Pulse Brain · Growing Health Evidence Index
Tier 2 — RCT / large cohortPeer-reviewed

Cardiovascular safety and efficacy of the PCSK9 inhibitor evolocumab in patients with and without diabetes and the effect of evolocumab on glycaemia and risk of new-onset diabetes: a prespecified analysis of the FOURIER randomised controlled trial

Marc S. Sabatine, Lawrence A. Leiter, Stephen D. Wiviott, Robert P. Giugliano, Prakash Deedwania, Gaetano Maria De Ferrari, Sabina A. Murphy, Julia Kuder, Ioanna Gouni‐Berthold, Basil S. Lewis, Yehuda Handelsman, Armando Lira Pineda, Narimon Honarpour, Anthony Keech, Peter S. Sever, Terje R. Pedersen

The Lancet Diabetes & Endocrinology · 2017

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Summary

This prespecified analysis of the FOURIER randomised controlled trial examined the cardiovascular efficacy and safety of evolocumab (a PCSK9 inhibitor) across patient subgroups defined by diabetes status, and investigated potential effects on glucose homeostasis and diabetes development. The trial appears to have assessed whether PCSK9 inhibition confers consistent cardiovascular benefit regardless of baseline glucose metabolism, and whether the drug influences diabetes risk. As a large cardiovascular outcomes trial in The Lancet Diabetes & Endocrinology, the analysis likely contributes evidence on the metabolic tolerability of intensive LDL-lowering therapy in high-risk populations.

UK applicability

Findings would be directly relevant to UK clinical practice and NICE guideline development for lipid management and cardiovascular risk reduction, particularly for patients with concurrent or at-risk diabetes. The evidence base supports consideration of PCSK9 inhibitors within NHS treatment pathways, subject to cost-effectiveness and commissioning decisions.

Key measures

Cardiovascular events, lipid panels (LDL-cholesterol), glycaemic markers, incidence of new-onset diabetes, safety outcomes

Outcomes reported

The study evaluated cardiovascular safety and efficacy of evolocumab (a PCSK9 inhibitor) in patients with and without diabetes, and assessed its effects on glycaemic control and risk of new-onset diabetes. Prespecified subgroup analyses examined outcomes stratified by baseline diabetes status.

Theme
Nutrition & health
Subject
Dietary patterns & chronic disease
Study type
Research
Study design
RCT
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1016/s2213-8587(17)30313-3
Catalogue ID
SNmohdw9er-t403xr

Topic tags

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