STEP trial programme: difference between revisions
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| Revision 20 — 11:49, 17 May 2025 CiteBot (talk) bot: expand PMID to full citation 4,391 bytes ±0 | Revision 21 — 16:20, 16 Jun 2025 PioneerPerdita (talk) consistent en dashes in ranges 5,114 bytes +723 | ||
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| 36 | Analysis populations matter. The primary estimand in several of these trials treats data after treatment discontinuation in a defined way, and the "treatment policy" and "trial product" estimands give different numbers from the same data. See [[Intention-to-treat analysis]].{{r|davies2021}} | 36 | Analysis populations matter. The primary estimand in several of these trials treats data after treatment discontinuation in a defined way, and the "treatment policy" and "trial product" estimands give different numbers from the same data. See [[Intention-to-treat analysis]].{{r|davies2021}} |
| 37 | 37 | ||
| + | 38 | == What the programme does and does not establish == | |
| + | 39 | It establishes efficacy for weight reduction against placebo in the studied populations over the studied durations, and it establishes the adverse-effect profile at those doses — gastrointestinal events dominating and concentrated in escalation.{{r|wilding2021,ich_e9}} | |
| + | 40 | ||
| + | 41 | It does not establish outcomes. Weight is an intermediate endpoint; the cardiovascular outcome question was addressed separately by [[SELECT trial|SELECT]]. Nor does it establish durability beyond the trial durations, or effect in populations not studied. | |
| + | 42 | ||
| 38 | == References == | 43 | == References == |
| 39 | {{reflist}} | 44 | {{reflist}} |
| ⋮ | ⋮ | ||
| 41 | <ref name="davies2021">Davies M, Færch L, Jeppesen OK, et al. "Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2)." ''The Lancet'' 397(10278):971–984 (2021). PMID 33667417.</ref> | 46 | <ref name="davies2021">Davies M, Færch L, Jeppesen OK, et al. "Semaglutide 2.4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2)." ''The Lancet'' 397(10278):971–984 (2021). PMID 33667417.</ref> |
| 42 | <ref name="rubino2021">Rubino D, Abrahamsson N, Davies M, et al. "Effect of continued weekly subcutaneous semaglutide vs placebo on weight loss maintenance (STEP 4)." ''JAMA'' 325(14):1414–1425 (2021). PMID 33755728.</ref> | 47 | <ref name="rubino2021">Rubino D, Abrahamsson N, Davies M, et al. "Effect of continued weekly subcutaneous semaglutide vs placebo on weight loss maintenance (STEP 4)." ''JAMA'' 325(14):1414–1425 (2021). PMID 33755728.</ref> |
| + | 48 | <ref name="ich_e9">International Council for Harmonisation, ''E9(R1): Estimands and Sensitivity Analysis in Clinical Trials'' (2019).</ref> | |
| 43 | 49 | ||
| 44 | == See also == | 50 | == See also == |