title: Long-term efficacy and tolerability of lanthanum carbonate: results from a 3-year study.
abstract: BACKGROUND
  Control of serum phosphate over the long term is essential in patients with end-stage renal disease. Six-month and 2-year extensions to a 6-month study evaluated the long-term safety, tolerability and efficacy of the new phosphate binder lanthanum carbonate.
  
  
  METHODS
  Patients who participated in a 6-month, randomized trial comparing lanthanum carbonate with calcium carbonate were eligible for a 24-week, open-label extension. Lanthanum carbonate-treated patients continued taking their established maintenance dose ('continued-lanthanum group') and calcium carbonate-treated patients switched to lanthanum carbonate, 375-3,000 mg/day ('switch group'). Patients could also enter a further 2-year extension. Efficacy parameters, including serum phosphate, were monitored.
  
  
  RESULTS
  Mean serum phosphate was approximately 1.80 mmol/l throughout the trial. The percentage of patients with controlled serum phosphate (< or =1.80 mmol/l) after the 6-month extension was 63.3 and 58.4% in the continued-lanthanum and switch groups, respectively; after the 2-year extension, 54.4% of patients had controlled serum phosphate. After discontinuation of calcium carbonate and initiation of lanthanum carbonate, the hypercalcemia incidence was 2.7%, compared with 20.2% during the double-blind phase. Calcium x phosphate product was maintained at an acceptable level. Lanthanum carbonate was well tolerated; adverse events were mild/moderate and mainly gastrointestinal.
  
  
  CONCLUSIONS
  Lanthanum carbonate maintains effectiveness with continued tolerability for up to 3 years.
authors.affiliation: Manchester Royal Infirmary, Manchester, UK. alastair.hutchison@cmmc.nhs.uk
authors.forename: Alastair J
authors.initials: AJ
authors.lastname: Hutchison
authors.forename: Bart
authors.initials: B
authors.lastname: Maes
authors.forename: Johan
authors.initials: J
authors.lastname: Vanwalleghem
authors.forename: Gernot
authors.initials: G
authors.lastname: Asmus
authors.forename: Elfatih
authors.initials: E
authors.lastname: Mohamed
authors.forename: Roland
authors.initials: R
authors.lastname: Schmieder
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Backs
authors.forename: Rene
authors.initials: R
authors.lastname: Jamar
authors.forename: Andre
authors.initials: A
authors.lastname: Vosskühler
mesh_terms: D000328:Adult; D000368:Aged; D002118:Calcium / Q000097:blood; D002119:Calcium Carbonate / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006934:Hypercalcemia / Q000188:drug therapy / Q000209:etiology; D007676:Kidney Failure, Chronic / Q000097:blood / Q000150:complications* / Q000628:therapy; D007811:Lanthanum / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010710:Phosphates / Q000097:blood*; D006435:Renal Dialysis; D016896:Treatment Outcome
chemical_list: D010710:Phosphates; C119467:lanthanum carbonate; D007811:Lanthanum; D002119:Calcium Carbonate; D002118:Calcium