Mortality and bone safety outcomes in patients with end-stage renal disease receiving lanthanum carbonate: A long-term, observational study

INTRODUCTION AND AIMS: Lanthanum carbonate (LaC) is a non-calcium, noniron- based phosphate binder that has been available for the management of hyperphosphatemia in patients with ESRD in the USA since 2005 and in Europe since 2006. The aim of this observational, post-marketing study was to examine the longterm safety of LaC in patients with ESRD in the USA (NCT00567723). METHODS: The study comprised two groups. Patients (≥18 years old) who provided informed consent and had received LaC for ≥12 consecutive weeks formed the exposed group; these patients were recruited from completed and ongoing trials of LaC, or patients who had been prescribed LaC during normal clinical practice. Patients who had been treated with any other phosphate binder were included in a comparator group and were identified from the USRDS using 1:4 matching (exposed:comparator). Patients were matched by age, sex, number of consecutive weeks of dialysis at screening (≥12), and first year of starting dialysis. Primary outcomes were incidence of and time to all-cause mortality and first bone fracture requiring hospitalization. Secondary outcomes were incidence of and time to gastrointestinal (GI) disease, liver disease, malignancy and major infectious episodes requiring hospitalization. We present the final analysis based on 5-year follow-up data from the 2015 USRDS. A Cox proportional hazards (CPH) model, adjusted for patient baseline characteristics, compared primary and secondary outcomes between groups. RESULTS: Overall, 2136 exposed patients were enrolled, of whom 2026 were included for analysis; the comparator group comprised 8094 matched patients. Baseline characteristics were similar between groups (Table 1). All-cause mortality was 51.8% and 54.4% and bone fracture rates were 6.3% and 7.2% for the exposed and comparator groups, respectively. Kaplan-Meier analysis showed that median 5-year survival (95% CI) was 51.7 (49.3-54.2) and 49.0 (47.5-50.3) months for patients in the exposed and comparator groups, respectively. Incidences of secondary outcomes were: GI disease, 17.8% vs 19.1%; liver disease, 5.1% vs 6.2%; malignancy, 1.1% and 1.4%; and infectious episodes, 46.2% vs 49.3% for the exposed and comparator groups, respectively. CPH model results are shown in Table 2. CONCLUSIONS: LaC was not associated with increased risk of all-cause mortality, first bone fracture requiring hospitalization or any of the secondary safety outcomes compared with patients receiving any other phosphate binder. These data support the positive long-term safety profile of LaC in patients with ESRD. (Table presented).