Efficacy and tolerability of a new extended-release formulation of nicotinic acid in Korean adults with mixed dyslipidemia: an 8-week, multicenter, prospective, randomized, double-blind, and placebo-controlled trial.

BACKGROUND: Nicotinic acid is an effective treatment for dyslipidemia. Patients are more tolerant of the extended-release form of nicotinic acid because it has a lower incidence of side effects, such as facial flushing, than the immediate-release formulation.

OBJECTIVE: This study was designed to evaluate the efficacy and tolerability of an experimental extended-release formulation of nicotinic acid in Korean adults with mixed dyslipidemia as a regulatory requirement to allow marketing of this product in Korea.

METHODS: This study was a multicenter, prospective, randomized, double-blind, and placebo-controlled trial. Patients with low high-density lipoprotein cholesterol (HDL-C) levels, high low-density lipoprotein cholesterol (LDL-C) levels, or high triglyceride levels were enrolled. Patients in the treatment group received 500 mg of extended-release niacin for 4 weeks and 1000 mg of extended-release niacin for the next 4 weeks.

RESULTS: Twenty-five patients (24% males; mean [SD] age, 57.4 [6.9] years) comprised the treatment group, and 22 patients (5% males; mean [SD] age 61.8 [8.3] years) comprised the placebo group. After 8 weeks of treatment, HDL-C levels were increased significantly in the treatment group (17.6% vs -1.7%, respectively, from 35 [7] mg/dL to 42 [11] mg/dL in the treatment group and from 38 [6] mg/dL to 36 [7] mg/dL in the placebo group; P < 0.001). LDL-C levels were decreased significantly in the treatment group (-11.4% vs 3.6%, respectively, from 147 [33] mg/dL to 126 [22] mg/dL in the treatment group and from 146 [31] mg/dL to 148 [26] mg/dL in the placebo group; P = 0.003). The incidence of drug-related adverse events, including facial flushing in the treatment group, was not significantly different from that in the placebo group.

CONCLUSIONS: The tested extended-release formulation of nicotinic acid increased HDL-C levels significantly but decreased LDL-C levels with a low incidence of facial flushing in this small, select group of Korean adults with mixed dyslipidemia.