Comparison of the prophylactic antithrombotic effect of indobufen and warfarin in patients with nephrotic syndrome: a randomized controlled trial
AbstractPurpose 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 n...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Taylor & Francis Group
2023-12-01
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| Series: | Renal Failure |
| Subjects: | |
| Online Access: | https://www.tandfonline.com/doi/10.1080/0886022X.2022.2163505 |
| _version_ | 1797658443574673408 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Xin-Yi Gao |
| collection | DOAJ |
| description | AbstractPurpose 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. |
| first_indexed | 2024-03-11T18:00:10Z |
| format | Article |
| id | doaj.art-8c035c059f20453b8596492ad422c427 |
| institution | Directory Open Access Journal |
| issn | 0886-022X 1525-6049 |
| language | English |
| last_indexed | 2024-03-11T18:00:10Z |
| publishDate | 2023-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Renal Failure |
| spelling | doaj.art-8c035c059f20453b8596492ad422c4272023-10-17T09:23:24ZengTaylor & Francis GroupRenal Failure0886-022X1525-60492023-12-0145110.1080/0886022X.2022.2163505Comparison of the prophylactic antithrombotic effect of indobufen and warfarin in patients with nephrotic syndrome: a randomized controlled trialXin-Yi Gao0Yue-Ming Liu1Dan-Na Zheng2Yi-Wen Li3Hua Li4Xiao-Ling Xiong5Hong-Yu Chen6Hua Wang7Xiao-Yong Yu8Kai Qu9Juan Jin10Bo Lin11Qiang He12Urology & Nephrology Center, Department of Nephrology, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou Medical College, Hangzhou, ChinaUrology & Nephrology Center, Department of Nephrology, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou Medical College, Hangzhou, ChinaUrology & Nephrology Center, Department of Nephrology, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou Medical College, Hangzhou, ChinaUrology & Nephrology Center, Department of Nephrology, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou Medical College, Hangzhou, ChinaDepartment of Nephrology, Sir Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, ChinaDepartment of Nephrology, Sir Run Shaw Hospital, Zhejiang University School of Medicine, Hangzhou, ChinaDepartment of Nephrology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, ChinaDepartment of Nephrology, Hangzhou Hospital of Traditional Chinese Medicine, Hangzhou, ChinaDepartment of Nephrology, Shaanxi Traditional Chinese Medicine Hospital, Xi’an, ChinaDepartment of Nephrology, Shaanxi Traditional Chinese Medicine Hospital, Xi’an, ChinaUrology & Nephrology Center, Department of Nephrology, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou Medical College, Hangzhou, ChinaUrology & Nephrology Center, Department of Nephrology, Zhejiang Provincial People’s Hospital, Affiliated People’s Hospital, Hangzhou Medical College, Hangzhou, ChinaDepartment of Nephrology, First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine), Hangzhou, ChinaAbstractPurpose 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.https://www.tandfonline.com/doi/10.1080/0886022X.2022.2163505Antithrombotic effectindobufenwarfarinnephrotic syndromerandomized controlled trial |
| spellingShingle | 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 Comparison of the prophylactic antithrombotic effect of indobufen and warfarin in patients with nephrotic syndrome: a randomized controlled trial Renal Failure Antithrombotic effect indobufen warfarin nephrotic syndrome randomized controlled trial |
| title | Comparison of the prophylactic antithrombotic effect of indobufen and warfarin in patients with nephrotic syndrome: a randomized controlled trial |
| title_full | Comparison of the prophylactic antithrombotic effect of indobufen and warfarin in patients with nephrotic syndrome: a randomized controlled trial |
| title_fullStr | Comparison of the prophylactic antithrombotic effect of indobufen and warfarin in patients with nephrotic syndrome: a randomized controlled trial |
| title_full_unstemmed | Comparison of the prophylactic antithrombotic effect of indobufen and warfarin in patients with nephrotic syndrome: a randomized controlled trial |
| title_short | Comparison of the prophylactic antithrombotic effect of indobufen and warfarin in patients with nephrotic syndrome: a randomized controlled trial |
| title_sort | comparison of the prophylactic antithrombotic effect of indobufen and warfarin in patients with nephrotic syndrome a randomized controlled trial |
| topic | Antithrombotic effect indobufen warfarin nephrotic syndrome randomized controlled trial |
| url | https://www.tandfonline.com/doi/10.1080/0886022X.2022.2163505 |
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