FLOW trial: difference between revisions
Diff·revision 15 → 16·09:22, 27 May 2025
Difference between revision 15 and revision 16 of FLOW trial. 6 lines changed; the page grew by 933 bytes.
| Revision 15 — 16:22, 4 May 2025 AppendixAlva (talk) add the PMID 3,481 bytes ±0 | Revision 16 — 09:22, 27 May 2025 OpenLabelOtto (talk) fix indentation in the source 4,414 bytes +933 | ||
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| 33 | An initial dip in filtration rate after starting is expected with several renoprotective therapies and reflects haemodynamic change rather than injury; interpreting an early fall as harm is a common error, and trials of this kind pre-specify the analysis to account for it.{{r|ich_e9}} | 33 | An initial dip in filtration rate after starting is expected with several renoprotective therapies and reflects haemodynamic change rather than injury; interpreting an early fall as harm is a common error, and trials of this kind pre-specify the analysis to account for it.{{r|ich_e9}} |
| 34 | 34 | ||
| + | 35 | == Interpretation == | |
| + | 36 | FLOW supports a renal benefit for semaglutide 1.0 mg in type 2 diabetes with chronic kidney disease, added to standard renal protection. It does not establish benefit in kidney disease without diabetes, at other doses, or for other members of the class.{{r|perkovic2024}} | |
| + | 37 | ||
| + | 38 | Together with [[SELECT trial|SELECT]] and [[LEADER trial|LEADER]]{{r|marso2016}} it forms the outcome evidence base for this molecule and its predecessor, and the pattern across those three — cardiovascular benefit in diabetes, cardiovascular benefit without diabetes, renal benefit in diabetic kidney disease — is what distinguishes an agent with outcome data from one with only intermediate endpoints.{{r|lincoff2023}} | |
| + | 39 | ||
| 35 | == References == | 40 | == References == |
| 36 | {{reflist}} | 41 | {{reflist}} |
| ⋮ | ⋮ | ||
| 38 | <ref name="lincoff2023">Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. "Semaglutide and cardiovascular outcomes in obesity without diabetes." ''New England Journal of Medicine'' 389(24):2221–2232 (2023). PMID 37952131.</ref> | 43 | <ref name="lincoff2023">Lincoff AM, Brown-Frandsen K, Colhoun HM, et al. "Semaglutide and cardiovascular outcomes in obesity without diabetes." ''New England Journal of Medicine'' 389(24):2221–2232 (2023). PMID 37952131.</ref> |
| 39 | <ref name="ich_e9">International Council for Harmonisation, ''E9(R1): Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> | 44 | <ref name="ich_e9">International Council for Harmonisation, ''E9(R1): Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> |
| + | 45 | <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). PMID 27295427.</ref> | |
| 40 | 46 | ||
| 41 | == See also == | 47 | == See also == |