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Review
. 2016 Dec;21(12):987-994.
doi: 10.1111/nep.12864.

Lanthanum Carbonate: Safety Data After 10 Years

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Free PMC article
Review

Lanthanum Carbonate: Safety Data After 10 Years

Alastair J Hutchison et al. Nephrology (Carlton). .
Free PMC article

Abstract

Despite 10 years of post-marketing safety monitoring of the phosphate binder lanthanum carbonate, concerns about aluminium-like accumulation and toxicity persist. Here, we present a concise overview of the safety profile of lanthanum carbonate and interim results from a 5-year observational database study (SPD405-404; ClinicalTrials.gov identifier: NCT00567723). The pharmacokinetic paradigms of lanthanum and aluminium are different in that lanthanum is minimally absorbed and eliminated via the hepatobiliary pathway, whereas aluminium shows appreciable absorption and is eliminated by the kidneys. Randomised prospective studies of paired bone biopsies revealed no evidence of accumulation or toxicity in patients treated with lanthanum carbonate. Patients treated with lanthanum carbonate for up to 6 years showed no clinically relevant changes in liver enzyme or bilirubin levels. Lanthanum does not cross the intact blood-brain barrier. The most common adverse effects are mild/moderate nausea, diarrhoea and flatulence. An interim Kaplan-Meier analysis of SPD405-404 data from the United States Renal Data System revealed that the median 5-year survival was 51.6 months (95% CI: 49.1, 54.2) in patients who received lanthanum carbonate (test group), 48.9 months (95% CI: 47.3, 50.5) in patients treated with other phosphate binders (concomitant therapy control group) and 40.3 months (95% CI: 38.9, 41.5) in patients before the availability of lanthanum carbonate (historical control group). Bone fracture rates were 5.9%, 6.7% and 6.4%, respectively. After more than 850 000 person-years of worldwide patient exposure, there is no evidence that lanthanum carbonate is associated with adverse safety outcomes in patients with end-stage renal disease.

Keywords: end-stage renal disease; hyperphosphatemia; lanthanum carbonate; long-term safety; pharmacokinetics; phosphate binder.

Figures

Figure 1
Figure 1
Comparison of the pharmacokinetics of lanthanum and aluminium. ESRD, end‐stage renal disease.
Figure 2
Figure 2
Kaplan–Meier analysis of time to all‐cause mortality based on United States Renal Data System data from 2014 (full analysis set). Horizontal reference line shows median survival time. CI, confidence interval.

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