LEADER trial: difference between revisions
Diff·revision 2 → 3·16:25, 20 Sep 2024
Difference between revision 2 and revision 3 of LEADER trial. 6 lines changed; the page grew by 844 bytes.
| Revision 2 — 16:19, 12 Sep 2024 PioneerPerdita (talk) British spelling per PP:MOS 1,120 bytes ±0 | Revision 3 — 16:25, 20 Sep 2024 FlowTrialFraser (talk) consistent en dashes in ranges 1,964 bytes +844 | ||
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| 11 | The primary composite outcome occurred in 13.0% of the liraglutide group and 14.9% of the placebo group, a hazard ratio of 0.87 (95% CI 0.78–0.97). Cardiovascular death was reduced, and all-cause mortality was lower in the liraglutide group.{{r|marso2016}} | 11 | The primary composite outcome occurred in 13.0% of the liraglutide group and 14.9% of the placebo group, a hazard ratio of 0.87 (95% CI 0.78–0.97). Cardiovascular death was reduced, and all-cause mortality was lower in the liraglutide group.{{r|marso2016}} |
| 12 | 12 | ||
| + | 13 | == Design and context == | |
| + | 14 | Cardiovascular outcome trials for glucose-lowering drugs were mandated by regulators following concerns about an earlier drug class, and were designed as non-inferiority trials to exclude excess risk. LEADER was designed on that basis and tested for superiority in a pre-specified hierarchy after non-inferiority was established.{{r|marso2016}} | |
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| + | 16 | The population was enriched for events: participants were 50 or older with established cardiovascular, cerebrovascular or renal disease, or 60 or older with risk factors. Enrichment increases the event rate and therefore the power of a trial of a given size, and it also limits generalisation to lower-risk populations.{{r|ich_e9}} | |
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| 13 | == References == | 18 | == References == |
| 14 | {{reflist}} | 19 | {{reflist}} |
| 15 | <ref name="marso2016">Marso SP, Daniels GH, Brown-Frandsen K, et al. "Liraglutide and cardiovascular outcomes in type 2 diabetes." ''New England Journal of Medicine'' 375(4):311–322 (2016). DOI:10.1056/NEJMoa1603827. PMID 27295427.</ref> | 20 | <ref name="marso2016">Marso SP, Daniels GH, Brown-Frandsen K, et al. "Liraglutide and cardiovascular outcomes in type 2 diabetes." ''New England Journal of Medicine'' 375(4):311–322 (2016). DOI:10.1056/NEJMoa1603827. PMID 27295427.</ref> |
| + | 21 | <ref name="ich_e9">International Council for Harmonisation, ''E9(R1): Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> | |
| 16 | 22 | ||
| 17 | {{DEFAULTSORT:LEADER trial}} | 23 | {{DEFAULTSORT:LEADER trial}} |