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Efficacy and Safety of Evocalcet Evaluated by Dialysate Calcium Concentration in Patients with Secondary Hyperparathyroidism Undergoing Hemodialysis

Authors Shigematsu T, Asada S, Endo Y, Kawata T, Fukagawa M, Akizawa T

Received 21 December 2019

Accepted for publication 20 March 2020

Published 12 May 2020 Volume 2020:13 Pages 97—106


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Professor Pravin Singhal

Takashi Shigematsu,1 Shinji Asada,2 Yuichi Endo,3 Takehisa Kawata,2,3 Masafumi Fukagawa,4 Tadao Akizawa5

1Department of Nephrology, Wakayama Medical University, Wakayama, Japan; 2Medical Affairs Department, Kyowa Kirin Co., Ltd., Tokyo, Japan; 3R&D Division, Kyowa Kirin Co., Ltd., Tokyo, Japan; 4Division of Nephrology, Endocrinology, and Metabolism, Department of Internal Medicine, Tokai University School of Medicine, Kanagawa, Japan; 5Division of Nephrology, Department of Medicine, Showa University School of Medicine, Tokyo, Japan

Correspondence: Takashi Shigematsu
Department of Nephrology, Wakayama Medical University, 811-1 Kimiidera, Wakayama 641-8509, Japan
Tel +81-73-441-0638
Fax +81-73-441-0639

Purpose: Evocalcet is a novel oral calcimimetic drug that has demonstrated similar efficacy to cinacalcet in regulating serum parathyroid hormone (PTH), calcium, and phosphate levels, with fewer upper gastrointestinal tract-related adverse drug reactions (ADRs) in patients with secondary hyperparathyroidism undergoing hemodialysis in Japan. We investigated the efficacy and safety of once-daily oral evocalcet under different dialysate calcium concentrations.
Patients and Methods: A post hoc analysis by dialysate calcium concentration (2.5, 2.75, and 3.0 mEq/L) was performed using data from a previous Phase 3 study that included cinacalcet as an active control. Efficacy endpoints were the proportion of patients who achieved the target intact PTH levels of ≥ 60 and ≤ 240 pg/mL between Week 28 and Week 30; time-course changes in serum intact PTH; calcium and phosphorus levels, bone turnover markers, and fibroblast growth factor 23 (FGF23) over the 30-week study period. Safety endpoints were overall ADRs and hypocalcemia- and upper gastrointestinal tract-related ADRs.
Results: A total of 634 patients were included in the analysis. Levels of intact PTH, calcium, phosphate, bone turnover markers, and FGF23 showed improvement in all sub-groups, irrespective of dialysate calcium concentration. The incidence of upper gastrointestinal tract-related ADRs was significantly lower in the evocalcet group than the cinacalcet group with dialysate calcium concentrations of 2.75 and 3.0 mEq/L (p< 0.05 for both concentrations).
Conclusion: Evocalcet was effective and safe in regulating the levels of serum intact PTH, calcium, and phosphate in patients with secondary hyperparathyroidism undergoing hemodialysis, irrespective of dialysate calcium concentration.

Keywords: hypocalcemia, intact parathyroid hormone, oral calcimimetic, post hoc analysis, upper gastrointestinal tract

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