Conclusions There is no evidence to support differences in the effects of long-acting GH compared with those of daily GH .
Purpose Long-acting growth hormone ( GH ) has been developed to address the noncompliance and decreased efficacy associated with daily GH injections .
We aim ed to evaluate the efficacy and safety of long-acting GH replacement therapy in children with short stature .
Three-year efficacy and safety of LB03002, a once-weekly sustained-release growth hormone (GH) preparation, in prepubertal children with GH deficiency (GHD).
BACKGROUND GH treatment currently requires daily sc injections , result ing in suboptimal compliance . A GH regimen with fewer injections may offer patients and caregivers a less arduous option . LB03002 is a novel sustained-release GH formulation for once-weekly dosing . PATIENTS AND METHODS GH-deficient , GH-naive prepubertal children were r and omized to four groups who received 0.2 mg/kg/wk LB03002 for 12 months , followed by 0.5 mg/kg/wk for another 24 months ( n=13 ) ; 0.5 mg/kg/wk LB03002 for 36 months ( n=13 ) ; 0.7 mg/kg/wk LB03002 for 12 months , followed by 0.5 mg/kg/wk for another 24 months ( n=13 ) ; or daily GH 0.03 mg/kg/d for 24 months , switched to 0.5 mg/kg/wk LB03002 for 12 months ( n = 12 ) . RESULTS Height velocity increased in all groups ; the increase was less for the 0.2 mg/kg/wk LB03002 group at 12 ( P = 0.008 ) and 24 months ( P = 0.030 ) , with no statistically significant differences at any time for the 0.5 mg/kg/wk and 0.7 mg/kg/wk LB03002 groups , vs. daily GH . Height sd score gain at 12 months was significantly ( P = 0.023 ) less for the 0.2 mg/kg/wk group ( 1.05 ± 0.38 ) than daily GH ( 1.47 ± 0.29 ) , but with no statistically significant difference for the 0.5 mg/kg/wk ( 1.37 ± 0.39 ) and 0.7 mg/kg/wk ( 1.50 ± 0.44 ) LB03002 groups vs. daily GH . There were no significant differences in height sd score gain between any groups at 24 and 36 months . Bone maturation did not differ for any LB03002 dose compared with daily GH . Serum IGF-I concentrations increased as expected , with no long-term differences between groups . Mean fasting glucose and glycosylated hemoglobin concentrations did not exceed normal ranges for any treatment group at any time . CONCLUSION LB03002 at doses of 0.5 mg/kg/wk and 0.7 mg/kg/wk was shown to be effective and safe with once-weekly dosing in GH-deficient children , and 0.5 mg/kg/wk LB03002 was chosen as the optimal dose for long-term assessment
Conclusions There is no evidence to support differences in the effects of long-acting GH compared with those of daily GH .
Purpose Long-acting growth hormone ( GH ) has been developed to address the noncompliance and decreased efficacy associated with daily GH injections .
We aim ed to evaluate the efficacy and safety of long-acting GH replacement therapy in children with short stature .