Lanthanum carbonate: a postmarketing observational study of efficacy and safety

J Nephrol. 2012 Jul-Aug;25(4):490-6. doi: 10.5301/jn.5000118.

Abstract

Background: Hyperphosphatemia is associated with morbidity and mortality in hemodialysis patients. The use of calcium chelators is restricted by the risk of hypercalcemia and vascular calcifications. Sevelamer, a non-calcium chelator, is associated with risks of metabolic acidosis and poor compliance. Lanthanum carbonate is a non-calcium chelator not associated with these issues. However, accumulation in liver and bone has been a reason for concern.

Methods: Adult patients (n=112) from 9 hemodialysis centers, with serum phosphorus >5.5 mg/dL and on hemodialysis for >1 year, were selected to switch to lanthanum carbonate (mean dosage: 2,189 ± 491 mg/day); 103 completed the study. Laboratory assays for serum phosphate, calcium, parathyroid hormone, alkaline phosphatase, gamma-glutamyl transpeptidase (gammaGT), aspartate transaminase, alanine transaminase and plasma bicarbonate were performed monthly. Seven patients underwent a bone biopsy for evaluation of lanthanum bone content.

Results: Switching to lanthanum carbonate led to a reduction in mean serum phosphate levels (-18.2%; p<0.001) and calcium × phosphorus product (-17.6%; p<0.0001). There were no important changes in other variables, except for an increase in transaminases in 2 patients with preexisting liver disease, who discontinued therapy. An increase in plasma bicarbonate concentration was observed (p=0.001). Although some lanthanum was detected in bone, its distribution did not follow the mineralization front.

Conclusions: Lanthanum carbonate is effective and well tolerated, provided that recipients do not have preexisting liver disease. After 8 months of treatment, lanthanum was not detected in the mineralization front of bone. In hemodialysis patients, lanthanum carbonate does not seem to be involved in metabolic bone disease.

Publication types

  • Multicenter Study

MeSH terms

  • Aged
  • Alanine Transaminase / blood
  • Alkaline Phosphatase / blood
  • Aspartate Aminotransferases / blood
  • Bicarbonates / blood
  • Biomarkers / blood
  • Biopsy
  • Bone Density / drug effects
  • Bone Diseases, Metabolic / blood
  • Bone Diseases, Metabolic / etiology
  • Bone Diseases, Metabolic / pathology
  • Calcium / blood
  • Chelating Agents / adverse effects
  • Chelating Agents / therapeutic use*
  • Drug Substitution
  • Female
  • Humans
  • Hyperphosphatemia / blood
  • Hyperphosphatemia / drug therapy*
  • Hyperphosphatemia / etiology
  • Italy
  • Kidney Diseases / blood
  • Kidney Diseases / complications
  • Kidney Diseases / therapy*
  • Lanthanum / adverse effects
  • Lanthanum / therapeutic use*
  • Male
  • Parathyroid Hormone / blood
  • Phosphates / blood
  • Phosphorus / blood
  • Product Surveillance, Postmarketing
  • Prospective Studies
  • Renal Dialysis* / adverse effects
  • Retrospective Studies
  • Risk Assessment
  • Risk Factors
  • Time Factors
  • Treatment Outcome
  • gamma-Glutamyltransferase / blood

Substances

  • Bicarbonates
  • Biomarkers
  • Chelating Agents
  • PTH protein, human
  • Parathyroid Hormone
  • Phosphates
  • Phosphorus
  • lanthanum carbonate
  • Lanthanum
  • gamma-Glutamyltransferase
  • Aspartate Aminotransferases
  • Alanine Transaminase
  • Alkaline Phosphatase
  • Calcium