Expert Opinion on Drug Safety最新文献_第10页

Association of ocular adverse events with varenicline solution use: a population-based study. 使用伐尼克兰溶液与眼部不良事件的关联：一项基于人群的研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2025-02-08 DOI: 10.1080/14740338.2025.2460454

Moiz Lakhani, Angela T H Kwan, Anne Xuan-Lan Nguyen, Marko M Popovic, Roger S McIntyre, Albert Y Wu

{"title":"Association of ocular adverse events with varenicline solution use: a population-based study.","authors":"Moiz Lakhani, Angela T H Kwan, Anne Xuan-Lan Nguyen, Marko M Popovic, Roger S McIntyre, Albert Y Wu","doi":"10.1080/14740338.2025.2460454","DOIUrl":"10.1080/14740338.2025.2460454","url":null,"abstract":"Background: Approved by the FDA in 2021, varenicline solution is the first nasal spray specifically designed to enhance basal tear film production for treating dry eye disease (DED). However, there is a lack of data comprehensively comparing its safety profile to conventional DED therapies. Herein, we assess whether ocular adverse events (AEs) are disproportionately reported with the real-world use of varenicline solution.Research design and methods: This observational, population-based pharmacovigilance study analyzed the Food and Drug Administration Adverse Event Reporting System (FAERS) data (inception-April 2024) using reporting odds ratio (ROR), with significance defined as a 95% CI lower bound > 1.0. Nasal saline and systane were the controls.Results: A total of 1,125 AE reports were associated with varenicline solution. No disproportionate reporting of specific ocular AEs was observed when comparing varenicline solution with nasal saline. However, when compared with systane, varenicline solution showed higher odds of lacrimation (ROR = 2.18, 95%CI = 1.46-3.26, p < 0.0001), visual impairment (ROR = 2.27, 95%CI = 1.24-4.16, p = 0.0085), and photophobia (ROR = 7.50, 95%CI = 3.68-15.27, p < 0.0001).Conclusions: Although a direct causal relationship for higher RORs cannot be established for varenicline solution compared to systane, our findings provide evidence for potential risk signals and highlight the crucial role of post-marketing pharmacovigilance in monitoring long-term safety.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"665-673"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A real-world pharmacovigilance study of FDA adverse event reporting system events for atogepant. 美国食品药物管理局不良事件报告系统对阿托格潘事件的真实世界药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-07-08 DOI: 10.1080/14740338.2024.2377347

Heli Wen, Yitian Ding, Feichi Chen

{"title":"A real-world pharmacovigilance study of FDA adverse event reporting system events for atogepant.","authors":"Heli Wen, Yitian Ding, Feichi Chen","doi":"10.1080/14740338.2024.2377347","DOIUrl":"10.1080/14740338.2024.2377347","url":null,"abstract":"Background: Atogepant, an orally administered, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist, is being investigated for the treatment of migraine.Methods: We collected data from the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Four algorithms (ROR, PRR, BCPNN, and EBGM) were used as measures to detect signals of atogepant-associated adverse events (AEs) in real-world data.Result: Of the 3,552,072 reports, 2876 expressly stated the use of atogepant. Women accounted for the majority of adverse events (AEs), with a notable age concentration of 45-65 years. The percentage of reported adverse events was the highest in the United States. Significant system organ categories (SOC) included nervous system disorders, gastrointestinal disorders, nervous system disorders, surgical and medical procedures, ear and labyrinth disorders. Notably, preferred terms (PTs) related to atogepant include migraine, constipation, nausea, vertigo, somnolence, decreased appetite, dizziness and fatigue. Unexpected adverse events such as abnormal dreams, self-injurious ideation, brain fog, tension headache, nightmare, brain neoplasm, feeling abnormal, euphoric mood, hyperacusis and post concussion syndrome were also identified.Conclusions: The present investigation has detected new and unexpected signals of atogepant-related adverse drug reactions (ADRs). In order to confirm these solve safety issues that were previously overlooked, more research is necessary.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"745-752"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141544673","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Hypercalcemia in children induced by denosumab: a case report and an analysis of the FDA adverse event reporting system database. 地诺单抗诱发的儿童高钙血症：病例报告和美国食品药物管理局不良事件报告系统数据库分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-07-15 DOI: 10.1080/14740338.2024.2379446

