Effects of sevelamer and calcium-based phosphate binders on mortality in hemodialysis patients: results of a randomized clinical trial.
BACKGROUND
Elevated serum phosphorus and calcium are associated with arterial calcification and mortality in dialysis patients. Sevelamer, a phosphate-binding polymer, attenuates the progression of arterial calcification; it is unknown whether this improves outcomes.


METHODS
A randomized comparison of sevelamer and calcium-based phosphate binders was performed in hemodialysis patients treated up to 45 months. The primary endpoint was mortality. Secondary endpoints included cause-specific mortality and hospitalization; 2103 patients were randomized, 2040 received treatment, and 1065 completed treatment.


RESULTS
Overall mortality was not significantly reduced by sevelamer (adjusted relative risk = 0.92; 95% confidence interval, 0.78 to 1.09; log-rank P = .40). Among patients > or = 65 years of age, sevelamer reduced the risk of death (adjusted relative risk = 0.77; 95% confidence interval, 0.62 to 0.97; log-rank P = .02). Sevelamer patients had a trend toward fewer hospitalizations (P = .06) and fewer hospital days (P = .09).


CONCLUSIONS
A statistically significant reduction in mortality in the overall study population was not observed. Sevelamer was associated with a survival benefit among patients > or = 65 years of age.
Suki
Wadi N
WN
Kidney Institute and Department of Medicine, Baylor College of Medicine, Houston, Texas 77054, USA. wsuki@bcm.tmc.edu
D000328:Adult; D000368:Aged; D002119:Calcium Carbonate / Q000009:adverse effects / Q000627:therapeutic use*; D017610:Calcium Compounds / Q000009:adverse effects / Q000627:therapeutic use*; D002423:Cause of Death; D002614:Chelating Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007676:Kidney Failure, Chronic / Q000628:therapy; D008297:Male; D008875:Middle Aged; D018579:Patient Selection; D028044:Phosphate-Binding Proteins; D011073:Polyamines / Q000009:adverse effects / Q000627:therapeutic use*; D006435:Renal Dialysis / Q000401:mortality*; D000069603:Sevelamer
D017610:Calcium Compounds; D002614:Chelating Agents; D028044:Phosphate-Binding Proteins; D011073:Polyamines; D000069603:Sevelamer; D002119:Calcium Carbonate