Comparison of the effects of pemafibrate and omega-3 fatty acid ethyl on fatty liver index in patients with dyslipidemia treated with statin: a sub-analysis from the PROUD48 study
Abstract
BACKGROUND: Fatty liver index (FLI) calculated by using body mass index, waist circumference and levels of triglycerides and γ-glutamyl transpeptidase is a noninvasive biomarker for diagnosis of metabolic dysfunction-associated steatotic liver disease (MASLD), which is one of the high-risk conditions of atherosclerotic cardiovascular diseases. To compare the effects of pemafibrate and omega-3 fatty acid ethyl on FLI, we conducted a sub-analysis study of the Pemafibrate Reduction of triglyceride-rich lipoproteins compared with Omega-3 fatty acid ethyl for Unmet needs in Dyslipidemic patients on target to apoB-48 (PROUD48) study.
METHODS: 57 participants in the pemafibrate 0.4 mg per day treatment group (PEMA, men/women: 37/20, mean 64 years) and 60 participants in the omega-3 fatty acid ethyl 4 g per day treatment group (OMEGA-3, men/women: 35/25, mean 63 years) in the PROUD48 study were included in the present study. Changes in FLI and prevalence of MASLD from baseline to week 16 in PEMA and OMEGA-3 were investigated.
RESULTS: Median FLI was significantly decreased by both PEMA (69.7 to 47.6, P < 0.001) and OMEGA-3 (64.8 to 59.5, P < 0.001). There was a significant difference in change in FLI between PEMA and OMEGA-3 (-18.3 ± 14.1 vs. -5.5 ± 9.4, P < 0.001). The proportions of MASLD estimated by FLI (baseline/week 16) in PEMA and OMEGA-3 were 93.0/68.4% (P = 0.002) and 90.0/85.0% (P = 0.582), respectively.
CONCLUSIONS: Pemafibrate is superior to omega-3 fatty acid ethyl in…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 60 participants or records.
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