PMID- 29500310
OWN - NLM
STAT- MEDLINE
DCOM- 20180501
LR  - 20190124
IS  - 1479-683X (Electronic)
IS  - 0804-4643 (Print)
IS  - 0804-4643 (Linking)
VI  - 178
IP  - 5
DP  - 2018 May
TI  - Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 
      26-week randomized, controlled trial.
PG  - 491-499
LID - 10.1530/EJE-17-1073 [doi]
AB  - OBJECTIVE: Somapacitan is a reversible albumin-binding growth hormone (GH) 
      derivative, developed for once-weekly administration. This study aimed to 
      evaluate the safety of once-weekly somapacitan vs once-daily Norditropin((R)). 
      Local tolerability and treatment satisfaction were also assessed. DESIGN: 26-week 
      randomized, controlled phase 3 safety and tolerability trial in six countries 
      (Nbib2382939). METHODS: Male or female patients aged 18-79 years with adult GH 
      deficiency (AGHD), treated with once-daily GH for >/=6 months, were randomized to 
      once-weekly somapacitan (n = 61) or once-daily Norditropin (n = 31) administered 
      subcutaneously by pen. Both treatments were dose titrated for 8 weeks to achieve 
      insulin-like growth factor I (IGF-I) standard deviation score (SDS) levels within 
      the normal range, and then administered at a fixed dose. Outcome measures were 
      adverse events (AEs), including injection site reactions; occurrence of 
      anti-somapacitan/anti-GH antibodies and change in treatment satisfaction, 
      assessed using the Treatment Satisfaction Questionnaire for Medication-9 
      (TSQM-9). RESULTS: Mean IGF-I SDS remained between 0 and 2 SDS throughout the 
      trial in both groups. AEs were mostly mild or moderate and transient in nature. 
      The most common AEs were nasopharyngitis, headache and fatigue in both groups. 
      More than 1500 somapacitan injections were administered and no clinically 
      significant injection site reactions were reported. No anti-somapacitan or 
      anti-GH antibodies were detected. The TSQM-9 score for convenience increased 
      significantly more with somapacitan vs Norditropin (P = 0.0171). CONCLUSIONS: In 
      this 26-week trial in patients with AGHD, somapacitan was well tolerated and no 
      safety issues were identified. Once-weekly somapacitan was reported to be more 
      convenient than once-daily Norditropin.
CI  - (c) 2018 The authors.
FAU - Johannsson, Gudmundur
AU  - Johannsson G
AD  - University of Goteborg and Sahlgrenska University HospitalGoteborg, Sweden.
FAU - Feldt-Rasmussen, Ulla
AU  - Feldt-Rasmussen U
AD  - RigshospitaletCopenhagen, Denmark.
FAU - Hakonsson, Ida Holme
AU  - Hakonsson IH
AD  - Global DevelopmentNovo Nordisk A/S, Soborg, Denmark.
FAU - Biering, Henrik
AU  - Biering H
AD  - MediCover Berlin-Mitte MVZBerlin, Germany.
FAU - Rodien, Patrice
AU  - Rodien P
AD  - Reference Centre for Rare Diseases of Thyroid and Hormone ReceptorsMember of 
      EndoERN Network, CHU Angers Centre Hospitalier Universitaire, Angers, France.
FAU - Tahara, Shigeyuki
AU  - Tahara S
AD  - Nippon Medical SchoolTokyo, Japan.
FAU - Toogood, Andrew
AU  - Toogood A
AD  - Queen Elizabeth Hospital BirminghamBirmingham, UK.
FAU - Rasmussen, Michael Hojby
AU  - Rasmussen MH
AD  - Global DevelopmentNovo Nordisk A/S, Soborg, Denmark.
CN  - REAL 2 Study Group
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20180302
PL  - England
TA  - Eur J Endocrinol
JT  - European journal of endocrinology
JID - 9423848
RN  - 0 (Serum Albumin)
RN  - 12629-01-5 (Human Growth Hormone)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Cholelithiasis/chemically induced
MH  - Drug Administration Schedule
MH  - Dwarfism, Pituitary/*blood/diagnosis/*drug therapy
MH  - Female
MH  - Human Growth Hormone/*administration & dosage/adverse effects/*analogs & 
      derivatives
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Serum Albumin/*metabolism
PMC - PMC5920019
FIR - Biering, Henrik
IR  - Biering H
FIR - Karges, Wolfram
IR  - Karges W
FIR - Mann, Alexander
IR  - Mann A
FIR - Christiansen, Jens Sandahl
IR  - Christiansen JS
FIR - Hansen, Troels Krarup
IR  - Hansen TK
FIR - Andersen, Marianne
IR  - Andersen M
FIR - Feldt-Rasmussen, Ulla
IR  - Feldt-Rasmussen U
FIR - Borresen, Sine
IR  - Borresen S
FIR - Rodien, Patrice
IR  - Rodien P
FIR - Borson-Chazot, Francoise
IR  - Borson-Chazot F
FIR - Kerlan, Veronique
IR  - Kerlan V
FIR - Cariou, Bertrand
IR  - Cariou B
FIR - Verges, Bruno
IR  - Verges B
FIR - Tahara, Shigeyuki
IR  - Tahara S
FIR - Matsuno, Akira
IR  - Matsuno A
FIR - Takano, Koji
IR  - Takano K
FIR - Tagami, Tetsuya
IR  - Tagami T
FIR - Takahashi, Yutaka
IR  - Takahashi Y
FIR - Takahashi, Toshikazu
IR  - Takahashi T
FIR - Yamamoto, Masahiro
IR  - Yamamoto M
FIR - Johannsson, Gudmundur
IR  - Johannsson G
FIR - Hoybye, Charlotte
IR  - Hoybye C
FIR - Erfurth, Eva-Marie
IR  - Erfurth EM
FIR - Drake, William
IR  - Drake W
FIR - Higham, Claire
IR  - Higham C
FIR - Murray, Robert
IR  - Murray R
FIR - Toogood, Andrew
IR  - Toogood A
FIR - Brooke, Antonia
IR  - Brooke A
EDAT- 2018/03/04 06:00
MHDA- 2018/05/02 06:00
PMCR- 2018/04/27
CRDT- 2018/03/04 06:00
PHST- 2017/12/27 00:00 [received]
PHST- 2018/03/02 00:00 [accepted]
PHST- 2018/03/04 06:00 [pubmed]
PHST- 2018/05/02 06:00 [medline]
PHST- 2018/03/04 06:00 [entrez]
PHST- 2018/04/27 00:00 [pmc-release]
AID - EJE-17-1073 [pii]
AID - EJE171073 [pii]
AID - 10.1530/EJE-17-1073 [doi]
PST - ppublish
SO  - Eur J Endocrinol. 2018 May;178(5):491-499. doi: 10.1530/EJE-17-1073. Epub 2018 
      Mar 2.