Key result
Atorvastatin plus omega-3 reduces non-HDL-C by ~4% versus atorvastatin alone in hypertriglyceridemic patients.
Why the study?
Residual cardiovascular risk in patients with hypertriglyceridemia despite intensive statin therapy remains a global health issue, motivating evaluation of combining high-dose atorvastatin with omega-3 fatty acids.
Does a fixed-dose combination of atorvastatin 40 mg and omega-3 fatty acids 4 g reduce non-HDL-C in patients with residual hypertriglyceridemia despite atorvastatin monotherapy?
RCT (n=200)
Double-blind
randomly assigned
Yes
Does a fixed-dose combination of atorvastatin 40 mg and omega-3 fatty acids 4 g reduce non-HDL-C in patients with residual hypertriglyceridemia despite atorvastatin monotherapy?
In patients with residual hypertriglyceridemia on statin therapy, adding 4 g of omega-3 fatty acids to atorvastatin 40 mg significantly reduces non-HDL-C and triglycerides without increasing adverse events.
Supports adding omega-3 to atorvastatin for residual hypertriglyceridemia; extends RCT evidence on non-HDL-C lowering.
PurposeResidual cardiovascular risk in patients with hypertriglyceridemia, despite optimal low-density lipoprotein cholesterol levels being achieved with intensive statin treatment, is a global health issue. The purpose of this study was to investigate the efficacy and tolerability of treatment with a combination of high-dose atorvastatin/Ω-3 fatty acid compared to atorvastatin + placebo in patients with hypertriglyceridemia who did not respond to statin treatment.MethodsIn this multicenter, randomized, double-blind, placebo-controlled study, patients who had residual hypertriglyceridemia after a 4-week run-in period of atorvastatin treatment were randomly assigned to receive UI-018 (fixed-dose combination atorvastatin/Ω-3 fatty acid 40 mg/4 g) or atorvastatin 40 mg + placebo (control). The primary efficacy end points were the percentage change from baseline in non–high density lipoprotein cholesterol (non–HDL-C) level at the end of treatment and the adverse events recorded during treatment. A secondary end point was the percentage change from baseline in triglyceride level.FindingsAfter 8 weeks of treatment, the percentage changes from baseline in non–HDL-C (–4.4% vs +0.6%; p = 0.02) and triglycerides (–18.5% vs +0.9%; p < 0.01) were significantly greater in the UI-018 group (n = 101) than in the control group (n = 99). These changes were present in subgroups of advanced age (≥65 years), status (body mass index ≥25 kg/m2), or without diabetes. The prevalences of adverse events did not differ between the 2 treatment groups.ImplicationsIn patients with residual hypertriglyceridemia despite receiving statin treatment, a combination of high-dose atorvastatin/Ω-3 fatty acid was associated with a greater reduction of triglyceride and non–HDL-C compared with atorvastatin + placebo, without significant adverse events.
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Woo et al. (2021) conducted an RCT in hypertriglyceridemia (n=200). UI-018 (fixed-dose combination atorvastatin/Ω-3 fatty acid) vs. atorvastatin 40 mg + placebo was evaluated on percentage change from baseline in non-HDL-C level at the end of treatment (p=0.02). A fixed-dose combination of atorvastatin 40 mg and Ω-3 fatty acid 4 g significantly reduced non-HDL-C compared to atorvastatin alone (-4.4% vs +0.6%; p=0.02) in hypertriglyceridemic patients.
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