Lusutrombopag for thrombocytopenia in Chinese patients with chronic liver disease undergoing invasive procedures
Year: 2022
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Purpose Probing efficacy and safety of lusutrombopag in Chinese chronic liver disease (CLD) and severe thrombocytopenia (PLT < 50 × 109/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 × 109/L that increased to ≥ 20 × 109/L from the baseline and not received rescue therapy for bleeding) on Day 8 (the day after seven-day treatment) were assessed. PLT ≥ 50 × 109/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 × 109/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.
Source: Hepatology International
Authors: Zhenbin Ding, Hong Wu, Yongyi Zeng, Ming Kuang, Wei Yang, Zhiqiang Meng, Yajin Chen, Chunyi Hao, Shubing Zou, Huichuan Sun, Chang Liu, Kecan Lin, Guoming Shi, Xiaoying Wang, Xiutao Fu, Rongxin Chen, Yi Chen, Ruifang Liang, Takeshi Kano, Huiyan Pan, Suna Yang, Jia Fan, Jian Zhou
Institutions: Fudan University, Zhongshan Hospital, West China Hospital of Sichuan University, Fujian Medical University, Mengchao Hepatobiliary Hospital, The First Affiliated Hospital, Sun Yat-sen University, First Affiliated Hospital of Xi'an Jiaotong University, Fudan University Shanghai Cancer Center, Sun Yat-sen University, Sun Yat-sen Memorial Hospital, Peking University Cancer Hospital, Second Affiliated Hospital of Nanchang University, Shionogi (Japan)
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,190
Funder: Shionogi
OpenAlex ID: W4306745303