Long‐term safety of growth hormone—A combined registry analysis

Stochholm, Kirstine; Kieß, Wieland

doi:10.1111/cen.13502

Cited by 61 publications

(41 citation statements)

References 85 publications

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“…In PATRO Adults, development of neoplasms and diabetes mellitus was reported in 26 and 4 patients, respectively. Of note, a relationship between development of cancer (in 8 patients) or relapse of pituitary tumor and rhGH treatment was not suspected by the treating physician or study sponsor for any of the patients, consistent with observations in a previous review [25]. Regarding the onset of diabetes mellitus, rhGH treatment might impair glucose metabolism, especially in obese patients with a family history of diabetes mellitus.…”

Section: Discussionsupporting

confidence: 83%

Ten years with biosimilar rhGH in clinical practice in Sweden – experience from the prospective PATRO children and adult studies

et al. 2020

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Background: In 2007, Omnitrope® was the first biosimilar recombinant human growth hormone (rhGH) to be approved in Sweden for treatment in adults and children. Over 10 years' safety and effectiveness data for biosimilar rhGH can now be presented. Methods: PATRO Children and PATRO Adults are multicenter, longitudinal, observational, post-marketing surveillance studies. Eligible patients include children 0-18 years and adults receiving biosimilar rhGH treatment. Adverse events (AEs) are monitored for safety evaluation. Growth variables in children and metabolic data in adults are recorded for effectiveness evaluation. Results: As of January 2019, data from 136 children (48% male) were reported from Swedish centers. Mean age in rhGH treatment-naïve patients at study entry (n = 114) was 7.5 years, with mean 3.6 years treatment duration. No severe AEs of diabetes, impaired glucose tolerance, or malignancy were reported. The most frequently reported AE was nasopharyngitis (n = 16 patients). No clinically relevant anti-hGH or neutralizing antibodies were observed. The mean change from baseline in height standard deviation score (SDS) in naïve prepubertal GH deficiency patients was + 0.79 at 1 year, + 1.27 at 2 years, and + 1.55 at 3 years. Data from 293 adults (44% rhGH-naïve, 51% male) were included. Fatigue was the most frequently reported AE (n = 26 patients). The incidence of new neoplasms or existing neoplasm progression was 23.8 patients per 1000 patient-years. Type 2 diabetes mellitus was reported in four patients. At baseline in rhGH-naïve adults, mean (SD) body mass index (BMI) was 29.1 (5.6) kg/m 2 and mean (SD) insulin-like growth factor (IGF)-I SDS was − 3.0 (1.4). Mean daily dose increased from 0.1 mg at baseline to 0.3 mg after 4 years. IGF-I SDS normalized during the first year of treatment. Mean BMI and glucose were unchanged over 4 years, while low−/high-density lipoprotein cholesterol ratio decreased. Conclusions: For the first time, Swedish data from the PATRO Children and Adults studies are presented. The 10year data suggest that biosimilar rhGH is well tolerated across pediatric and adult indications. Safety and effectiveness were similar to previous reports for other rhGH preparations. These results need to be confirmed in larger cohorts, highlighting the importance of long-term post-marketing studies.

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Section: Discussionsupporting

confidence: 83%

Ten years with biosimilar rhGH in clinical practice in Sweden – experience from the prospective PATRO children and adult studies

et al. 2020

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“…In the present study, 23% of participants were children with Turner syndrome, PWS, CRF or CF or who were SGA. The present study, as well as others, suggests that GH may enhance the development of diabetes in predisposed participants [21]. People at high risk of diabetes such as children with a family history of diabetes, obesity, PWS, Turner syndrome, CF, MPHD and CRF need special attention.…”

