A comparison of sevelamer and calcium-based phosphate binders on mortality, hospitalization, and morbidity in hemodialysis: a secondary analysis of the Dialysis Clinical Outcomes Revisited (DCOR) randomized trial using claims data.
BACKGROUND
The Dialysis Clinical Outcomes Revisited (DCOR) trial, a large, randomized, multicenter, open-label study, compared effects of sevelamer with calcium-based phosphate binders on mortality and hospitalization in hemodialysis patients. Many patients were lost to follow-up, precluding intent-to-treat analysis by using prospective data collection.


METHODS
Preplanned secondary analysis, intent-to-treat design for all outcomes, using Centers for Medicare & Medicaid Services (CMS) data.


METHODS
Participants were 18 years or older and on hemodialysis therapy for more than 3 months, with Medicare as primary payor. The trial was completed at the end of 2004.


METHODS
Sevelamer, calcium-based phosphate binders.


RESULTS
Mortality, morbidity, and hospitalization end points.


METHODS
DCOR subjects were linked to the CMS End-Stage Renal Disease database. Outcomes were evaluated through the CMS End-Stage Renal Disease enrollment and claims database; baseline characteristics and comorbid conditions were evaluated using CMS and case-report data.


RESULTS
Groups were well balanced except for a greater percentage of calcium-group patients with atherosclerotic heart disease. Analyses were adjusted by using 10 baseline characteristics. All-cause (17.7 versus 17.4 deaths/100 patient-years; P = 0.8 unadjusted; P = 0.9 adjusted) and cardiovascular mortality (9.0 versus 8.2 deaths/100 patient-years; P = 0.3 unadjusted; P = 0.4 adjusted) did not differ significantly between treatment groups. First hospitalization, cause-specific multiple hospitalizations, first morbidity, and multiple morbidity rates also did not differ significantly. Multiple all-cause hospitalization rate (1.7 versus 1.9 admissions/patient-year; P = 0.03 unadjusted; P = 0.02 adjusted) and hospital days (12.3 versus 13.9 days/patient-year; P = 0.05 unadjusted; P = 0.03 adjusted) were lower in the sevelamer group.


CONCLUSIONS
Outcome parameters and cardiovascular comorbidity assessments were derived from Medicare claims data; only subjects with Medicare-as-primary-payor status were included in hospitalization and morbidity analyses.


CONCLUSIONS
In this secondary analysis, treatment with sevelamer versus calcium-based binders did not affect overall mortality (primary outcome), cause-specific mortality, morbidity, or first or cause-specific hospitalization (secondary outcomes), but there was evidence for a beneficial effect on multiple all-cause hospitalizations and hospital days (secondary outcomes).
St Peter
Wendy L
WL
Chronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, MN 55404, USA. wstpeter@cdrg.org
Liu
Jiannong
J
Weinhandl
Eric
E
Fan
Qiao
Q
D000085:Acetates / Q000627:therapeutic use*; D000368:Aged; D017610:Calcium Compounds / Q000627:therapeutic use; D002614:Chelating Agents / Q000627:therapeutic use*; D005260:Female; D015312:Hemodialysis Solutions; D006760:Hospitalization / Q000706:statistics & numerical data; D006801:Humans; D054559:Hyperphosphatemia / Q000188:drug therapy*; D007676:Kidney Failure, Chronic / Q000401:mortality / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D011073:Polyamines / Q000627:therapeutic use*; D006435:Renal Dialysis / Q000009:adverse effects; D000069603:Sevelamer
D000085:Acetates; D017610:Calcium Compounds; D002614:Chelating Agents; D015312:Hemodialysis Solutions; D011073:Polyamines; D000069603:Sevelamer; C120662:calcium acetate