PMID- 28161880
OWN - NLM
STAT- MEDLINE
DCOM- 20180319
LR  - 20181113
IS  - 1720-8386 (Electronic)
IS  - 0391-4097 (Print)
IS  - 0391-4097 (Linking)
VI  - 40
IP  - 6
DP  - 2017 Jun
TI  - Long-term safety and efficacy of Omnitrope((R)) in adults with growth hormone 
      deficiency: Italian interim analysis of the PATRO Adults study.
PG  - 669-678
LID - 10.1007/s40618-016-0604-8 [doi]
AB  - PURPOSE: To report the long-term effectiveness and safety of the recombinant 
      human growth hormone Omnitrope((R)), a somatropin biosimilar to Genotropin((R)), in 
      Italian patients with growth hormone deficiency (GHD) enrolled in the PATRO 
      Adults study. METHODS: The PATRO Adults study is an ongoing observational, 
      longitudinal, non-interventional global post-marketing surveillance study, 
      conducted in several European countries. The primary endpoint is long-term 
      safety; secondary endpoints include the effectiveness of Omnitrope((R)), which was 
      assessed using serum insulin-like growth factor-1 levels, body composition, bone 
      mineral density and lipid levels. Here we report the data from the Italian 
      patients enrolled in the study. RESULTS: Sixty-seven patients (mean age 50.4 
      years, 61.2% male) have been enrolled and have received a mean 45.4 +/- 24.3 months 
      of Omnitrope((R)). A total of 55.2% of patients were reported to have experienced 
      adverse events (AEs), including arthralgia, myalgia, abdominal distension and 
      hypoaesthesia, and 4.5% had adverse drug reactions. Fourteen serious AEs have 
      been recorded; none of these are considered related to the study drug. The 
      effectiveness of Omnitrope((R)) was similar to other available somatropin 
      preparations. CONCLUSIONS: This study confirms the effectiveness and safety of 
      Omnitrope((R)) in adult patients with GHD in Italy. However, due to the limited 
      size of the study population, these results need to be further confirmed by the 
      global PATRO Adults study.
FAU - Ferone, D
AU  - Ferone D
AD  - Endocrinology Unit, Department of Internal Medicine and Medical Specialties 
      (DiMI), Center of Excellence for Biomedical Research (CEBR), IRCCS AOU San 
      Martino-IST, University of Genova, Viale Benedetto XV, 6, 16132, Genova, Italy. 
      ferone@unige.it.
FAU - Profka, E
AU  - Profka E
AD  - Endocrinology and Metabolic Diseases Unit, Department of Clinical Sciences and 
      Community Health, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico 
      Ca' Granda Ospedale Maggiore Policlinico, University of Milano, Milan, Italy.
FAU - Gasco, V
AU  - Gasco V
AD  - Endocrinology, Diabetes and Metabolism, Department of Medical Science, Citta 
      della Salute e della Scienza di Torino, University of Torino, Turin, Italy.
FAU - Ambrosio, M R
AU  - Ambrosio MR
AD  - Section of Endocrinology and Internal Medicine, Department of Medical Sciences, 
      University of Ferrara, Ferrara, Italy.
FAU - Colao, A
AU  - Colao A
AD  - Department of Clinical Medicine and Surgery, University Federico II of Napoli, 
      Naples, Italy.
FAU - Di Somma, C
AU  - Di Somma C
AD  - Institute of Diagnostic and Nuclear Research, Fondazione Istituto di Ricovero e 
      Cura a Carattere Scientifico SDN, Naples, Italy.
FAU - Puxeddu, E
AU  - Puxeddu E
AD  - Veterinary and Forensic Biotechnological Sciences Department of Medicine Section, 
      Internal Medicine, Endocrine and Metabolic Sciences, University of Perugia, 
      Perugia, Italy.
FAU - Arnaldi, G
AU  - Arnaldi G
AD  - Clinica di Endocrinologia e Malattie del Metabolismo, Ospedali Riuniti di Ancona, 
      Ancona, Italy.
FAU - Pagano, C
AU  - Pagano C
AD  - Department of Medicine, Internal Medicine 3, University of Padova, Padua, Italy.
FAU - Zecchi, E
AU  - Zecchi E
AD  - Sandoz S.p.A., Origgio, VA, Italy.
FAU - Pietropoli, A
AU  - Pietropoli A
AD  - Hexal AG, Holzkirchen, Germany.
FAU - Beck-Peccoz, P
AU  - Beck-Peccoz P
AD  - Endocrinology and Diabetology Unit, Medical Sciences Department, Fondazione 
      Istituto di Ricovero e Cura a Carattere Scientifico Ca Granda Ospedale Maggiore 
      Policlinico, Milan, Italy.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20170204
PL  - Italy
TA  - J Endocrinol Invest
JT  - Journal of endocrinological investigation
JID - 7806594
RN  - 12629-01-5 (Human Growth Hormone)
SB  - IM
EIN - J Endocrinol Invest. 2017 Jun;40(6):679-681. PMID: 28421564
MH  - Adult
MH  - Aged
MH  - Body Height/*drug effects
MH  - Bone Density/*drug effects
MH  - Female
MH  - Growth Disorders/*drug therapy
MH  - Human Growth Hormone/*therapeutic use
MH  - Humans
MH  - Longitudinal Studies
MH  - Male
MH  - Middle Aged
MH  - Safety
PMC - PMC5443881
OTO - NOTNLM
OT  - Growth hormone deficiency
OT  - Hypopituitarism
OT  - Insulin-like growth factor-1
OT  - Omnitrope(R)
OT  - Recombinant human growth hormone
OT  - Safety
COIS- P. Beck-Peccoz is a member of the PATRO Adults Monitoring Committee supported by 
      Sandoz; E. Zecchi and A. Pietropoli are employees of Sandoz; all the other 
      Authors declare no conflicts of interest.
EDAT- 2017/02/06 06:00
MHDA- 2018/03/20 06:00
PMCR- 2017/02/04
CRDT- 2017/02/06 06:00
PHST- 2016/10/10 00:00 [received]
PHST- 2016/12/23 00:00 [accepted]
PHST- 2017/02/06 06:00 [pubmed]
PHST- 2018/03/20 06:00 [medline]
PHST- 2017/02/06 06:00 [entrez]
PHST- 2017/02/04 00:00 [pmc-release]
AID - 10.1007/s40618-016-0604-8 [pii]
AID - 604 [pii]
AID - 10.1007/s40618-016-0604-8 [doi]
PST - ppublish
SO  - J Endocrinol Invest. 2017 Jun;40(6):669-678. doi: 10.1007/s40618-016-0604-8. Epub 
      2017 Feb 4.