Atherosclerotic cardiovascular disease and cardiovascular risk reduction — compounds assessed
The 11 compounds the Institute assesses in atherosclerotic cardiovascular disease and cardiovascular risk reduction.
§4Compounds assessed
Compounds the Institute assesses in this indication, with the class of each and its overall certainty. A compound appears here whether or not the evidence supports its use, because recording that a compound has been studied and found wanting is as much part of the assessment as recording that one has not.
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MACE hazard ratio 0.88 in a population with a majority without established cardiovascular disease — The only large GLP-1 outcome trial enrolling a majority in primary prevention, which the Institute regards as an important distinguishing feature of this…
High -
GLP-1 receptor agonist (exendin-based, short- and extended-release)1 contributing trialfull monograph
MACE hazard ratio 0.91 — non-inferior to placebo but not superior — The Institute records this as a clear negative superiority result and cautions against class-wide extrapolation of cardiovascular benefit from it.
High -
MACE hazard ratio 0.87 in type 2 diabetes at high cardiovascular risk — Event-driven with independent adjudication; 9,340 participants.
High -
MACE hazard ratio 1.02 — neutral — A clearly neutral event-driven result in a post-acute-coronary-syndrome population. The Institute cites ELIXA whenever the assertion of a class-wide cardiovascular benefit is made.
High -
Three-point MACE hazard ratio 0.80 in adults with overweight or obesity and established cardiovascular disease without diabetes — SELECT randomised 17,604 participants and was event-driven with independent adjudication. The Institute grades event reduction as…
High -
GLP-1 receptor agonist, oral formulation with absorption enhancer2 contributing trialsfull monograph
MACE hazard ratio 0.79 (non-inferiority design) in PIONEER 6; 0.86 in the event-driven SOUL trial — PIONEER 6 was powered for non-inferiority only. SOUL provides the superiority result; the Institute grades moderate rather than high pending independent…
Moderate -
A phase 2 trial in ST-elevation myocardial infarction did not reduce infarct size — A clear null result on an objective imaging endpoint.
Moderate -
MACE hazard ratio 0.92 versus dulaglutide 1.5 mg in an active-controlled non-inferiority design — An active-controlled non-inferiority result establishes that tirzepatide is not inferior to an agent of proven benefit. It does not establish superiority to…
Moderate -
Growth-hormone secretagogue, non-selective ghrelin receptor agonist (hexapeptide)0 contributing trialsfull monograph
No randomised human evidence identified — Cardioprotective claims derive entirely from rodent models.
Very low -
No randomised controlled human trial identified — Preclinical cardiac-repair work used the full-length protein.
Very low -
Phase 1 safety study completed; no efficacy conclusion — Preclinical cardiac-repair findings were not confirmed clinically.
Very low
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
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.