Prophylactic use of anti-emetic medications reduced nausea and vomiting associated with exenatide treatment: a retrospective analysis of an open-label, parallel-group, single-dose study in healthy subjects.

Ellero C, Han J, Bhavsar S, Cirincione BB, Deyoung MB, Gray AL, Yushmanova I, Anderson PW

Diabetic medicine : a journal of the British Diabetic Association1 Oct 2010Cited by 28 (Europe PMC)

PMID20854385PMCIDPMC3066409DOI10.1111/j.1464-5491.2010.03085.xPepBankPUB-20854385

Summary

AimsTransient nausea and, to a lesser extent, vomiting are common adverse effects of exenatide that can be mitigated by dose titration and usually do not result in treatment discontinuation. This retrospective analysis of data from a phase 1, open-label, parallel-group, single-dose study in healthy subjects evaluated the effect of oral anti-emetics on exenatide-associated nausea and vomiting and on the pharmacokinetics of exenatide.MethodsA single subcutaneous dose (10 μg) of exenatide was administered to 120 healthy subjects (19-65 years, BMI 23-35 kg/m(2) ). Incidences of nausea and vomiting were compared between 60 subjects premedicated with two oral anti-emetics 30 min before the exenatide dose and 60 non-premedicated subjects. Similarly, the area under the concentration-time curve (AUC) and the maximum observed concentration (C(max) ) of plasma exenatide concentrations over 8 h post-dose were compared.ResultsAmong all subjects [61% male, 32 ± 12 years, body mass index (BMI) 29.1 ± 3.4 kg/m(2) (mean ± sd)], mild to moderate nausea was the most frequent adverse event after exenatide dosing. Vomiting was also observed. Subjects premedicated with anti-emetics experienced significantly less nausea and vomiting (16.7 and 6.7%, respectively) vs. non-premedicated subjects (61.7 and 38.3%, respectively; P-value <0.0001 for both nausea and vomiting). The mean area under the concentration-time curve and the maximum observed concentration AUC and C(max) of plasma exenatide concentrations during 8 h post-dose were not significantly different between groups.ConclusionAdministration of oral anti-emetics before a single 10-μg exenatide dose was associated with significant reductions in treatment-emergent nausea and vomiting, with no discernible effect on the pharmacokinetics of exenatide. Use of anti-emetic therapy may provide a short-term strategy to minimize the nausea and vomiting associated with exenatide treatment.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone5

In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Exenatide (exendin-4).

