Long-Term Efficacy and Safety Profile of Lanthanum Carbonate: Results for up to 6 Years of Treatment

Abstract

Background/Aims: Lanthanum carbonate (LC, FOSRENOL®) is an effective phosphate binder for which tolerability and a safety profile have been reported in haemodialysis patients. Patients from previous studies entered a 2-year extension, enabling assessment of efficacy and safety for up to 6 years of LC monotherapy. Methods: Patients from four previous trials entered this study. Results: Ninety-three patients started the extension, with 22 entering a sixth year of LC treatment. Two-thirds of all patients received LC doses of 2,250 or 3,000 mg/day. Reductions in serum phosphate and calcium × phosphate product were maintained for up to 6 years. There were no new or unexpected adverse events (AEs), and no increase in the incidence of events with increasing treatment exposure. Over the complete duration of therapy, treatment-related AEs occurred in 25.8% of patients and were primarily gastrointestinal in nature. No clinically relevant changes in liver function tests were observed and there was no evidence of adverse effects on the liver, bone or the central nervous system. Conclusions: LC monotherapy was effective and well tolerated for up to 6 years with no evidence of safety concerns or increased frequency of AEs.

Lanthanum Carbonate Reduces Phosphorus Burden in Patients with CKD Stages 3 and 4

“…Data from animal studies (26,27) have demonstrated lanthanum deposition in bone and increased levels in the liver; the latter is consistent with its hepatic route of excretion (28,29). In patients with CKD stage 5 undergoing dialysis, data on the safety of lanthanum carbonate are published for up to 6 yr of treatment (18). In this long-term follow-up study, lanthanum carbonate was not associated with organ-specific toxicity in liver or bone.…”

“…Both short-and long-term clinical studies have demonstrated efficacy and an acceptable safety profile (15)(16)(17)(18). This study was designed to evaluate the efficacy and safety of lanthanum carbonate for use in patients with CKD stages 3 and 4, a population in which randomized, controlled clinical trials of phosphate binders are sparse (19).…”

Ferric Citrate Hydrate for the Treatment of Hyperphosphatemia in Nondialysis-Dependent CKD

“…The efficacy of noncalcium-containing phosphate binders, such as sevelamer and lanthanum, has been confirmed for this indication (17,18); however, sevelamer must be taken in large quantities to achieve adequate efficacy and is commonly associated with gastrointestinal side effects, such as constipation and bloating (19). Lanthanum accumulation in bone and other tissues has also been observed, although no safety issues related to tissue accumulation have been identified so far (20). There remains an unmet need for a highly efficacious and well tolerated phosphate binder that can be used in patients with nondialysis-dependent CKD.…”

Clinical Efficacy and Cost-Effectiveness of Lanthanum Carbonate as Second-Line Therapy in Hemodialysis Patients in Japan

“…However, we did not examine this point in the sensitivity analysis, because of difficulties in predicting the effect on either costs or clinical outcomes. Thus, although long-term clinical trials have shown that LC maintains reduction in serum phosphorus over time (44), further studies are needed to examine the effect of adherence to LC on phosphorus management and its resultant clinical outcomes.…”