PMID- 38025238 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20231201 IS - 2468-0249 (Electronic) IS - 2468-0249 (Linking) VI - 8 IP - 11 DP - 2023 Nov TI - Comparison of the Oral Calcimimetics Evocalcet and Cinacalcet in East Asian Patients on Hemodialysis with Secondary Hyperparathyroidism. PG - 2294-2306 LID - 10.1016/j.ekir.2023.08.034 [doi] AB - 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. CI - (c) 2023 Published by Elsevier, Inc., on behalf of the International Society of Nephrology. FAU - Ni, Zhaohui AU - Ni Z AD - Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China. FAU - Liang, Xinling AU - Liang X AD - Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, Guangdong, China. FAU - Wu, Chia-Chao AU - Wu CC AD - Tri-Service General Hospital, Taipei, Taiwan. FAU - Jin, Kyubok AU - Jin K AD - Keimyung University School of Medicine, Daegu, Republic of Korea. FAU - Kim, Yong-Lim AU - Kim YL AD - School of Medicine, Kyungpook National University, Daegu, Republic of Korea. FAU - Lu, Kuo-Cheng AU - Lu KC AD - Taipei Tzu Chi Hospital, Taipei, Taiwan. FAU - Chan, Tak Mao AU - Chan TM AD - The University of Hong Kong, Hong Kong, China. FAU - Fukagawa, Masafumi AU - Fukagawa M AD - Tokai University School of Medicine, Kanagawa, Japan. FAU - Kinoshita, Jun AU - Kinoshita J AD - Kyowa Kirin Co., Ltd., Tokyo, Japan. FAU - Nagai, Chisato AU - Nagai C AD - Kyowa Kirin Co., Ltd., Tokyo, Japan. FAU - Kojima, Masahiro AU - Kojima M AD - Kyowa Kirin Co., Ltd., Tokyo, Japan. FAU - Yu, Xueqing AU - Yu X AD - Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, Guangdong, China. CN - Orchestra Study Group LA - eng PT - Journal Article DEP - 20230829 PL - United States TA - Kidney Int Rep JT - Kidney international reports JID - 101684752 PMC - PMC10658267 OTO - NOTNLM OT - East Asia OT - cinacalcet OT - evocalcet OT - gastrointestinal OT - randomized controlled trial OT - secondary hyperparathyroidism FIR - Xinling, Liang IR - Xinling L FIR - Shuangxin, Liu IR - Shuangxin L FIR - Sijia, Li IR - Sijia L FIR - Lixia, Xu IR - Lixia X FIR - Zhiming, Ye IR - Zhiming Y FIR - Zhonglin, Feng IR - Zhonglin F FIR - Renwei, Huang IR - Renwei H FIR - Zhilian, Li IR - Zhilian L FIR - Wei, Chen IR - Wei C FIR - Xunhua, Zheng IR - Xunhua Z FIR - Naya, Huang IR - Naya H FIR - Zhen, Ai IR - Zhen A FIR - Xin, Wang IR - Xin W FIR - Xunhua, Zheng IR - Xunhua Z FIR - Former Pi IR - Former Pi FIR - Ni, Zhaohui IR - Ni Z FIR - Present Pi IR - Present Pi FIR - Renhua, Lu IR - Renhua L FIR - Jianxiao, Shen IR - Jianxiao S FIR - Yijun, Zhou IR - Yijun Z FIR - Xinghui, Lin IR - Xinghui L FIR - Yuanyuan, Xie IR - Yuanyuan X FIR - Jiahui, Zhang IR - Jiahui Z FIR - Miaolin, Che IR - Miaolin C FIR - Yan, Fang IR - Yan F FIR - Huihua, Pang IR - Huihua P FIR - Xinyu, Su IR - Xinyu S FIR - Leyi, Gu IR - Leyi G FIR - Wei, Jin IR - Wei J FIR - Peipei, Zhao IR - Peipei Z FIR - Yiwei, Shen IR - Yiwei S FIR - Liou, Zao IR - Liou Z FIR - Wei, Lu IR - Wei L FIR - Haidong, Huang IR - Haidong H FIR - Gang, Ji IR - Gang J FIR - Hao, Li IR - Hao L FIR - Former Pi IR - Former Pi FIR - Deguang, Wang IR - Deguang W FIR - Present Pi IR - Present Pi FIR - Deguang, Wang IR - Deguang W FIR - Liang, Yuan IR - Liang Y FIR - Lihong, Ding IR - Lihong D FIR - Xuerong, Wang IR - Xuerong W FIR - Huai, Li IR - Huai L FIR - Hong, Liu IR - Hong L FIR - Fang, Yuan IR - Fang Y FIR - Panai, Song IR - Panai S FIR - An, Zhou IR - An Z FIR - Xiaojun, Chen IR - Xiaojun C FIR - Xiejia, Li IR - Xiejia L FIR - Liyu, He IR - Liyu H FIR - Xia, Tan IR - Xia T FIR - Jing, Chen IR - Jing C FIR - Minmin, Zhang IR - Minmin Z FIR - Qian, Zhang IR - Qian Z FIR - Jing, Qian IR - Jing Q FIR - Yaozhong, Kong IR - Yaozhong K FIR - Youyuan, Chen IR - Youyuan C FIR - Wei, Shen IR - Wei S FIR - Guanqing, Xiao IR - Guanqing X FIR - Dezhen, Chen IR - Dezhen C FIR - Dao, Li IR - Dao L FIR - Aizhen, Hou IR - Aizhen H FIR - Xiaolei, Li IR - Xiaolei L FIR - Hanchang, He IR - Hanchang H FIR - Huizhen, Ye IR - Huizhen Y FIR - Zhuxing, Sun IR - Zhuxing S FIR - Xiran, Zhang IR - Xiran Z FIR - Weiwei, Shan IR - Weiwei S FIR - Jing, Xue IR - Jing X FIR - Yong, Chen IR - Yong C FIR - Changying, Xing IR - Changying X FIR - Li, Li IR - Li L FIR - Xiangbao, Yu IR - Xiangbao Y FIR - Kang, Liu IR - Kang L FIR - Yifei, Ge IR - Yifei G FIR - Yili, Xu IR - Yili X FIR - Zhimin, Huang IR - Zhimin H FIR - Jingjing, Wu IR - Jingjing W FIR - Bicheng, Liu IR - Bicheng L FIR - Yan, Tu IR - Yan T FIR - Mingming, Pan IR - Mingming P FIR - Hongli, Lin IR - Hongli L FIR - Dapeng, Wang IR - Dapeng W FIR - Qingyang, Meng IR - Qingyang M FIR - Renna, Luo IR - Renna L FIR - Guohua, Ding IR - Guohua D FIR - Ming, Shi IR - Ming S FIR - Changjian, Qiu IR - Changjian Q FIR - Xifeng, Lv IR - Xifeng L FIR - Guojuan, Zhang IR - Guojuan Z FIR - Liping, Jiang IR - Liping J FIR - Ning, Ding IR - Ning D FIR - Huiying, Zhao IR - Huiying Z FIR - Shumin, Bao IR - Shumin B FIR - Wei, Chen IR - Wei C FIR - Shen, Chen IR - Shen C FIR - Qiaojing, Liang IR - Qiaojing L FIR - Mei, Zhang IR - Mei Z FIR - Kanfu, Peng IR - Kanfu P FIR - Pan, Xie IR - Pan X FIR - Qian, Yuan IR - Qian Y FIR - Yan, Zhuo IR - Yan Z FIR - Shaohua, Li IR - Shaohua L FIR - Yonghui, Mao IR - Yonghui M FIR - Ban, Zhao IR - Ban Z FIR - Songlan, Wang IR - Songlan W FIR - Xianguang, Chen