PMID- 28058769 OWN - NLM STAT- MEDLINE DCOM- 20171010 LR - 20221207 IS - 1463-1326 (Electronic) IS - 1462-8902 (Print) IS - 1462-8902 (Linking) VI - 19 IP - 5 DP - 2017 May TI - Upper and/or lower gastrointestinal adverse events with glucagon-like peptide-1 receptor agonists: Incidence and consequences. PG - 672-681 LID - 10.1111/dom.12872 [doi] AB - AIMS: To characterize gastrointestinal adverse events (AEs) with different glucagon-like peptide-1 receptor agonists (GLP-1RAs). METHODS: Two retrospective intention-to-treat analyses of 6-month patient-level data were conducted. Data from three studies comparing exenatide once weekly (n = 617) with exenatide twice daily (n = 606) were pooled, and one (DURATION-6) comparing exenatide once weekly (n = 461) with liraglutide (n = 450) was analysed separately. Patient-reported gastrointestinal AEs were classified as upper or lower, AE incidences and timing were determined, subgroups were analysed, and associations of gastrointestinal AEs with efficacy were examined. RESULTS: Nausea was the most common gastrointestinal AE for all treatments. Fewer exenatide once-weekly-treated vs exenatide twice-daily- or liraglutide-treated patients reported gastrointestinal AEs (34% vs 45% and 25% vs 41%, respectively; both P < .0001). Fewer exenatide once-weekly-treated patients reported upper plus lower events than liraglutide-treated patients ( P < .001); the difference between exenatide once weekly and twice daily was not significant. Within each group, more women than men reported gastrointestinal AEs. Events occurrred early and were predominantly mild. Glycated haemoglobin reductions were similar for patients with or without gastrointestinal AEs. Weight loss was greater for patients with gastrointestinal AEs with exenatide once weekly and exenatide twice daily ( P < .05); no difference was observed in DURATION-6. CONCLUSIONS: Gastrointestinal AEs were less frequent with exenatide once weekly vs exenatide twice daily or liraglutide, and combined upper and lower events occurred less often. Gastrointestinal AEs were typically mild and occurred early. Gastrointestinal AEs did not affect glycaemic control but may be associated with greater weight loss. CI - (c) 2017 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. FAU - Horowitz, Michael AU - Horowitz M AD - Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, South Australia, Australia. FAU - Aroda, Vanita R AU - Aroda VR AD - Community Clinical Research Center, MedStar Health Research Institute, Hyattsville, Maryland. FAU - Han, Jenny AU - Han J AD - Pharmapace, San Diego, California. FAU - Hardy, Elise AU - Hardy E AD - Clinical Research, AstraZeneca, Gaithersburg, Maryland. FAU - Rayner, Chris K AU - Rayner CK AUID- ORCID: 0000-0002-5527-256X AD - Centre of Research Excellence in Translating Nutritional Science to Good Health, University of Adelaide, Adelaide, South Australia, Australia. LA - eng GR - UL1 TR001409/TR/NCATS NIH HHS/United States PT - Comparative Study PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20170217 PL - England TA - Diabetes Obes Metab JT - Diabetes, obesity & metabolism JID - 100883645 RN - 0 (Glucagon-Like Peptide-1 Receptor) RN - 0 (Glycated Hemoglobin A) RN - 0 (Incretins) RN - 0 (Peptides) RN - 0 (Venoms) RN - 0 (hemoglobin A1c protein, human) RN - 839I73S42A (Liraglutide) RN - 9P1872D4OL (Exenatide) SB - IM MH - Diabetes Mellitus, Type 2/blood/*drug therapy MH - Drug Administration Schedule MH - Exenatide MH - Female MH - Gastrointestinal Diseases/*chemically induced/epidemiology/physiopathology MH - Glucagon-Like Peptide-1 Receptor/*agonists/metabolism MH - Glycated Hemoglobin/analysis MH - Humans MH - Hyperglycemia/prevention & control MH - Hypoglycemia/prevention & control MH - Incidence MH - Incretins/administration & dosage/*adverse effects/therapeutic use MH - Intention to Treat Analysis MH - Liraglutide/administration & dosage/*adverse effects/therapeutic use MH - Male MH - Nausea/chemically induced/epidemiology/physiopathology MH - Patient Dropouts MH - Peptides/administration & dosage/*adverse effects/therapeutic use MH - Retrospective Studies MH - Self Report MH - Severity of Illness Index MH - Sex Factors MH - Venoms/administration & dosage/*adverse effects/therapeutic use MH - Weight Loss/drug effects PMC - PMC5412849 OTO - NOTNLM OT - GLP-1 receptor agonists OT - adverse events OT - exenatide OT - gastrointestinal disorders OT - liraglutide OT - type 2 diabetes EDAT- 2017/01/07 06:00 MHDA- 2017/10/11 06:00 PMCR- 2017/05/02 CRDT- 2017/01/07 06:00 PHST- 2016/10/14 00:00 [received] PHST- 2016/12/16 00:00 [revised] PHST- 2016/12/29 00:00 [accepted] PHST- 2017/01/07 06:00 [pubmed] PHST- 2017/10/11 06:00 [medline] PHST- 2017/01/07 06:00 [entrez] PHST- 2017/05/02 00:00 [pmc-release] AID - DOM12872 [pii] AID - 10.1111/dom.12872 [doi] PST - ppublish SO - Diabetes Obes Metab. 2017 May;19(5):672-681. doi: 10.1111/dom.12872. Epub 2017 Feb 17.