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document
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 .
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Intervention_Pharmacological
sevelamer hydrochloride and calcium carbonate
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Intervention_Pharmacological
sevelamer hydrochloride with or without calcium carbonate ( CC )
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Intervention_Pharmacological
CC to sevelamer
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Intervention_Pharmacological
group A , sevelamer 6.0 g/day
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Intervention_Pharmacological
CC 3.0 g/day ; group C
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Intervention_Pharmacological
CC 3.0 g/day
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Intervention_Pharmacological
sevelamer
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Intervention_Pharmacological
sevelamer
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Outcome_Physical
hyperphosphatemia
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Outcome_Physical
target serum phosphorous concentration
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Outcome_Physical
corrected calcium concentration ( Ca )
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Outcome_Physical
concentration of P
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Outcome_Physical
Ca concentration
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Outcome_Physical
Ca
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Outcome_Adverse-effects
Side-effects
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Outcome_Adverse-effects
additive effect
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Outcome_Other
tolerated
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Outcome_Mental
patient compliance
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Participant_Condition
hyperphosphatemia in hemodialysis patients
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Participant_Condition
Japan
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Participant_Sample-size
86
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Participant_Condition
hemodialysis
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Participant_Sample-size
62
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Participant_Sample-size
N=16
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Participant_Sample-size
N=26
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Participant_Sample-size
N=20