Article
Author: Lee, Hyoungwoo ; Kim, Sang Hyun ; Lim, Hong-Seok ; Hur, Seung-Ho ; Hong, Soon Jun ; Lee, Sang Hak ; Kim, Chee Hae ; Lim, Sang-Wook ; Kim, Dong-Bin ; Kim, Seok Yeon ; Min, Kyungwan ; Hong, Young Joon ; Kim, SeongHwan ; Park, Ie Byung ; Kim, In Joo ; Won, Kyungheon ; Byun, Dong Won ; Yu, Jaemyung ; Kim, Hyo-Soo ; Sung, Jidong ; Ahn, Chul Woo ; Lee, Kwang-Jae ; Han, Kyung Ah ; Jeon, Hui Kyung ; Han, Ki Hoon
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.