IR - Xianguang C FIR - Xiaonong, Chen IR - Xiaonong C FIR - Chenni, Gao IR - Chenni G FIR - Haijin, Yu IR - Haijin Y FIR - Qinjie, Weng IR - Qinjie W FIR - Yuanmeng, Jin IR - Yuanmeng J FIR - Xiaobo, Ma IR - Xiaobo M FIR - Ping, Luo IR - Ping L FIR - Dan, Gao IR - Dan G FIR - Man, Wu IR - Man W FIR - Yonghui, Qi IR - Yonghui Q FIR - Ping, Zhang IR - Ping Z FIR - Xiaoying, Du IR - Xiaoying D FIR - Lihui, Qu IR - Lihui Q FIR - Chunping, Xu IR - Chunping X FIR - Kaixiang, Sheng IR - Kaixiang S FIR - Yi, Yang IR - Yi Y FIR - Song, Wang IR - Song W FIR - Xinkui, Tian IR - Xinkui T FIR - Hongxia, Guo IR - Hongxia G FIR - Wenhan, Bao IR - Wenhan B FIR - Weifeng, Lin IR - Weifeng L FIR - Sijia, Zhou IR - Sijia Z FIR - Zhuan, Cui IR - Zhuan C FIR - Wenling, Yang IR - Wenling Y FIR - Kaijie, Su IR - Kaijie S FIR - Lian, He IR - Lian H FIR - Zhihong, Zhou IR - Zhihong Z FIR - Yu, Zheng IR - Yu Z FIR - Shubei, Zheng IR - Shubei Z FIR - Lingwei, Jin IR - Lingwei J FIR - Yan, Chen IR - Yan C FIR - Min, Pan IR - Min P FIR - Guojuan, Zhang IR - Guojuan Z FIR - Liping, Jiang IR - Liping J FIR - Ning, Ding IR - Ning D FIR - Huiying, Zhao IR - Huiying Z FIR - Shumin, Bao IR - Shumin B FIR - Wei, Chen IR - Wei C FIR - Shen, Chen IR - Shen C FIR - Qiaojing, Liang IR - Qiaojing L FIR - Mei, Zhang IR - Mei Z FIR - Wu, Chia-Chao IR - Wu CC FIR - SungShuei-Liong Lin, Chih-Chien IR - SungShuei-Liong Lin CC FIR - Wu, Ming-Shiou IR - Wu MS FIR - Huang, Jenq-Wen IR - Huang JW FIR - Chiang, Wen Chih IR - Chiang WC FIR - Chiang, Chih-Kang IR - Chiang CK FIR - Yang, Shao-Yu IR - Yang SY FIR - Wu, Vin-Cent IR - Wu VC FIR - Huang, Tao-Min IR - Huang TM FIR - Chen, Yi-Ting IR - Chen YT FIR - Lai, Tai-Shuan IR - Lai TS FIR - Lai, Chun-Fu IR - Lai CF FIR - Tarng, Der-Cherng IR - Tarng DC FIR - Ou, Shuo-Ming IR - Ou SM FIR - Yang, Chih-Yu IR - Yang CY FIR - Tseng, Wei-Cheng IR - Tseng WC FIR - Lin, Yao-Ping IR - Lin YP FIR - Sung, Junne-Ming IR - Sung JM FIR - Kuo, Te-Hui IR - Kuo TH FIR - Chang, Yu-Tzu IR - Chang YT FIR - Wu, An-Bang IR - Wu AB FIR - Lin, Wei-Hung IR - Lin WH FIR - Fang, Hua-Chang IR - Fang HC FIR - Chen, Hsin-Yu IR - Chen HY FIR - Hsu, Chih-Yang IR - Hsu CY FIR - Lee, Po-Tsang IR - Lee PT FIR - Chen, Chien-Liang IR - Chen CL FIR - Chou, Kang-Ju IR - Chou KJ FIR - Ho, Tzung-Yu IR - Ho TY FIR - Lee, Chien-Te IR - Lee CT FIR - Ng, Hwee-Yeong IR - Ng HY FIR - Lee, Yueh-Ting IR - Lee YT FIR - Chiu, Yi-Wen IR - Chiu YW FIR - Kuo, Hung-Tien IR - Kuo HT FIR - Hung, Chi-Chih IR - Hung CC FIR - Kuo, Mei-Chuan IR - Kuo MC FIR - Lee, Jia-Jung IR - Lee JJ FIR - Tsai, Jer-Chia IR - Tsai JC FIR - Chang, Jer-Ming IR - Chang JM FIR - Lee-Moay