Phase III clinical trial comparing the efficacy and safety of adamgammadex with sugammadex for reversal of rocuronium- induced neuromuscular block

作者全名："Zhang, Yujun; Jiang, Yingying; Lei, Qian; Li, Chaoyu; Jin, Shu'an; Wang, Qin; Huang, Yidan; Li, Yalan; Hong, Yi; Wang, Shoushi; Lin, Han; Li, Hong; Ou, Yangwen; Zou, Xiaohua; Sun, Qiang; Guo, Qulian; Chen, Zhigang; Min, Su; Qi, Youmao; Jie, Qing; Liu, Jin; Liu, Bin; Zhang, Wensheng"

作者地址："[Zhang, Yujun; Jiang, Yingying; Liu, Jin; Liu, Bin; Zhang, Wensheng] Sichuan Univ, West China Hosp, Dept Anaesthesiol, Chengdu, Peoples R China; [Zhang, Yujun; Liu, Jin; Zhang, Wensheng] Sichuan Univ, West China Hosp, Natl Local Joint Engn Res Ctr Translat Med Anaesth, Lab Anaesthesia & Crit Care Med, Chengdu, Peoples R China; [Lei, Qian] Univ Elect Sci & Technol China, Sichuan Acad Med Sci & Sichuan Prov Peoples Hosp, Dept Anaesthesiol, Chengdu, Peoples R China; [Li, Chaoyu] Second Peoples Hosp Neijiang, Dept Anaesthesiol, Neijiang, Peoples R China; [Jin, Shu'an; Wang, Qin] Shandong First Med Univ, Cent Hosp, Dept Anaesthesiol, Jinan, Peoples R China; [Huang, Yidan] Liuzhou Peoples Hosp, Dept Anaesthesiol, Liuzhou, Peoples R China; [Li, Yalan] Jinan Univ, Affiliated Hosp 1, Guangzhou Overseas Chinese Hosp, Dept Anaesthesiol, Guangzhou, Peoples R China; [Hong, Yi] Xinjiang Med Univ, Affiliated Hosp 1, Dept Anaesthesiol, Urumqi, Peoples R China; [Wang, Shoushi] Qingdao Cent Hosp Grp, Dept Anaesthesiol, Qingdao, Peoples R China; [Lin, Han] Wenzhou Med Univ, Affiliated Hosp 2, Dept Anaesthesiol, WMU, Wenzhou, Peoples R China; [Li, Hong] Army Med Univ, Affiliated Hosp 2, Dept Anaesthesiol, Chongqing, Peoples R China; [Ou, Yangwen] Cent South Univ, Xiangya Hosp 3, Dept Anaesthesiol, Changsha, Peoples R China; [Zou, Xiaohua] Guizhou Med Univ, Affiliated Hosp, Dept Anaesthesiol, Guiyang, Peoples R China; [Sun, Qiang] Southern Med Univ, Guangdong Prov Peoples Hosp, Guangdong Acad Med Sci, Dept Anaesthesiol, Guangzhou, Peoples R China; [Guo, Qulian; Chen, Zhigang] Cent South Univ, Xiangya Hosp, Dept Anaesthesiol, Changsha, Peoples R China; [Min, Su] Chongqing Med Univ, Affiliated Hosp 1, Dept Anaesthesiol, Chongqing, Peoples R China; [Qi, Youmao; Jie, Qing] Hangzhou Adamerck Pharmlabs Inc, Hangzhou, Peoples R China"

通信作者："Liu, B; Zhang, WS (通讯作者)，Sichuan Univ, West China Hosp, Dept Anaesthesiol, Chengdu, Peoples R China."

来源：BRITISH JOURNAL OF ANAESTHESIA

ESI学科分类：CLINICAL MEDICINE

WOS号：WOS:001165333900001

JCR分区：Q1

影响因子：9.8

年份：2024

卷号：132

期号：1

开始页：45

结束页：52

文献类型：Article

关键词：adamgammadex; adverse drug reaction; neuromuscular blocking agent; pharmacodynamics; reversal; rocuronium; sugammadex

摘要："Background: Preliminary clinical trials of adamgammadex, a new cyclodextrin-based selective reversal agent, have demonstrated its efficacy in reversing neuromuscular block by rocuronium. Methods: This multicentre, randomised, double-blind, positive-controlled, non-inferiority phase III clinical trial compared the efficacy and safety of adamgammadex and sugammadex. We randomised 310 subjects to receive adamgammadex (4 mg kg(-1)) or sugammadex (2 mg kg(-1)) at reappearance of the second twitch of the train-of-four (TOF), and standard safety data were collected. Results: For the primary outcome, the proportion of patients with TOF ratio >= 0.9 within 5 min was 98.7% in the adamgammadex group vs 100% in the sugammadex group, with a point estimate and 95% confidence interval (CI) of 1.3% (-4.6%, +1.3%); the lower limit was greater than the non-inferiority margin of -10%. For the key secondary outcome, the median (inter quartile range) time from the start of administration of adamgammadex or sugammadex to recovery of TOF ratio to 0.9 was 2.25 (1.75, 2.75) min and 1.75 (1.50, 2.00) min, respectively. The difference was 0.50 (95% CI: 0.25, 0.50); the upper limit was lower than the non-inferiority margin of 5 min. In addition, there were no inferior results observed in secondary outcomes. Adamgammadex had a lower incidence of adverse drug reactions compared with sugammadex (anaphylactic reaction, recurarisation, decreased heart rate, and laryngospasm; P=0.047). Conclusions: Adamgammadex was non-inferior to sugammadex with a possible lower incidence of adverse drug reactions compared with sugammadex. Adamgammadex may have a potential advantage in terms of its overall risk-benefit profile."

基金机构："Hangzhou Adamerck Pharmlabs Inc. (Hangzhou, China)"

基金资助正文："Hangzhou Adamerck Pharmlabs Inc. (Hangzhou, China) ."