Long-term comparison of sevelamer hydrochloride to calcium-containing phosphate binders.

AIM: In patients with end-stage renal disease (ESRD), hyperphosphataemia and an elevated calcium-phosphorus (Ca-P) product contribute to morbidity and mortality. Suggested target goals for serum phosphorus concentration and calcium-phosphorus product have recently been lowered. As a result, long-term comparative studies of the efficacy of phosphate binders are critical. This study compares the long-term efficacy of sevelamer hydrochloride to calcium-containing binders (CCB). METHODS: A retrospective chart review was conducted in 30 patients receiving sevelamer hydrochloride for >1 years and 25 patients receiving CCB. RESULTS: Patients on sevelamer hydrochloride had lower serum bicarbonate concentration than those on CCB, 18.6 +/- 2.7 versus 20.3 +/- 1.8 mmol/L (P = 0.0017). Serum phosphorus concentration was higher in patients on sevelamer hydrochloride compared to CCB 2.10 +/- 0.87 versus 1.74 +/- 0.28 mmol/L (P = 0.0013), as was the Ca-P product 4.97 +/- 0.94 mmol2L2 (62.1 +/- 11.8 mg2/dL2) versus 3.97 +/- 1.18 mmol2/L2 (49.7 +/- 14.7 mg2/dL2), P = 0.0009). Only 36% of patients on sevelamer hydrochloride compared with 68% on CCB (P = 0.015) met the serum phosphorus goal of < or =1.78 mmol/L. CONCLUSION: Patients on sevelamer hydrochloride for >1 years compared to those on CCB had a lower serum bicarbonate concentration, a higher serum phosphorus concentration and a higher Ca-P product. Clinicians should balance the increase in calcium load with CCB versus the cost and effectiveness of sevelamer hydrochloride in choosing a phosphate binder for ESRD patients.

Cinacalcet for secondary hyperparathyroidism in patients receiving hemodialysis.

BACKGROUND: Treatment of secondary hyperparathyroidism with vitamin D and calcium in patients receiving dialysis is often complicated by hypercalcemia and hyperphosphatemia, which may contribute to cardiovascular disease and adverse clinical outcomes. Calcimimetics target the calcium-sensing receptor and lower parathyroid hormone levels without increasing calcium and phosphorus levels. We report the results of two identical randomized, double-blind, placebo-controlled trials evaluating the safety and effectiveness of the calcimimetic agent cinacalcet hydrochloride. METHODS: Patients who were receiving hemodialysis and who had inadequately controlled secondary hyperparathyroidism despite standard treatment were randomly assigned to receive cinacalcet (371 patients) or placebo (370 patients) for 26 weeks. Once-daily doses were increased from 30 mg to 180 mg to achieve intact parathyroid hormone levels of 250 pg per milliliter or less. The primary end point was the percentage of patients with values in this range during a 14-week efficacy-assessment phase. RESULTS: Forty-three percent of the cinacalcet group reached the primary end point, as compared with 5 percent of the placebo group (P<0.001). Overall, mean parathyroid hormone values decreased 43 percent in those receiving cinacalcet but increased 9 percent in the placebo group (P<0.001). The serum calcium-phosphorus product declined by 15 percent in the cinacalcet group and remained unchanged in the placebo group (P<0.001). Cinacalcet effectively reduced parathyroid hormone levels independently of disease severity or changes in vitamin D sterol dose. CONCLUSIONS: Cinacalcet lowers parathyroid hormone levels and improves calcium-phosphorus homeostasis in patients receiving hemodialysis who have uncontrolled secondary hyperparathyroidism.