ECE2019 Poster Presentations Pituitary and Neuroendocrinology 1 (72 abstracts)
1University Hospital, Universitätsmedizin Mainz, der Johannes Gutenberg-Universität, Mainz, Germany; 2Novo Nordisk Healthcare AG, Zürich, Switzerland; 3Department of Endocrinology and Department of Molecular Medicine and Surgery, Karolinska University Hospital and Karolinska Institute, Stockholm, Sweden.
Czech Republic background: NordiNet® IOS (NCT00960128), a non-interventional study (20062016), assessed the effectiveness and safety of real-life treatment with Norditropin. From 23 countries, 2,321 adults with GHD were included; 971, GH-naïve at baseline, were included in the effectiveness analysis set (EAS). Baseline characteristics in the six largest contributing countries were evaluated.
Methods: Patient information was entered at routine clinic visits by participating physicians. EAS baseline data are presented (Table 1).
Results: Proportionally more females than males were enrolled in France and Czech Republic versus other countries. Patients were older in Sweden, Germany and UK; males were older than females except in France and Czech Republic. Mean baseline IGF-I SDS was below 0 across all countries. Mean GH peak was lower in males than in females and varied across countries. Mean BMI (kg/m2) was >25 across all countries. Average baseline GH dose was lowest in Sweden, highest in UK (females) and lowest in Sweden, highest in France (males).
Germany | Sweden | Denmark | France | UK | Czech Republic | |
N (% of patients enrolled) | 389 (40) | 199 (20) | 151 (16) | 72 (7) | 41 (4) | 37 (4) |
Females (%) | 44 | 42 | 37 | 65 | 46 | 54 |
Age (years) | 48.1 [14.7]: 50.1 [14.8] | 49.8 [13.7]: 53.5 [13.6] | 43.4[13.9]:49.6[13.4] | 43.3 [11.6]: 38.6 [13.5] | 46.6 [14.2]:52.1 [13.2] | 45.4 [9.0]: 42.5 [12.8] |
IGF-I SDS | 1.25 [1.54]: 1.32 [1.68] | 1.05 [1.14]: 0.91 [1.29] | 0.55 [1.29]:0.70 [1.02] | 0.71 [1.62]: 0.75 [2.19] | 1.01 [0.94]:1.02 [2.91] | 1.09 [1.58]: 0.94 [1.26] |
GH peak (ng/mL) | 1.83 [3.41]: 1.49 [1.79] | 5.07 [8.34]: 2.04 [2.04] | 1.52 [1.92]:0.97 [1.34] | 3.01 [3.46]: 1.35 [1.55] | 4.01 [9.16]:0.58 [0.90] | 1.10 [1.87]: 0.74 [0.77] |
Waist circumference (cm) | 98.16 [16.63]: 103.00 [13.77] | 97.32[14.41]:102.90[12.04] | 92.21 [20.64]:106.5 [13.86] | 94.60 [14.51]:100.70 [14.62] | 93.00 [7.78]:114.00 [11.14] | 92.38 [15.95]:91.30 [9.37] |
BMI (kg/m2) | 28.85 [6.63]: 29.47 [5.50] | 28.93 [5.84]: 28.51 [4.94] | 27.64 [6.77]:28.79 [4.84] | 29.62 [8.16]: 29.65 [5.92] | 29.35 [6.85]:31.90 [5.30] | 29.98 [9.86]:25.62 [4.66] |
Average baseline GH dose (mg/kg/day) | 0.23 [0.16]: 0.24 [0.15] | 0.17 [0.13]: 0.16 [0.12] | 0.30 [0.15]:0.27 [0.21] | 0.28 [0.10]: 0.29 [0.15] | 0.31 [0.19]:0.25 [0.07] | 0.24 [0.20]: 0.26 [0.21] |
Baseline values, mean [SD] for females:males unless shown as N or %. |
Conclusions: This report on adult patients enrolled in NordiNet IOS revealed variations in baseline characteristics, suggesting that national diagnostic and clinical characteristics may affect the country-specific profiles of GHD in adults.