Clinical Evidence

Proven Head-to-head evidence: Care-2

Similar CAC progression rates... less therapy burden vs sevelamer

A randomized, multicenter, noninferiority study...
Calcium Acetate Renagel Evaluation Care-2 Study

CARE-2 was a 1-year clinical trial designed to prove that when ESRD patients achieve the same level
of lipid control, there would be no significant difference in the development of cardiovascular
calcification (CAC)

In this study

203 prevalent HD patients at 26 dialysis centers were randomized to receive calcium acetate (n=103) or sevelamer (n=100) for 12 months to achieve phosphorus levels of 3.5–5.5 mg/dL

Interventions

  • Atorvastatin was added to achieve serum LDL-C levels <70 mg/dL in both treatment groups
      —97.1% patients in calcium acetate group (n=100)
      —79% patients after 8 weeks in sevelamer group (n=79)
  • Dialysis calcium concentration was kept constant at 2.5 mEq/L
  • Vitamin D use was controlled to achieve goal iPTH level of 150–300 pg/mL

Burden of therapy

  • Mean total PB dose was 33% greater with sevelamer vs calcium acetate:
      —Calcium acetate: 5.5 grams
      —Sevelamer: 7.3 grams

Results

In this 1-year trial:

  • Calcium acetate as a phosphate binder did not further contribute to the progression of CAC
  • Intensive LDL-C–lowering therapy with atorvastatin was associated with similar progression of CAC in HD patients treated with either calcium acetate or sevelamer
  • Mean total dose of PB therapy was lower with calcium acetate vs sevelamer

*In clinical trial, Phoslyra was shown to be bioequivalent to calcium acetate gelcaps and should be considered to have the same safety and efficacy profiles.

Reference: 1. Qunibi W. Moustafa M, Muenz LR, et al. A 1-year randomized trial of calcium acetate versus sevalamer on progresion of coronary artery calcification in hemodialysis patients with comparable limid control: the calcium acetate renagel evaluation-2 (CARE-2) study. AM J Kidney Dis. 2008;51:952-965