%0 Journal Article
%T [Safety and efficacy of growth hormone treatment: GeNeSIS study in Spain].
%A Luzuriaga Tomás C
%A Oyarzabal Irigoyen M
%A Caveda Cepas E
%A Vázquez Salvi LA
%A García-Pérez LE
%A  
%J An Pediatr (Barc)
%V 84
%N 3
%D Mar 2016
%M 26139238
%F 2.377
%R 10.1016/j.anpedi.2015.05.002
%X <B>BACKGROUND: </B>Country-specific information on pediatric GH therapy is available from multi-national studies.<BR><B>METHODS: </B>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%).<BR><B>RESULTS: </B>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.<BR><B>CONCLUSIONS: </B>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.