Why the study?
It remains unknown whether icosapent ethyl added an advantage to lifestyle modification alone in low-risk individuals with serum triglyceride levels between 150 mg/dl and 499 mg/dl.
Does icosapent ethyl add an advantage to lifestyle modification in a low-risk population with serum triglycerides between 150 mg/dl and 499 mg/dl?
Does icosapent ethyl add an advantage to lifestyle modification in a low-risk population with serum triglycerides between 150 mg/dl and 499 mg/dl?
While icosapent ethyl is FDA-approved for cardiovascular risk reduction in high-risk patients with hypertriglyceridemia, its potential benefit in lower-risk populations with mild-to-moderate hypertriglyceridemia remains an area of clinical interest.
Hypertriglyceridemia is believed to be independently associated with an elevated risk of cardiovascular disease (CVD) events. Lifestyle changes and dietary modifications are recommended for individuals with high serum triglyceride (TG) levels (150-499 mg/dl), and pharmacological therapy in addition to lifestyle modification is recommended when serum TG levels ≥ 500 mg/dl. A residual cardiovascular risk remains even in statin appropriate treated patients with CVD risk factors, and in this patient population, hypertriglyceridemia poses an independent and increased risk of ischemic events. In December 2019, the US FDA approved icosapent ethyl (IPE) as an adjunct to a maximally tolerated statin to reduce the risk of CVD events in adults with serum triglycerides > 150 mg/dl and have either established cardiovascular disease or diabetes and two or more additional CVD risk factors. Since IPE significantly decreases total ischemic events in the aforementioned patient population, it would be intriguing to know whether IPE alone added an advantage to lifestyle modification in the low-risk population, who has serum triglyceride between 150 mg/dl and 499 mg/dl.
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Khan et al. (2021) studied this question.
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