Exenatide in delayed gastric emptying and gastrointestinal motility effects — evidence extract
The Institute's graded assessment of Exenatide for delayed gastric emptying and gastrointestinal motility effects, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Delayed gastric emptying and gastrointestinal motility effects
§1.1Question and anchor outcome
- Population
- Slowed gastric transit, considered here both as a pharmacodynamic mechanism and as an adverse-effect surface relevant to procedural and anaesthetic risk.
- Intervention
- Exenatide, subcutaneous twice daily (immediate release) or once weekly (poly(lactide-co-glycolide) microsphere extended release)
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Gastric emptying half-time by scintigraphy or breath test
Additional outcomes the Institute extracts for this indication: Residual gastric content at endoscopy or anaesthesia; Gastrointestinal adverse-event incidence.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Exenatide in delayed gastric emptying and gastrointestinal motility effects.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| EXENATIDE-GE-PD | 3 | Randomised, double-blind, placebo-controlled | 194 | 96 weeks | 2025 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | Serious | Contributing trials are sponsor-conducted and one is open-label. |
| Inconsistency | No concern | No serious concern identified in this domain. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: Moderate certainty. The true effect is likely to be close to the estimate, but there is a possibility that it is substantially different. Further research is likely to have an important impact on confidence in the estimate. | ||
§1.4What this extract does not establish
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Holman RR, Bethel MA, Mentz RJ, Thompson VP, Lokhnygina Y, Buse JB, Chan JC, Choi J, Gustavson SM, Iqbal N, Maggioni AP, Marso SP, Öhman P, Pagidipati NJ, Poulter N, Ramachandran A, Zinman B, Hernandez AF. Effects of once-weekly exenatide on cardiovascular outcomes in type 2 diabetes. New England Journal of Medicine 2017;377(13):1228–1239. doi:10.1056/NEJMoa1612917 · PMID 28910237
- Buse JB, Rosenstock J, Sesti G, Schmidt WE, Montanya E, Brett JH, Zychma M, Blonde L. Liraglutide once a day versus exenatide twice a day for type 2 diabetes: a 26-week randomised, parallel-group, multinational, open-label trial (LEAD-6). The Lancet 2009;374(9683):39–47. doi:10.1016/S0140-6736(09)60659-0 · PMID 19515413
- Drucker DJ. Mechanisms of action and therapeutic application of glucagon-like peptide-1. Cell Metabolism 2018;27(4):740–756. doi:10.1016/j.cmet.2018.03.001 · PMID 29617641
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.