01HumanNot a test of Exenatide (exendin-4) aloneNon-randomized trialSafety outcome
In healthy subjects, mild to moderate nausea was the most frequent adverse event after exenatide dosing across premedication groups.
In plain wordsIn healthy subjects across premedication groups, mild to moderate nausea was the most frequent adverse event after exenatide.
Peptide
Exenatide (exendin-4)
Outcome
Not applicableNausea severity and frequency
Study
n = 120
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Source sentences
Summary
Among all subjects [61% male, 32 ± 12 years, body mass index (BMI) 29.1 ± 3.4 kg/m(2) (mean ± sd)], mild to moderate nausea was the most frequent adverse event after exenatide dosing.
3 context sentences(design, population, supporting numbers)
Summary · context
This retrospective analysis of data from a phase 1, open-label, parallel-group, single-dose study in healthy subjects evaluated the effect of oral anti-emetics on exenatide-associated nausea and vomiting and on the pharmacokinetics of exenatide.
Summary · context
A single subcutaneous dose (10 μg) of exenatide was administered to 120 healthy subjects (19-65 years, BMI 23-35 kg/m(2) ).
Summary · context
Incidences of nausea and vomiting were compared between 60 subjects premedicated with two oral anti-emetics 30 min before the exenatide dose and 60 non-premedicated subjects.
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Show in the study text Report a problemFND-2085438501
02HumanNot a test of Exenatide (exendin-4) aloneNon-randomized trialSafety outcome
In healthy subjects receiving exenatide, anti-emetic premedication was associated with less nausea than no premedication.
In plain wordsIn healthy subjects receiving exenatide, anti-emetic premedication was linked to less nausea than no premedication.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseNausea with anti-emetic premedication
Study
n = 120
Comparator
Exenatide without anti-emetic premedication
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Measurements
Nausea
16.7%
premedicated
Nausea
61.7%
non-premedicated
Source sentences
Summary
Subjects premedicated with anti-emetics experienced significantly less nausea and vomiting (16.7 and 6.7%, respectively) vs. non-premedicated subjects (61.7 and 38.3%, respectively; P-value <0.0001 for both nausea and vomiting).
3 context sentences(design, population, supporting numbers)
Summary · context
This retrospective analysis of data from a phase 1, open-label, parallel-group, single-dose study in healthy subjects evaluated the effect of oral anti-emetics on exenatide-associated nausea and vomiting and on the pharmacokinetics of exenatide.
Summary · context
A single subcutaneous dose (10 μg) of exenatide was administered to 120 healthy subjects (19-65 years, BMI 23-35 kg/m(2) ).
Summary · context
Incidences of nausea and vomiting were compared between 60 subjects premedicated with two oral anti-emetics 30 min before the exenatide dose and 60 non-premedicated subjects.
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Show in the study text Report a problemFND-2085438502
03HumanNot a test of Exenatide (exendin-4) aloneNon-randomized trialSafety outcome
In healthy subjects receiving exenatide, anti-emetic premedication was associated with less vomiting than no premedication.
In plain wordsIn healthy subjects receiving exenatide, anti-emetic premedication was linked to less vomiting than no premedication.
Peptide
Exenatide (exendin-4)
Outcome
DecreaseVomiting with anti-emetic premedication
Study
n = 120
Comparator
Exenatide without anti-emetic premedication
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Measurements
Vomiting
6.7%
premedicated
Vomiting
38.3%
non-premedicated
Source sentences
Summary
Subjects premedicated with anti-emetics experienced significantly less nausea and vomiting (16.7 and 6.7%, respectively) vs. non-premedicated subjects (61.7 and 38.3%, respectively; P-value <0.0001 for both nausea and vomiting).
3 context sentences(design, population, supporting numbers)
Summary · context
This retrospective analysis of data from a phase 1, open-label, parallel-group, single-dose study in healthy subjects evaluated the effect of oral anti-emetics on exenatide-associated nausea and vomiting and on the pharmacokinetics of exenatide.
Summary · context
A single subcutaneous dose (10 μg) of exenatide was administered to 120 healthy subjects (19-65 years, BMI 23-35 kg/m(2) ).
Summary · context
Incidences of nausea and vomiting were compared between 60 subjects premedicated with two oral anti-emetics 30 min before the exenatide dose and 60 non-premedicated subjects.
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Show in the study text Report a problemFND-2085438503
04HumanNot a test of Exenatide (exendin-4) aloneNon-randomized trialPharmacokinetics
In healthy subjects receiving exenatide, anti-emetic premedication did not significantly change exenatide AUC versus no premedication.
In plain wordsIn healthy subjects, exenatide exposure was similar with and without anti-emetic premedication.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeExenatide AUC
Study
n = 120
Comparator
Exenatide without anti-emetic premedication
Outcome group
Pharmacokinetics · Pharmacology
Source sentences
Summary
The mean area under the concentration-time curve and the maximum observed concentration AUC and C(max) of plasma exenatide concentrations during 8 h post-dose were not significantly different between groups.
3 context sentences(design, population, supporting numbers)
Summary · context
This retrospective analysis of data from a phase 1, open-label, parallel-group, single-dose study in healthy subjects evaluated the effect of oral anti-emetics on exenatide-associated nausea and vomiting and on the pharmacokinetics of exenatide.
Summary · context
A single subcutaneous dose (10 μg) of exenatide was administered to 120 healthy subjects (19-65 years, BMI 23-35 kg/m(2) ).
Summary · context
Incidences of nausea and vomiting were compared between 60 subjects premedicated with two oral anti-emetics 30 min before the exenatide dose and 60 non-premedicated subjects.
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Show in the study text Report a problemFND-2085438504
05HumanNot a test of Exenatide (exendin-4) aloneNon-randomized trialPharmacokinetics
In healthy subjects receiving exenatide, anti-emetic premedication did not significantly change exenatide maximum concentration versus no premedication.
In plain wordsIn healthy subjects, peak exenatide concentrations were similar with and without anti-emetic premedication.
Peptide
Exenatide (exendin-4)
Outcome
No significant changeExenatide maximum concentration
Study
n = 120
Comparator
Exenatide without anti-emetic premedication
Outcome group
Pharmacokinetics · Pharmacology
Source sentences
Summary
The mean area under the concentration-time curve and the maximum observed concentration AUC and C(max) of plasma exenatide concentrations during 8 h post-dose were not significantly different between groups.
3 context sentences(design, population, supporting numbers)
Summary · context
This retrospective analysis of data from a phase 1, open-label, parallel-group, single-dose study in healthy subjects evaluated the effect of oral anti-emetics on exenatide-associated nausea and vomiting and on the pharmacokinetics of exenatide.
Summary · context
A single subcutaneous dose (10 μg) of exenatide was administered to 120 healthy subjects (19-65 years, BMI 23-35 kg/m(2) ).
Summary · context
Incidences of nausea and vomiting were compared between 60 subjects premedicated with two oral anti-emetics 30 min before the exenatide dose and 60 non-premedicated subjects.
In this study, Exenatide (exendin-4) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Exenatide (exendin-4).
Show in the study text Report a problemFND-2085438505

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Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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