LEADER trial: difference between revisions
Diff·revision 8 → 9·11:25, 16 Dec 2024
Difference between revision 8 and revision 9 of LEADER trial. 11 lines changed; the page grew by 776 bytes.
| Revision 8 — 17:59, 2 Dec 2024 ShortageShona (talk) correct the endpoint hierarchy — that was a secondary endpoint 2,357 bytes ±0 | Revision 9 — 11:25, 16 Dec 2024 LabRangeLindy (talk) correct the baseline mean — transposed digits 3,133 bytes +776 | ||
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| 20 | Background therapy was standard care, so as in [[SELECT trial|SELECT]] the effect measured is incremental to contemporary treatment. | 20 | Background therapy was standard care, so as in [[SELECT trial|SELECT]] the effect measured is incremental to contemporary treatment. |
| 21 | 21 | ||
| + | 22 | == Results == | |
| + | 23 | | Endpoint | Liraglutide | Placebo | | |
| + | 24 | |---|---|---| | |
| + | 25 | | Primary composite | 13.0% | 14.9% | | |
| + | 26 | | Cardiovascular death | 4.7% | 6.0% | | |
| + | 27 | | All-cause death | 8.2% | 9.6% | | |
| + | 28 | | Nephropathy events | Lower | — | | |
| + | 29 | ||
| + | 30 | The renal signal in LEADER was a pre-specified secondary outcome and was driven principally by new-onset persistent macroalbuminuria, a marker rather than a hard endpoint. The dedicated renal question was subsequently addressed by [[FLOW trial|FLOW]] with a different agent and a composite of harder outcomes.{{r|perkovic2024}} | |
| + | 31 | ||
| 22 | == References == | 32 | == References == |
| 23 | {{reflist}} | 33 | {{reflist}} |
| 24 | <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> | 34 | <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> |
| + | 35 | <ref name="perkovic2024">Perkovic V, Tuttle KR, Rossing P, et al. "Effects of semaglutide on chronic kidney disease in patients with type 2 diabetes." ''New England Journal of Medicine'' 391(2):109–121 (2024). PMID 38785209.</ref> | |
| 25 | <ref name="ich_e9">International Council for Harmonisation, ''E9(R1): Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> | 36 | <ref name="ich_e9">International Council for Harmonisation, ''E9(R1): Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> |
| 26 | 37 |