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Treatment of hyperphosphatemia in hemodialysis patients: The Calcium Acetate Renagel Evaluation (CARE Study)
Wajeh Y Qunibi1, Robert E Hootkins, Laveta L McDowell
1Department of Medicine, University of Texas Health Sciences Center at San Antonio, San Antonio, Texas 78229-3900, USA.
Insights
Calcium acetate is more effective than sevelamer hydrochloride in managing hyperphosphatemia for hemodialysis patients. It better controls phosphorus and calcium-x-phosphorus product levels, making it the preferred treatment choice.
Area of Science:
- Nephrology
- Clinical Pharmacology
- Internal Medicine
Background:
- Hyperphosphatemia is a significant complication in hemodialysis patients, contributing to secondary hyperparathyroidism, renal osteodystrophy, and increased mortality.
- Elevated serum phosphorus and calcium-phosphate product are key indicators of poor outcomes in chronic kidney disease patients undergoing dialysis.
Purpose of the Study:
- To compare the efficacy of calcium acetate and sevelamer hydrochloride in achieving target serum phosphorus levels (<=5.5 mg/dL) and calcium x phosphorus product (<=55 mg(2)/dL(2)).
- To evaluate which phosphate binder is superior for managing mineral and bone disorder in hemodialysis patients.
Main Methods:
- An 8-week, randomized, double-blind study involving 100 hemodialysis patients.
- Patients were randomized to receive either calcium acetate or sevelamer hydrochloride.
- Primary endpoints included time-averaged serum phosphorus and calcium x phosphorus product levels.
Main Results:
- Calcium acetate treatment resulted in significantly lower serum phosphorus (P=0.0006) and calcium x phosphorus product (P=0.022) compared to sevelamer hydrochloride.
- Calcium acetate recipients were more likely to achieve goal phosphorus (OR 2.37) and calcium x phosphorus product (OR 2.16) levels.
- Transient hypercalcemia was observed in 16.7% of calcium acetate recipients, particularly those on vitamin D therapy. Sevelamer hydrochloride led to lower serum bicarbonate levels (P < 0.0001).
Conclusions:
- Calcium acetate demonstrates superior efficacy in controlling serum phosphorus and the calcium-phosphate product compared to sevelamer hydrochloride.
- In the absence of hypercalcemia, calcium acetate is recommended as the primary treatment for hyperphosphatemia in hemodialysis patients.
- Further consideration of calcium-related side effects and acid-base balance is warranted when selecting phosphate binders.
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 =5.5 mg/dL and Ca x P product =55 mg(2)/dL(2), 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 x P (6.1 mg(2)/dL(2) 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 x 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.
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