Efficacy, Tolerability, and Safety of Lanthanum Carbonate in Hyperphosphatemia: A 6-Month, Randomized, Comparative Trial versus Calcium Carbonate

Background/Aims: Hyperphosphatemia is an important clinical consequence of renal failure, and its multiple adverse systemic effects are associated with signifi cantly increased risks of morbidity and mortality in dialysis patients. Existing oral phosphate binders have not permitted control of serum phosphate within currently accepted guidelines. This study compares lanthanum carbonate with calcium carbonate for control of serum phosphate in hemodialysis patients. Methods: In this European multicentre study, 800 patients were randomised to receive either lanthanum or calcium carbonate and the dose titrated over 5 weeks to achieve control of serum phosphate. Serum levels of phosphate, calcium and parathryoid hormone were followed over the following 20 weeks. Results: Around 65% of patients in each group achieved phosphate control, but in the calcium carbonate group this was at the expense of signifi cant hypercalcemia (20.2% of patients vs. 0.4%). Consequently, cal- cium × phosphate product tended to be better controlled in the lanthanum group. Conclusion: This 6-month study demonstrates that serum phosphate control with lanthanum carbonate (750–3,000 mg/day) is similar to that seen with calcium carbonate (1,500–9,000 mg/day), but with a signifi cantly reduced incidence of hypercalcemia. Lanthanum carbonate is well tolerated and may be more effective in reducing calcium × phosphate product than calcium carbonate

Long-Term Efficacy and Tolerability of Lanthanum Carbonate: Results from a 3-Year Study

Background: Control of serum phosphate over the long term is essential in patients with end-stage renal disease. Six-month and 2-year extensions to a 6-month study evaluated the long-term safety, tolerability and effi cacy of the new phosphate binder lanthanum carbonate. Methods: Patients who participated in a 6-month, randomized trial comparing lanthanum carbonate with calcium carbonate were eligible for a 24-week, open-label extension. Lanthanum carbonate-treated patients continued taking their established maintenance dose (‘continued- lanthanum group’) and calcium carbonate-treated patients switched to lanthanum carbonate, 375–3,000 mg/day (‘switch group’). Patients could also enter a further 2-year extension. Effi cacy parameters, including serum phosphate, were monitored. Results: Mean serum phosphate was _ 1.80 mmol/l throughout the trial. The percentage of patients with controlled serum phosphate ( ^ 1.80 mmol/l) after the 6-month extension was 63.3 and 58.4% in the continued-lanthanum and switch groups, respectively; after the 2-year extension, 54.4% of patients had controlled serum phosphate. After discontinuation of calcium carbonate and initiation of lanthanum carbonate, the hypercalcemia incidence was 2.7%, compared with 20.2% during the double-blind phase. Calcium ! phosphate product was maintained at an acceptable level. Lanthanum carbonate was well tolerated; adverse events were mild/moderate and mainly gastrointestinal. Conclusions: Lanthanum carbonate maintains effectiveness with continued tolerability for up to 3 years