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Assessment of adverse events of the novel cardiovascular drug vericiguat: a real-world pharmacovigilance study based on FAERS. 新型心血管药物 vericiguat 的不良事件评估:基于 FAERS 的真实世界药物警戒研究。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-07-19 DOI: 10.1080/14740338.2024.2382226
Jin Rao, Xiangyu Chen, Yudi Liu, Xuefu Wang, Pengchao Cheng, Zhinong Wang

Background: This study aims to analyze the adverse event reports (AERs) to vericiguat using data from the Food and Drug Administration Adverse Event Reporting System (FAERS) and provide evidence for the clinical use.

Methods: AERs due to vericiguat from 2021Q1 to 2024Q1 identified as the primary suspect were screened, with duplicate reports subsequently eliminated. Various quantitative signal detection methods, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network, and multi-item gamma poisson shrinker, were then employed for data mining and analysis. Signal strength is represented by the 95% confidence interval, information component (IC), and empirical Bayesian geometric mean (EBGM).

Results: A total of 617 vericiguat-related AERs were identified. Strong signals were observed in 21 system organ classes. Furthermore, the most frequently reported preferred terms (PT) was hypotension (n = 86, ROR 25.92, PRR 24.11, IC 4.59, EBGM 24.07), followed by dizziness (n = 52, ROR 6.44, PRR 6.20, IC 2.63, EBGM 6.20), malaise (n = 25, ROR 3.59, PRR 3.54, IC 1.82, EBGM 3.54), blood pressure decreased (n = 23, ROR 20.00, PRR 19.64, IC 4.29, EBGM 19.61), and anemia (n = 21, ROR 6.67, PRR 6.57, IC 2.72, EBGM 6.57).

Conclusions: This study extended the adverse reactions documented in the FDA instruction and provided supplementary evidence regarding the clinical safety of vericiguat.

研究背景本研究旨在利用美国食品和药物管理局不良事件报告系统(FAERS)的数据分析韦立克(vericiguat)的不良事件报告(AERs),并为临床应用提供证据:筛选了2021Q1至2024Q1期间被确定为主要疑似药物的韦立克AER,随后剔除了重复报告。然后采用各种定量信号检测方法,包括报告几率比(ROR)、比例报告比(PRR)、贝叶斯置信度传播神经网络和多项目伽马泊松收缩器,进行数据挖掘和分析。信号强度用 95% 置信区间、信息成分(IC)和经验贝叶斯几何平均数(EBGM)表示:结果:共发现了 617 个与 vericiguat 相关的 AER。在 21 个系统器官类别中观察到强烈信号。此外,最常报告的首选术语(PT)是低血压(n = 86,ROR 25.92,PRR 24.11,IC 4.59,EBGM 24.07),其次是头晕(n = 52,ROR 6.44,PRR 6.20,IC 2.63,EBGM 6.20)、乏力(n = 25,ROR 3.59,PRR 3.54,IC 1.82,EBGM 3.54)、血压下降(n = 23,ROR 20.00,PRR 19.64,IC 4.29,EBGM 19.61)和贫血(n = 21,ROR 6.67,PRR 6.57,IC 2.72,EBGM 6.57):本研究扩展了 FDA 说明书中记录的不良反应,为 vericiguat 的临床安全性提供了补充证据。
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引用次数: 0
Safety assessment of sildenafil use in neonates: a real-world data analysis based on the FDA adverse event reporting system (FAERS). 新生儿使用西地那非的安全性评估:基于 FDA 不良事件报告系统 (FAERS) 的真实世界数据分析。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-07-22 DOI: 10.1080/14740338.2024.2383710
Bo Wang, Jia Zhang, Rui Cheng

Background: The safety of neonatal sildenafil use remains uncertain. This study aimed to investigate adverse events (AEs) associated with sildenafil use in neonates.

Research design and methods: We collected data on AEs associated with sildenafil use in neonates from the US Food and Drug Administration Adverse Event Reporting System database, spanning from its inception of the database in 2004 to 2023. Disproportionality measures were employed to analyze the correlation between AEs and sildenafil.

