Comparison of the Oral Calcimimetics Evocalcet and Cinacalcet in East Asian Patients on Hemodialysis with Secondary Hyperparathyroidism

Abstract

Evocalcet is an oral calcimimetic agent with proven efficacy and safety in treating secondary hyperparathyroidism (SHPT) in Japanese patients on dialysis. This randomized, double-blind, intrapatient dose-adjustment, parallel-group, international multicenter study compared the efficacy and safety of evocalcet versus cinacalcet for 52 weeks in East Asian hemodialysis patients with SHPT. In total, 203 and 200 patients were randomized to receive evocalcet or cinacalcet, respectively (overall, 70.1% had baseline intact parathyroid hormone (PTH) levels≥500 pg/ml, with no between-group difference). Mean percentage changes in intact PTH levels from baseline were-34.7% and-30.2% in the evocalcet and cinacalcet groups at 52 weeks (between-group difference-4.4%, 95% confidence interval [CI]-13.1%, 4.3%, below the predefined 15% noninferiority margin). Overall, 67.3% and 58.7% of patients in the evocalcet and cinacalcet groups, respectively, achieved≥30% decrease in intact PTH levels from baseline (between-group difference 8.6%; 95% CI-1.8%, 19.1%). No major safety concerns were observed. Gastrointestinal adverse events (AEs) were significantly less frequent with evocalcet compared with cinacalcet (33.5% vs. 50.5%, P= 0.001), whereas the incidence of hypocalcemia did not differ. Evocalcet might be a better alternative to cinacalcet for East Asian patients on hemodialysis with SHPT.