Yiyu Chen, Chuxuan Fang, Zhiyong Yang, Guosheng Qiu, Shuangyi Tang

{"title":"Hypercalcemia in children induced by denosumab: a case report and an analysis of the FDA adverse event reporting system database.","authors":"Yiyu Chen, Chuxuan Fang, Zhiyong Yang, Guosheng Qiu, Shuangyi Tang","doi":"10.1080/14740338.2024.2379446","DOIUrl":"10.1080/14740338.2024.2379446","url":null,"abstract":"Background: The potential risks of denosumab on pediatric patients have raised concerns about its safety. This article aims to analyze the adverse effects of denosumab in minors, with a specific focus on hypercalcemia.Research design and methods: A case study involving a child was analyzed. The OpenVigil 2.1 was utilized to extract adverse event data from the FAERS database, focusing on denosumab as the primary suspect drug in pediatric patients. The study also reviewed published cases of children developing hypercalcemia after discontinuing denosumab.Results: The incidence of denosumab induced hypercalcemia in individuals under 18 years old is significantly higher than the overall incidence. The signal value for hypercalcemia was higher in the male group and was highest in the adolescent group. Hypercalcemia usually appeared approximately 4 months after denosumab discontinuation. Males had a higher peak blood calcium level. Patients aged 0-11 years had a higher average peak serum calcium compared to aged 12-17 years.Conclusions: This study highlights the risk of hypercalcemia after discontinuation of denosumab in minors, with young age and male gender identified as potential high-risk factors. These findings offer valuable safety warnings and preventative measures for the secure administration of this drug in pediatric populations.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"719-730"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141616140","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Recommendations for the selection of nucleoside analogues as antihuman herpesvirus drugs: a real-world analysis of reported cases from the FDA adverse event reporting system. 选择核苷类似物作为抗人类疱疹病毒药物的建议：对美国食品药物管理局不良事件报告系统所报告病例的实际分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-07-04 DOI: 10.1080/14740338.2024.2374919

Caixia Gao, Xiaomei Dong, Jun Zhang, Lejiao Mao, Changxin Guo, Xia Qin, Zhen Zou

{"title":"Recommendations for the selection of nucleoside analogues as antihuman herpesvirus drugs: a real-world analysis of reported cases from the FDA adverse event reporting system.","authors":"Caixia Gao, Xiaomei Dong, Jun Zhang, Lejiao Mao, Changxin Guo, Xia Qin, Zhen Zou","doi":"10.1080/14740338.2024.2374919","DOIUrl":"10.1080/14740338.2024.2374919","url":null,"abstract":"Objective: The aim of this study is to provide guidance for refining medication protocols, developing alternative strategies, and enhancing protection against herpesvirus infections in personalized clinical settings.Methods: Adverse drug events (ADEs) data for anti-herpesvirus from the first quarter of 2004 to the fourth quarter of 2022 were collected from the FDA Adverse Event Reporting System (FAERS). Disproportionality analysis was performed using Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Bayesian Confidence Propagation Neural Network (BCPNN) methods for data mining.Results: A total of 18,591, 24,206, 6,150, and 419 reports of ADEs associated with acyclovir (ACV), valacyclovir (VACV), ganciclovir (GCV), and famciclovir (FCV) were screened and extracted from the FAERS. In this study, the report summarized the high frequency and strong correlation of ADEs for the four drugs at the Preferred Term (PT) level. Additionally, the analysis also identified the relationship between ADEs and factors such as age, gender, and severity of outcome at the System Organ Class (SOC) level.Conclusion: The safety reports for the four-nucleoside analogue anti-herpesvirus drugs are diverse and interconnected. Dosing for patients with herpesvirus infections should be tailored to their specific conditions and the potential risk of disease.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"695-709"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141467299","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A pharmacovigilance study on the safety of faricimab in real-world scenario using FDA adverse event reporting system database. 利用FDA不良事件报告系统数据库对法利昔单抗在现实情况下的安全性进行药物警戒研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2025-01-21 DOI: 10.1080/14740338.2025.2456173

