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Study results: Effects of GH treatment on SGA children treated until reaching their final height
Adapted from Dahlgren J, et al. 2005.3
Study methods3
Observational study of 77 prepubertal short children born SGA (−2 SD birth weight or length; mean age 10.7 years) in which patients received 0.033 mg/kg/day GH treatment until final height is reached (1 year after height velocity <1 cm/year). During puberty, 28 children were randomised to receive 66 μg/kg/day GH. Children were subdivided according to the duration of GH treatment before puberty (>2 years [n=36] and <2 years [n=41]). Growth response was compared with a comparison group of 34 untreated short prepubertal SGA children. The values are the means ± SE. Mid-parental height SD score.
Study findings
GH normalised final height in short children born SGA, allowing most patients (86%) to reach their target final height.3
Adverse events in the long-term treatment of children with growth disturbance due to born SGA (Clinical trials)2
Local product document, Somatropin 5.3 mg and 12 mg formulation, Genotropin : Version LPDGEN072022.
*Reported in GH-deficient children treated with somatropin, but the incidence appears to be similar to that in children without GHD.
†In general, these adverse effects are mild to moderate, arise within the first months of treatment and subside spontaneously or with dose reduction. The incidence of these adverse effects is related to the administered dose, the age of the patients and possibly inversely related to the age of the patients at the onset of GHD.
‡Transient injection site reactions in children have been reported.
§Clinical significance is unknown.
ADR, adverse drug reaction; BMD, bone mineral density; GH, growth hormone; GHD, growth hormone deficiency; HDL, high-density lipoprotein; LDL, low-density lipoprotein; QoL, quality of life; SD, standard deviation; SE, standard error; SGA, small for gestational age; TS, Turner syndrome.
References:
PP-GEN-IND-0942 June 2023
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