[Safety and efficacy of growth hormone treatment: GeNeSIS study in Spain]

C Luzuriaga Tomás1, M Oyarzabal Irigoyen2, E Caveda Cepas3

  • 1Unidad de Endocrinología Pediátrica, Hospital Marqués de Valdecilla, Santander, Cantabria, España.

Insights

Pediatric growth hormone (GH) therapy in Spain improved height gain in children with GH deficiency (GHD). The treatment demonstrated a favorable safety profile, consistent with established knowledge of GH therapy.

Area of Science:

  • Pediatric Endocrinology
  • Growth Hormone Therapy
  • Clinical Research

Background:

  • Multi-national studies provide country-specific data on pediatric growth hormone (GH) therapy.
  • The Genetics and Neuroendocrinology of Short-stature International Study (GeNeSIS) collected data in Spain.

Purpose of the Study:

  • To assess the effectiveness and safety of GH replacement therapy in a Spanish pediatric cohort.
  • To analyze height gain and adverse events associated with GH treatment in children.

Main Methods:

  • An observational study enrolled 1294 children in Spain (GeNeSIS).
  • GH therapy effectiveness was evaluated in children with GH deficiency (GHD).
  • Adverse events were monitored in all GH-treated patients.

Main Results:

  • GH therapy significantly increased height velocity and improved height standard deviation score (SDS) over 4 years in children with GHD.
  • Final height SDS was close to target height SDS.
  • The incidence of treatment-emergent adverse events was 8.1%, with a low rate of serious GH-related events.

Conclusions:

  • GH replacement therapy is effective in improving height gain for pediatric patients in Spain.
  • The safety profile of GH therapy in this cohort aligns with previously reported data.
Abstract

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