J Lipid Atheroscler.  2019 Sep;8(2):221-231. 10.12997/jla.2019.8.2.221.

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

Affiliations
  • 1Division of Endocrinology and Metabolism, Department of Internal Medicine, The Catholic University of Korea, Bucheon St. Mary's Hospital, Bucheon, Korea. sjyoo@catholic.ac.kr
  • 2Division of Endocrinology & Metabolism, Department of Internal Medicine, Soonchunhyang University Bucheon Hospital, Bucheon, Korea.
  • 3Department of Internal Medicine, Inha University College of Medicine, Incheon, Korea.
  • 4Department of Endocrinology, Gachon University of Medicine and Science, Gil Medical Center, Incheon, Korea.

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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02305355

Keyword

Diabetes mellitus, type 2; Hypertriglyceridemia; Fatty acids, omega-3
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