Results: Sildenafil was identified as the primary suspect drug in 75 AE reports, involving 214 AEs. Three system organ classes, namely, eye disorders, hepatobiliary disorders, and vascular disorders were associated with sildenafil use. Six preferred terms, namely, flushing, retinopathy of prematurity, hyperbilirubinemia, pulmonary hemorrhage, hypotension, and diarrhea were associated with sildenafil use. Notably, hyperbilirubinemia and pulmonary hemorrhage were previously unreported AEs associated with sildenafil use.

Conclusion: The results highlight the ongoing uncertainty surrounding the safety of neonatal sildenafil use and provide vital support for risk monitoring and identification in neonates receiving sildenafil. Additionally, the study underscores the need for continuous safety surveillance in neonates treated with sildenafil and suggests further exploration of the precise causal relationships between AEs and sildenafil.

背景:新生儿使用西地那非的安全性仍不确定。本研究旨在调查与新生儿使用西地那非相关的不良事件(AEs):我们从美国食品和药物管理局不良事件报告系统数据库中收集了与新生儿使用西地那非相关的AEs数据,时间跨度为2004年数据库建立之初至2023年。结果显示,西地那非被确定为导致新生儿AE的主要药物:在75例AE报告中,西地那非被确定为主要可疑药物,涉及214例AE。三个系统器官类别,即眼部疾病、肝胆疾病和血管疾病与使用西地那非有关。六个首选术语,即潮红、早产儿视网膜病变、高胆红素血症、肺出血、低血压和腹泻与使用西地那非有关。值得注意的是,高胆红素血症和肺出血是以前未报告过的与使用西地那非有关的AE:研究结果凸显了新生儿使用西地那非安全性的不确定性,为新生儿使用西地那非的风险监测和识别提供了重要支持。此外,该研究还强调了对接受西地那非治疗的新生儿进行持续安全监测的必要性,并建议进一步探讨AE与西地那非之间的确切因果关系。
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引用次数: 0
Identifying factors influencing clinicians' reporting of medication errors: a systematic review and qualitative evidence synthesis using the theoretical domains framework. 确定影响临床医生报告用药错误的因素:利用理论领域框架进行系统回顾和定性证据综述。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-09-16 DOI: 10.1080/14740338.2024.2396397
Neda J Takhtinejad, Derek Stewart, Zachariah Nazar, Anas Hamad, Muhammad A Hadi

Introduction: Medication errors have a significant impact on patient safety and professional practice. The widespread under-reporting of errors by clinicians indicates the critical need for behavioral change. This systematic review aimed to identify and synthesize qualitative evidence on factors influencing clinicians' reporting of medication errors.

Areas covered: Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus, PubMed, and Embase were searched until March 2023 for studies on factors influencing clinicians' reporting of medication errors. Two independent reviewers conducted the screening, data extraction, and quality appraisal. Using framework synthesis approach, the identified themes were mapped to Theoretical Domains Framework (TDF).

Expert opinion: The review analyzed fourteen high-quality studies across various regions. Facilitators of reporting were identified in the TDF domains of beliefs about consequences knowledge and social/professional role and identity. More themes emerged as barriers, mapped to the domains of beliefs about consequences, emotions, environmental context and resources and knowledge. The review suggests aligning these barriers with key behavior change techniques, such as emphasizing the risks of non-reporting, promoting emotional well-being, improving accessibility of reporting systems and advancing knowledge through educational programs. Future work should focus on developing these behavior change techniques into practical interventions.

