Abstract：
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.
BACKGROUND: Chinese Clinical Trial Registry, ChiCTR2000039525. Registered October 30, 2020. https://www.chictr.org.cn/showproj.html?proj=56825.
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.
BACKGROUND: Chinese Clinical Trial Registry, ChiCTR2000039525. Registered October 30, 2020. https://www.chictr.org.cn/showproj.html?proj=56825.
摘要：
背景：adamgammadex的初步临床试验，一种新型的基于环糊精的选择性逆转剂，已证明其在逆转罗库溴铵神经肌肉阻滞中的功效。
方法：这个多中心，随机化，双盲,阳性对照,非劣效性III期临床试验比较了adamgammadex和sugammadex的疗效和安全性。我们随机分配了310名受试者，以在四人组（TOF）的第二次抽搐出现时接受adamgammadex（4mgkg-1）或sugammadex（2mgkg-1），并收集标准安全性数据.
结果：对于主要结果，在adamgammadex组中，5分钟内TOF比率≥0.9的患者比例为98.7％，在sugammadex组中为100％，点估计和95%置信区间(CI)为1.3%(-4.6%，+1.3%）；下限大于-10%的非劣效性边缘。对于关键的次要结果，从开始服用adamgammadex或sugammadex到TOF比率恢复到0.9的中位数（四分位数间）时间为2.25（1.75，2.75）min和1.75（1.50，2.00）min，分别。差异为0.50（95％CI：0.25，0.50）；上限低于5分钟的非劣效性边缘。此外,在次要结局中未观察到较差的结果.与sugammadex相比，Adamgammadex的药物不良反应发生率较低（过敏反应，递归，心率下降,和喉痉挛；P=0.047）。
结论：Adamgammadex不劣于sugammadex，与sugammadex相比，药物不良反应的发生率可能更低。Adamgammadex在其整体风险收益方面可能具有潜在优势。
背景：中国临床试验注册中心，ChiCTR2000039525。2020年10月30日注册。https://www.chictr.org.cn/showproj.html?proj=56825。
方法：这个多中心，随机化，双盲,阳性对照,非劣效性III期临床试验比较了adamgammadex和sugammadex的疗效和安全性。我们随机分配了310名受试者，以在四人组（TOF）的第二次抽搐出现时接受adamgammadex（4mgkg-1）或sugammadex（2mgkg-1），并收集标准安全性数据.
结果：对于主要结果，在adamgammadex组中，5分钟内TOF比率≥0.9的患者比例为98.7％，在sugammadex组中为100％，点估计和95%置信区间(CI)为1.3%(-4.6%，+1.3%）；下限大于-10%的非劣效性边缘。对于关键的次要结果，从开始服用adamgammadex或sugammadex到TOF比率恢复到0.9的中位数（四分位数间）时间为2.25（1.75，2.75）min和1.75（1.50，2.00）min，分别。差异为0.50（95％CI：0.25，0.50）；上限低于5分钟的非劣效性边缘。此外,在次要结局中未观察到较差的结果.与sugammadex相比，Adamgammadex的药物不良反应发生率较低（过敏反应，递归，心率下降,和喉痉挛；P=0.047）。
结论：Adamgammadex不劣于sugammadex，与sugammadex相比，药物不良反应的发生率可能更低。Adamgammadex在其整体风险收益方面可能具有潜在优势。
背景：中国临床试验注册中心，ChiCTR2000039525。2020年10月30日注册。https://www.chictr.org.cn/showproj.html?proj=56825。
