title: Extended-release niacin/laropiprant effects on lipoprotein subfractions in patients with type 2 diabetes mellitus.
abstract: BACKGROUND
  A potentially atherogenic lipid profile often found in patients with type 2 diabetes mellitus (T2DM) includes increased concentrations of small, low-density lipoprotein (LDL) and intermediate-density lipoprotein (IDL) and decreased concentration of medium/large high-density lipoprotein (HDL) particles. Extended-release niacin/laropiprant (ERN/LRPT) lowers LDL-cholesterol (LDL-C) and triglycerides (TG), and raises HDL cholesterol (HDL-C) levels with attenuation of niacin-induced flushing.
  
  
  METHODS
  Plasma HDL, LDL, IDL, very-low-density lipoprotein (VLDL), and chylomicron particle concentration and size at were evaluated at baseline and week 12 using nuclear magnetic resonance (NMR). The data were acquired from a randomized, multicenter, double-blind, placebo-controlled study including 796 patients with T2DM treated with either 1 tablet of ERN 1 gram/LRPT 20 mg or matching placebo daily, increased after 4 weeks to 2 tablets daily.
  
  
  RESULTS
  ERN/LRPT significantly (P≤0.001 for all) reduced LDL-C 17.9% and TG 23.1%, and increased HDL-C levels 23.2%. Compared to placebo, ERN/LRPT decreased LDL, IDL, VLDL, and chylomicron particle concentrations [median concentration of smallest LDL particles decreased 16.6%, 95% confidence interval (CI) -22.3, -10.9, whereas the largest LDL particles decreased 11.0%, 95% CI -18.7, -3.2, and total VLDL/chylomicron mean plasma particle concentration decreased 34.7%, 95% CI -41.3, -28.1]. Compared to placebo, ERN/LRPT shifted the distribution of HDL particle diameter from smaller to larger (median concentration of the largest HDL particles increased 32.7% (95% CI 25.30, 40.58), whereas concentration of the smallest HDL particles decreased 8.2% (95% CI -11.29, -5.06).
  
  
  CONCLUSIONS
  Compared with placebo in patients with T2DM, ERN/LRPT shifted the lipoprotein profile toward a potentially less atherogenic pattern with reduced atherogenic LDL and IDL particle concentrations, and increased large HDL plasma particle concentrations. (ClinicalTrials.gov: NCT00485758).
authors.affiliation: L-Marc, Louisville, Kentucky, USA.
authors.forename: Harold
authors.initials: H
authors.lastname: Bays
authors.forename: Hilde
authors.initials: H
authors.lastname: Giezek
authors.forename: James M
authors.initials: JM
authors.lastname: McKenney
authors.forename: Edward A
authors.initials: EA
authors.lastname: O'Neill
authors.forename: Andrew M
authors.initials: AM
authors.lastname: Tershakovec
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D050197:Atherosclerosis / Q000378:metabolism; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D002914:Chylomicrons / Q000737:chemistry / Q000378:metabolism; D003692:Delayed-Action Preparations / Q000627:therapeutic use; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy* / Q000378:metabolism*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D000960:Hypolipidemic Agents / Q000008:administration & dosage; D007211:Indoles / Q000008:administration & dosage*; D008055:Lipids / Q000097:blood; D008074:Lipoproteins / Q000378:metabolism*; D009682:Magnetic Resonance Spectroscopy / Q000379:methods; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000008:administration & dosage*; D010919:Placebos; D014280:Triglycerides / Q000097:blood
chemical_list: D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D002914:Chylomicrons; D003692:Delayed-Action Preparations; D000960:Hypolipidemic Agents; D007211:Indoles; D008055:Lipids; D008074:Lipoproteins; C518174:MK-0524; D010919:Placebos; D014280:Triglycerides; D009525:Niacin