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
- Authors
- Woo, Jong Shin; Hong, Soon Jun; Cha, Dong Hoon; Kim, Kee Sik; Kim, Moo Hyun; Lee, Jun-Won; Jeong, Myung Ho; Jeong, Jin-Ok; Lee, Jun-Hee; Jeon, Doo Soo; Cho, Eun Joo; Kim, Soon Kil; Kwan, Jun; Park, Chang Gyu; Lee, Hae Young; Hong, Taek Jong; Shin, Jinho; Youn, Ho Joong; Jeon, Dong Woon; Chung, Wook Jin; Jeong, Ju Cheol; Kim, Chong Jin
- Issue Date
- Aug-2021
- Publisher
- ELSEVIER
- Keywords
- atorvastatin; combination treatment; hypertriglyceridemia; non–HDL-C; Ω-3 fatty acid
- Citation
- Clinical Therapeutics, v.43, no.8, pp.1419 - 1430
- Journal Title
- Clinical Therapeutics
- Volume
- 43
- Number
- 8
- Start Page
- 1419
- End Page
- 1430
- URI
- https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/82774
- DOI
- 10.1016/j.clinthera.2021.07.001
- ISSN
- 0149-2918
- 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. © 2021 The Author(s)
- Files in This Item
- There are no files associated with this item.
- Appears in
Collections - 의과대학 > 의학과 > 1. Journal Articles
![qrcode](https://api.qrserver.com/v1/create-qr-code/?size=55x55&data=https://scholarworks.bwise.kr/gachon/handle/2020.sw.gachon/82774)
Items in ScholarWorks are protected by copyright, with all rights reserved, unless otherwise indicated.