title: Efficacy and safety of nicotinamide in haemodialysis patients: the NICOREN study.
abstract: BACKGROUND
  Nicotinamide (NAM) has been proposed as an alternative treatment to phosphate binders for hyperphosphataemia in chronic kidney disease.
  
  
  METHODS
  The NICOREN multicentre, open-label and randomized study was designed to examine non-inferiority and safety of NAM when compared with sevelamer (SEV) in chronic haemodialysis patients. One hundred patients were randomized to either NAM or SEV treatment for 24 weeks. Serum biochemistry and NAM's main metabolite, N -methyl-2-pyridone-5-carboxamide (2PY), were measured to assess compliance, efficacy and safety.
  
  
  RESULTS
  After 24 weeks, we observed a comparable decrease in serum phosphorus in the NAM and SEV treatment arms, from 2.1 ± 0.4 to 1.8 ± 0.5 and 2.3 ± 0.5 to 1.7 ± 0.5 mM (P = not significant), respectively. The criterion for non-inferiority was, however, not met due to a more limited number of patients being included than planned. Treatment discontinuation due to adverse events was 1.6 times higher in the NAM than in the SEV group with only 55% of study completers in the NAM arm versus 90% in the SEV arm. Thrombocytopenia was observed in four NAM-treated patients. Serum 2PY levels were comparable at baseline, but increased markedly in the NAM group, but not in the SEV group, at 24 weeks (P < 0.0001).
  
  
  CONCLUSIONS
  Thus, both drugs are equally effective in lowering serum phosphorus, but patients' tolerance of NAM was largely inferior to that of SEV. Extremely high 2PY levels may contribute to NAM's side effects.
authors.affiliation: INSERM U1088, Jules Verne University of Picardie, Amiens, France.|Pharmacy, University Hospital, Amiens, France.
authors.forename: Aurélie
authors.initials: A
authors.lastname: Lenglet
authors.affiliation: INSERM U1088, Jules Verne University of Picardie, Amiens, France.|Clinical Research Centre and Division of Clinical Pharmacology, University Hospital, Amiens, France.
authors.forename: Sophie
authors.initials: S
authors.lastname: Liabeuf
authors.affiliation: Department of Nephrology Internal Medicine, Dialysis, Transplantation and Intensive Care, University Hospital, Amiens, France.
authors.forename: Najeh
authors.initials: N
authors.lastname: El Esper
authors.affiliation: Clinical Research Centre and Division of Clinical Pharmacology, University Hospital, Amiens, France.
authors.forename: Sandrine
authors.initials: S
authors.lastname: Brisset
authors.affiliation: Department of Nephrology, Centre Hospitalier de Soissons, Soissons, France.
authors.forename: Janette
authors.initials: J
authors.lastname: Mansour
authors.affiliation: Laboratory of Pharmacology and Toxicology, University Hospital, Amiens, France.
authors.forename: Anne-Sophie
authors.initials: AS
authors.lastname: Lemaire-Hurtel
authors.affiliation: INSERM U1088, Jules Verne University of Picardie, Amiens, France.|Pharmacy, University Hospital, Amiens, France.
authors.forename: Aurelien
authors.initials: A
authors.lastname: Mary
authors.affiliation: INSERM U1088, Jules Verne University of Picardie, Amiens, France.|Laboratory of Endocrine and Bone Biology, University Hospital, Amiens, France.
authors.forename: Michel
authors.initials: M
authors.lastname: Brazier
authors.affiliation: INSERM U1088, Jules Verne University of Picardie, Amiens, France.|Laboratory of Endocrine and Bone Biology, University Hospital, Amiens, France.
authors.forename: Said
authors.initials: S
authors.lastname: Kamel
authors.affiliation: INSERM U1088, Jules Verne University of Picardie, Amiens, France.|Laboratory of Endocrine and Bone Biology, University Hospital, Amiens, France.
authors.forename: Romuald
authors.initials: R
authors.lastname: Mentaverri
authors.affiliation: INSERM U1088, Jules Verne University of Picardie, Amiens, France.|Department of Nephrology Internal Medicine, Dialysis, Transplantation and Intensive Care, University Hospital, Amiens, France.
authors.forename: Gabriel
authors.initials: G
authors.lastname: Choukroun
authors.affiliation: Department of Nephrology Internal Medicine, Dialysis, Transplantation and Intensive Care, University Hospital, Amiens, France.
authors.forename: Albert
authors.initials: A
authors.lastname: Fournier
authors.affiliation: Division of Nephrology, Ambroise Paré Hospital-APHP and Paris Ile de France Ouest University (UVSQ), Boulogne-Billancourt, France.|Inserm U-1018, Centre de recherche en épidémiologie et santé des populations (CESP), Equipe 5, Villejuif, France.|Paris-Sud University (PSU), Orsay, France.|University of Paris Ouest-Versailles-Saint-Quentin-en-Yvelines (UVSQ), Versailles, France.
authors.forename: Ziad A
authors.initials: ZA
authors.lastname: Massy
mesh_terms: D000328:Adult; D000368:Aged; D005260:Female; D006801:Humans; D054559:Hyperphosphatemia / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000008:administration & dosage*; D010758:Phosphorus / Q000097:blood*; D011446:Prospective Studies; D006435:Renal Dialysis; D051436:Renal Insufficiency, Chronic / Q000150:complications* / Q000628:therapy; D000069603:Sevelamer / Q000008:administration & dosage*
chemical_list: D009536:Niacinamide; D010758:Phosphorus; D000069603:Sevelamer
keywords: chronic kidney disease; haemodialysis; hyperphosphataemia; nicotinamide; phosphate binders