Furong Han, Xiang Li, Tao Tao, Jiawei Wang

{"title":"A pharmacovigilance study on the safety of faricimab in real-world scenario using FDA adverse event reporting system database.","authors":"Furong Han, Xiang Li, Tao Tao, Jiawei Wang","doi":"10.1080/14740338.2025.2456173","DOIUrl":"10.1080/14740338.2025.2456173","url":null,"abstract":"Background: Faricimab is predominantly prescribed for conditions such as age-related macular degeneration (AMD), diabetic macular edema (DME), and macular edema related to retinal vein occlusion (RVO-ME). Currently, a notable absence of large-scale, real-world studies focusing on the adverse reactions of faricimab exists.Methods: This study assesses the side effects of faricimab by analyzing reports of adverse events (AEs) from the FDA's AE Reporting System (FAERS) database. Through disproportionality analysis, this study substantiates the drug's safety oversight.Results: Our study revealed 2,746 instances of adverse events linked to faricimab, spanning 21 system organ classes (SOCs). The study retained 121 significant disproportionality preferred terms (PTs) that met criteria across all four analytical methods. Faricimab-associated AEs not documented in the drug instructions included visual impairment, blindness, retinal hemorrhage, anterior chamber inflammation, keratic precipitates, dry eye, chorioretinitis, diabetic retinopathy, and others.Conclusion: The majority of our results align with earlier clinical studies and the details outlined in the product's manual. Additionally, we identified several unforeseen and potential AE signals related to faricimab use. These insights are instrumental for ongoing clinical surveillance and risk assessment associated with the drug.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"657-664"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143002908","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Safety assessment of clomiphene: a real-world pharmacovigilance analysis from the Food and Drug Administration adverse event reporting system. 克罗米芬的安全性评估：来自食品药品管理局不良事件报告系统的真实世界药物警戒分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2024-05-23 DOI: 10.1080/14740338.2024.2358972

Yifeng Shao, Lisha Ma, Jianqing Zhou, Baicai Yang

{"title":"Safety assessment of clomiphene: a real-world pharmacovigilance analysis from the Food and Drug Administration adverse event reporting system.","authors":"Yifeng Shao, Lisha Ma, Jianqing Zhou, Baicai Yang","doi":"10.1080/14740338.2024.2358972","DOIUrl":"10.1080/14740338.2024.2358972","url":null,"abstract":"Background: Clomiphene is widely used for the treatment of anovulatory infertility, yet there remain many unrecognized adverse events (AEs). The objective of this study is to provide a comprehensive overview of the safety profile of clomiphene.Methods: The data were derived from the first quarter of 2004 to the third quarter of 2023 from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. The detection of new AE signals involved the use of four algorithms: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean (EBGM).Results: A total of 16,677,289 AE reports were acquired from the FAERS database, and there were 2,620 AEs specifically reported in 720 patients following clomiphene use. The AEs encompassed 102 preferred terms (PTs) across 24 system organ classes (SOCs). Some new AEs were identified, including conjoined twins (0.5%), Potter's syndrome (0.3%), genitalia external ambiguous (0.3%), esophageal atresia (0.6%), and anal atresia (0.3%).Conclusions: Although the majority of AEs aligned with the drug instruction, some new AE signals such as conjoined twins and genitalia external ambiguous were not captured. Well-designed studies are required to demonstrate the safety of clomiphene.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"759-766"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141075903","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

An update on the safety of biologic therapies for the treatment of polyarticular juvenile idiopathic arthritis. 生物疗法治疗多关节幼年特发性关节炎安全性的最新进展。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-06-01 Epub Date: 2025-02-16 DOI: 10.1080/14740338.2025.2467179

