BACKGROUND
REDUCE-IT, a multinational, double-blind trial, randomized 8179 statin-treated patients
with controlled low density lipoprotein cholesterol, elevated triglycerides, and cardiovascular
(CV) risk, to icosapent ethyl (IPE) 4 grams daily or placebo. IPE reduced the primary
(CV death, myocardial infarction [MI], stroke, coronary revascularization, hospitalization
for unstable angina) and key secondary (CV death, MI, stroke) endpoints 25% and 26%,
respectively (each p < 0.000001). At baseline, median body mass index (BMI) was 30.8
kg/m2, and 58.5% of REDUCE-IT patients had diabetes mellitus (DM). In patients with
DM, the primary and key secondary endpoints were reduced 23% and 30%, respectively
(each p≤0.00005).
METHODS AND RESULTS
We evaluated if BMI modulated CV risk reduction with IPE in patients with or without
DM. In the full cohort, similar CV risk reduction was observed across the prespecified
endpoint testing hierarchy (interaction p=ns for all), and relative safety between
treatment groups was generally consistent. In persons with or without DM, similar
reductions in the primary endpoint were observed across BMI categories (Figure), with
similar findings in the key secondary endpoint (interaction p=ns for all).
CONCLUSION
The significant cardiovascular risk reduction provided by IPE 4g/day is consistent
across BMI in patients with and without DM.
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© 2021 Published by Elsevier Inc.
