Table 2.
Efficacy results in both treatment groups (per-protocol set).
Study group (Growtropin-II) (n = 24) | Control group (Genotropin) (n = 28) | P value | |
ΔaHV at Wk 52 (cm/year) | 5.28 ± 2.03 | 4.63 ± 6.19 | .65 ± 2.12∗ [−0.53,1.83]† |
Ht-SDS | |||
Baseline | −2.70 ± 0.83 | -2.62 ± 0.64 | .8472 |
Wk 26 | 0.70 ± 0.20 | 0.65 ± 0.19 | .3583 |
Wk 52 | 1.23 ± 0.33 | 1.10 ± 0.28 | .1894 |
Skeletal maturity | |||
Baseline (BA/CA) | 0.76 ± 0.13 | 0.77 ± 0.13 | .8007 |
Wk 26 (ΔBA/ΔCA) | 0.60 ± 0.71 | 1.00 ± 0.80 | .0840 |
Week 52 (ΔBA/ΔCA) | 0.97 ± 0.50 | 1.11 ± 0.49 | .3056 |
IGF-1 (ng/mL) | |||
Baseline | 108.72 ± 51.82 | 122.75 ± 52.68 | .2364 |
ΔIGF-1 at Wk 26 | 162.59 ± 73.76 | 158.50 ± 116.60 | .4246 |
ΔIGF-1 at Wk 52 | 180.95 ± 85.84 | 190.64 ± 87.39 | .6896 |
IGF-1 SDS | |||
Baseline | -0.81 ± 0.83 | -0.53 ± 0.67 | .1824 |
Wk 26 | 1.61 ± 1.43 | 1.85 ± 2.03 | .5508 |
Wk 52 | 1.47 ± 1.21 | 2.14 ± 1.98 | .3399 |
IGFBP-3 (μg/mL) | |||
Baseline | 3.21 ± 0.55 | 3.36 ± 0.66 | .4045 |
ΔIGFBP-3 at Wk 26 | 1.39 ± 0.70 | 1.26 ± 0.78 | .5046 |
ΔIGFBP-3 at Wk 52 | 1.91 ± 0.76 | 1.60 ± 0.84 | .1681 |