Conversion to lanthanum carbonate monotherapy effectively controls serum phosphorus with a reduced tablet burden: a multicenter open-label study

Abstract

BackgroundLanthanum carbonate (FOSRENOL®) is an effective, well-tolerated phosphate binder. The ability of lanthanum to reduce serum phosphorus levels to ≤5.5 mg/dL in patients with end-stage renal disease (ESRD) was assessed in a clinical practice setting.MethodsA 16-week, phase IV study enrolled 2763 patients at 223 US sites to evaluate the efficacy of lanthanum carbonate in controlling serum phosphorus in patients with ESRD, and patient and physician satisfaction with, and preference for, lanthanum carbonate after conversion from other phosphate-binder medications. Patients received lanthanum carbonate prescriptions from physicians. These prescriptions were filled at local pharmacies rather than obtaining medication at the clinical trial site. Changes from serum phosphorus baseline values were analyzed using paired t tests. Patient and physician preferences for lanthanum carbonate versus previous medications were assessed using binomial proportion tests. Satisfaction was analyzed using the McNemar test. Daily dose, tablet burden, and laboratory values including albumin-adjusted serum calcium, calcium × phosphorus product, and parathyroid hormone levels were secondary endpoints.ResultsSerum phosphorus control (≤5.5 mg/dL) was effectively maintained in patients converting to lanthanum carbonate monotherapy; 41.6% of patients had controlled serum phosphate levels at 16 weeks. Patients and physicians expressed markedly higher satisfaction with lanthanum carbonate, and preferred lanthanum carbonate over previous medication. There were significant reductions in daily dose and daily tablet burden after conversion to lanthanum carbonate.ConclusionsSerum phosphorus levels were effectively maintained in patients converted from other phosphate-binder medications to lanthanum carbonate, with increased satisfaction and reduced tablet burden.Trial RegistrationClinicalTrials.gov: NCT0016012

Cost-Minimization Analysis of Lanthanum Carbonate Versus Sevelamer Hydrochloride in US Patients With End-stage Renal Disease

“…With regard to clinical efficacy, serum phosphate levels after conversion to lanthanum carbonate monotherapy were similar to those achieved with baseline sevelamer hydrochloride monotherapy, in accordance with the results of the primary study of Vemuri et al 25 In a recent analysis of the data from Vemuri et al, we reported that sevelamer hydrochloride and lanthanum carbonate achieved comparable efficacy with an overall dose-relativity ratio of 2.8. 26 The present economic evaluation of dose data from the study by Vemuri In addition to cost saving, conversion to lanthanum carbonate 1000-mg tablets from sevelamer hydrochloride 800-mg tablets would reduce the mean tablet burden by 470%.…”

“…The study design and patient demographic characteristics were described in detail in the article by Vemuri et al 25 In brief, the primary study was a 16-week, open-label, Phase IV, multicenter study of adult US patients (Z18 years of age) with ESRD who were converted to lanthanum carbonate monotherapy from other phosphate binder regimens. There was an initial screening visit and a 1-week observation period during which patients remained on the previous phosphate binder therapy with no dose modifications permitted.…”

“…The 2 forms of sevelamer are equivalent in terms of both efficacy [14][15][16] and cost. 17 Although several studies have compared the cost-effectiveness of sevelamer hydrochloride [18][19][20][21] or lanthanum carbonate 22 with that of calcium-based binders, Park et al 23 In a Phase IV study of the efficacy of lanthanum carbonate within a clinical practice setting, Vemuri et al 25 reported that conversion to lanthanum carbonate from other phosphate binder medications resulted in the maintenance of baseline serum phosphate levels and a significantly reduced phosphate binder dose and tablet burden. In the present study, we report a post hoc analysis of patient-level data from the study by Vemuri et al, with the objective of assessing the cost-effectiveness of lanthanum carbonate monotherapy compared with sevelamer hydrochloride monotherapy in US patients with ESRD.…”

Effect of Tenapanor on Serum Phosphate in Patients Receiving Hemodialysis

“…30 Studies have also reported improved satisfaction among patients with CKD stage 5 when switched from their existing phosphate binder to one with a lower pill burden. 34,35 Tenapanor, administered once or twice daily in milligram quantities, may provide a means to reduce pill burden and mass in patients with hyperphosphatemia, thereby improving adherence to treatment. As is the case with phosphate binders, patients took the study drug (tenapanor or placebo) with meals in our study.…”

Sevelamer Carbonate and Lanthanum Usage Evaluation and Cost Considerations at a Veteran's Affairs Medical Center

“…Comparing the drug acquisition cost of lanthanum and sevelamer hydrochloride, a post hoc evaluation of cost-effectiveness in non-VA patients was compiled by Keith et al based on a 16-week (phase IV) trial converting sevelamer hydrochloride to lanthanum by Vemuri et al 2,7 The analysis of 691 patients showed an average savings for lanthanum of $11.03 per day based on average wholesale price (AWP) while still maintaining phosphorus control. 2 This cost savings was directly proportional to the dose of sevelamer hydrochloride, with savings beginning with doses greater than or equal to 4,905 mg/day.…”