Why the study?
Because some trials have found that patients from the United States derive less benefit than patients enrolled outside the United States, this study evaluated the degree of benefit of icosapent ethyl in the US cohort.
Does icosapent ethyl 4 g/d reduce the composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina in statin-treated US patients with elevated triglycerides and a history of atherosclerosis or diabetes mellitus?
Population
3146 statin-treated US patients with elevated triglycerides and atherosclerosis or diabetes mellitus
Comparison
Icosapent ethyl 4 g/d vs placebo
Design
Prespecified randomized subgroup analysis
Follow-up
Median of 4.9 years
Authors
Discussion
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Member takes
Implication
Supports icosapent ethyl in high-risk US patients on statins; extends REDUCE-IT benefit to this population.
Structured PICO
Does icosapent ethyl 4 g/d reduce the composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable angina in statin-treated US patients with elevated triglycerides and a history of atherosclerosis or diabetes mellitus?
P
Population
3,146 US patients (subgroup of 8,179 total trial patients), 32.3% women, 9.7% Hispanic. Key inclusion: statin-treated with qualifying triglycerides ≥135 and <500 mg/dL, low-density lipoprotein cholesterol >40 and ≤100 mg/dL, and a history of atherosclerosis or diabetes mellitus.
I
Intervention
Icosapent ethyl 4 g/d
C
Comparator
Placebo
O
Outcome
Composite of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or hospitalization for unstable anginacomposite
In the US subgroup of the REDUCE-IT trial, icosapent ethyl significantly reduced cardiovascular events and all-cause mortality compared to placebo in statin-treated patients with elevated triglycerides and cardiovascular risk.
Cite This Study
Bhatt et al. (2019) studied this question.