parallel randomized trial
EXALT
Does Glucagon-like Peptide (GLP-1) Receptor Agonist Stimulation Reduce Alcohol Intake in Patients With Alcohol Dependence?
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | Placebo Placebo | standard AUD behavioral treatment, therapy sessions every second week; lifestyle: not reported | 65 | 65 | |
| A2 | Exenatide extended release 2 mg subcutaneous once weekly Exenatide 2 mg once weekly | standard AUD behavioral treatment, therapy sessions every second week; lifestyle: not reported | 62 | 62 |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | Placebo A1 | Exenatide extended release 2 mg subcutaneous once weekly A2 | Whole trial ALL |
|---|---|---|---|---|
| age | mean (years) | 52 | ||
| bmi: 25.0 to 29.9 | n | 26 | 18 | |
| bmi: 25.0 to 29.9 | percent | 41.3 | 29.5 | |
| bmi: 30.0 to 34.9 | n | 12 | 10 | |
| bmi: 30.0 to 34.9 | percent | 19.1 | 16.4 | |
| bmi: 35 or more | n | 3 | 5 | |
| bmi: 35 or more | percent | 4.8 | 8.2 | |
| bmi: less than 25.0 | n | 22 | 28 | |
| bmi: less than 25.0 | percent | 34.9 | 45.9 | |
| other male | percent | 60 | ||
| white | percent | 100 |
Analyses this trial contributes to
- Serious adverse eventsAlcohol use disorder; longest follow-up; network meta-analysis
- Serious adverse eventsAlcohol use disorder; longest follow-up; network meta-analysis
- NauseaAlcohol use disorder; longest follow-up; network meta-analysis
- NauseaAlcohol use disorder; longest follow-up; network meta-analysis
- VomitingAlcohol use disorder; longest follow-up; network meta-analysis
- VomitingAlcohol use disorder; longest follow-up; network meta-analysis
- Acute pancreatitisAlcohol use disorder; longest follow-up; descriptive only
- Acute pancreatitisAlcohol use disorder; longest follow-up; descriptive only
Results
9 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Serious adverse events (2 lines; O25)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 18.5 | 65 | not stated; randomized; R0012402:Results | |||
| A2 | events | 24.2 | 62 | not stated; randomized; R0012402:Results |
Nausea (2 lines; O27A)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 15.4 | 65 | not stated; randomized; R0012402:Results | |||
| A2 | events | 37.1 | 62 | not stated; randomized; R0012402:Results |
Vomiting (2 lines; O27B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 7.7 | 65 | not stated; randomized; R0012402:Results | |||
| A2 | events | 22.6 | 62 | not stated; randomized; R0012402:Results |
Acute pancreatitis (2 lines; O29)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A1 | events | 0 / 65 | not stated; randomized; R0012402:Results | ||||
| A2 | events | 0 / 62 | not stated; randomized; R0012402:Results |
Death by suicide (1 lines; O35B)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| A2 | events | 1 / 62 | not stated; randomized; R0012402:Results |