Comparison of the prophylactic antithrombotic effect of indobufen and warfarin in patients with nephrotic syndrome: a randomized controlled trial

The risk of thromboembolic events is elevated in patients with nephrotic syndrome, and warfarin use has been associated with an increased risk of bleeding. Indobufen, a selective cyclooxygenase-1 inhibitor, is currently being evaluated for the prevention of thromboembolic events in nephrotic syndrom...

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Published in:Renal failure 2023-12, Vol.45 (1), p.2163505
Main Authors: Gao, Xin-Yi, Liu, Yue-Ming, Zheng, Dan-Na, Li, Yi-Wen, Li, Hua, Xiong, Xiao-Ling, Chen, Hong-Yu, Wang, Hua, Yu, Xiao-Yong, Qu, Kai, Jin, Juan, Lin, Bo, He, Qiang
Format: Article
Language:English
Subjects:
Adult
Adverse events
Anticoagulants
Antithrombotic effect
Atrial Fibrillation
Bleeding
Clinical Study
Cyclooxygenase-1
Fibrinolytic Agents - therapeutic use
Hemorrhage - chemically induced
Hemorrhage - complications
Humans
indobufen
Nephrotic syndrome
Nephrotic Syndrome - chemically induced
Nephrotic Syndrome - complications
Nephrotic Syndrome - drug therapy
randomized controlled trial
Thromboembolism
Thromboembolism - chemically induced
Thromboembolism - prevention & control
Treatment Outcome
Warfarin
Warfarin - adverse effects
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Summary:The risk of thromboembolic events is elevated in patients with nephrotic syndrome, and warfarin use has been associated with an increased risk of bleeding. Indobufen, a selective cyclooxygenase-1 inhibitor, is currently being evaluated for the prevention of thromboembolic events in nephrotic syndrome. This study aimed to compare the efficacy and safety of indobufen with that of warfarin in patients with nephrotic syndrome. This multicenter, randomized, three-arm, open-label, parallel controlled trial involved a total of 180 adult patients with nephrotic syndrome from four centers in China. Patients were randomly assigned to receive 100 mg indobufen (bid), 200 mg indobufen (bid), and 3 mg warfarin (qd) daily for 12 weeks. The primary endpoints included thromboembolic and bleeding events, while laboratory results and adverse events constituted secondary endpoints. No thromboembolic events occurred in the high-/low-dose indobufen and warfarin groups. Moreover, the use of a low dose of indobufen significantly reduced the risk of minor bleeding events compared with warfarin use (2% versus 18%, p 
ISSN:0886-022X
1525-6049
1525-6049
DOI:10.1080/0886022X.2022.2163505