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Lusutrombopag for thrombocytopenia in Chinese patients with chronic liver disease undergoing invasive procedures

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机构: [1]Fudan Univ, Zhongshan Hosp, Liver Canc Inst, Dept Liver Surg & Transplantat, Shanghai 200032, Peoples R China [2]Sichuan Univ, West China Hosp, Dept Liver Surg & Liver Transplantat, Chengdu 610041, Sichuan, Peoples R China [3]Fujian Med Univ, Mengchao Hepatobiliary Hosp, United Innovat Mengchao Hepatobiliary Technol Key, Fuzhou 350025, Fujian, Peoples R China [4]Sun Yat Sen Univ, Affiliated Hosp 1, Dept Liver Surg, Guangzhou 510080, Guangdong, Peoples R China [5]Xi An Jiao Tong Univ, Affiliated Hosp 1, Dept Hepatobiliary Surg, Xian 710061, Shanxi, Peoples R China [6]Fudan Univ, Minimally Invas Therapy Ctr, Shanghai Canc Ctr, Shanghai 200032, Peoples R China [7]Sun Yat Sen Univ, Sun Yat Sen Mem Hosp, Dept Hepatobiliary Surg, Guangzhou 510120, Guangdong, Peoples R China [8]Beijing Canc Hosp, Dept Hepatobiliary Surg, Beijing 100142, Peoples R China [9]Nanchang Univ, Affiliated Hosp 2, Dept Hepatobiliary Surg, Nanchang 330006, Jiangxi, Peoples R China [10]Fudan Univ, Zhongshan Hosp, Liver Canc Inst, Shanghai 200032, Peoples R China [11]Eddingpharm Co Ltd, Unit 122-129,Bldg A3,700 Wanrong Rd, Shanghai, Peoples R China [12]Shion & Co Ltd, Chuou Ku, 3-13,Imabashi 3 Chome, Osaka 5410042, Japan [13]Fudan Univ, Minist Educ, Key Lab Carcinogenesis & Canc Invas, Shanghai 200032, Peoples R China
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关键词: Thrombopoietin receptor agonist Clinical study Platelet Thrombosis Hemorrhage Placebo Cirrhosis Hepatitis B Dose-stopping Platelet transfusion

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Purpose Probing efficacy and safety of lusutrombopag in Chinese chronic liver disease (CLD) and severe thrombocytopenia (PLT < 50 x 10(9)/L) patients undergoing elective invasive procedures. Methods In this double-blind, parallel-group phase 3 study, 66 patients with CLD and severe thrombocytopenia were randomized 2:1 to lusutrombopag or placebo arm treatment regimens for seven days at 9 centers in China. Responders (PLT >= 50 x 10(9)/L that increased to >= 20 x 10(9)/L from the baseline and not received rescue therapy for bleeding) on Day 8 (the day after seven-day treatment) were assessed. PLT >= 50 x 10(9)/L on or after Day 8 and within 2 days before invasive procedure (alternative criteria for not requiring platelet transfusion) were also analyzed. Adverse events (AEs) were recorded. Results The proportion of responders on Day 8 was evidently higher (p = 0.0011) in the lusutrombopag group (43.2%, 19/44) versus placebo (4.5%, 1/22). And 72.7% (32/44) patients receiving lusutrombopag met the alternative criteria for not requiring platelet transfusion, while 18.2% (4/22) in the placebo group. The median maximum PLT in lusutrombopag group increased to 80.5 x 10(9)/L, and median time to reach maximum was 14.5 days. Compared with placebo, the lusutrombopag group had a lower incidence of bleeding events (6.8% versus 13.6%), and only one patient had thrombotic-related AE. Overall, the incidence of treatment-emergent AEs was comparable between two groups. Conclusions Lusutrombopag was effective in raising PLT, diminishing platelet transfusion requirement, and documented a safety profile like the placebo in CLD and severe thrombocytopenia patients in a Chinese cohort undergoing elective invasive procedures. Chinese clinical trial registration number: CTR20192384.

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大类 | 2 区 医学
小类 | 3 区 胃肠肝病学
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大类 | 2 区 医学
小类 | 3 区 胃肠肝病学
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Q1 GASTROENTEROLOGY & HEPATOLOGY
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Q1 GASTROENTEROLOGY & HEPATOLOGY

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第一作者机构: [1]Fudan Univ, Zhongshan Hosp, Liver Canc Inst, Dept Liver Surg & Transplantat, Shanghai 200032, Peoples R China
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通讯机构: [1]Fudan Univ, Zhongshan Hosp, Liver Canc Inst, Dept Liver Surg & Transplantat, Shanghai 200032, Peoples R China [13]Fudan Univ, Minist Educ, Key Lab Carcinogenesis & Canc Invas, Shanghai 200032, Peoples R China
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