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Switching to lanthanum carbonate monotherapy provides effective phosphate control with a low tablet burden.

Hutchison AJ, Laville M, SPD405-313 Lanthanum Study Gro - Nephrol. Dial. Transplant. (2008)

Bottom Line: It is likely that this is partly due to poor adherence by patients to their phosphate-binder treatment regimens, which often comprise large daily tablet burdens.Mean serum phosphate levels were significantly reduced following 12 weeks of lanthanum carbonate monotherapy versus previous phosphate-binder therapy.The mean number of phosphate-binder tablets being taken per day at screening was 7.6, but during treatment with lanthanum carbonate, most patients were taking doses of up to 3000 mg/day, achievable with 3 x 1000 mg tablets per day (maximum of 6).

View Article: PubMed Central - PubMed

Affiliation: Manchester Institute of Nephrology and Transplantation, Manchester Royal Infirmary, Manchester, UK. alastair.hutchison@cmmc.nhs.uk

ABSTRACT

Background: Despite recognized risks associated with hyperphosphataemia in patients with chronic kidney disease (CKD) Stage 5 on dialysis, the achievement of target levels of serum phosphate is poor. It is likely that this is partly due to poor adherence by patients to their phosphate-binder treatment regimens, which often comprise large daily tablet burdens.

Methods: In this multicentre, open-label trial, patients on a stable dialysis regimen were screened while receiving phosphate-binder therapy, then entered into a washout phase. Patients with serum phosphate > 1.78 mmol/L after washout entered into the main 12-week treatment phase (N = 367), during which they were treated to target [Kidney Disease Outcomes Quality Initiative (K/DOQI)]: 1.13-1.78 mmol/L; 3.5-5.5 mg/dL) with lanthanum carbonate monotherapy. Efficacy variables included serum phosphate levels and the percentage of patients with serum phosphate control. Safety and tolerability assessments were also conducted.

Results: Mean serum phosphate levels were significantly reduced following 12 weeks of lanthanum carbonate monotherapy versus previous phosphate-binder therapy. The mean number of phosphate-binder tablets being taken per day at screening was 7.6, but during treatment with lanthanum carbonate, most patients were taking doses of up to 3000 mg/day, achievable with 3 x 1000 mg tablets per day (maximum of 6).

Conclusion: These findings suggest that lanthanum carbonate monotherapy offers effective control of serum phosphate and, due to a low tablet burden, may help to simplify the management of hyperphosphataemia in patients with CKD Stage 5.

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Related in: MedlinePlus

Study design. Note: Week 12 was the end of study visit (visit 8) for patients who did not continue into the extension phase and was the first visit of the extension phase (visit E1) for patients who chose to continue into the extension phase. Week E3 was the end of study visit for patients who continued into the extension phase.
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Figure 1: Study design. Note: Week 12 was the end of study visit (visit 8) for patients who did not continue into the extension phase and was the first visit of the extension phase (visit E1) for patients who chose to continue into the extension phase. Week E3 was the end of study visit for patients who continued into the extension phase.

Mentions: The study design is summarized in Figure 1. Patients receiving prior phosphate binder(s) discontinued their treatment and entered a 1- to 2-week washout period. Serum phosphate levels were reviewed after each week. Patients whose serum phosphate levels rose above 1.78 mmol/L were eligible to begin lanthanum carbonate treatment and considered to be at baseline at this point. Those who did not demonstrate this level of serum phosphate after 2 weeks were excluded from the study. Patients who were not receiving any phosphate-binder treatment and had serum levels above 1.78 mmol/L entered the treatment period immediately following the screening period.


Switching to lanthanum carbonate monotherapy provides effective phosphate control with a low tablet burden.

Hutchison AJ, Laville M, SPD405-313 Lanthanum Study Gro - Nephrol. Dial. Transplant. (2008)

Study design. Note: Week 12 was the end of study visit (visit 8) for patients who did not continue into the extension phase and was the first visit of the extension phase (visit E1) for patients who chose to continue into the extension phase. Week E3 was the end of study visit for patients who continued into the extension phase.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2568007&req=5

Figure 1: Study design. Note: Week 12 was the end of study visit (visit 8) for patients who did not continue into the extension phase and was the first visit of the extension phase (visit E1) for patients who chose to continue into the extension phase. Week E3 was the end of study visit for patients who continued into the extension phase.
Mentions: The study design is summarized in Figure 1. Patients receiving prior phosphate binder(s) discontinued their treatment and entered a 1- to 2-week washout period. Serum phosphate levels were reviewed after each week. Patients whose serum phosphate levels rose above 1.78 mmol/L were eligible to begin lanthanum carbonate treatment and considered to be at baseline at this point. Those who did not demonstrate this level of serum phosphate after 2 weeks were excluded from the study. Patients who were not receiving any phosphate-binder treatment and had serum levels above 1.78 mmol/L entered the treatment period immediately following the screening period.

Bottom Line: It is likely that this is partly due to poor adherence by patients to their phosphate-binder treatment regimens, which often comprise large daily tablet burdens.Mean serum phosphate levels were significantly reduced following 12 weeks of lanthanum carbonate monotherapy versus previous phosphate-binder therapy.The mean number of phosphate-binder tablets being taken per day at screening was 7.6, but during treatment with lanthanum carbonate, most patients were taking doses of up to 3000 mg/day, achievable with 3 x 1000 mg tablets per day (maximum of 6).

View Article: PubMed Central - PubMed

Affiliation: Manchester Institute of Nephrology and Transplantation, Manchester Royal Infirmary, Manchester, UK. alastair.hutchison@cmmc.nhs.uk

ABSTRACT

Background: Despite recognized risks associated with hyperphosphataemia in patients with chronic kidney disease (CKD) Stage 5 on dialysis, the achievement of target levels of serum phosphate is poor. It is likely that this is partly due to poor adherence by patients to their phosphate-binder treatment regimens, which often comprise large daily tablet burdens.

Methods: In this multicentre, open-label trial, patients on a stable dialysis regimen were screened while receiving phosphate-binder therapy, then entered into a washout phase. Patients with serum phosphate > 1.78 mmol/L after washout entered into the main 12-week treatment phase (N = 367), during which they were treated to target [Kidney Disease Outcomes Quality Initiative (K/DOQI)]: 1.13-1.78 mmol/L; 3.5-5.5 mg/dL) with lanthanum carbonate monotherapy. Efficacy variables included serum phosphate levels and the percentage of patients with serum phosphate control. Safety and tolerability assessments were also conducted.

Results: Mean serum phosphate levels were significantly reduced following 12 weeks of lanthanum carbonate monotherapy versus previous phosphate-binder therapy. The mean number of phosphate-binder tablets being taken per day at screening was 7.6, but during treatment with lanthanum carbonate, most patients were taking doses of up to 3000 mg/day, achievable with 3 x 1000 mg tablets per day (maximum of 6).

Conclusion: These findings suggest that lanthanum carbonate monotherapy offers effective control of serum phosphate and, due to a low tablet burden, may help to simplify the management of hyperphosphataemia in patients with CKD Stage 5.

Show MeSH
Related in: MedlinePlus