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. 2021 Sep 12;12(10):2783–2794. doi: 10.1007/s13300-021-01140-9
Why carry out this study?
Gastrointestinal (GI) events are the most frequent treatment-emergent adverse events reported for glucagon-like peptide-1 receptor agonist therapies.
Providing tolerability information can inform both clinicians’ and patients’ expectations for dose escalation and may improve adherence.
This post hoc analysis of the AWARD-11 phase 3 trial assessed the GI tolerability of dulaglutide at once-weekly doses of 1.5 mg, 3.0 mg, and 4.5 mg.
What was learned from the study?
The gastrointestinal tolerability profiles of dulaglutide at doses of 3.0 mg and 4.5 mg were consistent with that established for the 1.5-mg dose.
The incidences of nausea, vomiting, and diarrhea peaked soon after treatment initiation and declined thereafter, even with dose escalation.
Most events were mild to moderate in severity and led to few treatment discontinuations.