Long-Term Mortality and Bone Safety in Patients with End-Stage Renal Disease Receiving Lanthanum Carbonate

Abstract

Background/aims: This post-marketing observational study assessed the long-term safety of lanthanum carbonate (LaC) in US patients with end-stage renal disease (NCT00567723).

Methods: Patients (≥18 years old) undergoing dialysis, who had Medicare as their primary healthcare payer, and records in the United States Renal Data System were followed-up for 5 years. Patients who had received LaC for at least 12 consecutive weeks formed the exposed cohort. During the same time period, patients who had undergone dialysis for at least 12 consecutive weeks and had been treated with any other phosphate binder formed the primary comparator cohort. A historical cohort was also evaluated. Primary outcomes were all-cause mortality, and time to and incidence of first bone-fracture event requiring hospitalization. Secondary outcomes were time to first occurrence of and incidence of specific gastrointestinal (GI) disease, liver disease, malignancy, and major infectious episode requiring hospitalization. -Results: 2,026 and 8,094 patients were included in the exposed and primary comparator cohorts, respectively. A Cox proportional hazards model showed that patients receiving LaC were not at increased risk of all-cause mortality (adjusted hazard ratio 0.94; 95% CI 0.88-1.01; p = 0.078), bone fractures (0.86; 0.71-1.05; p = 0.130), specific GI disease (0.86; 0.76-0.97; p = 0.015), liver disease (0.88; 0.70-1.09; p = 0.236), malignancy (0.85; 0.54-1.34; p = 0.496), or major infectious episodes (0.87; 0.80-0.94; p < 0.001) requiring hospitalization compared with primary comparator patients.

Conclusions: LaC was not associated with increased risk of mortality, bone fractures, or any secondary outcome.

Keywords: Chronic kidney disease; Dialysis; End-stage renal disease; Phosphate binder; Phosphatemia.

© 2018 The Author(s) Published by S. Karger AG, Basel.

Figures

Fig. 1

Kaplan-Meier analysis for time to (a) all-cause mortality and (b) first bone fracture requiring hospitalization. The primary comparator cohort included patients who had received a phosphate binder other than LaC during the time of this study; patients in the historical cohort had data in the USRDS prior to the availability of LaC. The horizontal reference line indicates the median. Median estimates are not calculable for bone fractures requiring hospitalization (too few events). LaC, lanthanum carbonate; USRDS, United States Renal Data System.

Fig. 2

Kaplan-Meier analysis for time to secondary outcomes: (a) specific GI disease, (b) liver disease, (c) malignancy, and (d) major infectious episode requiring hospitalization. The primary comparator cohort included patients who had received a phosphate binder other than LaC during the time of this study; patients in the historical cohort had data in the USRDS prior to the availability of LaC. The horizontal reference line indicates the median. Median estimates are not calculable for specific gastrointestinal disease, liver disease, and malignancy requiring hospitalization (too few events). GI, gastrointestinal; LaC, lanthanum carbonate; USRDS, United States Renal Data System.