COMPARATIVE STUDY
JOURNAL ARTICLE
RANDOMIZED CONTROLLED TRIAL

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

Wendy L St Peter, Jiannong Liu, Eric Weinhandl, Qiao Fan
American Journal of Kidney Diseases: the Official Journal of the National Kidney Foundation 2008, 51 (3): 445-54
18295060

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).

Full Text Links

Find Full Text Links for this Article

Discussion

You are not logged in. Sign Up or Log In to join the discussion.

Related Papers

Remove bar
Read by QxMD icon Read
18295060
×

Save your favorite articles in one place with a free QxMD account.

×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"