title: Extended-release niacin/laropiprant lowers serum phosphorus concentrations in patients with type 2 diabetes.
abstract: BACKGROUND
  Niacin compounds lower serum phosphorus concentrations in patients with end-stage renal disease.
  
  
  METHODS
  We evaluated the impact of extended release niacin, given in fixed-dose combination with laropiprant, a specific inhibitor of prostaglandin-mediated, niacin-induced flushing, versus placebo, on serum phosphorus concentrations measured serially (at weeks 0, 4, 8, 12, 18, 24, 30, and 36) during a 36-week randomized, controlled trial. All subjects had a confirmed diagnosis of type 2 diabetes (n = 446 niacin/laropiprant; n = 339 placebo). Estimated glomerular filtration rate ranged from 36 to 184 mL/min/1.73 m(2), with n = 111 (14.1%) having a value <60 mL/min/1.73 m(2). Subjects received one tablet daily of extended-release niacin/laropiprant (1g niacin/ 20 mg laropiprant) for the first 4 weeks, and 2 tablets once daily, thereafter, or matched placebo. Niacin lowered serum phosphorus concentrations by 0.36 mg/dL (95% CI: -0.40, -0.31; P < .001), relative to placebo, from baseline values of 3.57 and 3.56 mg/dL in the niacin and placebo groups, respectively. Subgroup analyses revealed no evidence for phosphorus-lowering effect modification by these baseline variables: glomerular filtration rate <60 (n = 111;14.1%) vs ≥60 mL/min/m(2) (n = 674; 85.9%); phosphorus ≤3.5 mg/dL (n = 392; 49.9%) vs >3.5 mg/dL (n = 393; 50.1%); or prior statin use (n = 618; 78.7%) vs nonuse (n = 167; 21.3%).
  
  
  CONCLUSIONS
  These data confirm that niacin's phosphorus-lowering effects-which may have therapeutic implications for the management of hyperphosphatemia and possible prevention of cardiorenal outcomes in renal disease-extend across a broad spectrum of renal function in type 2 diabetics without stage 4 or 5 chronic kidney disease (a glomerular filtration rate ≥30 mL/min/1.73 m(2)).
authors.affiliation: Rhode Island Hospital, Division of Kidney Diseases and Hypertension, 593 Eddy Street, Providence, RI 02903, USA. abostom@lifespan.org
authors.forename: Andrew G
authors.initials: AG
authors.lastname: Bostom
authors.forename: Alexandra A
authors.initials: AA
authors.lastname: Maclean
authors.forename: Darbie
authors.initials: D
authors.lastname: Maccubbin
authors.forename: Diane
authors.initials: D
authors.lastname: Tipping
authors.forename: Hilde
authors.initials: H
authors.lastname: Giezek
authors.forename: William A
authors.initials: WA
authors.lastname: Hanlon
mesh_terms: D000368:Aged; D003692:Delayed-Action Preparations; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications* / Q000188:drug therapy; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005919:Glomerular Filtration Rate; D006801:Humans; D054559:Hyperphosphatemia / Q000188:drug therapy*; D000960:Hypolipidemic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D007211:Indoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007676:Kidney Failure, Chronic / Q000150:complications; D008297:Male; D008875:Middle Aged; D009525:Niacin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D010758:Phosphorus / Q000097:blood*; D011982:Receptors, Prostaglandin / Q000037:antagonists & inhibitors
chemical_list: D003692:Delayed-Action Preparations; D004338:Drug Combinations; D000960:Hypolipidemic Agents; D007211:Indoles; C518174:MK-0524; D011982:Receptors, Prostaglandin; D009525:Niacin; D010758:Phosphorus