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

doi:10.1053/j.ajkd.2007.12.002

American Journal of Kidney Diseases

Volume 51, Issue 3, March 2008, Pages 445-454

https://doi.org/10.1053/j.ajkd.2007.12.002 Get rights and content

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).

Section snippets

Study Design

The DCOR trial was a multicenter, randomized, open-label, parallel-design trial. Subjects were enrolled from March 2001 through January 2002 and randomly assigned to sevelamer (Renagel; Genzyme, Cambridge, MA) or calcium-based phosphate binders (calcium acetate [PhosLo; Braintree Laboratories, Inc, Braintree, MA] or calcium carbonate [TUMS; GlaxoSmithKline, Philadelphia, PA]). Included subjects were 18 years or older and on hemodialysis therapy for more than 3 months, with Medicare as primary

Baseline Characteristics and Medicare-as-Primary-Payor Status

The CRF and CMS ESRD databases, linked by the USRDS Coordinating Center, were used for analyses. Of 2,103 subjects enrolled in the study, 2,101 could be linked to the CMS ESRD database, 1,051 in the sevelamer and 1,050 in the calcium group. Of 2,101 subjects, 1,947 (92.7%) met the Medicare-as-primary-payor criterion, 979 in the sevelamer and 968 in the calcium group. Figure 1 shows patient disposition. Baseline characteristics for all randomly assigned patients who were linked to the CMS ESRD

Discussion

The primary outcome parameter of the DCOR trial was all-cause mortality, with secondary outcomes of cardiovascular mortality and all-cause hospitalization and hospital days.¹¹ Follow-up started at randomization and ended at the earliest of death, study end (December 31, 2004), or 90 days after early discontinuation. Unfortunately, many subjects were lost to follow-up after 90 days, and a true intent-to-treat analysis was not possible by using prospectively collected CRF data. However, this

Acknowledgements

Appreciation is extended to Paul W. Eggers, PhD, Co-project officer, USRDS, and Program Director, Kidney and Urology Epidemiology (National Institute of Diabetes and Digestive and Kidney Diseases [NIDDK]); Lawrence Y. C. Agodoa, MD, Co-project officer, USRDS, and Director, ESRD Program (NIDDK); and Chronic Disease Research Group colleagues Robert N. Foley, MB, who reviewed the report, and Nan Booth, MSW, MPH, who edited the report.

Support: See financial disclosure.

Financial Disclosure: Genzyme

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: Originally published online as doi:10.1053/j.ajkd.2008.01.004 on January 31, 2008.

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Original InvestigationDialysisA 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

Study Design

Setting & Participants

Intervention

Outcomes

Measurements

Results

Limitations

Conclusions

Section snippets

Study Design

Baseline Characteristics and Medicare-as-Primary-Payor Status

Discussion

Acknowledgements

Am J Kidney Dis

Kidney Int

Kidney Int

Kidney Int

Kidney Int

Kidney Int

Kidney Int

Mineral metabolism, mortality, and morbidity in maintenance hemodialysis

J Am Soc Nephrol

Original Investigation
Dialysis
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