Angela Zimmer, Gerd Horneff

{"title":"An update on the safety of biologic therapies for the treatment of polyarticular juvenile idiopathic arthritis.","authors":"Angela Zimmer, Gerd Horneff","doi":"10.1080/14740338.2025.2467179","DOIUrl":"10.1080/14740338.2025.2467179","url":null,"abstract":"Introduction: An increasing number of patients with polyarticular course juvenile idiopathic arthritis are treated with biologics with great efficacy. Consequently, the importance regarding safety data in general as well as especially serious infections, incident autoimmune processes, or malignancies rises. In children, this is crucial concerning occurrences that manifest rarely and only after a prolonged latency period.Areas covered: This study aims to analyze safety under therapy with the five most commonly used biologicals for the treatment of juvenile idiopathic arthritis in Germany: abatacept, adalimumab, etanercept, golimumab, and tocilizumab, and a control cohort, who received methotrexate. For this, data from the Biologics in Pediatric Rheumatology (BiKeR) Registry were analyzed with a focus on potential adverse drug reactions like serious infections, autoimmune processes or malignancies.Expert opinion: Besides JIA category-specific differences, investigating side effects like severe infections and the development of additional autoimmune processes due to therapy is crucial. Future clinical randomized double-blinded studies are essential for direct drug comparisons, enabling optimal individualized therapy considering comorbidities and individual risks. Large patient data over a (life-)long period beyond childhood are particularly important, especially concerning the risk of malignancy after prolonged latency.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"627-642"},"PeriodicalIF":3.0,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Two first-generation KRAS inhibitor safety profiles: a disproportionality analysis of individual reports from the FDA adverse event reporting system. 两种第一代KRAS抑制剂的安全性概况：来自FDA不良事件报告系统的个别报告的不成比例分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-27 DOI: 10.1080/14740338.2025.2499219

Ying Zhang, Shuhua Tong, Li Wan

{"title":"Two first-generation KRAS inhibitor safety profiles: a disproportionality analysis of individual reports from the FDA adverse event reporting system.","authors":"Ying Zhang, Shuhua Tong, Li Wan","doi":"10.1080/14740338.2025.2499219","DOIUrl":"10.1080/14740338.2025.2499219","url":null,"abstract":"Background: First-generation KRAS inhibitors, sotorasib and adagrasib, are approved for treating non-small cell lung cancer and colorectal cancer with specific KRAS mutations. This study analyzed data from FAERS database to evaluate adverse events (AEs) associated with KRAS inhibitors.Research design and methods: Four disproportionality analysis methods were applied to measure risk signals: reporting odds ratio (ROR), proportional reporting ratio (PRR), bayesian confidence propagation neural network (BCPNN), and multi-item gamma poisson shrinker (MGPS) algorithms.Results: Between Q2 2021 and Q1 2024, 5,580 AEs in 2,958 reports on sotorasib or adagrasib were identified. Most patients were 45 and above, with a median age of 67. After meeting four algorithms' criteria, sotorasib and adagrasib retained 43 and 18 disproportionate priority items (PTs), respectively. Common AEs were diarrhea, hepatotoxicity, and pneumonitis. Unexpected important AEs included pericardial effusion, colitis, and pancreatitis associated with sotorasib; seizure, encephalopathy, unresponsiveness to stimuli and disorientation with adagrasib. Most AEs emerged within the first month of treatment. The median time to onset was 50 days for sotorasib and 21 days for adagrasib.Conclusions: Our research revealed potential new AE signals and provided a comprehensive safety profile of KRAS inhibitors, emphasizing the importance of careful monitoring and supportive care.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143999739","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Unveiling the hidden ocular risks of isotretinoin: a comprehensive FAERS-Based analysis. 揭示异维甲酸隐藏的眼部风险：基于faers的综合分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-23 DOI: 10.1080/14740338.2025.2505530