IR - Lee-Moay FIR - Lim IR - Lim FIR - Hwang, Shang-Jyh IR - Hwang SJ FIR - Hwang, Jyh-Chang IR - Hwang JC FIR - Wang, Hsien-Yi IR - Wang HY FIR - Kan, Wei-Chih IR - Kan WC FIR - Wu, Chia-Chun IR - Wu CC FIR - Jiang, Ming-Yan IR - Jiang MY FIR - Chien, Chih-Chiang IR - Chien CC FIR - Wu, Ming-Ju IR - Wu MJ FIR - Tsai, Shang-Feng IR - Tsai SF FIR - Chen, Cheng-Hsu IR - Chen CH FIR - Chen, Hsi-Hsien IR - Chen HH FIR - Kao, Chih-Chin IR - Kao CC FIR - Lin, Yen-Chung IR - Lin YC FIR - Wu, Yueh-Lin IR - Wu YL FIR - Yeh, Shu-Ching IR - Yeh SC FIR - Mao Chan, Daniel Tak IR - Mao Chan DT FIR - Yee Mok, Maggie Ming IR - Yee Mok MM FIR - Yuen Kwan, Lorraine Pui IR - Yuen Kwan LP FIR - Wang Chan, Gary Chi IR - Wang Chan GC FIR - Kim, Yong-Lim IR - Kim YL FIR - Cho, Jang-Hee IR - Cho JH FIR - Lim, Jeong-Hoon IR - Lim JH FIR - Jung, Hee-Yeon IR - Jung HY FIR - Park, Sun-Hee IR - Park SH FIR - Kim, Chan-Duck IR - Kim CD FIR - Kim, Kyu Yeun IR - Kim KY FIR - Park, Jung Tak IR - Park JT FIR - Yoo, Tae-Hyun IR - Yoo TH FIR - Han, Seung Hyeok IR - Han SH FIR - Chung, Wookyung IR - Chung W FIR - Jung, Ji Yong IR - Jung JY FIR - Lee, Hyun Hee IR - Lee HH FIR - Chang, Jae Hyun IR - Chang JH FIR - Ro, Han IR - Ro H FIR - Kim, Ae Jin IR - Kim AJ FIR - Lee, Jong Soo IR - Lee JS FIR - Park, Jongha IR - Park J FIR - Park, Kyung Sun IR - Park KS FIR - Yoo, Kyoung Don IR - Yoo KD FIR - Chang, Tae Ik IR - Chang TI FIR - Kang, Ea Wha IR - Kang EW FIR - Park, Kyoung Sook IR - Park KS FIR - Jin, Kyubok IR - Jin K FIR - Kim, Yaerim IR - Kim Y FIR - Paek, Jinhyuk IR - Paek J FIR - Park, Wooyeong IR - Park W FIR - Han, Seungyeup IR - Han S FIR - Kwon, Ohyun IR - Kwon O FIR - Park, Sung Bae IR - Park SB FIR - Kim, Myung-Gyu IR - Kim MG FIR - Oh, SeWon IR - Oh S FIR - Lee, Jung Pyo IR - Lee JP FIR - Lee, Jeonghwan IR - Lee J FIR - Jung, Jihoon IR - Jung J FIR - Park, Cheol Whee IR - Park CW FIR - Kim, Hyung Duk IR - Kim HD FIR - Kim, Sunggyun IR - Kim S FIR - Song, Youngrim IR - Song Y FIR - Joo, Narae IR - Joo N FIR - Lee, Hyungsuk IR - Lee H FIR - Choi, Bum-Soon IR - Choi BS FIR - Park, Hoon Suk IR - Park HS FIR - Ban, Tae Hyun IR - Ban TH EDAT- 2023/11/29 18:43 MHDA- 2023/11/29 18:44 PMCR- 2023/08/29 CRDT- 2023/11/29 16:25 PHST- 2023/02/10 00:00 [received] PHST- 2023/08/15 00:00 [revised] PHST- 2023/08/21 00:00 [accepted] PHST- 2023/11/29 18:44 [medline] PHST- 2023/11/29 18:43 [pubmed] PHST- 2023/11/29 16:25 [entrez] PHST- 2023/08/29 00:00 [pmc-release] AID - S2468-0249(23)01471-7 [pii] AID - 10.1016/j.ekir.2023.08.034 [doi] PST - epublish SO - Kidney Int Rep. 2023 Aug 29;8(11):2294-2306. doi: 10.1016/j.ekir.2023.08.034. eCollection 2023 Nov.