Session: SUN 624-646-Growth: Clinical Trials & Observational Studies
Poster Board SUN-635
Methods: Sixty-five children born SGA (age 3–<8 years) received 0.033 mg/kg/day GH (n=31; 64.5% male; mean age 5.34 years; height SDS -3.00) or 0.067 mg/kg/day GH (n=34; 58.8% male; mean age 5.27 years; height SDS -2.83) for 260 weeks (5 years). Change from baseline (mean [SD]) was recorded for insulin-like growth factor-I (IGF-I) SDS, insulin-like growth factor binding protein-3 (IGFBP-3) SDS, glycosylated haemoglobin A1C (HbA1C), glucose, insulin, cholesterol, low density lipoprotein-cholesterol (LDL-c), high density lipoprotein-cholesterol (HDL-c), blood pressure (BP) (systolic/diastolic) and BMI. Treatment differences (0.067–0.033 mg/kg/day) (from baseline to 260 weeks) were analysed using ANOVA (mean [95% CI]); significance, p<0.05.
Results: Untreated SGA children were lean (mean range) (BMI 14.16–14.42 kg/m2), with normal BP (systolic 94.3–96.6 mmHg) and lipids (cholesterol 166.9–181.4 mg/dL; LDL-c 94.8–104.7 mg/dL; HDL-c 56.9–61.9 mg/dL). The mean increase in height SDS was significantly greater in the 0.067 than in the 0.033 mg/kg/day group (0.82 [0.51, 1.13]). Change from baseline was significantly greater in the high dose group for IGF-I (0.86 [0.17, 1.54]) but not IGFBP-3 (0.14 [-0.72, 1.00]) and both remained within normal limits (-2 to +2 SDS). During treatment BMI increased towards the normal range. Small non-significant increases in BP were observed. Cholesterol and LDL-c decreased from baseline in both groups and to a greater extent in the 0.067 than in the 0.033 mg/kg/day group (cholesterol -15.1 [-28.2, -2.1]) mg/dL; LDL-c -11.0 [-21.3, -0.6] mg/dL). HDL-c increased in both groups with a significantly greater change in the low dose than in the high dose group (-5.7 [-11.2, -0.2]). Insulin levels increased from baseline during treatment (0.033 mg/kg/day, 3.4 [2.0] to 9.4 [6.1]; 0.067 mg/kg/day, 3.1 [2.1] to 8.8 [4.9] μU/mL). At 260 weeks, blood glucose levels were unchanged from baseline. Mean HbA1C increased in both groups during treatment, but no subject had an HbA1C value above the reference range (4.6–6.2%).
Conclusions: Long-term GH therapy in short Japanese children born SGA was associated with a dose-dependent increase in height SDS. During treatment, positive changes in BMI and lipid levels were observed and no negative effects on BP or carbohydrate metabolism were reported.
Disclosure: AMK: Employee, Novo Nordisk. YO: Employee, Novo Nordisk. FK: Employee, Novo Nordisk. Nothing to Disclose: RH, TT, SY
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