title: Efficacy and safety of nicotinamide in the management of hyperphosphatemia in pediatric patients on regular hemodialysis.
abstract: BACKGROUND
  Hyperphosphatemia is a common problem in patients with end-stage renal disease (ESRD) who are on maintenance hemodialysis (HD) and contributes to the development of secondary hyperparathyroidism and cardiovascular complications. Nicotinamide (NAM) has been shown in some studies to inhibit intestinal and renal sodium/phosphorus co-transporters and reduce serum phosphorus levels. We have therefore evaluated the efficacy and safety of NAM as adjunctive therapy to calcium-based phosphate binders to control hyperphosphatemia in hemodialysis patients.
  
  
  METHODS
  Sixty pediatric HD outpatients were randomly divided into two equally sized groups (30 children each). One group received calcium-based phosphate binder (control group), and the other received both the calcium-based phosphate binder + NAM at a dose of 100 mg twice or three times daily (nicotinamide group). Both groups were followed for a 6-month period.
  
  
  RESULTS
  Over the 6-month treatment period, children in the NAM group showed a significant decline in the levels of serum phosphorus (p = 0.0001), serum calcium-phosphorus (Ca × P; p = 0.0001) product and parathyroid hormone (p = 0.02) versus baseline values and those of the control group. After 6 months of NAM treatment, the mean serum high-density lipoprotein cholesterol levels had increased significantly (p = 0.01), and the median serum triglyceride levels had decreased (p = 0.009). There was no significant change in any of these parameters among the children of the control group. The major adverse events associated with the NAM therapy were diarrhea, flushing and nausea.
  
  
  CONCLUSIONS
  The addition of NAM to therapy with phosphate binders is effective in lowering phosphorus levels and has a beneficial effect on the lipid profile with only mild side effects.
authors.affiliation: Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, 4 Street 292, New Maadi, Cairo, Egypt.
authors.forename: Radwa
authors.initials: R
authors.lastname: El Borolossy
authors.affiliation: Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, 4 Street 292, New Maadi, Cairo, Egypt. lamywak@yahoo.com.
authors.forename: Lamia Mohamed
authors.initials: LM
authors.lastname: El Wakeel
authors.affiliation: Department of Pediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt.
authors.forename: Ihab
authors.initials: I
authors.lastname: El Hakim
authors.affiliation: Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, 4 Street 292, New Maadi, Cairo, Egypt.
authors.forename: Nagwa
authors.initials: N
authors.lastname: Sabri
mesh_terms: D000293:Adolescent; D002614:Chelating Agents / Q000627:therapeutic use; D002648:Child; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D054559:Hyperphosphatemia / Q000188:drug therapy*; D007676:Kidney Failure, Chronic / Q000628:therapy; D008297:Male; D009536:Niacinamide / Q000009:adverse effects / Q000627:therapeutic use*; D010758:Phosphorus / Q000097:blood; D006435:Renal Dialysis; D014803:Vitamin B Complex / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D002614:Chelating Agents; D014803:Vitamin B Complex; D009536:Niacinamide; D010758:Phosphorus
keywords: Hemodialysis; Hyperphosphatemia; Lipid profile; Nicotinamide; Pediatric patients