title: Mortality in kidney disease patients treated with phosphate binders: a randomized study.
abstract: OBJECTIVE
  Dietary phosphorous overload and excessive calcium intake from calcium-containing phosphate binders promote coronary artery calcification (CAC) that may contribute to high mortality of dialysis patients. CAC has been found in patients in early stages of nondialysis-dependent CKD. In this population, no study has evaluated the potential role of phosphorus binders on mortality. This study aimed to evaluate all-cause mortality as the primary end point in nondialysis-dependent CKD patients randomized to different phosphate binders; secondary end points were dialysis inception and the composite end point of all-cause mortality and dialysis inception.
  
  
  METHODS
  This is a randomized, multicenter, nonblinded pilot study. Consecutive outpatients (n=212; stage 3-4 CKD) were randomized to either sevelamer (n=107) or calcium carbonate (n=105). Phosphorus concentration was maintained between 2.7 and 4.6 mg/dl for patients with stage 3-4 CKD and between 3.5 and 5.5 mg/dl for patients with stage 5 CKD. The CAC score was assessed by computed tomography at study entry and after 6, 12, 18, and 24 months. All-cause mortality, dialysis inception, and the composite end point were recorded for up to 36 months.
  
  
  RESULTS
  In patients randomized to sevelamer, all-cause mortality and the composite end point were lower; a nonsignificant trend was noted for dialysis inception.
  
  
  CONCLUSIONS
  Sevelamer provided benefits in all-cause mortality and in the composite end point of death or dialysis inception but not advantages in dialysis inception. Larger studies are needed to confirm these results.
authors.affiliation: Department of Nephrology, Ospedale A. Landolfi di Solofra, Avellino, Italy. diiorio@gmail.com
authors.forename: Biagio
authors.initials: B
authors.lastname: Di Iorio
authors.forename: Antonio
authors.initials: A
authors.lastname: Bellasi
authors.forename: Domenico
authors.initials: D
authors.lastname: Russo
mesh_terms: D000368:Aged; D015415:Biomarkers / Q000097:blood; D002119:Calcium Carbonate / Q000009:adverse effects / Q000627:therapeutic use*; D002423:Cause of Death; D002614:Chelating Agents / Q000009:adverse effects / Q000627:therapeutic use*; D017023:Coronary Angiography; D003324:Coronary Artery Disease / Q000097:blood / Q000000981:diagnostic imaging / Q000401:mortality*; D005260:Female; D006801:Humans; D007558:Italy; D007674:Kidney Diseases / Q000097:blood / Q000150:complications / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D010710:Phosphates / Q000097:blood*; D010758:Phosphorus / Q000097:blood; D010865:Pilot Projects; D011073:Polyamines / Q000009:adverse effects / Q000627:therapeutic use*; D006435:Renal Dialysis / Q000401:mortality; D000069603:Sevelamer; D016019:Survival Analysis; D013997:Time Factors; D016896:Treatment Outcome; D061205:Vascular Calcification / Q000097:blood / Q000000981:diagnostic imaging / Q000401:mortality*
chemical_list: D015415:Biomarkers; D002614:Chelating Agents; D010710:Phosphates; D011073:Polyamines; D010758:Phosphorus; D000069603:Sevelamer; D002119:Calcium Carbonate