Section: Discussionsupporting

confidence: 63%

Prevalence of diabetes among children treated with growth hormone in Israel

et al. 2019

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AimsTo determine the long-term risk of diabetes in a cohort of children treated with recombinant human growth hormone in Israel, using data from the Israeli National Diabetes Register.Methods Between 1988 and 2009, 2513 children were approved for growth hormone treatment. They were assigned to one of two groups. The first group included children treated for isolated growth hormone deficiency and who were small for gestational age and the second included those treated for multiple pituitary hormone deficiency, chronic renal failure, Turner syndrome or Prader-Willi syndrome. The cohort was cross-linked with the Israeli National Diabetes Register for 2014 (mean follow-up duration 12.1AE5.3 years), and prevalent cases of diabetes were identified. Standardized prevalence ratios for diabetes were calculated for people aged 10-29 years.Results In 2014, a total of 23 individuals were identified with diabetes (four with pre-existing diabetes, seven developed diabetes before age 17 years and 12 developed it at a later age). In the isolated growth hormone deficiency and small-forgestational-age group there was no difference in the prevalence of diabetes compared with the general population (standardized prevalence ratio 2.05, 95% CI 0.94-3.89). In the group that included people with multiple pituitary hormone deficiency, chronic renal failure, Turner syndrome and Prader-Willi syndrome there was a significantly higher diabetes prevalence (standardized prevalence ratio 11.94, 95% CI 6.53-20.00) compared with the general population.Conclusions No difference in diabetes prevalence was found in the isolated growth hormone deficiency and small-forgestational-age group, compared with the general population. Children treated with growth hormone with pre-existing risk factors had an increased prevalence of diabetes. It is advisable to monitor blood glucose levels closely during and after growth hormone treatment, especially in such children.

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“…Moreover, short-term treatments with GH are useful and safe, as we demonstrated previously, even in the case that the patient is not GH-deficient [6,26,27,60]. In addition, although GH replacement therapy has been related to the related to the future development of stroke [61], more recent studies rule out this possibility [62,63].…”

Section: Discussionmentioning

confidence: 76%

Cognitive Evolution of a Patient Who Suffered a Subarachnoid Haemorrhage Eight Years Ago, after Being Treated with Growth Hormone, Melatonin and Neurorehabilitation

Quintana¹,

Agra²,

Outeiral³

et al. 2018

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Abstract:To describe the cognitive evolution of a patient who suffered a subarachnoid haemorrhage resulting in a total loss of his cognitive functions. The patient was initially treated with GH (0.8 mg/day), melatonin (50 mg/day) and neurorehabilitation 1 year after his brain damage, during 3 months. Then continued with GH (0.5 mg/day, 6 months/year, during 2 years) and melatonin treatments and neurorehabilitation (3 days/week). 5 years later the patient came back to our Centre due to the absence of recent memory and personal and spatio-temporal orientation and he received an intensive specific neurorehabilitation, including EINA (Auditory Stimulation and Neurosensory Integration), together with GH (0.8 mg/day) and melatonin, for 6 months. At discharge of his first treatment period cognitive functions showed very poor changes but these had been improved when he came back 5 years later. A review carried out 8 years after SHA demonstrated that the patient significantly recovered in all the cognitive functions and he was able to live an independent life. GH plays a key role on cognition, including its actions on recent memory. Melatonin, in turn, helps as a neuroprotective agent. A specific neurostimulation must be performed so that the effects of GH can be expressed. Within neurostimulation, EINA seems to play a very important role for enhancing the effects of medical and rehabilitative treatments on brain plasticity.

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Long‐term safety of growth hormone—A combined registry analysis

Abstract: Patients with risk factors for malignancy or type 2 diabetes should be treated with caution and monitored during follow-up, but current published data provide reassurance on the long-term safety profile of GH in patients receiving GH treatment.

Cited by 61 publications

References 85 publications

Ten years with biosimilar rhGH in clinical practice in Sweden – experience from the prospective PATRO children and adult studies

Ten years with biosimilar rhGH in clinical practice in Sweden – experience from the prospective PATRO children and adult studies

Prevalence of diabetes among children treated with growth hormone in Israel

Cognitive Evolution of a Patient Who Suffered a Subarachnoid Haemorrhage Eight Years Ago, after Being Treated with Growth Hormone, Melatonin and Neurorehabilitation

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