PMID- 34104396
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20220423
IS  - 2042-0188 (Print)
IS  - 2042-0196 (Electronic)
IS  - 2042-0188 (Linking)
VI  - 12
DP  - 2021
TI  - Long-term follow up of carbohydrate metabolism and adverse events after 
      termination of Omnitrope(R) treatment in children born small for gestational age.
PG  - 20420188211013121
LID - 10.1177/20420188211013121 [doi]
LID - 20420188211013121
AB  - 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.
CI  - (c) The Author(s), 2021.
FAU - Walczak, Mieczyslaw
AU  - Walczak M
AD  - Department of Pediatrics, Endocrinology, Diabetology, Metabolic Diseases and 
      Cardiology of the Developmental Age, Pomeranian Medical University, Szczecin, 
      Zachodniopomorskie, Poland.
FAU - Szalecki, Mieczyslaw
AU  - Szalecki M
AD  - Collegium Medicum UJK, Kielce, Children's Memorial Health Institute, Warsaw, 
      Poland.
FAU - Horneff, Gerd
AU  - Horneff G
AD  - Department of Pediatrics, Center for Pediatric Rheumatology, Asklepios Clinic 
      Sankt Augustin, Sankt Augustin, Germany.
FAU - Lebl, Jan
AU  - Lebl J
AD  - Department of Pediatrics, Charles University and University Hospital Motol, 
      Prague, Czech Republic.
FAU - Kalina-Faska, Barbara
AU  - Kalina-Faska B
AD  - Department of Pediatrics and Pediatric Endocrinology, Medical University of 
      Silesia, Faculty of Medical Science, Katowice, Slaskie, Poland.
FAU - Giemza, Tomasz
AU  - Giemza T
AD  - Sandoz Poland, Warsaw, Poland.
FAU - Moldovanu, Florentina
AU  - Moldovanu F
AD  - National Institute for Mother and Child Health, 'Alessandrescu Rusescu', 
      Bucharest, Romania.
FAU - Nanu, Michaela
AU  - Nanu M
AD  - National Institute for Mother and Child Health, 'Alessandrescu Rusescu', 
      Bucharest, Romania.
FAU - Zouater, Hichem
AU  - Zouater H
AUID- ORCID: 0000-0002-6572-8946
AD  - Sandoz Biopharmaceuticals, Hexal AG, Industriestr. 18/5, Holzkirchen D-83607, 
      Germany.
LA  - eng
PT  - Journal Article
DEP - 20210505
PL  - United States
TA  - Ther Adv Endocrinol Metab
JT  - Therapeutic advances in endocrinology and metabolism
JID - 101532143
PMC - PMC8111548
OTO - NOTNLM
OT  - growth hormone
OT  - paediatrics
OT  - recombinant human growth hormone
OT  - small for gestational age
COIS- Conflict of interest statement: MS has been involved in clinical trials for, and 
      received consultancy and speaker's fees from, Novo Nordisk, Pfizer, AstraZeneca, 
      and Sandoz. MW has received fees from Sandoz as the country coordinating 
      investigator for the study in Poland. JL has been involved in clinical trials 
      for, and received consultancy and speaker's fees from, Pfizer, Novo Nordisk, 
      Merck, and Sandoz. FM, MN, GH and BKF have no relevant financial or non-financial 
      interests to disclose. TG and HZ are employees of Sandoz Biopharmaceuticals.
EDAT- 2021/06/10 06:00
MHDA- 2021/06/10 06:01
PMCR- 2021/05/05
CRDT- 2021/06/09 06:46
PHST- 2020/11/25 00:00 [received]
PHST- 2021/04/08 00:00 [accepted]
PHST- 2021/06/09 06:46 [entrez]
PHST- 2021/06/10 06:00 [pubmed]
PHST- 2021/06/10 06:01 [medline]
PHST- 2021/05/05 00:00 [pmc-release]
AID - 10.1177_20420188211013121 [pii]
AID - 10.1177/20420188211013121 [doi]
PST - epublish
SO  - Ther Adv Endocrinol Metab. 2021 May 5;12:20420188211013121. doi: 
      10.1177/20420188211013121. eCollection 2021.