The highest incidences of nausea (≤ 8%), vomiting (≤ 2%), and diarrhea (≤ 4%) were observed soon after initiating dulaglutide treatment.
Nausea, vomiting, and diarrhea events were most frequent during the first two weeks of treatment.
Incidence of these gastrointestinal events decreased over the course of the study, even with dose increases.
Most gastrointestinal treatment-emergent adverse events were mild to moderate, with severe cases occurring in ≤ 0.6% of patients.
Discontinuation of treatment due to nausea was low, at ≤ 1.5% across all treatment groups.
Tolerability profiles for dulaglutide doses of 3.0 mg and 4.5 mg were similar to that of the 1.5 mg dose.
Simplified
BACKGROUND: Gastrointestinal () events are the most frequent treatment-emergent adverse events (TEAEs) reported for glucagon-like peptide-1 receptor agonist therapies. This post hoc analysis of the AWARD-11 phase 3 trial assessed the GI tolerability of dulaglutide at once-weekly doses of 1.5, 3.0, and 4.5 mg.
METHODS: The AWARD-11 trial randomized patients to once-weekly dulaglutide 1.5 mg (n = 612), 3.0 mg (n = 616), or 4.5 mg (n = 614) for 52 weeks. Patients started on dulaglutide 0.75 mg for 4 weeks before escalating stepwise every 4 weeks until the final randomized dose was reached. This study analyzes the onsets, incidences, prevalences, and severities of nausea, vomiting, and diarrhea events reported through 52 weeks.
RESULTS: The highest incidences of nausea (≤ 8%), vomiting (≤ 2%), and diarrhea (≤ 4%) were primarily observed soon after the initiation of dulaglutide treatment at 0.75 mg. Incidence then declined throughout the remainder of the study, even with dose escalation to 1.5, 3.0, and 4.5 mg. Most of these GI TEAEs were mild to moderate in severity, with severe nausea, vomiting, or diarrhea events occurring in ≤ 0.6% of patients. Treatment discontinuation due to nausea was low across treatment groups (≤ 1.5%).
CONCLUSIONS: The tolerability profiles of dulaglutide 3.0 mg and 4.5 mg were consistent with that of the 1.5-mg dose. Patients experiencing GI events were most likely to do so within 2 weeks of treatment initiation, and few patients experienced a new GI event after escalating to the 3.0-mg or 4.5-mg dose. Severe events were infrequent, and when they did occur, no relationship with dose at time of event was observed. Supplementary file1 (MP4 33880 kb).
Key numbers
≤ 8%
Incidence of Nausea
Peak incidence observed shortly after treatment initiation.
≤ 0.6%
Severe TEAEs
Proportion of patients experiencing severe nausea, vomiting, or diarrhea.
≤ 1.5%
Treatment Discontinuation Due to Nausea
Percentage of patients discontinuing treatment across all doses.
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