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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

Mean (95% CI) serum phosphate levels for the ITT population (n = 359) and patients previously treated with one (n = 204) or two (n = 137) phosphate binders.
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Figure 3: Mean (95% CI) serum phosphate levels for the ITT population (n = 359) and patients previously treated with one (n = 204) or two (n = 137) phosphate binders.

Mentions: At screening, when patients were still using their previous phosphate binder, the mean (95% CI) serum phosphate level was 1.99 (1.92, 2.06) mmol/L. During the 1- to 2-week washout period, serum phosphate levels increased as expected, and then decreased with lanthanum carbonate treatment. At week 12, the mean (95% CI) serum phosphate level was 1.84 (1.78, 1.90) mmol/L. The mean reduction from screening in serum phosphate levels after 12 weeks (for patients with both screening and week 12 measurements) on lanthanum carbonate treatment was significant [mean (SE) change from screening, −0.13 (0.05) mmol/L; P = 0.007 using the one-sample t-test based on the 98.1% patients receiving phosphate binders at screening]. Furthermore, mean serum phosphate levels improved with 12 weeks of lanthanum carbonate monotherapy regardless of whether patients were previously receiving monotherapy (1.83 versus 1.98 mmol/L) or combination binder therapy (1.87 versus 1.97 mmol/L) (Figure 3).


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)

Mean (95% CI) serum phosphate levels for the ITT population (n = 359) and patients previously treated with one (n = 204) or two (n = 137) phosphate binders.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

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

Figure 3: Mean (95% CI) serum phosphate levels for the ITT population (n = 359) and patients previously treated with one (n = 204) or two (n = 137) phosphate binders.
Mentions: At screening, when patients were still using their previous phosphate binder, the mean (95% CI) serum phosphate level was 1.99 (1.92, 2.06) mmol/L. During the 1- to 2-week washout period, serum phosphate levels increased as expected, and then decreased with lanthanum carbonate treatment. At week 12, the mean (95% CI) serum phosphate level was 1.84 (1.78, 1.90) mmol/L. The mean reduction from screening in serum phosphate levels after 12 weeks (for patients with both screening and week 12 measurements) on lanthanum carbonate treatment was significant [mean (SE) change from screening, −0.13 (0.05) mmol/L; P = 0.007 using the one-sample t-test based on the 98.1% patients receiving phosphate binders at screening]. Furthermore, mean serum phosphate levels improved with 12 weeks of lanthanum carbonate monotherapy regardless of whether patients were previously receiving monotherapy (1.83 versus 1.98 mmol/L) or combination binder therapy (1.87 versus 1.97 mmol/L) (Figure 3).

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