title: Lanthanum carbonate: a postmarketing observational study of efficacy and safety.
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.
authors.affiliation: Nephrology and Dialysis Unit, S. Andrea Hospital, La Spezia, Italy. giuseppe.rombola@asl5.liguria.it
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Rombolà
authors.forename: Francesco
authors.initials: F
authors.lastname: Londrino
authors.forename: Valentina
authors.initials: V
authors.lastname: Corbani
authors.forename: Valeria
authors.initials: V
authors.lastname: Falqui
authors.forename: Michela
authors.initials: M
authors.lastname: Ardini
authors.forename: Tito
authors.initials: T
authors.lastname: Zattera
mesh_terms: D000368:Aged; D000410:Alanine Transaminase / Q000097:blood; D000469:Alkaline Phosphatase / Q000097:blood; D001219:Aspartate Aminotransferases / Q000097:blood; D001639:Bicarbonates / Q000097:blood; D015415:Biomarkers / Q000097:blood; D001706:Biopsy; D015519:Bone Density / Q000187:drug effects; D001851:Bone Diseases, Metabolic / Q000097:blood / Q000209:etiology / Q000473:pathology; D002118:Calcium / Q000097:blood; D002614:Chelating Agents / Q000009:adverse effects / Q000627:therapeutic use*; D057915:Drug Substitution; D005260:Female; D006801:Humans; D054559:Hyperphosphatemia / Q000097:blood / Q000188:drug therapy* / Q000209:etiology; D007558:Italy; D007674:Kidney Diseases / Q000097:blood / Q000150:complications / Q000628:therapy*; D007811:Lanthanum / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D010281:Parathyroid Hormone / Q000097:blood; D010710:Phosphates / Q000097:blood; D010758:Phosphorus / Q000097:blood; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D006435:Renal Dialysis / Q000009:adverse effects; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D005723:gamma-Glutamyltransferase / Q000097:blood
chemical_list: D001639:Bicarbonates; D015415:Biomarkers; D002614:Chelating Agents; C470125:PTH protein, human; D010281:Parathyroid Hormone; D010710:Phosphates; D010758:Phosphorus; C119467:lanthanum carbonate; D007811:Lanthanum; D005723:gamma-Glutamyltransferase; D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase; D002118:Calcium