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

Nirupama Vemuri,Michael F Michelis,Albert Matalon

doi:10.1186/1471-2369-12-49

Nirupama Vemuri, Michael F Michelis + Show 1 more

Open Access

https://doi.org/10.1186/1471-2369-12-49

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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

Highlights

IntroductionThe 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
Lanthanum carbonate (FOSRENOL®) is an effective, well-tolerated phosphate binder
The Kidney Disease Outcomes Quality Initiative (KDOQI) proposed a target serum phosphorus range of 3.5 to 5.5 mg/dL for end-stage renal disease (ESRD) patients, which could be achieved by a combination of

Summary

Introduction

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. Uncontrolled serum phosphorus is strongly associated with increased mortality in patients with end-stage renal disease (ESRD) [1]. Many patients receiving maintenance dialysis do not achieve target serum phosphorus levels for a variety of reasons, including the complexity of their medical condition, poor adherence to dietary restrictions, and poor adherence to phosphate-binder therapy [3]. Reasons for nonadherence to medication regimens have been shown to be complex and multifactorial [4,5,6,7], but the high daily tablet burden associated with most phosphate-binder medications may be a contributing factor [8,9].

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