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

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.

Figures

Fig. 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.

Fig. 2

Categorization of previous phosphate-binder therapy for the main study population (ITT population).

Fig. 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.

Fig. 4

Distribution of lanthanum carbonate dose levels at Week 12 (ITT population). For each dose, the proportion of patients with serum phosphate levels controlled to K/DOQI targets is shown by the split bar; the number inside the ‘controlled’ bar demonstrates the percentage of patients controlled at that particular dose.