Chee Hae Kim1, Kyung Ah Han2, Jaemyung Yu3, Sang Hak Lee4, Hui Kyung Jeon5, Sang Hyun Kim6, Seok Yeon Kim7, Ki Hoon Han8, Kyungheon Won7, Dong-Bin Kim9, Kwang-Jae Lee10, Kyungwan Min2, 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, Hyo-Soo Kim23. 1. Department of Internal Medicine, Seoul National University Hospital, Cardiovascular Centre, Seoul, Korea. 2. Diabetes Center, Eulji University, Seoul Eulji hospital, Seoul, Korea. 3. Kangnam Sacred Heart Hospital, Seoul, Korea. 4. Cardiology Division, Yonsei University College of Medicine, Severance Cardiovascular Hospital, Seoul, Korea. 5. Department of Internal Medicine, Division of Cardiology, The Catholic University of Korea, Seoul, Korea. 6. Department of Cardiology, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea. 7. Department of Internal Medicine, Seoul Medical Center, Seoul, Korea. 8. Departments of Cardiology, Ischemic Heart Disease Center, Asan Medical Center Heart Institute, Seoul, Korea. 9. Department of Cardiology, Catholic University of Korea College of Medicine, Seoul, Korea. 10. Department of Endocrinology, Daedong Hospital, Seoul, Korea. 11. Endocrinology and Metabolism, Soonchunhyang University Hospital, Seoul, Korea. 12. Department of Cardiology, Bundang Cha General Hospital, Seoul, Korea. 13. Department of Internal Medicine, Gangnam Severance Hospital, Seoul, Korea. 14. Division of Cardiology, Department of Medicine, Korea University Ansan Hospital, Seoul, Korea. 15. Heart Center of Chonnam National University Hospital, Chonnam National University, Seoul, Korea. 16. Division of Cardiology, Cardiac and Vascular Center, Samsung Medical Center, Seoul, Korea. 17. Department of Cardiology, Keimyung University Dongsan Hospital, Daegu, Korea. 18. Korea University Medical Center, Korea University, Seoul, Korea. 19. Department of Cardiology, Ajou University School of Medicine, Suwon, Korea. 20. Division of Endocrinology and Metabolism, Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, Korea. 21. Department of Internal Medicine, Pusan National University College of Medicine, Busan, Korea. 22. Department of Internal Medicine, Yeungnam University College of Medicine, Daegu, Korea. 23. Department of Internal Medicine, Seoul National University Hospital, Cardiovascular Centre, Seoul, Korea. Electronic address: usahyosoo@gmail.com.
Abstract
PURPOSE: The purpose of this study was to examine the efficacy and safety of adding ω-3 fatty acids to rosuvastatin in patients with residual hypertriglyceridemia despite statin treatment. METHODS: This study was a multicenter, randomized, double-blind, placebo-controlled study. After a 4-week run-in period of rosuvastatin treatment, the patients who had residual hypertriglyceridemia were randomized to receive rosuvastatin 20 mg/d plus ω-3 fatty acids 4 g/d (ROSUMEGA group) or rosuvastatin 20 mg/d (rosuvastatin group) with a 1:1 ratio and were prescribed each medication for 8 weeks. FINDINGS:A total of 201 patients were analyzed (mean [SD] age, 58.1 [10.7] years; 62.7% male). After 8 weeks of treatment, the percentage change from baseline in triglycerides (TGs) and non-HDL-C was significantly greater in the ROSUMEGA group than in the rosuvastatin group (TGs: -26.3% vs -11.4%, P < 0.001; non-HDL-C: -10.7% vs -2.2%, P = 0.001). In the linear regression analysis, the lipid-lowering effect of ω-3 fatty acids was greater when baseline TG or non-HDL-C levels were high and body mass index was low. The incidence of adverse events was not significantly different between the 2 groups. IMPLICATIONS: In patients with residual hypertriglyceridemia despite statin treatment, a combination ofω-3 fatty acids and rosuvastatin produced a greater reduction of TGs and non-HDL-C than rosuvastatin alone. Further study is needed to determine whether the advantages of this lipid profile of ω-3 fatty acids actually leads to the prevention of cardiovascular event. ClinicalTrials.gov identifier: NCT03026933.
RCT Entities:
PURPOSE: The purpose of this study was to examine the efficacy and safety of adding ω-3 fatty acids to rosuvastatin in patients with residual hypertriglyceridemia despite statin treatment. METHODS: This study was a multicenter, randomized, double-blind, placebo-controlled study. After a 4-week run-in period of rosuvastatin treatment, the patients who had residual hypertriglyceridemia were randomized to receive rosuvastatin 20 mg/d plus ω-3 fatty acids 4 g/d (ROSUMEGA group) or rosuvastatin 20 mg/d (rosuvastatin group) with a 1:1 ratio and were prescribed each medication for 8 weeks. FINDINGS: A total of 201 patients were analyzed (mean [SD] age, 58.1 [10.7] years; 62.7% male). After 8 weeks of treatment, the percentage change from baseline in triglycerides (TGs) and non-HDL-C was significantly greater in the ROSUMEGA group than in the rosuvastatin group (TGs: -26.3% vs -11.4%, P < 0.001; non-HDL-C: -10.7% vs -2.2%, P = 0.001). In the linear regression analysis, the lipid-lowering effect of ω-3 fatty acids was greater when baseline TG or non-HDL-C levels were high and body mass index was low. The incidence of adverse events was not significantly different between the 2 groups. IMPLICATIONS: In patients with residual hypertriglyceridemia despite statin treatment, a combination of ω-3 fatty acids and rosuvastatin produced a greater reduction of TGs and non-HDL-C than rosuvastatin alone. Further study is needed to determine whether the advantages of this lipid profile of ω-3 fatty acids actually leads to the prevention of cardiovascular event. ClinicalTrials.gov identifier: NCT03026933.
Authors: Ji Eun Jun; In Kyung Jeong; Jae Myung Yu; Sung Rae Kim; In Kye Lee; Kyung Ah Han; Sung Hee Choi; Soo Kyung Kim; Hyeong Kyu Park; Ji Oh Mok; Yong Ho Lee; Hyuk Sang Kwon; So Hun Kim; Ho Cheol Kang; Sang Ah Lee; Chang Beom Lee; Kyung Mook Choi; Sung Ho Her; Won Yong Shin; Mi Seung Shin; Hyo Suk Ahn; Seung Ho Kang; Jin Man Cho; Sang Ho Jo; Tae Joon Cha; Seok Yeon Kim; Kyung Heon Won; Dong Bin Kim; Jae Hyuk Lee; Moon Kyu Lee Journal: Diabetes Metab J Date: 2019-06-20 Impact factor: 5.376