PMID- 27097971
OWN - NLM
STAT- MEDLINE
DCOM- 20171031
LR  - 20171128
IS  - 1463-1326 (Electronic)
IS  - 1462-8902 (Linking)
VI  - 18
IP  - 9
DP  - 2016 Sep
TI  - Gastrointestinal safety across the albiglutide development programme.
PG  - 930-5
LID - 10.1111/dom.12679 [doi]
AB  - Gastrointestinal (GI) adverse events (AEs) are the most frequently reported 
      treatment-related AEs associated with glucagon-like peptide-1 receptor agonists 
      (GLP-1RAs) in the treatment of type 2 diabetes mellitus. The GI safety of 
      albiglutide, a once-weekly GLP-1RA, was assessed using data from five phase III 
      studies. In a pooled analysis of four placebo-controlled trials, the most common 
      GI AEs were diarrhoea (albiglutide, 14.5% vs. placebo, 11.5%) and nausea 
      (albiglutide, 11.9% vs. placebo, 10.3%), with most patients experiencing 1-2 
      events. The majority were mild or moderate in intensity and their median duration 
      was 3-4 days. Vomiting occurred in 4.9% of patients in the albiglutide vs. 2.6% 
      in the placebo group. For both albiglutide and placebo, serious GI AEs (2.0% vs. 
      1.5%) and withdrawals attributable to GI AEs (1.7% vs. 1.5%) were low. In a 
      32-week trial of albiglutide 50 mg weekly versus liraglutide 1.8 mg daily, nausea 
      occurred in 9.9% of patients in the albiglutide group vs. 29.2% in the 
      liraglutide group. Vomiting occurred in 5.0% in the albiglutide vs. 9.3% in the 
      liraglutide group. In conclusion, albiglutide has an acceptable GI tolerability 
      profile, with nausea and vomiting rates slightly higher than those for placebo 
      but lower than those for liraglutide.
CI  - (c) 2016 John Wiley & Sons Ltd.
FAU - Leiter, L A
AU  - Leiter LA
AD  - Li Ka Shing Knowledge Institute and Keenan Research Centre for Biomedical 
      Science, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
FAU - Mallory, J M
AU  - Mallory JM
AD  - Annapurna Therapeutics, Philadelphia, PA, USA.
FAU - Wilson, T H
AU  - Wilson TH
AD  - PAREXEL International, Research Triangle Park, NC, USA.
FAU - Reinhardt, R R
AU  - Reinhardt RR
AD  - GlaxoSmithKline, King of Prussia, PA, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20160531
PL  - England
TA  - Diabetes Obes Metab
JT  - Diabetes, obesity & metabolism
JID - 100883645
RN  - 0 (Incretins)
RN  - 5E7U48495E (rGLP-1 protein)
RN  - 89750-14-1 (Glucagon-Like Peptide 1)
SB  - IM
MH  - Abdominal Pain/chemically induced
MH  - Clinical Trials, Phase III as Topic
MH  - Constipation/*chemically induced
MH  - Diabetes Mellitus, Type 2/*drug therapy
MH  - Diarrhea/*chemically induced
MH  - Gastroesophageal Reflux/chemically induced
MH  - Gastrointestinal Diseases/chemically induced
MH  - Glucagon-Like Peptide 1/adverse effects/*analogs & derivatives
MH  - Humans
MH  - Incretins/*adverse effects
MH  - Nausea/*chemically induced
MH  - Severity of Illness Index
MH  - Vomiting/*chemically induced
OTO - NOTNLM
OT  - GLP-1 receptor agonists
OT  - albiglutide
OT  - gastrointestinal safety
OT  - incretins
EDAT- 2016/04/22 06:00
MHDA- 2017/11/01 06:00
CRDT- 2016/04/22 06:00
PHST- 2015/11/09 00:00 [received]
PHST- 2016/04/06 00:00 [revised]
PHST- 2016/04/14 00:00 [accepted]
PHST- 2016/04/22 06:00 [entrez]
PHST- 2016/04/22 06:00 [pubmed]
PHST- 2017/11/01 06:00 [medline]
AID - 10.1111/dom.12679 [doi]
PST - ppublish
SO  - Diabetes Obes Metab. 2016 Sep;18(9):930-5. doi: 10.1111/dom.12679. Epub 2016 May 
      31.