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
Received 11 July 2007; accepted 6 December 2007. published online 01 February 2008.
Refers to article:
Phosphate Binder Choice in Dialysis Patients: A Call for Evidence-Based Rather Than Marketing-Based Clinical Practice
Wolfgang C. Winkelmayer, Marcello Tonelli
American Journal of Kidney Diseases
March 2008 (Vol. 51, Issue 3, Pages 362-365) Full Text |
Full-Text PDF (71 KB)
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.
Study Design
Preplanned secondary analysis, intent-to-treat design for all outcomes, using Centers for Medicare & Medicaid Services (CMS) data.
Setting & Participants
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.
Intervention
Sevelamer, calcium-based phosphate binders.
Outcomes
Mortality, morbidity, and hospitalization end points.
Measurements
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.
Limitations
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).
1Chronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, MN
2College of Pharmacy, University of Minnesota, Minneapolis, MN.
Address correspondence to Wendy L. St. Peter, PharmD, Chronic Disease Research Group, Minneapolis Medical Research Foundation, 914 South 8th St, Ste S-206, Minneapolis, MN 55404.
ABSTRACT