Dialysis – Transplantation

Kidney International (2004) 65, 1914–1926; doi:10.1111/j.1523-1755.2004.00590.x

Treatment of hyperphosphatemia in hemodialysis patients: The Calcium Acetate Renagel Evaluation (CARE Study)

Wajeh Y Qunibi, Robert E Hootkins, Laveta L McDowell, Micah S Meyer, Matthias Simon, Rodolfo O Garza, Russell W Pelham, Mark V B Cleveland, Larry R Muenz, David Y He and Charles R Nolan

Department of Medicine, University of Texas Health Sciences Center at San Antonio, San Antonio, Texas; Austin Diagnostic Clinic, Austin, Texas; Braintree Laboratories, Braintree, Massachusetts; and Larry R. Muenz & Associates, Gaithersburg, Maryland

Correspondence: Charles R. Nolan, M.D., Professor of Medicine & Surgery, Organ Transplant Division, University of Texas Health Sciences Center at San Antonio, 7703 Floyd Curl Drive, San Antonio, TX 78229–3900. E-mail: nolan@uthscsa.edu

Received 13 November 2003; Revised 10 January 2003; Re-revised 7 March 2003; Re-revised 12 October 2003; Accepted 12 December 2003.

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Abstract

Treatment of hyperphosphatemia in hemodialysis patients: The Calcium Acetate Renagel Evaluation (CARE Study).

Background

 

Hyperphosphatemia underlies development of hyperparathyroidism, osteodystrophy, extraosseous calcification, and is associated with increased mortality in hemodialysis patients.

Methods

 

To determine whether calcium acetate or sevelamer hydrochloride best achieves recently recommended treatment goals of phosphorus less than or equal to5.5 mg/dL and Ca times P product less than or equal to55 mg2/dL2, we conducted an 8-week randomized, double-blind study in 100 hemodialysis patients.

Results

 

Comparisons of time-averaged concentrations (weeks 1 to 8) demonstrated that calcium acetate recipients had lower serum phosphorus (1.08 mg/dL difference, P = 0.0006), higher serum calcium (0.63 mg/dL difference, P < 0.0001), and lower Ca times P (6.1 mg2/dL2 difference, P = 0.022) than sevelamer recipients. At each week, calcium acetate recipients were 20% to 24% more likely to attain goal phosphorus [odds ratio (OR) 2.37, 95% CI 1.28–4.37, P = 0.0058], and 15% to 20% more likely to attain goal Ca times P (OR 2.16, 95% CI 1.20–3.86, P = 0.0097). Transient hypercalcemia occurred in 8 of 48 (16.7%) calcium acetate recipients, all of whom received concomitant intravenous vitamin D. By regression analysis hypercalcemia was more likely with calcium acetate (OR 6.1, 95% CI 2.8–13.3, P < 0.0001). Week 8 intact PTH levels were not significantly different. Serum bicarbonate levels were significantly lower with sevelamer hydrochloride treatment (P < 0.0001).

Conclusion

 

Calcium acetate controls serum phosphorus and calcium-phosphate product more effectively than sevelamer hydrochloride. Cost-benefit analysis indicates that in the absence of hypercalcemia, calcium acetate should remain the treatment of choice for hyperphosphatemia in hemodialysis patients.

Keywords:

calcium acetate, sevelamer hydrochloride, hyperphosphatemia, hypercalcemia, hypocalcemia, metabolic acidosis

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