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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.
Am J Kidney Dis. 2008 Mar; 51(3):445-54.AJ

Abstract

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).

Authors+Show Affiliations

Chronic Disease Research Group, Minneapolis Medical Research Foundation, Minneapolis, MN 55404, USA. wstpeter@cdrg.orgNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

18295060

Citation

St Peter, Wendy L., et al. "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." American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, vol. 51, no. 3, 2008, pp. 445-54.
St Peter WL, Liu J, Weinhandl E, et al. 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. Am J Kidney Dis. 2008;51(3):445-54.
St Peter, W. L., Liu, J., Weinhandl, E., & Fan, Q. (2008). 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. American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation, 51(3), 445-54. https://doi.org/10.1053/j.ajkd.2007.12.002
St Peter WL, et al. 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. Am J Kidney Dis. 2008;51(3):445-54. PubMed PMID: 18295060.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - St Peter,Wendy L, AU - Liu,Jiannong, AU - Weinhandl,Eric, AU - Fan,Qiao, PY - 2007/07/11/received PY - 2007/12/06/accepted PY - 2008/2/26/pubmed PY - 2008/3/28/medline PY - 2008/2/26/entrez SP - 445 EP - 54 JF - American journal of kidney diseases : the official journal of the National Kidney Foundation JO - Am J Kidney Dis VL - 51 IS - 3 N2 - 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). SN - 1523-6838 UR - https://www.unboundmedicine.com/medline/citation/18295060/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_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0272-6386(07)01590-9 DB - PRIME DP - Unbound Medicine ER -