PMID- 23515245
OWN - NLM
STAT- PubMed-not-MEDLINE
DCOM- 20130322
LR  - 20211021
IS  - 2042-0188 (Print)
IS  - 2042-0196 (Electronic)
IS  - 2042-0188 (Linking)
VI  - 4
IP  - 1
DP  - 2013 Feb
TI  - Design of, and first data from, PATRO Children, a multicentre, noninterventional 
      study of the long-term efficacy and safety of Omnitrope((R)) in children requiring 
      growth hormone treatment.
PG  - 3-11
LID - 10.1177/2042018813479644 [doi]
AB  - OBJECTIVE: To describe the rationale, design and first data from PATRO Children, 
      a postmarketing surveillance of the long-term efficacy and safety of somatropin 
      (Omnitrope((R))) for the treatment of children requiring growth hormone treatment. 
      METHODS: PATRO Children is a multicentre, open, longitudinal, noninterventional 
      study being conducted in children's hospitals and specialised endocrinology 
      clinics. The primary objective is to assess the long-term safety of Omnitrope((R)) 
      in routine clinical practice. Eligible patients are infants, children and 
      adolescents (male or female) who are receiving treatment with Omnitrope((R)) and 
      who have provided informed consent. Patients who have been treated with another 
      recombinant human growth hormone (rhGH) product before starting Omnitrope((R)) are 
      eligible for inclusion. All adverse events (AEs) are monitored and recorded, with 
      particular emphasis on: long-term safety; the recording of malignancies; the 
      occurrence and clinical impact of anti-hGH antibodies; the development of 
      diabetes during Omnitrope((R)) treatment in children short for gestational age 
      (SGA); safety issues in patients with Prader-Willi syndrome (PWS). Efficacy 
      assessments include auxological parameters, plus insulin-like growth factor-1 and 
      insulin-like growth factor binding protein-3. RESULTS: As of September 2012, 1837 
      patients were enrolled in the study from 184 sites in 10 European countries. To 
      date, efficacy data are reassuring and consistent with previous studies. In 
      addition, there have been no confirmed cases of diabetes occurring under 
      Omnitrope((R)) treatment, no reports of malignancy and no safety issues in PWS 
      patients. CONCLUSIONS: The efficacy and safety profile of Omnitrope((R)) in the 
      PATRO Children study so far are as expected. The ongoing study will extend the 
      safety database for Omnitrope((R)), and rhGH products more generally, in paediatric 
      indications. Of particular interest, PATRO Children will add important 
      information on the diabetogenic potential of rhGH in children born SGA, the risk 
      of malignancies in children receiving rhGH, and AEs with a possible causal 
      relationship to rhGH treatment in children with PWS.
FAU - Pfaffle, Roland
AU  - Pfaffle R
AD  - Department of Paediatric Endocrinology, University of Leipzig Medical School, 
      Leipzig, Germany.
FAU - Schwab, Karl Otfried
AU  - Schwab KO
FAU - Marginean, Otilia
AU  - Marginean O
FAU - Walczak, Mieczyslaw
AU  - Walczak M
FAU - Szalecki, Mieczyslaw
AU  - Szalecki M
FAU - Schuck, Ellen
AU  - Schuck E
FAU - Zabransky, Markus
AU  - Zabransky M
FAU - Zucchini, Stefano
AU  - Zucchini S
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Ther Adv Endocrinol Metab
JT  - Therapeutic advances in endocrinology and metabolism
JID - 101532143
PMC - PMC3593298
OTO - NOTNLM
OT  - Omnitrope(R)
OT  - children
OT  - paediatric
OT  - recombinant human growth hormone
COIS- Conflict of interest statement: Ellen Schuck and Markus Zabransky are employees 
      of Sandoz.
EDAT- 2013/03/22 06:00
MHDA- 2013/03/22 06:01
PMCR- 2013/02/01
CRDT- 2013/03/22 06:00
PHST- 2013/03/22 06:00 [entrez]
PHST- 2013/03/22 06:00 [pubmed]
PHST- 2013/03/22 06:01 [medline]
PHST- 2013/02/01 00:00 [pmc-release]
AID - 10.1177_2042018813479644 [pii]
AID - 10.1177/2042018813479644 [doi]
PST - ppublish
SO  - Ther Adv Endocrinol Metab. 2013 Feb;4(1):3-11. doi: 10.1177/2042018813479644.