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Hoybye, Charlotte; Beck-Peccoz, Paolo; Simsek, Suat; Zabransky, Markus; Zouater, Hichem; Stalla, Guenter and Murray, Robert D. (2020): Safety of current recombinant human growth hormone treatments for adults with growth hormone deficiency and unmet needs. In: Expert Opinion on Drug Safety, Vol. 19, No. 12: pp. 1539-1548

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Abstract

Introduction: Growth hormone (GH) deficiency (GHD) in adults is characterized by abnormal body composition, unfavorable cardiovascular risk factors, and poor quality of life. The diagnosis is made within appropriate clinical settings and according to established guidelines. Numerous studies have shown that GH treatment improves body composition, cardiovascular risk factors, physical capacity, and quality of life while issues on safety, in particular long-term safety, remain. Areas covered Short- and long-term safety of GH replacement in adults with GHD. Expert opinion Adults with GHD are an inhomogeneous group of patients and GH replacement requires individual considerations. Most adverse effects are mild and transient and related to fluid retention and GH dose. In patients without comorbidities long-term GH treatment is safe and development of diabetes, cardiovascular disease, or tumors are not increased. Furthermore, mortality is not increased. Patients with risk factors should be identified before GH treatment is initiated and an optimal balance between benefit and risk established. Studies with sufficient duration and power to identify the development of cardiovascular diseases and cancers are still awaited. Effective management of comorbidities can be expected to decrease morbidity and mortality and improve quality of life. Studies with long-acting GH formulations are ongoing and available data indicate similar effects and short-time safety.

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