Risk of angioedema and thrombolytic therapy among stroke patients: An analysis of data from the FDA Adverse Event Reporting System database
The angioedema risk may vary among stroke patients receiving different thrombolytic agents. This study aimed to investigate the angioedema risk associated with different thrombolytic agents and to identify associated risk factors. We conducted a large-scale retrospective pharmacovigilance study usin...
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Elsevier
2025-01-01
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| Series: | Neurotherapeutics |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1878747924001612 |
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| author | Hunong Xiang Yu Ma Xiaochao Luo Jian Guo Minghong Yao Yanmei Liu Ke Deng Xin Sun Ling Li |
| author_facet | Hunong Xiang Yu Ma Xiaochao Luo Jian Guo Minghong Yao Yanmei Liu Ke Deng Xin Sun Ling Li |
| author_sort | Hunong Xiang |
| collection | DOAJ |
| description | The angioedema risk may vary among stroke patients receiving different thrombolytic agents. This study aimed to investigate the angioedema risk associated with different thrombolytic agents and to identify associated risk factors. We conducted a large-scale retrospective pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database. Stroke patients receiving thrombolytic therapy (i.e., alteplase or tenecteplase) were identified, and the associations with angioedema were explored using disproportionality analysis and time-to-onset analysis. Additionally, we used adapted Bradford Hill criteria to confirm these associations. Risk factors for angioedema were explored using stepwise logistic regression. A total of 17,776 stroke patients were included, with 2973 receiving alteplase and 278 receiving tenecteplase. Disproportionality analysis revealed that angioedema might be associated with alteplase (adjusted ROR [aROR] 5.13 [95 % CI, 4.55–5.79]) or tenecteplase (aROR 2.72 [95 % CI, 1.98–3.67]). The adapted Bradford Hill criteria suggested a probable causal relationship between alteplase and angioedema, whereas there was insufficient evidence of a probable causal relationship with tenecteplase. Multivariate analysis revealed that ACE-inhibitors use (aROR 9.73 [95 % CI, 7.29–12.98]), female sex (aROR 1.38 [95 % CI, 1.13–1.67]) and hypertension (aROR 2.11 [95 % CI, 1.52–2.92]) were significant risk factors for angioedema among alteplase-treated stroke patients. Our study suggested that alteplase is associated with a greater risk of angioedema among stroke patients, but there is insufficient evidence to support an association between tenecteplase and angioedema. Clinicians should be vigilant for this potentially life-threatening complication, particularly in patients with identified risk factors. It is also prudent to consider tenecteplase as an alternative, if available. |
| format | Article |
| id | doaj-art-777eb63e1a67455ab1b0caad92ee74f8 |
| institution | Kabale University |
| issn | 1878-7479 |
| language | English |
| publishDate | 2025-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Neurotherapeutics |
| spelling | doaj-art-777eb63e1a67455ab1b0caad92ee74f82025-02-01T04:11:51ZengElsevierNeurotherapeutics1878-74792025-01-01221e00474Risk of angioedema and thrombolytic therapy among stroke patients: An analysis of data from the FDA Adverse Event Reporting System databaseHunong Xiang0Yu Ma1Xiaochao Luo2Jian Guo3Minghong Yao4Yanmei Liu5Ke Deng6Xin Sun7Ling Li8Department of Neurology and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China; NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, 610041, China; Sichuan Center of Technology Innovation for Real World Data, Chengdu, 610041, ChinaDepartment of Neurology and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China; NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, 610041, China; Sichuan Center of Technology Innovation for Real World Data, Chengdu, 610041, ChinaDepartment of Neurology and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China; NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, 610041, China; Sichuan Center of Technology Innovation for Real World Data, Chengdu, 610041, ChinaDepartment of Neurology, West China Hospital, Sichuan University, Chengdu, 610041, ChinaDepartment of Neurology and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China; NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, 610041, China; Sichuan Center of Technology Innovation for Real