Long-term follow up of carbohydrate metabolism and adverse events after termination of Omnitrope(R) treatment in children born small for gestational age
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064203%3A_____%2F21%3A10427712" target="_blank" >RIV/00064203:_____/21:10427712 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11130/21:10427712
Result on the web
<a href="https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=~2m7Izj-MB" target="_blank" >https://verso.is.cuni.cz/pub/verso.fpl?fname=obd_publikace_handle&handle=~2m7Izj-MB</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1177/20420188211013121" target="_blank" >10.1177/20420188211013121</a>
Alternative languages
Result language
angličtina
Original language name
Long-term follow up of carbohydrate metabolism and adverse events after termination of Omnitrope(R) treatment in children born small for gestational age
Original language description
Background: Recombinant human growth hormone (rhGH) therapy can affect carbohydrate metabolism and lead to impaired glucose tolerance during treatment. In addition, short children born small for gestational age (SGA) are predisposed to metabolic abnormalities. This study assessed the long-term safety of rhGH (Omnitrope(R)) use in short children born SGA. Methods: This was a follow-up observational study of patients from a phase IV study. The baseline visit was the final visit of the phase IV study. Further visits were planned after 6 months (F1), 1 year (F2), 5 years (F3), and 10 years (F4). The primary objective was to evaluate the long-term effect of rhGH treatment on the development of diabetes mellitus; secondary objectives included incidence/severity of adverse events (AEs). Results: In total, 130 subjects were enrolled in the follow-up study; 99 completed F1, 88 completed F2, and 13 completed F3 (no subject reached F4). The full analysis set for evaluation comprised 118 patients (64 female). Mean (standard deviation) duration of follow up was 39.6 (24.4) months. No subject was newly diagnosed with diabetes. The results for carbohydrate metabolism parameters were consistent with this finding. A total of 144 AEs were reported in 54 subjects; these were mostly of mild-to-moderate intensity (96.5%) and not suspected to be related to previous rhGH treatment (94.4%). Serious AEs (n = 18) were reported in eight patients; three (in one patient) were suspected as possibly related to previous rhGH treatment (anemia, menorrhagia, oligomenorrhoea). One fatal event occurred (sepsis), which was judged as not related to previous rhGH treatment. Conclusions: None of the participating subjects, who had all been previously treated with Omnitrope(R) in a phase IV study, developed diabetes during this follow-up study. In addition, no other unexpected or concerning safety signals were observed.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30209 - Paediatrics
Result continuities
Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2021
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
Therapeutic Advances in Endocrinology and Metabolism
ISSN
2042-0188
e-ISSN
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Volume of the periodical
12
Issue of the periodical within the volume
May
Country of publishing house
US - UNITED STATES
Number of pages
10
Pages from-to
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UT code for WoS article
000756302300001
EID of the result in the Scopus database
2-s2.0-85105485713