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document
Lanthanum carbonate ( Fosrenol ) efficacy and tolerability in the treatment of hyperphosphatemic patients with end-stage renal disease . AIMS High serum phosphorus levels are a common problem in patients receiving long-term dialysis treatment . Lanthanum carbonate ( Fosrenol ) is a new non-aluminum , non-calcium phosphate binder developed for the treatment of hyperphosphatemia in patients with end-stage renal disease ( ESRD ) . We report data from a recent trial , which , for the first time , assessed the efficacy and tolerability of lanthanum carbonate treatment , compared with placebo , in Chinese patients with ESRD . PATIENTS AND METHODS Following a one- to three-week washout phase and a four-week , open-label lanthanum carbonate dose-titration phase , male and female hemodialysis patients were randomized ( 1:1 ) to receive either lanthanum carbonate or placebo for four weeks . The primary efficacy parameter of the study was the control of serum phosphorus levels ( < or =1.8 mmol/l [ < or = 5.6 mg/dl ] ) . Secondary endpoints included the profile of serum phosphorus during titration and parathyroid hormone , calcium , and calcium x phosphorus ( Ca x P ) product levels . The safety and tolerability of lanthanum carbonate were assessed by monitoring adverse events throughout the study . RESULTS Mean serum phosphorus level at the end of washout was 2.5 +/- 0.5 mmol/l ( 7.7 +/- 1.5 mg/dl ; n=73 ) , and there was no evidence of a difference in levels between the treatment groups pre-randomization . At the end of the study , lanthanum carbonate-treated patients had significantly lower phosphorus levels ( 1.6 +/- 0.5 mmol/l [ 5.1 +/- 1.5 mg/dl ] ; n=30 ) than those receiving placebo ( 2.3 +/- 0.4 mmol/l [ 7.2 +/- 1.3 mg/dl ] ; n=31 ; p < 0.001 ) . In addition , a significantly higher proportion of patients receiving lanthanum carbonate had controlled serum phosphorus levels ( 60 % ) compared with the placebo group ( 10 % ; p < 0.001 ) . Ca x P product levels were also significantly lower in the lanthanum carbonate group at the end of randomized treatment ( p < 0.001 ) . Lanthanum carbonate was well tolerated ; only one serious adverse event was reported , which was unrelated to treatment . CONCLUSIONS Lanthanum carbonate was shown to be an effective and well-tolerated phosphate binder for the treatment of hyperphosphatemia in Chinese patients with ESRD . This finding supports the results of previous US and European studies , which have also shown that lanthanum carbonate treatment effectively controls serum phosphorus levels .
22306
Intervention_Pharmacological
Lanthanum carbonate ( Fosrenol )
22307
Intervention_Pharmacological
Lanthanum carbonate ( Fosrenol )
22308
Intervention_Pharmacological
lanthanum carbonate treatment
22309
Intervention_Control
placebo
22310
Intervention_Pharmacological
lanthanum carbonate
22311
Intervention_Pharmacological
lanthanum carbonate
22312
Intervention_Control
placebo
22313
Intervention_Pharmacological
lanthanum carbonate
22314
Intervention_Pharmacological
lanthanum carbonate-treated
22315
Intervention_Pharmacological
lanthanum carbonate
22316
Intervention_Pharmacological
lanthanum carbonate
22317
Intervention_Pharmacological
Lanthanum carbonate
22318
Intervention_Pharmacological
Lanthanum carbonate
22319
Intervention_Pharmacological
lanthanum carbonate
22320
Outcome_Other
efficacy and tolerability
22321
Outcome_Other
efficacy
22322
Outcome_Other
tolerability
22323
Outcome_Physical
serum phosphorus levels
22324
Outcome_Physical
the profile of serum phosphorus during titration and parathyroid hormone
22325
Outcome_Physical
calcium
22326
Outcome_Physical
calcium x phosphorus ( Ca x P ) product levels
22327
Outcome_Other
safety and tolerability of lanthanum carbonate
22328
Outcome_Adverse-effects
adverse events
22329
Outcome_Physical
Mean serum phosphorus level
22330
Outcome_Physical
phosphorus levels
22331
Outcome_Physical
serum phosphorus levels
22332
Outcome_Physical
Ca x P product levels
22333
Outcome_Other
tolerated
22334
Outcome_Adverse-effects
serious adverse event
22335
Outcome_Other
effective
22336
Outcome_Other
well-tolerated
22337
Outcome_Physical
serum phosphorus levels