title: [Safety and efficacy of growth hormone treatment: GeNeSIS study in Spain].
abstract: BACKGROUND
  Country-specific information on pediatric GH therapy is available from multi-national studies.
  
  
  METHODS
  A total of 1294 children in Spain enrolled in the observational Genetics and Neuroendocrinology of Short-stature International Study (GeNeSIS). Adverse events were assessed in all GH-treated patients (n=1267) and effectiveness in those with GH deficiency (GHD, 78%).
  
  
  RESULTS
  Mean age at time of entry to the study was 9.8 years. GH was initiated at a median (Q1-Q3) 0.22 (0.20-0.25) mg/kg/week and administered for 2.8 (1.6-4.4) years. For 262 patients with GHD and 4-year data, mean (95% CI) height velocity was 4.3 (4.1 - 4.6) cm/year at baseline, 9.0 (8.7 to 9.4) cm/year at 1-year, and 5.5 (5.2 to 5.8) cm/year at 4-years. Height standard deviation score (SDS) was -2.48 (-2.58 to -2.38) at baseline and -1.18 (-1.28 to -1.08) at 4 years. Final height SDS minus target height SDS (n=241) was -0.09 (-0.20 to 0.02). In 1143 GH-treated patients with ≥1 year follow-up, 93 (8.1%) reported treatment-emergent adverse events. Serious events were reported for 7 children, with 2 considered GH-related.
  
  
  CONCLUSIONS
  These data confirm the benefit of GH replacement therapy on height gain for the patients in Spain. The safety profile was consistent with that already known for GH therapy.
authors.affiliation: Unidad de Endocrinología Pediátrica, Hospital Marqués de Valdecilla, Santander, Cantabria, España.
authors.forename: C
authors.initials: C
authors.lastname: Luzuriaga Tomás
authors.affiliation: Unidad de Endocrinología Pediátrica, Complejo Hospitalario de Navarra, Pamplona, Navarra, España.
authors.forename: M
authors.initials: M
authors.lastname: Oyarzabal Irigoyen
authors.affiliation: Global Scientific Communications, Eli Lilly and Company, Alcobendas Madrid, España.
authors.forename: E
authors.initials: E
authors.lastname: Caveda Cepas
authors.affiliation: Departamento Médico, Eli Lilly and Company, Alcobendas Madrid, España.
authors.forename: L A
authors.initials: LA
authors.lastname: Vázquez Salvi
authors.affiliation: Global Medical Affairs, Eli Lilly and Company, Indianapolis, USA. Electronic address: leg@lilly.com.
authors.forename: L E
authors.initials: LE
authors.lastname: García-Pérez
mesh_terms: D001827:Body Height; D002648:Child; D006130:Growth Disorders / Q000188:drug therapy*; D019382:Human Growth Hormone / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D013030:Spain
chemical_list: D019382:Human Growth Hormone
keywords: Children; Crecimiento; Efectividad; Effectiveness; Final height; GH treatment; Growth; Niños; Safety; Seguridad; Short stature; Talla baja; Talla final; Tratamiento con GH