PMID- 16550750
OWN - NLM
STAT- MEDLINE
DCOM- 20060620
LR  - 20220318
IS  - 0301-0430 (Print)
IS  - 0301-0430 (Linking)
VI  - 65
IP  - 3
DP  - 2006 Mar
TI  - Lanthanum carbonate versus standard therapy for the treatment of 
      hyperphosphatemia: safety and efficacy in chronic maintenance hemodialysis 
      patients.
PG  - 191-202
AB  - AIMS: No conventional phosphate binder is entirely satisfactory for the treatment 
      of hyperphosphatemia in patients with end-stage renal disease (ESRD). 
      Consequently, there is a need for new agents. One such agent is lanthanum 
      carbonate (La). This large-scale study compares the safety of La with standard 
      therapy (any approved phosphate binder) in patients who were treated for up to 2 
      years. Efficacy, having previously been demonstrated, was a secondary endpoint. 
      MATERIALS AND METHODS: After washout, patients were randomized to receive La 
      (n=682) or their pre-study phosphate binder (n=677). Over a 6-week period, La was 
      titrated to a maximum daily dose of 3000 mg elemental lanthanum (serum phosphorus 
      target levels for titration were < or = 5.9 mg/dl (1.90 mmol/l)). Safety 
      assessments included adverse events (AEs), full laboratory parameters and blood 
      profiles. Efficacy assessments included serum phosphorus, calcium, calcium x 
      phosphorus product and parathyroid hormone (PTH) levels. RESULTS: Average 
      treatment exposure was greater in the standard therapy group (501.4 days) than in 
      the La group (370.3 days) because standard therapy patients who switched or 
      combined treatments were allowed to continue in the study. The most common AEs 
      were gastrointestinal. The incidences of AEs in the La and treatment 
      exposure-corrected standard therapy groups were nausea, 37 versus 29%; vomiting, 
      27 versus 22% and diarrhea (24% in each group). Hypercalcemia that was reported 
      as an AE (La versus treatment exposure-corrected standard therapy) occurred in 
      4.3% and 8.4% of patients, respectively. There was no indication of liver 
      toxicity, suppression of erythropoiesis or changes in the mini-mental state 
      examination. Over 2 years, phosphorus control was similar in both groups; in the 
      La group, however, serum calcium was lower and serum PTH levels were maintained 
      in the range recommended by the National Kidney Foundation Kidney Disease 
      Outcomes Quality Initiative (K/DOQI). CONCLUSIONS: The 2-year tolerability and 
      efficacy of La are similar to those seen with standard therapy, although lower 
      serum calcium levels and improved PTH levels were observed in the La group. These 
      results support La as a viable new option for the management of hyperphosphatemia 
      in ESRD.
FAU - Finn, W F
AU  - Finn WF
AD  - Department of Medicine, University of North Carolina, Chapel Hill, NC 27599-7155, 
      USA. wffinn@med.unc.edu
CN  - SPD 405-307 Lanthanum Study Group
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - Germany
TA  - Clin Nephrol
JT  - Clinical nephrology
JID - 0364441
RN  - 0 (Phosphates)
RN  - 27YLU75U4W (Phosphorus)
RN  - 490D9F069T (lanthanum carbonate)
RN  - 6I3K30563S (Lanthanum)
SB  - IM
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Kidney Failure, Chronic/therapy
MH  - Lanthanum/*therapeutic use
MH  - Male
MH  - Middle Aged
MH  - Phosphates/*blood
MH  - Phosphorus/blood
MH  - Renal Dialysis/*adverse effects
MH  - Treatment Outcome
EDAT- 2006/03/23 09:00
MHDA- 2006/06/21 09:00
CRDT- 2006/03/23 09:00
PHST- 2006/03/23 09:00 [pubmed]
PHST- 2006/06/21 09:00 [medline]
PHST- 2006/03/23 09:00 [entrez]
AID - 10.5414/cnp65191 [doi]
PST - ppublish
SO  - Clin Nephrol. 2006 Mar;65(3):191-202. doi: 10.5414/cnp65191.