Tao Tao, Guo Lei Du, Zhi-Jie Zhang, Zhan Yang Luo, Jia-Feng Tang, Xiang Li

{"title":"Unveiling the hidden ocular risks of isotretinoin: a comprehensive FAERS-Based analysis.","authors":"Tao Tao, Guo Lei Du, Zhi-Jie Zhang, Zhan Yang Luo, Jia-Feng Tang, Xiang Li","doi":"10.1080/14740338.2025.2505530","DOIUrl":"10.1080/14740338.2025.2505530","url":null,"abstract":"Objective: While extensive research has been conducted on isotretinoin's systemic side effects, studies focusing on its ocular side effects remain limited and often lack substantial sample sizes. To address this gap, we conducted a comprehensive investigation of isotretinoin-related ocular toxicity using data from the FAERS spanning 2004 to 2024.Methods: After excluding duplicate and incomplete records from the FAERS database, we identified 760 eye-related adverse event reports from a total of 45,258 isotretinoin-related entries. We employed the Reporting Odds Ratio (ROR) method to assess the risk of ocular problems. Additionally, we examined the onset timing of eye toxicity.Results: Among the 760 reports analyzed, dry eye emerged as the most frequently reported condition (n = 222), although it did not exhibit the strongest association. The ROR was observed for night blindness (ROR = 35.8, 95% CI = 29.66-43.21), indicating a significant risk. This finding underscores the need to focus on isotretinoin's impact on the retina and fundus, especially since night blindness and vision loss can manifest as early as the first day of treatment.Conclusion: These findings prompt new recommendations for safety monitoring by clinicians. However, additional clinical and fundamental research is essential to substantiate these observations and further elucidate the effects of isotretinoin on ocular health.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-9"},"PeriodicalIF":3.0,"publicationDate":"2025-05-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144086058","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Thromboembolic and bleeding events associated with angiogenesis inhibitors in cancer patients. 癌症患者血管生成抑制剂与血栓栓塞和出血事件相关。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-05-21 DOI: 10.1080/14740338.2025.2494688

Zhuo Ma, Yi Zhang, Dan Sun, Min Zhu, Jiawen Yi, Yixiao Zhang, Zhuoling An, Yuhui Zhang

{"title":"Thromboembolic and bleeding events associated with angiogenesis inhibitors in cancer patients.","authors":"Zhuo Ma, Yi Zhang, Dan Sun, Min Zhu, Jiawen Yi, Yixiao Zhang, Zhuoling An, Yuhui Zhang","doi":"10.1080/14740338.2025.2494688","DOIUrl":"10.1080/14740338.2025.2494688","url":null,"abstract":"Background: Angiogenesis inhibitors are associated with increased risk of thromboembolic events (TEEs) and hemorrhagic events. However, their clinical features are not well characterized in real-world studies.Research design and methods: First, we conducted a pharmacovigilance study to investigate characteristics of TEEs and bleeding and compare vascular endothelial growth factor and its receptor inhibitors (VEGF/VEGFRIs) with other antiangiogenic agents. Second, we performed a retrospective analysis of lung cancer patients who received bevacizumab or anlotinib to assess the incidence of VEGF/VEGFRI-associated TEEs and bleeding.Results: In the pharmacovigilance study, both VEGF/VEGFR-targeted biologics and VEGFR-tyrosine kinase inhibitors were associated with higher reporting of arterial thromboembolism (ATE) (reporting odd ratio (ROR) 2.91; ROR 1.25; respectively), and bleeding (ROR 2.56; ROR 2.35; respectively). Venous thromboembolism (VTE) was only associated with VEGF/VEGFR-targeted biologics (ROR 3.11). In the cohort study, bevacizumab, aflibercept, and ramucirumab showed the strongest associations with VTE, ATE, and bleeding, respectively. In the cohort study of 261 lung cancer patients treated with bevacizumab or anlotinib, 42.9% were older than 65 years, 62.1% were male, with TEEs occurred in 11.5%, and bleeding in 8.8%.Conclusions: All VEGF/VEGFRIs were associated with increased ATE and bleeding risk. VEGF/VEGFR-targeted biologics also significantly raise the risk of VTE.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-05-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143990012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0