Lixisenatide in type 2 diabetes mellitus: tolerability and discontinuation — summary of findings
Outcome-by-outcome summary with effect, certainty and the reason for each downgrade.
Templated review frame. This review question was generated by crossing an indication with a compound for which contributing trials exist. Its prose frame is templated and is shared with other questions of the same shape. Its included studies, its summary of findings and its certainty rating are computed from the underlying records and are not templated. The Institute publishes these questions because the alternative is to leave a question the document set can answer unanswered, and it labels them because the alternative is to present a templated frame as an authored one.
§4Summary of findings
§4.1Summary of findings
Table 7. Summary of findings for Lixisenatide in type 2 diabetes mellitus: tolerability and discontinuation.
| Outcome | Participants (studies) | Effect as reported | Certainty | Reason for downgrade |
|---|---|---|---|---|
| Change in HbA1c (%, mmol/mol)The outcome the Institute designates as anchor for this indication. | 7,689 (4) | Hazard ratio 1.02 (95 % CI 0.89 to 1.17); neutral | High | no downgrade |
| Discontinuation for adverse eventsReported as a summary-of-findings row rather than in a tolerability annex, following a public submission. | 6,061 (4) | Reported per contributing trial; see the included-studies table | High | no downgrade |
| Serious adverse eventsEvent counts are low; the estimate is imprecise by construction. | 6,250 (3) | Reported per contributing trial; see the included-studies table | Moderate | imprecision |
| Any adverse eventAscertained by spontaneous report in the contributing trials. | 6,438 (2) | Reported per contributing trial; see the included-studies table | Moderate | risk of bias |
| Proportion achieving HbA1c <7.0 % and ≤6.5 %A secondary outcome for this indication. Its hierarchical position within each contributing trial is recorded on that trial's abstract where the Institute holds it. | 5,735 (3) | Reported as a secondary outcome in a subset of contributing trials | Moderate | publication bias |
| Change in fasting serum glucoseA secondary outcome for this indication. Its hierarchical position within each contributing trial is recorded on that trial's abstract where the Institute holds it. | 3,633 (3) | Reported as a secondary outcome in a subset of contributing trials | Moderate | imprecision |
| Certainty ratings describe confidence in the effect estimate for the stated outcome. They are not recommendations and do not transfer between outcomes. | ||||
§4.2Forest plot
§4.3Certainty assessment for the anchor outcome
Table 8. Reasoning recorded against each certainty domain for the anchor outcome.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| 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: High certainty. The Institute is confident that the true effect lies close to the estimate. Further research is very unlikely to change confidence in the estimate. | ||
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.
- Pfeffer MA, Claggett B, Diaz R, Dickstein K, Gerstein HC, Køber LV, Lawson FC, Ping L, Wei X, Lewis EF, Maggioni AP, McMurray JJV, Probstfield JL, Riddle MC, Solomon SD, Tardif JC. Lixisenatide in patients with type 2 diabetes and acute coronary syndrome. New England Journal of Medicine 2015;373(23):2247–2257. doi:10.1056/NEJMoa1509225 · PMID 26630143
- 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
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