Efficacy and safety of patiromer for non-dialysis and dialysis patients with hyperkalemia: the randomized, placebo-controlled and long-term study.

Abstract

Listen

Translate article

The objectives of this phase two study are to investigate the efficacy of two starting doses of 8.4g and 16.8g and evaluate the long-term safety of patiromer in Japanese patients with hyperkalemia. This study comprised three cohorts; non-dialysis patients with baseline serum potassium (sK) level of 5.1 to < 6.0mmol/L (NDC1); 6.0 to < 6.5mmol/L (NDC2); dialysis patients with baseline sK level of 5.5 to < 6.5mmol/L (DC). The study design was one-week, randomized, double-blind, placebo-controlled, and open label extension for one year in NDC1, open label during the study in NDC2 and DC. Patients were randomly assigned to patiromer 8.4g, 16.8g or placebo in NDC1, 8.4g or 16.8g in NDC2 and DC. Dose was adjusted up to 25.2g according to the titration algorism in open label period. A total of 185 patients were randomized (NDC1:153, NDC2:10, and DC:22). The primary endpoint of the change in least squares mean sK levels at Week 1 in NDC1 was - 0.55, - 0.77 and - 0.10mmol/L for the 8.4g, 16.8g and placebo group (P < 0.001 for the patiromer group vs the placebo group). In all cohorts for each patiromer group, more than 80% of patients achieved normal sK at Week 5. There was no severe treatment-related adverse event. Treatment with patiromer was effective in lowering and maintaining target sK levels, also well tolerated for oneyear in Japanese patients with hyperkalemia.