a long-acting growth hormone preparation
title_full Guidance for the treatment of adult growth hormone deficiency with somapacitan, a long-acting growth hormone preparation
title_fullStr Guidance for the treatment of adult growth hormone deficiency with somapacitan, a long-acting growth hormone preparation
title_full_unstemmed Guidance for the treatment of adult growth hormone deficiency with somapacitan, a long-acting growth hormone preparation
title_short Guidance for the treatment of adult growth hormone deficiency with somapacitan, a long-acting growth hormone preparation
title_sort guidance for the treatment of adult growth hormone deficiency with somapacitan a long acting growth hormone preparation
topic somapacitan
growth hormone
adult growth hormone deficiency
insulin-like growth factor I
treatment recommendations
pharmacokinetic/pharmacodynamic modelling
url https://www.frontiersin.org/articles/10.3389/fendo.2022.1040046/full
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