ELIXA — structured trial abstract
ELIXA — Lixisenatide in cardiovascular and type 2 diabetes: event-driven cardiovascular outcome trial
§1Structured abstract
§1.1Objective
To evaluate Lixisenatide in atherosclerotic cardiovascular disease and cardiovascular risk reduction and type 2 diabetes mellitus, against the comparator specified in §2, with the primary endpoint stated below.
§1.2Design
- Design
- Randomised, double-blind, placebo-controlled, event-driven cardiovascular outcome trial
- Masking
- Double-blind with independent endpoint adjudication
- Phase
- Phase 3
- Randomised participants
- 6,068
- Duration of the primary analysis period
- Median 25 months
- Sponsor class
- Manufacturer-sponsored
- Registry identifier
- not reproduced — see the note in §1.5
§1.3Primary endpoint
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
§1.4Principal result
Hazard ratio 1.02 (95 % CI 0.89 to 1.17); neutral.[1]
The neutral ELIXA result is the Institute’s principal reason for declining to treat cardiovascular benefit as a class effect of GLP-1 receptor agonism.
§1.5Provenance of this abstract
Table 1. Field-by-field provenance. The Institute records which fields are extracted from a source and which are its own reconstruction, so that a reader can tell the two apart without leaving the page.
| Field | Provenance | Note |
|---|---|---|
| Design, phase, duration, primary endpoint | Extracted | Reproduced from the published report or the registry record. |
| Randomised participants | Extracted | Reproduced as published. |
| Principal result | Extracted | Reproduced as published, with the confidence interval where the Institute holds it. |
| Centres, countries and baseline characteristics | Reconstructed | Derived by the Institute from the design class and the randomised total. Presented in §2 as an illustrative operational profile and marked as such. These figures are not published characteristics of this trial. |
| Certainty assessment | Institute judgement | The Institute’s own domain-by-domain assessment, with reasoning recorded against each domain in §4. |
| Registry identifier | Not held | The Institute does not reproduce a registry identifier it has not verified and never constructs one. Documents are referenced by the Institute’s own identifier. |
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
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.