引言用药错误对患者安全和专业实践有着重大影响。临床医生对用药错误的报告率普遍偏低,这表明亟需改变用药行为。本系统性综述旨在确定和综合有关影响临床医生报告用药错误的因素的定性证据:截至 2023 年 3 月,我们检索了《护理与专职医疗文献累积索引》(CINAHL)、Scopus、PubMed 和 Embase,以查找有关影响临床医生报告用药错误的因素的研究。由两名独立审稿人进行筛选、数据提取和质量评估。采用框架综合法,将确定的主题映射到理论领域框架(TDF):综述分析了不同地区的 14 项高质量研究。在关于后果知识的信念和社会/专业角色与身份的 TDF 领域中确定了报告的促进因素。更多的主题是作为障碍出现的,与后果信念、情感、环境背景以及资源和知识等领域相对应。综述建议将这些障碍与关键的行为改变技术相结合,如强调不报告的风险、促进情绪健康、提高报告系统的可及性以及通过教育计划增进知识。未来的工作重点应是将这些行为改变技巧发展成实用的干预措施。
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引用次数: 0
Treatment-emergent Candida infections in patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis treated with ixekizumab: an integrated safety analysis of 25 clinical studies. 接受伊克珠单抗治疗的银屑病、银屑病关节炎和轴性脊柱关节炎患者治疗中出现的念珠菌感染:25 项临床研究的综合安全性分析。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-09-12 DOI: 10.1080/14740338.2024.2399092
Sergio Schwartzman, Luis Puig, Arnon D Cohen, Saakshi Khattri, Christian Jossart, Carlos Diaz, Alyssa Garrelts, Marcus Ngantcha, Nadezhda Eberhart, Areti Eleftheriadi, Nithi Tangsirisap, Christopher Schuster, Alice B Gottlieb

Background: This safety analysis investigates treatment-emergent mucosal/cutaneous Candida infections in patients treated with ixekizumab (IXE), an anti-interleukin-17A monoclonal antibody, across the approved indications: psoriasis (PsO), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA).

Research design and methods: Safety data were pooled from 25 clinical studies. Incidence rates (IRs) are expressed as per 100 patient-years (PY), using the entire duration of exposure.

Results: Candida infections had an IR of 1.9 per 100 PY in patients with PsO (N = 6892; total PY = 18025.7), 2.0 per 100 PY in patients with PsA (N = 1401; total PY = 2247.7), and 1.2 per 100 PY in patients with axSpA (N = 932; total PY = 2097.7). The majority of treatment-emergent Candida infections were: (i) experienced only once by patients (IR = 1.3;IR = 1.6;IR = 1.0), (ii) mild/moderate in severity (IR = 0.8/0.9;IR = 1.5/0.4;IR = 0.8/0.5) as opposed to severe (IR = 0.0; IR = 0.0; IR = 0.0), (iii) oral Candida or genital Candida (IR = 0.9/0.6;IR = 1.0/0.7;IR = 0.4/0.6), (iv) marked as recovered/resolved during the studies (89.3%;93.8%;90.3%), (v) not leading to IXE discontinuation (0.0%;0.0%;0.1% discontinued), (vi) managed with topical (34.7%;22.2%;11.5%) or no anti-fungal medications (63.5%;77.8%;80.8%) as opposed to systemic therapies (1.5%;0.0%;7.7%), (vii) typically resolved before next visit.

Conclusions: This integrated safety analysis shows that the risk of developing Candida infections is low with IXE, and the severity is mild-to-moderate in most instances across the approved IXE indications.

Trial registration: A comprehensive list of the clinical trials and their registration numbers is reported in Table S1 of the supplemental material.

