A 1-Year Randomized Trial of Calcium Acetate Versus Sevelamer on Progression of Coronary Artery Calcification in Hemodialysis Patients With Comparable Lipid Control: The Calcium Acetate Renagel Evaluation-2 (CARE-2) Study
Received 30 October 2007; accepted 26 February 2008. published online 23 April 2008.
Refers to article:
Calcification in CKD: No Closer to the Cure
Bryan Kestenbaum
American Journal of Kidney Diseases
June 2008 (Vol. 51, Issue 6, Pages 877-879) Full Text |
Full-Text PDF (63 KB)
Background
Previous clinical trials showed that progression of coronary artery calcification (CAC) may be slower in hemodialysis patients treated with sevelamer than those treated with calcium-based phosphate binders. Because sevelamer decreases low-density lipoprotein cholesterol (LDL-C) levels, we hypothesized that intensive lowering of LDL-C levels with atorvastatin in hemodialysis patients treated with calcium acetate would result in CAC progression rates similar to those in sevelamer-treated patients.
Study Design
Randomized, controlled, open-label, noninferiority trial with an upper bound for the noninferiority margin of 1.8.
Setting & Participants
203 prevalent hemodialysis patients at 26 dialysis centers with serum phosphorus levels greater than 5.5 mg/dL, LDL-C levels greater than 80 mg/dL, and baseline CAC scores of 30 to 7,000 units assessed by means of electron-beam computed tomography.
Interventions
103 patients were randomly assigned to calcium acetate, and 100 patients to sevelamer for 12 months to achieve phosphorus levels of 3.5 to 5.5 mg/dL. Atorvastatin was added to achieve serum LDL-C levels less than 70 mg/dL in both groups.
Outcomes & Measurements
The primary end point was change in CAC score assessed by means of electron-beam computed tomography.
Results
After 12 months, mean serum LDL-C levels decreased to 68.8 ± 22.0 mg/dL in the calcium-acetate group and 62.4 ± 23.0 mg/dL in the sevelamer group (P = 0.3). Geometric mean increases in CAC scores were 35% in the calcium-acetate group and 39% in the sevelamer group, with a covariate-adjusted calcium acetate–sevelamer ratio of 0.994 (95% confidence interval, 0.851 to 1.161).
Limitations
Treatment assignment was not blinded. The 1.8 a priori margin is large, CAC is a surrogate outcome, duration of treatment was short, and dropout rate was high.
Conclusions
With intensive lowering of LDL-C levels for 1 year, hemodialysis patients treated with either calcium acetate or sevelamer experienced similar progression of CAC.
6Los Angeles Biomedical Research Institute at Harbor UCLA, Torrance, CA.
Address correspondence to Wajeh Y. Qunibi, MD, Professor of Medicine, Medical Director of Dialysis Services, University of Texas Health Sciences Center at San Antonio, 7703 Floyd Curl Dr, San Antonio, TX 78229-3900.
A list of the CARE-2 Investigators appears at the end of this article.
ABSTRACT