Prospective randomized multicenter trial of sevelamer hydrochloride and calcium carbonate for the treatment of hyperphosphatemia in hemodialysis patients in Japan.
A prospective, randomized open-label trial of sevelamer hydrochloride with or without calcium carbonate (CC) involved 86 hemodialysis patients in Japan. The dosage of CC was fixed at 3.0 g/day for the 12-week study. After the first 4 weeks all subjects were changed from CC to sevelamer 3.0 g/day for another 4 weeks, then allocated randomly to three groups for the final 4 weeks: group A, sevelamer 6.0 g/day; group B, sevelamer 3.0 g/day and CC 3.0 g/day; group C, CC 3.0 g/day. The target serum phosphorous concentration (P)=5.5 mg/dL and the corrected calcium concentration (Ca) was 9.0-10.0 mg/dL. Of the 86 patients, 62 finished the study without a change of dosage and their data were analyzed (group A, N=16; group B, N=26; group C, N=20). At week 8 compared with week 4, the concentration of P increased from 5.7+/-1.4 to 6.4+/-1.7 mg/dL in group A, and decreased significantly in groups B and C, and in group B compared with groups A and C; groups A and C had similar concentrations at week 8. The Ca concentration decreased significantly from 9.7+/-1.0 to 9.1+/-0.7 mg/dL after the change to sevelamer. At week 8 Ca was not significantly changed in group A, whereas a significant increase occurred in groups B and C. Side-effects with sevelamer administration occurred in 34 of the 86 patients and 24 dropped out of the study, with a high frequency in group A (13/29; 44.8%). In conclusion, there was an additive effect of sevelamer for the treatment of hyperphosphatemia with CC. The combination therapy was better tolerated and showed higher patient compliance than CC or sevelamer monotherapy.
Koiwa
Fumihiko
F
Division of Nephrology, Showa University Fujigaoka Hospital, Yokohama, Japan.
Onoda
Noritaka
N
Kato
Hitoshi
H
Tokumoto
Akihide
A
Okada
Tomoyuki
T
Fukagawa
Masashi
M
Shigematsu
Takashi
T
D000704:Analysis of Variance; D002119:Calcium Carbonate / Q000627:therapeutic use*; D016009:Chi-Square Distribution; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007564:Japan; D007676:Kidney Failure, Chronic / Q000628:therapy; D008297:Male; D008875:Middle Aged; D010281:Parathyroid Hormone / Q000097:blood; D010760:Phosphorus Metabolism Disorders / Q000188:drug therapy* / Q000209:etiology; D011073:Polyamines / Q000627:therapeutic use*; D011446:Prospective Studies; D006435:Renal Dialysis / Q000009:adverse effects*; D000069603:Sevelamer; D016896:Treatment Outcome
D010281:Parathyroid Hormone; D011073:Polyamines; D000069603:Sevelamer; D002119:Calcium Carbonate