背景:本安全性分析调查了接受抗白细胞介素-17A单克隆抗体ixekizumab (IXE)治疗的患者在治疗过程中出现的皮肤粘膜念珠菌感染情况,该药物适用于已获批准的适应症:银屑病(PsO)、银屑病关节炎(PsA)和轴性脊柱关节炎(axSpA):汇集了 25 项临床研究的安全性数据。发病率(IRs)以每 100 个患者年(PY)为单位,使用整个暴露持续时间来表示:念珠菌感染在PsO患者(N = 6892;总PY = 18025.7)中的IR为每100例患者年1.9例,在PsA患者(N = 1401;总PY = 2247.7)中的IR为每100例患者年2.0例,在axSpA患者(N = 932;总PY = 2097.7)中的IR为每100例患者年1.2例。大多数治疗引起的念珠菌感染是(i) 患者仅发生过一次(IR = 1.3;IR = 1.6;IR = 1.0),(ii) 轻度/中度(IR = 0.8/0.9;IR = 1.5/0.4;IR = 0.8/0.5),而非重度(IR = 0.0;IR = 0.0;IR = 0.0),(iii) 口腔念珠菌或生殖器念珠菌(IR = 0.9/0.6;IR = 1.0/0.7;IR = 0.4/0.6),(iv) 标记为 "念珠菌感染"(IR = 1.3;IR = 1.6;IR = 1.0/0.6),(v) 标记为 "念珠菌感染"(IR = 1.3;IR = 1.6)。6),(iv) 在研究期间被标记为痊愈/解决(89.3%;93.8%;90.3%),(v) 未导致 IXE 停用(0.0%;0.0%;0.1%停用),(vi) 通过局部治疗(34.7%;22.2%;11.5%)或不使用抗真菌药物(63.5%;77.8%;80.8%),而不是使用全身疗法(1.5%;0.0%;7.7%);(vii) 通常在下次就诊前得到解决:综合安全性分析表明,使用 IXE 感染念珠菌的风险较低,在大多数情况下,IXE 获批适应症的严重程度为轻度至中度:临床试验及其注册号的完整列表见补充材料表 S1。
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引用次数: 0
Corticosteroids for the treatment of Duchenne muscular dystrophy: a safety review. 皮质类固醇治疗杜兴氏肌肉萎缩症:安全性审查。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-10-01 Epub Date: 2024-08-27 DOI: 10.1080/14740338.2024.2394578
Eszter Czifrus, Daniel J Berlau

Introduction: Duchenne muscular dystrophy (DMD) is an X-linked genetic disorder characterized by progressive muscle degeneration and weakness, caused by mutations in the dystrophin gene. DMD has effects in early age with significantly shortened lifespan and deteriorated quality of life in the second decade, creating an urgent need to develop better therapeutic options. Corticosteroid medication therapy is an integral tool for the management of DMD and several therapeutic options have been recently approved for use.

Areas covered: A comprehensive literature search was completed to examine efficacy and safety profiles of the three corticosteroid medications available for use in DMD patients. The review presents information about the three agents through clinical trials, significant preclinical trials, and comparative studies.

Expert opinion: Managing DMD takes a multidisciplinary approach, although long-term corticosteroid therapy remains a significant therapeutic tool. Based on the available published studies, unequivocal comparison between the benefits of the three medications cannot yet be made. When selecting a medication for a patient, the decision-making process will most likely rely on the minor differences in the adverse effect profiles. Whichever medication is utilized will surely be a part of a larger regimen that includes other novel therapeutic agents.

简介杜兴氏肌营养不良症(DMD)是一种 X 连锁遗传疾病,由肌营养不良蛋白基因突变引起,以进行性肌肉退化和无力为特征。DMD 发病年龄较早,患者寿命明显缩短,后十年生活质量下降,因此迫切需要开发更好的治疗方案。皮质类固醇药物治疗是治疗 DMD 不可或缺的工具,最近有几种治疗方案已被批准使用:我们完成了一项全面的文献检索,研究了可用于 DMD 患者的三种皮质类固醇药物的疗效和安全性。本综述通过临床试验、重要的临床前试验和比较研究介绍了这三种药物的相关信息:专家观点:尽管长期皮质类固醇治疗仍是一种重要的治疗手段,但治疗 DMD 需要采用多学科方法。根据已发表的研究结果,目前还无法对三种药物的疗效进行明确比较。在为患者选择药物时,决策过程很可能取决于不良反应方面的细微差别。无论使用哪种药物,都将是包括其他新型治疗药物在内的更大治疗方案的一部分。
{"title":"Corticosteroids for the treatment of Duchenne muscular dystrophy: a safety review.","authors":"Eszter Czifrus, Daniel J Berlau","doi":"10.1080/14740338.2024.2394578","DOIUrl":"10.1080/14740338.2024.2394578","url":null,"abstract":"<p><strong>Introduction: </strong>Duchenne muscular dystrophy (DMD) is an X-linked genetic disorder characterized by progressive muscle degeneration and weakness, caused by mutations in the dystrophin gene. DMD has effects in early age with significantly shortened lifespan and deteriorated quality of life in the second decade, creating an urgent need to develop better therapeutic options. Corticosteroid medication therapy is an integral tool for the management of DMD and several therapeutic options have been recently approved for use.</p><p><strong>Areas covered: </strong>A comprehensive literature search was completed to examine efficacy and safety profiles of the three corticosteroid medications available for use in DMD patients. The review presents information about the three agents through clinical trials, significant preclinical trials, and comparative studies.</p><p><strong>Expert opinion: </strong>Managing DMD takes a multidisciplinary approach, although long-term corticosteroid therapy remains a significant therapeutic tool. Based on the available published studies, unequivocal comparison between the benefits of the three medications cannot yet be made. When selecting a medication for a patient, the decision-making process will most likely rely on the minor differences in the adverse effect profiles. Whichever medication is utilized will surely be a part of a larger regimen that includes other novel therapeutic agents.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141995622","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
Mining of adverse event signals associated with inclisiran: a post-marketing analysis based on FAERS. 挖掘与 inclisiran 相关的不良事件信号:基于 FAERS 的上市后分析。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-30 DOI: 10.1080/14740338.2024.2409707
Xuezhong Shi, Ying Qiao, Yongli Yang, Nana Wang, Yi Zhang, Shangxin Shi, Guibin Shen, Xiaocan Jia

