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Gastrointestinal safety across the albiglutide development programme
Author(s) -
Leiter L. A.,
Mallory J. M.,
Wilson T. H.,
Reinhardt R. R.
Publication year - 2016
Publication title -
diabetes, obesity and metabolism
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.445
H-Index - 128
eISSN - 1463-1326
pISSN - 1462-8902
DOI - 10.1111/dom.12679
Subject(s) - liraglutide , placebo , tolerability , medicine , nausea , vomiting , gastroenterology , adverse effect , type 2 diabetes , endocrinology , diabetes mellitus , alternative medicine , pathology
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.