SUSTAIN trial programme: difference between revisions
Diff·revision 6 → 7·08:17, 16 Oct 2024
Difference between revision 6 and revision 7 of SUSTAIN trial programme. 5 lines changed; the page grew by 836 bytes.
| Revision 6 — 13:00, 21 Sep 2024 NavboxNiko (talk) add the randomisation ratio 2,824 bytes ±0 | Revision 7 — 08:17, 16 Oct 2024 API_Aurora (talk) state the analysis population: intention-to-treat or per-protocol 3,660 bytes +836 | ||
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| 26 | Comparator doses matter in every such trial and are frequently omitted from secondary reporting. A comparison against a comparator's lower approved dose is a different result from one against its highest.{{r|marso2016s}} | 26 | Comparator doses matter in every such trial and are frequently omitted from secondary reporting. A comparison against a comparator's lower approved dose is a different result from one against its highest.{{r|marso2016s}} |
| 27 | 27 | ||
| + | 28 | == SUSTAIN 6 and its interpretation == | |
| + | 29 | SUSTAIN 6 was powered as a non-inferiority trial for cardiovascular safety, as regulators required for glucose-lowering drugs at the time. The observed hazard ratio of 0.74 excluded 1.0, but the trial's design and event count mean the superiority finding is treated cautiously.{{r|marso2016s}} | |
| + | 30 | ||
| + | 31 | A secondary finding attracted attention: an increase in diabetic retinopathy complications in the semaglutide arm, concentrated in participants with pre-existing retinopathy and rapid glycaemic improvement. Rapid glucose lowering is a recognised precipitant of transient retinopathy worsening by other means, so the finding is generally attributed to the magnitude and speed of improvement rather than to the drug directly — an attribution that is plausible rather than established.{{r|marso2016s}} | |
| + | 32 | ||
| 28 | == References == | 33 | == References == |
| 29 | {{reflist}} | 34 | {{reflist}} |