World Data, Chengdu, 610041, ChinaDepartment of Neurology and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China; NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, 610041, China; Sichuan Center of Technology Innovation for Real World Data, Chengdu, 610041, ChinaDepartment of Neurology and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China; NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, 610041, China; Sichuan Center of Technology Innovation for Real World Data, Chengdu, 610041, ChinaDepartment of Neurology and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China; NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, 610041, China; Sichuan Center of Technology Innovation for Real World Data, Chengdu, 610041, China; Corresponding authors.Department of Neurology and Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu, 610041, China; NMPA Key Laboratory for Real World Data Research and Evaluation in Hainan, Chengdu, 610041, China; Sichuan Center of Technology Innovation for Real World Data, Chengdu, 610041, China; Corresponding authors.The angioedema risk may vary among stroke patients receiving different thrombolytic agents. This study aimed to investigate the angioedema risk associated with different thrombolytic agents and to identify associated risk factors. We conducted a large-scale retrospective pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) database. Stroke patients receiving thrombolytic therapy (i.e., alteplase or tenecteplase) were identified, and the associations with angioedema were explored using disproportionality analysis and time-to-onset analysis. Additionally, we used adapted Bradford Hill criteria to confirm these associations. Risk factors for angioedema were explored using stepwise logistic regression. A total of 17,776 stroke patients were included, with 2973 receiving alteplase and 278 receiving tenecteplase. Disproportionality analysis revealed that angioedema might be associated with alteplase (adjusted ROR [aROR] 5.13 [95 % CI, 4.55–5.79]) or tenecteplase (aROR 2.72 [95 % CI, 1.98–3.67]). The adapted Bradford Hill criteria suggested a probable causal relationship between alteplase and angioedema, whereas there was insufficient evidence of a probable causal relationship with tenecteplase. Multivariate analysis revealed that ACE-inhibitors use (aROR 9.73 [95 % CI, 7.29–12.98]), female sex (aROR 1.38 [95 % CI, 1.13–1.67]) and hypertension (aROR 2.11 [95 % CI, 1.52–2.92]) were significant risk factors for angioedema among alteplase-treated stroke patients. Our study suggested that alteplase is associated with a greater risk of angioedema among stroke patients, but there is insufficient evidence to support an association between tenecteplase and angioedema. Clinicians should be vigilant for this potentially life-threatening complication, particularly in patients with identified risk factors. It is also prudent to consider tenecteplase as an alternative, if available.http://www.sciencedirect.com/science/article/pii/S1878747924001612AlteplaseTenecteplaseAngioedemaFAERS |
| spellingShingle | Hunong Xiang Yu Ma Xiaochao Luo Jian Guo Minghong Yao Yanmei Liu Ke Deng Xin Sun Ling Li Risk of angioedema and thrombolytic therapy among stroke patients: An analysis of data from the FDA Adverse Event Reporting System database Neurotherapeutics Alteplase Tenecteplase Angioedema FAERS |
| title | Risk of angioedema and thrombolytic therapy among stroke patients: An analysis of data from the FDA Adverse Event Reporting System database |
| title_full | Risk of angioedema and thrombolytic therapy among stroke patients: An analysis of data from the FDA Adverse Event Reporting System database |
| title_fullStr | Risk of angioedema and thrombolytic therapy among stroke patients: An analysis of data from the FDA Adverse Event Reporting System database |
| title_full_unstemmed | Risk of angioedema and thrombolytic therapy among stroke patients: An analysis of data from the FDA Adverse Event Reporting System database |
| title_short | Risk of angioedema and thrombolytic therapy among stroke patients: An analysis of data from the FDA Adverse Event Reporting System database |
| title_sort | risk of angioedema and thrombolytic therapy among stroke patients an analysis of data from the fda adverse event reporting system database |
| topic | Alteplase Tenecteplase Angioedema FAERS |
| url | http://www.sciencedirect.com/science/article/pii/S1878747924001612 |
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