Background: This study analyzed adverse events (AEs) associated with inclisiran using the FDA's Adverse Event Reporting System (FAERS) to detect and characterize relevant safety signals.

Methods: We retrospectively extracted AE reports from the FAERS database spanning Q1 2022 to Q2 2024. Four disproportionality analysis algorithms were employed to identify AE signals for inclisiran, with subsequent comparisons made to PCSK9 monoclonal antibodies (alirocumab/evolocumab). Additionally, we examined the characteristics and onset timing of inclisiran-related AE.

Results: A total of 4,122 reports of inclisiran as the 'primary suspected'. Compared with all other drugs, the most significant system organ class (SOC) was 'musculoskeletal and connective tissue disorders' (ROR = 3.64, PRR = 3.19) and the most common SOC was 'general disorders and administration site conditions' (n = 2,769). These two SOCs were more strongly with inclisiran than evolocumab. At the preferred term level, strong signals were detected for cellulitis gangrenous (ROR = 101.29, PRR = 101.27, IC = 6.54, EBGM = 92.91) and bladder discomfort (ROR = 12.61, PRR = 12.61, IC = 3.64, EBGM = 12.48). The median onset time for inclisiran-related AEs was 43 days (interquartile range: 7-99 days).

Conclusions: This study enhanced our understanding of AEs to inclisiran. Future research on its long-term real-world use will offer insights into its safety.

