Comparison of the prophylactic antithrombotic effect of indobufen and warfarin in patients with nephrotic syndrome: a randomized controlled trial
Xin-Yi Gao,
Yue-Ming Liu,
Dan-Na Zheng,
Yi-Wen Li,
Hua Li,
Xiao-Ling Xiong,
Hong-Yu Chen,
Hua Wang,
Xiao-Yong Yu,
Kai Qu,
Juan Jin,
Bo Lin,
Qiang He
Affiliations
Xin-Yi Gao
Urology & Nephrology Center, Department of Nephrology, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou Medical College, Hangzhou, China
Yue-Ming Liu
Urology & Nephrology Center, Department of Nephrology, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou Medical College, Hangzhou, China
Dan-Na Zheng
Urology & Nephrology Center, Department of Nephrology, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou Medical College, Hangzhou, China
Yi-Wen Li
Urology & Nephrology Center, Department of Nephrology, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou Medical College, Hangzhou, China
Hua Li
Department of Nephrology, Sir Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China
Xiao-Ling Xiong
Department of Nephrology, Sir Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, China
Hong-Yu Chen
Department of Nephrology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, China
Hua Wang
Department of Nephrology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, China
Xiao-Yong Yu
Department of Nephrology, Shaanxi Traditional Chinese Medicine Hospital, Xi’an, China
Kai Qu
Department of Nephrology, Shaanxi Traditional Chinese Medicine Hospital, Xi’an, China
Juan Jin
Urology & Nephrology Center, Department of Nephrology, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou Medical College, Hangzhou, China
Bo Lin
Urology & Nephrology Center, Department of Nephrology, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou Medical College, Hangzhou, China
Qiang He
Department of Nephrology, First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine), Hangzhou, China
Purpose 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.Materials and methods 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.Results 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 < .05). Finally, adverse events were more frequent in warfarin-treated patients.Conclusions This study found that indobufen therapy provided equivalent effects in preventing thromboembolic events compared with warfarin therapy, while low dose of indobufen was associated with a reduced risk of bleeding events, thus it should be recommended for the prevention of thromboembolic events in clinical practice in patients with nephrotic syndrome.Trial registration number ChiCTR-IPR-17013428.
