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

作者：Ni, Zhaohui; Liang, Xinling; Wu, Chia-Chao; Jin, Kyubok; Kim, Yong-Lim; Lu, Kuo-Cheng; Chan, Tak Mao; Fukagawa, Masafumi; Kinoshita, Jun; Nagai, Chisato; Kojima, Masahiro; Yu, Xueqing^*

来源：Kidney International Reports, 2023, 8(11): 2294-2306.

DOI：10.1016/j.ekir.2023.08.034

• cinacalcet
• evocalcet
• gastrointestinal
• East Asia
• randomized controlled trial
• secondary hyperparathyroidism

Introduction: Evocalcet is an oral calcimimetic agent with proven efficacy and safety in treating secondary hyperparathyroidism (SHPT) in Japanese patients on dialysis.Methods: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.Results: 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.Conclusion: Evocalcet might be a better alternative to cinacalcet for East Asian patients on hemodialysis with SHPT.

• 单位
  上海交通大学; 南方医科大学; 广东省人民医院