Semaglutide in hypertension in the context of adiposity — evidence extract
The Institute's graded assessment of Semaglutide for hypertension in the context of adiposity, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Hypertension in the context of adiposity
§1.1Question and anchor outcome
- Population
- Sustained elevation of arterial pressure above accepted diagnostic thresholds, considered here as a weight-responsive outcome rather than a primary treatment indication.
- Intervention
- Semaglutide, subcutaneous once weekly; oral once daily with a permeation enhancer (see separate monograph)
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Change in systolic and diastolic blood pressure
Additional outcomes the Institute extracts for this indication: Ambulatory blood-pressure monitoring change; Antihypertensive medication burden.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Semaglutide in hypertension in the context of adiposity.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| STEP-1 | 3 | Randomised, double-blind, placebo-controlled | 1,961 | 68 weeks | 2021 |
| SELECT | 3 | Event-driven cardiovascular outcome trial | 17,604 | Mean 39.8 months | 2023 |
§1.3Certainty assessment
Table 2. Reasoning recorded against each certainty domain.
| Domain | Rating | Reasoning |
|---|---|---|
| Risk of bias | No concern | No serious concern identified in this domain. |
| Inconsistency | Serious | Estimates vary in magnitude across contributing trials beyond what chance would produce. |
| Indirectness | No concern | No serious concern identified in this domain. |
| Imprecision | No concern | No serious concern identified in this domain. |
| Publication bias | No concern | No serious concern identified in this domain. |
| Overall rating: Moderate certainty. The true effect is likely to be close to the estimate, but there is a possibility that it is substantially different. Further research is likely to have an important impact on confidence in the estimate. | ||
§1.4What this extract does not establish
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF. Once-weekly semaglutide in adults with overweight or obesity. New England Journal of Medicine 2021;384(11):989–1002. doi:10.1056/NEJMoa2032183 · PMID 33567185
- Davies M, Færch L, Jeppesen OK, Pakseresht A, Pedersen SD, Perreault L, Rosenstock J, Shimomura I, Viljoen A, Wadden TA, Lingvay I. Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial. The Lancet 2021;397(10278):971–984. doi:10.1016/S0140-6736(21)00213-0 · PMID 33667417
- Wadden TA, Bailey TS, Billings LK, Davies M, Frias JP, Koroleva A, Lingvay I, O’Neil PM, Rubino DM, Skovgaard D, Wallenstein SOR, Garvey WT. Effect of subcutaneous semaglutide vs placebo as an adjunct to intensive behavioral therapy on body weight in adults with overweight or obesity: the STEP 3 randomized clinical trial. JAMA 2021;325(14):1403–1413. doi:10.1001/jama.2021.1831 · PMID 33625476
Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.