Randomized Crossover Study of the Efficacy and Safety of Sevelamer Hydrochloride and Lanthanum Carbonate in Japanese Patients Undergoing Hemodialysis

Abstract

Insufficient control of serum calcium and phosphate levels in patients undergoing hemodialysis is associated with increased mortality. As commonly used calcium-containing phosphate binders can cause arterial calcification, newly developed calcium-free phosphate binders, such as sevelamer hydrochloride (SH) and lanthanum carbonate (LC), have received much attention. We assessed the efficacy and safety of SH and LC treatment in Japanese patients undergoing hemodialysis in a prospective randomized open blinded endpoint (PROBE) crossover study. Forty-two patients were randomized to receive SH or LC for 13 weeks, with the dosages adjusted every 2 weeks, followed by treatment with the other drug for another 13 weeks. The average daily doses of SH and LC were 2971 ± 1464 mg and 945 ± 449 mg, respectively. The mean dosage ratio of SH to LC was 3.05, which was maintained throughout the treatment period. SH and LC were similarly effective at controlling serum calcium and phosphate levels in the majority of patients (78-93%). A few serious adverse events (AEs) involving the biliary system occurred during the LC treatment period, but they were not considered to be treatment-induced. Although the incidence of constipation, the most common treatment-related AE, was higher during the SH period (27% vs. 5%; P < 0.05), no difference was observed in total treatment-related AEs. This study demonstrates that SH and LC are comparable treatments for controlling serum phosphate and calcium levels, and that both compounds are safe and well-tolerated in Japanese patients undergoing hemodialysis.