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Comparative Analysis of Human Growth Hormone in Serum Using SPRi, Nano-SPRi and ELISA Assays
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Monitoring rhGH Safety: rhGH Registries, SAGhE and Future Needs

Bradley S Miller1, Ron G Rosenfeld2

  • 1Division of Endocrinology, Department of Pediatrics, University of Minnesota Masonic Children's Hospital, Minneapolis, Minnesota, USA,

Pediatric Endocrinology Reviews : PER
|November 1, 2018
PubMed

Insights

Recombinant human growth hormone (rhGH) therapy shows an excellent safety profile in children and adults, with no increased mortality risk when adjusted for birth size. Long-acting growth hormone (LAGH) offers future safety study opportunities.

Area of Science:

  • Pediatric Endocrinology
  • Pharmacovigilance
  • Biologics Therapy

Background:

  • Extensive research exists on growth hormone (GH) therapy safety in pediatric populations.
  • Concerns regarding Creutzfeldt-Jacob disease transmission via pituitary-derived GH prompted rigorous safety surveillance for recombinant human GH (rhGH).

Purpose of the Study:

  • To evaluate the long-term safety profile of recombinant human GH (rhGH) therapy.
  • To assess potential safety concerns, including mortality risks, associated with rhGH treatment.
  • To explore the potential for long-term safety studies with new long-acting growth hormone (LAGH) products.

Main Methods:

  • Analysis of large Phase IV registries with over 600,000 patient-years of rhGH exposure.
  • Review of long-term safety data from adult cohorts treated with GH during childhood.
  • Examination of reported mortality risks and associated confounding factors.

Main Results:

  • rhGH demonstrates an excellent safety profile across extensive patient data.
  • Reported increased mortality risks were eliminated when corrected for small birth size.
  • Cerebrovascular disease mortality risk requires further investigation due to methodological limitations in existing studies.

Conclusions:

  • Recombinant human GH (rhGH) therapy is safe, with extensive data supporting its favorable risk-benefit profile.
  • Continued long-term safety monitoring is crucial, especially with the introduction of novel long-acting growth hormone (LAGH) formulations.

Keywords:
GrowthGrowth hormoneSafetyShort statureTreatment

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