Dulaglutide in atherosclerotic cardiovascular disease and cardiovascular risk reduction — evidence extract
The Institute's graded assessment of Dulaglutide for atherosclerotic cardiovascular disease and cardiovascular risk reduction, with the contributing trials and the domain-by-domain certainty reasoning.
§1Evidence extract: Atherosclerotic cardiovascular disease and cardiovascular risk reduction
§1.1Question and anchor outcome
- Population
- Established atherosclerotic disease of the coronary, cerebral or peripheral arterial beds, or a risk profile sufficient for enrolment in a cardiovascular outcome trial.
- Intervention
- Dulaglutide, subcutaneous once weekly
- Comparator
- As used in each contributing trial; reported per trial rather than pooled across comparator types
- Anchor outcome
- Three-point major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke)
Additional outcomes the Institute extracts for this indication: Cardiovascular death; All-cause death; Hospitalisation for heart failure.
§1.2Contributing trials
Table 1. Trials contributing to the assessment of Dulaglutide in atherosclerotic cardiovascular disease and cardiovascular risk reduction.
| Trial | Phase | Design | Randomised | Duration | Year |
|---|---|---|---|---|---|
| REWIND | 3 | Event-driven cardiovascular outcome trial | 9,901 | Median 5.4 years | 2019 |
§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 | No concern | No serious concern identified in this domain. |
| 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: High certainty. The Institute is confident that the true effect lies close to the estimate. Further research is very unlikely to change 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.
- Gerstein HC, Colhoun HM, Dagenais GR, Diaz R, Lakshmanan M, Pais P, Probstfield J, Riesmeyer JS, Riddle MC, Rydén L, Xavier D, Atisso CM, Dyal L, Hall S, Rao-Melacini P, Wong G, Avezum A, Basile J, Chung N, Conget I. Dulaglutide and cardiovascular outcomes in type 2 diabetes (REWIND): a double-blind, randomised placebo-controlled trial. The Lancet 2019;394(10193):121–130. doi:10.1016/S0140-6736(19)31149-3 · PMID 31189511
- Pratley RE, Aroda VR, Lingvay I, Lüdemann J, Andreassen C, Navarria A, Viljoen A. Semaglutide versus dulaglutide once weekly in patients with type 2 diabetes (SUSTAIN 7): a randomised, open-label, phase 3b trial. The Lancet Diabetes & Endocrinology 2018;6(4):275–286. doi:10.1016/S2213-8587(18)30024-X · PMID 29397376
- International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. ICH Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Harmonised Tripartite Guideline 1999;Step 4 version. identifier not held by the Institute
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.