title: Prospective randomized multicenter trial of sevelamer hydrochloride and calcium carbonate for the treatment of hyperphosphatemia in hemodialysis patients in Japan.
abstract: 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.
authors.affiliation: Division of Nephrology, Showa University Fujigaoka Hospital, Yokohama, Japan.
authors.forename: Fumihiko
authors.initials: F
authors.lastname: Koiwa
authors.forename: Noritaka
authors.initials: N
authors.lastname: Onoda
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Kato
authors.forename: Akihide
authors.initials: A
authors.lastname: Tokumoto
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Okada
authors.forename: Masashi
authors.initials: M
authors.lastname: Fukagawa
authors.forename: Takashi
authors.initials: T
authors.lastname: Shigematsu
mesh_terms: 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
chemical_list: D010281:Parathyroid Hormone; D011073:Polyamines; D000069603:Sevelamer; D002119:Calcium Carbonate