Safety of current recombinant human growth hormone treatments for adults with growth hormone deficiency and unmet needs

Höybye, Charlotte; Beck‐Peccoz, Paolo; Şimşek, Suat; Zabransky, Markus; Zouater, Hichem; Stalla, Günter; Murray, Robert

doi:10.1080/14740338.2020.1839410

Cited by 11 publications

(14 citation statements)

References 89 publications

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“…Furthermore, GH and IGF-I have mitogenic and anti-apoptotic properties and might induce tumorigenesis. The most common side effects of GH treatment are transient oedema, muscle pain, and headache, usually related to GH dose [ 18 ]. In general, these side effects are related to GH and IGF-I levels, age, and gender, with younger individuals and women needing higher doses than older individuals and men.…”

Section: Discussionmentioning

confidence: 99%

“…Of note, GH doses were higher in young individuals, particularly in some of the young women. GH treatment might lead to a decrease in cortisol and thyroxine levels [ 18 ]. In this study, morning cortisol and thyroid hormone levels were normal but, as this is not a longitudinal study, we were unable to see if the levels had changed over time.…”

Section: Discussionmentioning

confidence: 99%

“…GH induces insulin resistance by the stimulation of glycogenolysis and lipolysis and the inhibition of glycogenesis and lipogenesis; therefore, GH treatment would be expected to increase blood glucose and improve the lipid profile. Large observational studies of GH-treated adults without PWS have found either no increase or a mild increase in fasting blood glucose and reduced levels of LDL-cholesterol [ 18 ]. In accordance, a recent meta-analysis demonstrated that, in studies with a shorter duration (6–12 months), glucose metabolism, including fasting glucose, fasting insulin, and insulin resistance (HOMA-IR), deteriorated.…”

Section: Discussionmentioning

confidence: 99%

“…Daily injections might be inconvenient, painful, or distressing and lead to poor adherence [ 29 ]. The poor adherence has been a major incentive for the development of long-acting GH preparations (LAGH), with the hypothesis that fewer injections would increase the adherence and thereby the efficacy [ 18 ]. Several different formulations for prolonging the duration of the GH injection for one to two weeks have been developed and are in different study phases or have been registered [ 30 ].…”

Section: Discussionmentioning

confidence: 99%

“…Several different formulations for prolonging the duration of the GH injection for one to two weeks have been developed and are in different study phases or have been registered [ 30 ]. LAGH preparations have different pharmacokinetics and pharmacodynamics compared to daily GH, and there may be efficacy, dosing, and safety issues specific to these formulations that are still unsolved, especially for long-term use [ 18 , 30 ]. However, no differences in efficacy or short-term safety have been observed [ 18 , 31 ].…”

Section: Discussionmentioning

confidence: 99%

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Twenty Years of GH Treatment in Adults with Prader-Willi Syndrome

Sjöström

Höybye

2021

JCM

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Prader-Willi syndrome (PWS) is a rare neurodevelopmental genetic disorder. In adults, the syndrome is characterised by muscular hypotonia, a different body composition with more body fat than muscle mass, hyperphagia, behavioural problems, and cognitive dysfunction. Endocrine deficiencies are common, including growth hormone (GH) deficiency. Here, we present data from a cross-sectional study in adults with PWS with a focus on the long-term safety of GH treatment. A total of 22 patients (14 men) were treated with GH for a median of 20 years. Data on body composition, hormones, and metabolic parameters were retrieved from the patients’ medical records. The median age was 27 years. The median GH dose was 0.5 mg/day. Insulin-like growth factor 1 (IGF-I) and blood lipids were normal, while fasting glucose and HbA1c were slightly elevated in three men with diabetes. Fat mass was less than fat free mass in all, though this was less pronounced in women. GH treatment did not negatively affect the metabolic profile, and none developed cardiovascular diseases or cancer. All adults on long-term GH treatment had a normal body composition and our results indicate that treatment was safe. However, PWS is a complex, multisystemic disease and continuous, individual considerations are required during GH treatment, especially in patients with risk factors for adverse effects.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Twenty Years of GH Treatment in Adults with Prader-Willi Syndrome

Sjöström

Höybye

2021

JCM

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Safety of growth hormone (GH) treatment in GH deficient children and adults treated for cancer and non-malignant intracranial tumors—a review of research and clinical practice

et al. 2021

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Individuals surviving cancer and brain tumors may experience growth hormone (GH) deficiency as a result of tumor growth, surgical resection and/or radiotherapy involving the hypothalamic-pituitary region. Given the pro-mitogenic and anti-apoptotic properties of GH and insulin-like growth factor-I, the safety of GH replacement in this population has raised hypothetical safety concerns that have been debated for decades. Data from multicenter studies with extended follow-up have generally not found significant associations between GH replacement and cancer recurrence or mortality from cancer among childhood cancer survivors. Potential associations with secondary neoplasms, especially solid tumors, have been reported, although this risk appears to decline with longer follow-up. Data from survivors of pediatric or adult cancers who are treated with GH during adulthood are scarce, and the risk versus benefit profile of GH replacement of this population remains unclear. Studies pertaining to the safety of GH replacement in individuals treated for nonmalignant brain tumors, including craniopharyngioma and non-functioning pituitary adenoma, have generally been reassuring with regards to the risk of tumor recurrence. The present review offers a summary of the most current medical literature regarding GH treatment of patients who have survived cancer and brain tumors, with the emphasis on areas where active research is required and where consensus on clinical practice is lacking.

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Comparing treatment with daily and long-acting growth hormone formulations in adults with growth hormone deficiency: Challenging issues, benefits, and risks

Höybye

2023

Best Practice & Research Clinical Endocrinology & Metab

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Safety of current recombinant human growth hormone treatments for adults with growth hormone deficiency and unmet needs

Cited by 11 publications

References 89 publications

Twenty Years of GH Treatment in Adults with Prader-Willi Syndrome

Twenty Years of GH Treatment in Adults with Prader-Willi Syndrome

Safety of growth hormone (GH) treatment in GH deficient children and adults treated for cancer and non-malignant intracranial tumors—a review of research and clinical practice

Comparing treatment with daily and long-acting growth hormone formulations in adults with growth hormone deficiency: Challenging issues, benefits, and risks

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