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Weekly growth hormone regimen shows promise

Peter F. J Clin Endocrinol Metab. 2011;doi:10.1210/jc.2011-2234.

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A weekly sustained-release growth hormone formulation demonstrated safety and efficacy compared with daily injections in a cohort of prepubertal children, according to study results.

The study was conducted to determine whether the capacity of LB03002 as a once-weekly dosing option of sustained-release GH may offer patients relief from daily injections. The researchers hypothesized that a less rigorous dosing schedule could increase compliance.

Eligible participants were prepubertal children who were GH-deficient and GH-naive. They were randomly assigned to receive the following regimens:

• 0.2 mg/kg/week LB03002 for 12 months, followed by 0.5 mg/kg/week for another 24 months (n=13).
• 0.5 mg/kg/week LB03002 for 36 months (n=13).
• 0.7 mg/kg/week LB03002 for 12 months, followed by 0.5 mg/kg/week for another 24 months (n=13).
• Daily GH 0.03 mg/kg/day for 24 months, switched to 0.5 mg/kg/week LB03002 for 12 months (n=12).

Children in all groups experienced increases in height velocity. Compared with the daily regimen, a smaller increase was observed in the group receiving 0.2 mg/kg/week LB03002 at 12 (P=.008) and 24 months (P=.030). There were no statistically significant differences at any time point between daily GH and 0.5 mg/kg/week and 0.7 mg/kg/week LB03002 groups.

Children in the 0.2 mg/kg/week group had a significantly lower height standard deviation score gain at 12 months than daily GH (1.05 ± 0.38 vs. 1.47 ± 0.29; P=.023). No statistically significant difference was observed in height standard deviation score gain at 12 months for the 0.5 mg/kg/week (1.37 ± 0.39) and 0.7 mg/kg/week (1.50 ± 0.44) LB03002 groups vs. daily GH, according to the results.

Twenty-four and 36-month results indicated no significant differences in height standard deviation score gain between any groups. Also, no differences in bone maturation were observed for any of the studied regimens compared with the daily regimen.

There were no long-term differences between groups in serum insulin-like growth factor I concentrations. Those concentrations increased as expected. No treatment groups experienced mean fasting glucose and glycosylated hemoglobin concentrations that exceeded normal ranges.

The researchers said doses of 0.5 mg/kg/week and 0.7 mg/kg/week LB03002 may be safe and effective in this population of children, adding that the 0.5 mg/kg/week-dose was chosen as the optimal dose for long-term assessment.

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