LEADER trial: difference between revisions
Diff·revision 4 → 5·01:55, 10 Oct 2024
Difference between revision 4 and revision 5 of LEADER trial. 2 lines changed; the page grew by 223 bytes.
| Revision 4 — 09:48, 26 Sep 2024 ForestPlotFinn (talk) convert the endpoint list to a table for comparability 1,964 bytes ±0 | Revision 5 — 01:55, 10 Oct 2024 ParentCatPansy (talk) add the number randomised and the number completing 2,187 bytes +223 | ||
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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 | It was among the first trials to show that an incretin therapy could reduce cardiovascular events rather than merely not increase them, at a time when such trials were being run principally to exclude harm.{{r|marso2016}} | |
| + | 14 | ||
| 13 | == Design and context == | 15 | == 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}} | 16 | 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}} |