Efficacy and Safety of Prescription Omega-3 Fatty Acids Added to Stable Statin Therapy in Korean Patients with Type 2 Diabetes and Hypertriglyceridemia: a Randomized Controlled TrialEfficacy and Safety of Prescription Omega-3 Fatty Acids Added to Stable Statin Therapy in Korean Patients with Type 2 Diabetes and Hypertriglyceridemia: a Randomized Controlled Trial
- Other Titles
- Efficacy and Safety of Prescription Omega-3 Fatty Acids Added to Stable Statin Therapy in Korean Patients with Type 2 Diabetes and Hypertriglyceridemia: a Randomized Controlled Trial
- Authors
- 손장원; 김철희; 남문석; 박이병; 유순집
- Issue Date
- 2019
- Publisher
- 한국지질동맥경화학회
- Keywords
- Diabetes mellitus; type 2; Hypertriglyceridemia; Fatty acids; omega-3
- Citation
- 지질·동맥경화학회지, v.8, no.2, pp 221 - 231
- Pages
- 11
- Journal Title
- 지질·동맥경화학회지
- Volume
- 8
- Number
- 2
- Start Page
- 221
- End Page
- 231
- URI
- https://scholarworks.bwise.kr/sch/handle/2021.sw.sch/5021
- DOI
- 10.12997/jla.2019.8.2.221
- ISSN
- 2287-2892
2288-2561
- Abstract
- Objective: The aim of this study was to investigate the effects of omega-3 fatty acids added to statin monotherapy in Korean patients with type 2 diabetes who have persistent hypertriglyceridemia despite statin therapy.
Methods: This study was a randomized controlled trial conducted in 4 clinical sites between February 2009 and February 2011. The inclusion criteria were patients with type 2 diabetes who had received ≥6 weeks of statin therapy and had fasting triglyceride (TG) levels ≥1.7mmol/L and low-density lipoprotein (LDL) cholesterol levels <2.6 mmol/L. The study regimen consisted of 16 weeks of randomized treatment with omega-3 fatty acids (4 g/ day) plus a statin (n=26) or statin only (n=30). The primary endpoint was the change from baseline to final visit in mean TG level.
Results: A total of 56 participants were analyzed. At week 16, the change in the TG level in the combination therapy group differed significantly from the change in the statin monotherapy group (−34.8% vs. −15.2%, p=0.0176). Treatment with omega-3 fatty acids plus a statin was also associated with a significant decrease in non-high-density lipoprotein cholesterol compared with baseline, but the difference was not significant compared with the statin monotherapy group (−8.0% vs. −2.5%, p=0.165). The changes in LDL cholesterol and HbA1c levels did not differ significantly between groups. The study medications were well tolerated, and adverse events were comparable between two groups.
Conclusion: Adding omega-3 fatty acids to statin treatment reduced TG levels more effectively than statin monotherapy without undesirable effects in Korean type 2 diabetic patients who had hypertriglyceridemia despite well-controlled LDL cholesterol on stable statin therapy.
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