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

Abstract

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.

• Authors: Zhaohui Ni, Xinling Liang, Chia-Chao Wu, Kyubok Jin, Yong-Lim Kim, Kuo-Cheng Lu, Tak Mao Chan, Masafumi Fukagawa, Jun Kinoshita, Chisato Nagai, Masahiro Kojima, Xueqing Yu, Orchestra Study Group
• Journal: Kidney international reports (Kidney Int Rep) Vol. 8 Issue 11 Pg. 2294-2306 (Nov 2023) ISSN: 2468-0249 [Electronic] United States
• PMID: 38025238 (Publication Type: Journal Article)
• Copyright: © 2023 Published by Elsevier, Inc., on behalf of the International Society of Nephrology.