Gastrointestinal safety across the albiglutide development programme

• Published in: Diabetes, obesity & metabolism Vol. 18; no. 9; pp. 930 - 935
• Main Authors: Leiter, L. A., Mallory, J. M., Wilson, T. H., Reinhardt, R. R.
• Format: Journal Article
• Language: English
• Published: Oxford, UK Blackwell Publishing Ltd 01-09-2016; Wiley Subscription Services, Inc
• Subjects: Abdominal Pain - chemically induced; albiglutide; Clinical trials; Clinical Trials, Phase III as Topic; Constipation - chemically induced; Diabetes mellitus (non-insulin dependent); Diabetes Mellitus, Type 2 - drug therapy; Diarrhea; Diarrhea - chemically induced; Gastroesophageal Reflux - chemically induced; Gastrointestinal Diseases - chemically induced; gastrointestinal safety; GLP-1 receptor agonists; Glucagon; Glucagon-Like Peptide 1 - adverse effects; Glucagon-Like Peptide 1 - analogs & derivatives; Humans; incretins; Incretins - adverse effects; Nausea; Nausea - chemically induced; Placebos; Severity of Illness Index; Vomiting; Vomiting - chemically induced; albiglutide; gastrointestinal safety; incretins; GLP-1 receptor agonists
• ISSN: 1462-8902; 1463-1326
• DOI: 10.1111/dom.12679

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.