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Comparison of the Efficacy and Safety of Atorvastatin 40 mg/ω-3 Fatty Acids 4 g Fixed-dose Combination and Atorvastatin 40 mg Monotherapy in Hypertriglyceridemic Patients who Poorly Respond to Atorvastatin 40 mg Monotherapy: An 8-week, Multicenter, Randomized, Double-blind Phase III Study.

Division of Cardiology, Department of Internal Medicine, Kyung Hee University Hospital, Kyung Hee University, Seoul, Republic of Korea. Department of Cardiology, Cardiovascular Center, Korea University Anam Hospital, Seoul, Republic of Korea. Department of Cardiology, CHA Bundang Medical Center, CHA University, Sungnam, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Daegu Catholic University Medical Center, Daegu, Republic of Korea. Department of Cardiology, Dong-A University Medical Center, Busan, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Chungnam National University College of Medicine, Deajeon, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Kang-Dong Sacred Heart Hospital, College of Medicine, Hallym University, Seoul, Republic of Korea. Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea, Incheon St. Mary's Hospital, Incheon, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Yeouido St. Mary's Hospital, Catholic University, Seoul, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Hanyang University Guri Hospital, Guri, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Inha University Hospital, Inha University College of Medicine, Incheon, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Korea University Guro Hospital, Seoul, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Busan, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Hanyang University Hospital, Seoul, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Seoul St. Mary's Hospital, Seoul, Republic of Korea. Division of Cardiology, Department of Internal Medicine, NHIS Ilsan Hospital, Goyang, Republic of Korea. Division of Cardiology, Department of Internal Medicine, Gil Hospital, Gachon University, Incheon, Republic of Korea. Department of Pharmacology, School of Medicine, Chung-Ang University, Seoul, Republic of Korea. The Division of Cardiology, Department of Internal Medicine, Kyunghee University Hospital at Gangdong, Seoul, Republic of Korea. Electronic address: chongjinkim@naver.com.

Clinical therapeutics. 2021;(8):1419-1430
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Abstract

PURPOSE Residual 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. METHODS In 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. FINDINGS After 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. IMPLICATIONS In 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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