title: 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.
abstract: 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.
authors.affiliation: Cardiovascular Center, Seoul National University Hospital, Seoul, South Korea.
authors.forename: Sang-Hyun
authors.initials: SH
authors.lastname: Kim
authors.forename: Min-Kyung
authors.initials: MK
authors.lastname: Kim
authors.forename: Hae-Young
authors.initials: HY
authors.lastname: Lee
authors.forename: Hyun-Jae
authors.initials: HJ
authors.lastname: Kang
authors.forename: Yong-Jin
authors.initials: YJ
authors.lastname: Kim
authors.forename: Byung-Joo
authors.initials: BJ
authors.lastname: Park
authors.forename: Hyo-Soo
authors.initials: HS
authors.lastname: Kim
mesh_terms: D001794:Blood Pressure / Q000187:drug effects; D001835:Body Weight / Q000187:drug effects; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D050171:Dyslipidemias / Q000097:blood / Q000178:diet therapy / Q000188:drug therapy*; D005260:Female; D005483:Flushing / Q000139:chemically induced; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D056910:Republic of Korea; D016896:Treatment Outcome
chemical_list: D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D003692:Delayed-Action Preparations; D000960:Hypolipidemic Agents; D009525:Niacin