Trial abstract · §3
ELIXA — results
Primary endpoint, absolute and relative effect where derivable, and harms as reported.
§3Results
§3.1Primary endpoint
Table 3. Primary endpoint as reported.
| Endpoint | Result as reported | Certainty |
|---|---|---|
| Time to first occurrence of a four-point composite of cardiovascular death, myocardial infarction, stroke or hospitalisation for unstable angina after an acute coronary syndrome | Hazard ratio 1.02 (95 % CI 0.89 to 1.17); neutral | High |
| Reproduced from the published report. Where the report states a confidence interval the Institute reproduces it; where it does not, none is constructed. | ||
§3.2Endpoint hierarchy
Table 4. Relative and absolute effect. The Institute reports both, because a relative measure without a baseline risk cannot be acted on and systematically overstates benefit in lower-risk populations.
| Measure | Value | Note |
|---|---|---|
| Hazard ratio as reported | 1.02 | Reproduced from the published report. |
| Comparator event rate, % | 10.2 | Illustrative. A rate typical of the enrolled risk profile, used to convert the relative measure. Not a published figure. |
| Absolute risk difference, pp | -0.20 | Illustrative. Computed from the two rows above. |
| Number needed to treat | — | Illustrative. For the stated duration, at the comparator rate assumed above. Rises sharply as baseline risk falls. |
| Three of the four rows are Institute constructions and are marked. Only the hazard ratio is a published figure. | ||
§3.3Harms as reported
Table 5. Adverse events for Lixisenatide from the safety tables the Institute holds for this compound. Where a row names a different trial as its source, the figure is from that trial and not from this one.
| Event | Active, % | Comparator, % | Source trial |
|---|---|---|---|
| Nausea | 25.0 | 7.0 | GetGoal pooled |
| Vomiting | 10.0 | 2.0 | GetGoal pooled |
| Headache | 8.0 | 6.0 | GetGoal pooled |
| Symptomatic hypoglycaemia (with sulfonylurea) | 22.0 | 13.0 | GetGoal pooled |
| Antibody formation | 70.0 | — | GetGoal pooled — high incidence; efficacy attenuated only at very high titre |
| Discontinuation for adverse events | 7.0 | 3.0 | GetGoal pooled |
Compound Evidence Institute · CEI-TR-0092/3 · https://compoundevidence.com/trials/elixa/results/ · retrieved 30 July 2026