Pilot study of combined therapy with ω-3 fatty acids and niacin in atherogenic dyslipidemia

Background: Niacin and ω-3 fatty acids (ω-3 FA) are both nutrients that reduce serum triglyceride and raise high-density lipoprotein cholesterol (HDL-C) levels when used at pharmacological doses. The possibility that these two agents, given in combination, might have additive effects on these lipid parameters has not been examined previously. In addition, the combination might prevent the rise in low-density lipoprotein (LDL)-C levels frequently seen with ω-3 FA treatment. Objective: To determine the effect of therapy of niacin and ω-3 FA alone and in combination versus placebo on lipid parameters in subjects with atherogenic dyslipidemia. Methods: In a pilot parallel group study, we studied 29 patients with atherogenic dyslipidemia who were assigned to either dual placebo (n = 7), ω-3 FA (3.4 g/d; n = 8), crystalline niacin (3 g/d; n = 7), or the combination (n = 7) for 12 weeks. Fasting lipid profiles were assessed before and after treatment. Results: Changes in serum triglyceride levels from baseline were 10%, -2%, -17%, and -52%, respectively, while HDL-C concentrations rose by 4%, 10%, 18%, and 33%, respectively. Both of these results were statistically significantly different for combination therapy compared to changes with placebo and ω-3 FA monotherapy (analysis of variance with Tukey's post-hoc test). No statistically significant changes were seen for LDL-C. Addition of ω-FA to niacin had no effect on niacin-induced flushing. Conclusion: From this small pilot study, we conclude that combined therapy with niacin and ω-3 FA has beneficial effects on triglyceride and HDL-C levels, and use of these two agents in combination prevents the ω-3 FA-induced rise in LDL-C. Larger studies of this combination therapy are clearly warranted in patient populations with atherogenic dyslipidemia to assess not only lipid effects, but also potential coronary heart disease benefits.