title: Efficacy and safety of lanthanum carbonate in German patients on dialysis.
abstract: OBJECTIVE
  To assess the treatment efficacy and tolerability of lanthanum carbonate (LC) in patients with end-stage renal disease (ESRD) and hyperphosphatemia under daily-practice conditions.
  
  
  METHODS
  698 patients on dialysis in 116 outpatient dialysis centers in Germany were enrolled in this post-marketing surveillance study (mean treatment duration 6 months). LC treatment was compared to pretreatment (no or other phosphate binders) regarding laboratory parameters, adverse events and tablet burden.
  
  
  RESULTS
  Compared to baseline, LC significantly reduced mean serum phosphate (SP), serum calcium, and calcium × phosphate product (p < 0.0001). In monotherapy with LC, mean tablet burden was decreased to 3.0 tablets per day thus reducing the mean pre-study phosphatebinder tablet burden by nearly 50%. Adverse drug reactions associated with LC were reported in only 2.0% of the patients (n = 14). Overall, LC was considered safe and well tolerated.
  
  
  CONCLUSIONS
  Under daily-practice conditions, LC at an average dose of 2,509 ± 936 mg/d was well tolerated and effective in adjusting and maintaining control of SP in patients previously being unsatisfactorily controlled on other phosphate binders. The daily tablet burden with a phosphate binder can be reduced to 3 tablets of LC, particularly in patients on monotherapy. The lack of a comparison group should be considered in terms of careful interpretation of the study results.
authors.affiliation: Dialysis Center Karlstrasse, Düsseldorf, Germany. dellanna@praxis-mit-naehe.de
authors.forename: Frank
authors.initials: F
authors.lastname: Dellanna
authors.forename: Helmut
authors.initials: H
authors.lastname: Reichel
authors.forename: Frank
authors.initials: F
authors.lastname: Seibt
mesh_terms: D000328:Adult; D000368:Aged; D002118:Calcium / Q000097:blood; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000188:drug therapy*; D007811:Lanthanum / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D010710:Phosphates / Q000097:blood; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D006435:Renal Dialysis; D013607:Tablets
chemical_list: D010281:Parathyroid Hormone; D010710:Phosphates; D013607:Tablets; C119467:lanthanum carbonate; D007811:Lanthanum; D002118:Calcium