Effects of Omega-3 Free Fatty Acid on Nonhdl Cholesterol and Apolipoprotein B/A1 Ratio in Statin-Treated Patients with Residual Hypertriglyceridemia. Romantic (Rosuvastatin-OMAcor iN residual hyperTrIglyCeridemia) Randomized Controlled Trial

Presentation Number: SAT 507
Date of Presentation: April 1st, 2017

Kyung Ah Han*1, JaeMyung Yu2, Sang Hak Lee3, Hui Kyung Jeon4, Sang Hyun Kim5, Seok Yeon Kim6, Ki Hoon Han7, Kyungheon Won6, Dong-Bin Kim8, Kwang-Jae Lee9, Kyungwan Min10, Dong Won Byun11, Sang-Wook Lim12, Chul Woo Ahn13, SeongHwan Kim14, Young Joon Hong15, Jidong Sung16, Seung-Ho Hur17, Soon Jun Hong18, Hong-Seok Lim19, Ie Byung Park20, In Joo Kim21, Hyoungwoo Lee22 and Hyo-Soo Kim23
1Eulji University, Seoul Eulji hospital, Seoul, Korea, Republic of (South), 2Kangnam Sacred Heart Hospital, Seoul, Korea, Republic of (South), 3Severance Cardiovascular Hospital,, Seoul,, Korea, Republic of (South), 4Division of Cardiology, Seoul, Korea, Republic of (South), 5Seoul National University College of Medicine, Seoul, Korea, Republic of (South), 6Seoul Medical Center, Seoul, Korea, Republic of (South), 7Asan Medical Center Heart Institute, Seoul, Korea, Republic of (South), 8The Catholic University of Korea College of Medicine, Seoul, Korea, Republic of (South), 9Daedong Hospital, Seoul, Korea, Republic of (South), 10Eulji University Medical Center, Seoul, Korea, Republic of (South), 11Soonchunhyang University Hospital, Seoul, Korea, Republic of (South), 12Bundang Cha General Hospital, Seoul, Korea, Republic of (South), 13Gangnam Severance Hospital, Seoul, Korea, Republic of (South), 14Korea University Ansan Hospital, Seoul, Korea, Republic of (South), 15Chonnam National University, Seoul, Korea, Republic of (South), 16Samsung Medical Center, Seoul, Korea, Republic of (South), 17Department of Internal Medicine, Daegu, Korea, Republic of (South), 18Korea University, Seoul, Korea, Republic of (South), 19Ajou University School of Medicine, Suwon, Korea, Republic of (South), 20Gachon University Gil Medical Center, Incheon, Korea, Republic of (South), 21Pusan National University College of Medicine, Busan, Korea, Republic of (South), 22Yeungnam University College of Medicine, Daegu, Korea, Republic of (South), 23Cardiovascular Centre, Seoul, Korea, Republic of (South)


Ratio of apolipoprotein B/A1 (ApoB/A1) was known to be a stronger predictor of cardiovascular events than cholesterol. Lowering triglyceride with omega-3 free fatty acid (OM3-FA) may give further reduction in ApoB/A1 as a marker of CVD risk. This study was designed to evaluate the efficacy of adding OM3-FFA on statin therapy in lowering non-HDL-C, TG levels, and ApoB/A1 in subjects with persistent hypertriglyceridemia.

In this double-blind, parallel-group controlled trial, we enrolled patients with residual hypertriglyceridemia under treatment with rosuvastatin for more than 4 weeks (fasting TG levels between 200 and 500 mg/dL and LDL<110mg/dL) and randomized them into two groups: rosuvastatin (20 mg daily) with omega 3 fatty acid (4 g/d) (OM3-R, n=97) or rosuvastatin (20 mg daily) alone (R, n=104). Assessments included fasting serum levels of lipids and ApoB/A1, and 10-year risk for coronary heart disease Framingham point scores (CHD10)

Participants’ BMI was 27.5 kg/M2.. Male was 61.8 %, CHD10 was 9.5% without significant differences between two groups, The age was higher in OM3-R group than in R (59.7±10.8 and 56.6±10.4 years , respectively, P =0.0397). After 8 weeks, non-HDL-C levels were reduced from baseline more in OM3-R than in R (-13.1±2.6% vs -2.63±2.4%; P < 0.001), as were TG levels (78.1±9.5% vs -37.8±10.1%; P < 0.001). There were no differences between groups in HDL-C, Apo B, Apo A1, and ApoB/A1.

Within group analysis using paired T test showed that HDL-C levels significantly increased for 8 weeks interval both in OM3-R and R groups (40.9 to 42.3 mg/dl, p=0.035, 40.3 to 42.9 mg/dl, p<0.001, respectively). ApoB levels was decreased (87.0 to 72.5 mg/dl, p<0.001: 83.6 to 74.5 mg/dl, p<0.001, respectively). Apo-A1 levels insignificantly decreased in in OM3-R and increased in R.

Thus, ratio of Apo B/A1 significantly decreased in OM3-R (0.65 to 0.56 mg/dl, p<0.001), and also in R (0.63 to 0.55, p<0.001).

CHD10 was inversely correlated with percent change of the Apo B/A1 only in R (r= -0.369 p<0.001) and not in OM3-R after adjusting age, gender, and BMI. Presence of diabetes was still important determinant for percent change of nonHDL cholesterol and Apo B/A1 after controlling the effects of treatment groups (p=0.01, p=0.003, respectively) using ANCOVA (analysis of covariance).

These findings suggested that omega 3 fatty acid was well tolerated and effectively lowered non-HDL-C and TG levels, but no further decrease in Apo B/A1, in patients with persistent hypertriglyceridemia taking a statin. And it might be more effective in person with higher CHD10 or diabetes.