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Efficacy and safety of nicotinamide in the management of hyperphosphatemia in pediatric patients on regular hemodialysis

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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.

Conclusion

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.

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Disclosure of funding

No pharmaceutical and/or industrial support, and no funding was received from National Institute of Health (NIH), Welcome Trust, Howard Hughes Medical Institute (HHMI) or others.

Compliance with ethical standards

The study protocol was revised and approved by the ethics committee of the Faculty of Pharmacy, Ain Shams University. The study was performed in accordance with the Declaration of Helsinki. Prior to participation all caregivers of eligible children were informed about the study protocol and signed a written informed consent.

Conflict of interest

The authors declare that they have no conflict of interest.

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Authors and Affiliations

  1. Department of Clinical Pharmacy, Faculty of Pharmacy, Ain Shams University, 4 Street 292, New Maadi, Cairo, Egypt

    Radwa El Borolossy, Lamia Mohamed El Wakeel & Nagwa Sabri

  2. Department of Pediatrics, Faculty of Medicine, Ain Shams University, Cairo, Egypt

    Ihab El Hakim

Authors
  1. Radwa El Borolossy
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  2. Lamia Mohamed El Wakeel
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  3. Ihab El Hakim
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  4. Nagwa Sabri
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Corresponding author

Correspondence to Lamia Mohamed El Wakeel.

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El Borolossy, R., El Wakeel, L.M., El Hakim, I. et al. Efficacy and safety of nicotinamide in the management of hyperphosphatemia in pediatric patients on regular hemodialysis. Pediatr Nephrol 31, 289–296 (2016). https://doi.org/10.1007/s00467-015-3208-1

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  • DOI: https://doi.org/10.1007/s00467-015-3208-1

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