SURMOUNT trial programme: difference between revisions
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| Revision 18 — 00:42, 17 May 2025 PreregPriya (talk) name the funder in the sentence, per PP:MOS 3,589 bytes ±0 | Revision 19 — 03:47, 11 Jun 2025 StubSorterBot (talk) bot: expand PMID to full citation 4,572 bytes +983 | ||
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| 34 | Discontinuation for adverse events ran at roughly 4–7% across doses, with gastrointestinal events dominating. That is comparable with agents producing smaller weight effects, which is one of the more interesting observations in the programme and is not fully explained.{{r|garvey2023}} | 34 | Discontinuation for adverse events ran at roughly 4–7% across doses, with gastrointestinal events dominating. That is comparable with agents producing smaller weight effects, which is one of the more interesting observations in the programme and is not fully explained.{{r|garvey2023}} |
| 35 | 35 | ||
| + | 36 | == Scope of the evidence == | |
| + | 37 | The programme establishes weight efficacy in the studied populations and durations. It does not establish cardiovascular or other clinical outcomes; those are addressed by separate outcome trials, and weight is an intermediate endpoint.{{r|ich_e9}} | |
| + | 38 | ||
| + | 39 | Nor does it establish comparative efficacy against [[Semaglutide|semaglutide]] 2.4 mg, which has never been studied head-to-head in obesity within this programme. Comparisons drawn between SURMOUNT-1 and [[STEP trial programme|STEP 1]] are cross-trial and are confounded by population, duration and escalation differences.{{r|ich_e9,wilding2021}} | |
| + | 40 | ||
| 36 | == References == | 41 | == References == |
| 37 | {{reflist}} | 42 | {{reflist}} |
| 38 | <ref name="jastreboff2022">Jastreboff AM, Aronne LJ, Ahmad NN, et al. "Tirzepatide once weekly for the treatment of obesity." ''New England Journal of Medicine'' 387(3):205–216 (2022). DOI:10.1056/NEJMoa2206038. PMID 35658024.</ref> | 43 | <ref name="jastreboff2022">Jastreboff AM, Aronne LJ, Ahmad NN, et al. "Tirzepatide once weekly for the treatment of obesity." ''New England Journal of Medicine'' 387(3):205–216 (2022). DOI:10.1056/NEJMoa2206038. PMID 35658024.</ref> |
| 39 | <ref name="garvey2023">Garvey WT, Frias JP, Jastreboff AM, et al. "Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2)." ''The Lancet'' 402(10402):613–626 (2023). PMID 37385275.</ref> | 44 | <ref name="garvey2023">Garvey WT, Frias JP, Jastreboff AM, et al. "Tirzepatide once weekly for the treatment of obesity in people with type 2 diabetes (SURMOUNT-2)." ''The Lancet'' 402(10402):613–626 (2023). PMID 37385275.</ref> |
| + | 45 | <ref name="ich_e9">International Council for Harmonisation, ''E9(R1): Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> | |
| + | 46 | <ref name="wilding2021">Wilding JPH, Batterham RL, Calanna S, et al. "Once-weekly semaglutide in adults with overweight or obesity." ''New England Journal of Medicine'' 384(11):989–1002 (2021). PMID 33567185.</ref> | |
| 40 | 47 | ||
| 41 | == See also == | 48 | == See also == |