title: Colesevelam improved lipoprotein particle subclasses in patients with prediabetes and primary hyperlipidaemia.
abstract: BACKGROUND
  A randomised, double-blind, placebo-controlled study evaluated lipid- and glucose-lowering effects of colesevelam in patients with prediabetes and primary hyperlipidaemia. We report the effect of colesevelam on lipoprotein particle concentration and particle size (determined by nuclear magnetic resonance spectroscopy) in these patients.
  
  
  METHODS
  Adults with prediabetes (World Health Organization criteria), low-density lipoprotein cholesterol (LDL-C) ≥ 100 mg/dL (≥2.6 mmol/L) and triglycerides < 500 mg/dL (<5.6 mmol/L) were randomised to colesevelam 3.75 g/day or placebo for 16 weeks. The intent-to-treat population comprised 103 colesevelam and 106 placebo recipients.
  
  
  RESULTS
  At the end of the study, mean reduction from baseline in total LDL particle concentration was significantly greater with colesevelam versus placebo (mean treatment difference: -113 nmol/L; p = 0.02). Increases in total very low-density lipoprotein particle concentration (VLDL-P) and high-density lipoprotein particle concentration (HDL-P) did not differ significantly between the groups; however, with colesevelam versus placebo, there were significantly (p < 0.05) greater increases in large and medium VLDL-P and large HDL-P and reductions in small VLDL-P. Mean size increases were significantly greater with colesevelam for VLDL (mean treatment difference: 5.3 nm; p < 0.0001) and HDL (0.1 nm; p = 0.002).
  
  
  CONCLUSIONS
  Colesevelam improved the overall atherogenic lipoprotein profile in adults with prediabetes and primary hyperlipidaemia, despite potentially less favourable changes in VLDL particles.
authors.affiliation: Division of Endocrinology, Diabetes and Metabolism, University of Miami Miller School of Medicine, Miami, FL 33136, USA. rgoldber@med.miami.edu
authors.forename: Ronald B
authors.initials: RB
authors.lastname: Goldberg
authors.forename: Robert S
authors.initials: RS
authors.lastname: Rosenson
authors.forename: Eric
authors.initials: E
authors.lastname: Hernandez-Triana
authors.forename: Soamnauth
authors.initials: S
authors.lastname: Misir
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jones
mesh_terms: D000328:Adult; D000499:Allylamine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D008078:Cholesterol, LDL / Q000097:blood; D000069472:Colesevelam Hydrochloride; D003248:Constipation / Q000139:chemically induced; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D004415:Dyspepsia / Q000139:chemically induced; D005260:Female; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D006949:Hyperlipidemias / Q000097:blood / Q000150:complications / Q000188:drug therapy*; D057194:Intention to Treat Analysis; D008074:Lipoproteins / Q000097:blood* / Q000737:chemistry; D008075:Lipoproteins, HDL / Q000097:blood / Q000737:chemistry; D008079:Lipoproteins, VLDL / Q000097:blood / Q000737:chemistry; D008297:Male; D019906:Nuclear Magnetic Resonance, Biomolecular; D010316:Particle Size; D011236:Prediabetic State / Q000150:complications*; D014280:Triglycerides / Q000097:blood
chemical_list: D008078:Cholesterol, LDL; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D008074:Lipoproteins; D008075:Lipoproteins, HDL; D008079:Lipoproteins, VLDL; D014280:Triglycerides; D000499:Allylamine; D000069472:Colesevelam Hydrochloride