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

Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease

Marc S. Sabatine, Robert P. Giugliano, Anthony Keech, Narimon Honarpour, Stephen D. Wiviott, Sabina A. Murphy, Julia Kuder, Huei Wang, Thomas Liu, Scott M. Wasserman, Peter Sever, Terje R. Pedersen

New England Journal of Medicine · 2017

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Summary

This large randomised controlled trial (n=27,564) evaluated evolocumab, a PCSK9-inhibiting monoclonal antibody, as an adjunct to statin therapy in patients with established atherosclerotic cardiovascular disease. Over a median 2.2-year follow-up, evolocumab reduced LDL cholesterol by approximately 59% and significantly reduced the composite risk of major adverse cardiovascular events (hazard ratio 0.85) and the secondary composite of cardiovascular death, myocardial infarction, or stroke (hazard ratio 0.80), with no significant increase in adverse events except injection-site reactions.

UK applicability

This trial's findings are directly relevant to UK clinical practice, as the NHS routinely prescribes statins for cardiovascular disease prevention and this evidence supports PCSK9 inhibition as a further step in intensive lipid lowering for high-risk patients. However, the applicability to UK agricultural or food system contexts is negligible, as this is a pharmaceutical intervention study with no connection to farming systems, soil health, or nutrient density of foods.

Key measures

Percentage reduction in LDL cholesterol levels from baseline (median 92 mg/dL to 30 mg/dL); hazard ratios for primary composite endpoint (0.85; 95% CI 0.79–0.92) and key secondary endpoint (0.80; 95% CI 0.73–0.88); adverse event frequency including injection-site reactions

Outcomes reported

The study measured the effect of evolocumab (a PCSK9 inhibitor) on LDL cholesterol levels and cardiovascular events in patients with atherosclerotic cardiovascular disease already on statin therapy. Primary outcomes included composite cardiovascular death, myocardial infarction, stroke, hospitalisation for unstable angina, or coronary revascularisation; secondary outcomes focused on cardiovascular death, myocardial infarction, or stroke alone.

Theme
Nutrition & health
Subject
Dietary fats & fatty acids
Study type
Research
Study design
RCT
Source type
Peer-reviewed study
Status
Published
Geography
International
System type
Human clinical
DOI
10.1056/nejmoa1615664
Catalogue ID
SNmohdw9er-the3ub

Topic tags

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