A comparison of sevelamer hydrochloride with calcium acetate on biomarkers of bone turnover in hemodialysis patients.
OBJECTIVE
To evaluate the influence of sevelamer hydrochloride and calcium acetate on biomarkers of bone turnover in patients with hyperphosphatemia receiving hemodialysis.


METHODS
In this prospective, open-label, randomized, active-controlled study, 70 patients (38 men and 32 women) with hyperphosphatemia (serum phosphorus level >6.0 mg/dL) underwent a two-week washout period and were randomly selected to receive sevelamer hydrochloride (n = 37) or calcium acetate (n = 33) for eight weeks. Changes in serum levels of intact parathyroid hormone (iPTH), alkaline phosphatase (Alk-P), phosphorus, and calcium were measured and compared.


RESULTS
After eight weeks of treatment, calcium acetate lowered iPTH levels significantly more than sevelamer hydrochloride did (-178.0 vs. -69.0 pg/mL, p = 0.0019). Levels of Alk-P were significantly elevated in patients given sevelamer hydrochloride compared with levels in those given calcium acetate treatment (24.09 vs. 7.45 U/L, p = 0.0014). Changes in serum phosphorus levels did not differ between sevelamer hydrochloride (-1.93 mg/dL) and calcium acetate (-2.5 mg/dL) at the end of the study (p = 0.0514). Changes in the calcium and phosphorous product did not significantly differ between the sevelamer-hydrochloride group (-18.06 mg2/dL2) and the calcium-acetate group (-19.05 mg2/dL2, p = 0.6764). Fifteen patients (45.5%) treated with calcium acetate had hypercalcemia (serum-adjusted calcium level >10.5 mg/dL); the rate was significantly higher than that of patients treated with sevelamer (five [13.5%] of 37, p = 0.0039).


CONCLUSIONS
Treatment with sevelamer hydrochloride had the advantage of maintaining stable iPTH levels and elevating Alk-P levels while lowering serum phosphorus levels and calcium-phosphorous product.
Liu
Yao-Lung
YL
Division of Nephrology, Department of Medicine, China Medical University Hospital, No. 2 Yu-der Road, North District, Taichung City 404, Taiwan.
Lin
Hsin-Hung
HH
Yu
Chun-Chen
CC
Kuo
Huey-Liang
HL
Yang
Ya-Fei
YF
Chou
Che-Yi
CY
Lin
Po-Wen
PW
Liu
Jiung-Hsiun
JH
Liao
Pen-Yuan
PY
Huang
Chiu-Ching
CC
D000085:Acetates / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000469:Alkaline Phosphatase / Q000097:blood / Q000187:drug effects; D000704:Analysis of Variance; D015415:Biomarkers / Q000097:blood; D016723:Bone Remodeling / Q000187:drug effects*; D002118:Calcium / Q000097:blood; D017610:Calcium Compounds / Q000008:administration & dosage / Q000009:adverse effects; D002614:Chelating Agents / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D006934:Hypercalcemia / Q000097:blood / Q000139:chemically induced; D007676:Kidney Failure, Chronic / Q000097:blood* / Q000150:complications / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D010758:Phosphorus / Q000097:blood; D010760:Phosphorus Metabolism Disorders / Q000097:blood / Q000209:etiology; D011073:Polyamines / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D006435:Renal Dialysis; D012107:Research Design; D000069603:Sevelamer; D016896:Treatment Outcome
D000085:Acetates; D015415:Biomarkers; D017610:Calcium Compounds; D002614:Chelating Agents; D010281:Parathyroid Hormone; D011073:Polyamines; D010758:Phosphorus; D000069603:Sevelamer; D000469:Alkaline Phosphatase; D002118:Calcium; C120662:calcium acetate