背景:本研究利用美国食品药品管理局不良事件报告系统(FAERS)分析了与替吉瑞林相关的不良事件(AEs):本研究利用 FDA 的不良事件报告系统 (FAERS),分析了与 inclisiran 相关的不良事件 (AEs),以检测和描述相关的安全性信号:我们回顾性地从 FAERS 数据库中提取了 2022 年第一季度至 2024 年第二季度的 AE 报告。我们采用了四种比例失调分析算法来识别 inclisiran 的 AE 信号,随后与 PCSK9 单克隆抗体(alirocumab/evolocumab)进行比较。此外,我们还研究了与 inclisiran 相关的 AE 的特征和发病时间:共有 4122 份报告称 inclisiran 为 "主要疑似药物"。与所有其他药物相比,最重要的系统器官分类(SOC)是 "肌肉骨骼和结缔组织疾病"(ROR = 3.64,PRR = 3.19),最常见的系统器官分类是 "一般疾病和用药部位状况"(n = 2,769)。这两个 SOC 与 inclisiran 的关系比 evolocumab 更密切。在首选术语层面,检测到坏疽性蜂窝组织炎(ROR = 101.29,PRR = 101.27,IC = 6.54,EBGM = 92.91)和膀胱不适(ROR = 12.61,PRR = 12.61,IC = 3.64,EBGM = 12.48)的强烈信号。普利西兰相关AE的中位发病时间为43天(四分位间范围:7-99天):这项研究加深了我们对 inclisiran 相关不良反应的了解。结论:这项研究加深了我们对 inclisiran AEs 的了解,未来对其长期实际应用的研究将有助于深入了解其安全性。
{"title":"Mining of adverse event signals associated with inclisiran: a post-marketing analysis based on FAERS.","authors":"Xuezhong Shi, Ying Qiao, Yongli Yang, Nana Wang, Yi Zhang, Shangxin Shi, Guibin Shen, Xiaocan Jia","doi":"10.1080/14740338.2024.2409707","DOIUrl":"https://doi.org/10.1080/14740338.2024.2409707","url":null,"abstract":"<p><strong>Background: </strong>This study analyzed adverse events (AEs) associated with inclisiran using the FDA's Adverse Event Reporting System (FAERS) to detect and characterize relevant safety signals.</p><p><strong>Methods: </strong>We retrospectively extracted AE reports from the FAERS database spanning Q1 2022 to Q2 2024. Four disproportionality analysis algorithms were employed to identify AE signals for inclisiran, with subsequent comparisons made to PCSK9 monoclonal antibodies (alirocumab/evolocumab). Additionally, we examined the characteristics and onset timing of inclisiran-related AE.</p><p><strong>Results: </strong>A total of 4,122 reports of inclisiran as the 'primary suspected'. Compared with all other drugs, the most significant system organ class (SOC) was 'musculoskeletal and connective tissue disorders' (ROR = 3.64, PRR = 3.19) and the most common SOC was 'general disorders and administration site conditions' (n = 2,769). These two SOCs were more strongly with inclisiran than evolocumab. At the preferred term level, strong signals were detected for cellulitis gangrenous (ROR = 101.29, PRR = 101.27, IC = 6.54, EBGM = 92.91) and bladder discomfort (ROR = 12.61, PRR = 12.61, IC = 3.64, EBGM = 12.48). The median onset time for inclisiran-related AEs was 43 days (interquartile range: 7-99 days).</p><p><strong>Conclusions: </strong>This study enhanced our understanding of AEs to inclisiran. Future research on its long-term real-world use will offer insights into its safety.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142344393","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
Reassessment of pioglitazone and bladder cancer based on FAERS database. 基于 FAERS 数据库对吡格列酮与膀胱癌的重新评估。
IF 3 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-20 DOI: 10.1080/14740338.2024.2390000
Hai-Yan Chen, Hui Zhao, Jun-Jie Yang, Qian Zhang, Ming-Ming Yan, Xiao-Yan Qiu

Background: The association between pioglitazone (PLZ) and bladder cancer (BC) remains controversial in several randomized control trials, meta-analyses of multiple prospective studies, and large-scale observational studies.

Research design and methods: Adverse event (AE) data from 1 January 2004 to 31 March 2024 were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Disproportionality analysis were applied to quantify the signals of PLZ related BC.

Results: In total, 17,627,524 AE reports were recorded in the FAERS database, of which 1366 were PLZ-related BCs. More male than female patients were reported. The median age of patients was 70 years old. The peak in the annual report occurred in 2011. A total of 602 AEs reported time to onset (TTO) and the median TTO was 1023 days. In this study, BC and BC recurrence were strong signal, whereas BC stage 0 (with cancer in situ), stage ii and iii were weak signals.

Conclusions: This study comprehensively demostrated the PLZ-induced risk of BC in patients with diabetes mellitus using the FAERS database. The results demonstrated that the patients treated with PLZ were more likely to develop BC. The male and aging attributed more cases to BC-related reports of PLZ treated patients.

背景:在多项随机对照试验、多项前瞻性研究的荟萃分析以及大规模观察性研究中,吡格列酮与膀胱癌(BC)之间的关系仍存在争议:从美国食品和药物管理局不良事件报告系统(FAERS)数据库中提取了2004年1月1日至2024年3月31日期间的不良事件(AE)数据。应用比例失调分析量化与PLZ相关的BC信号:结果:FAERS数据库共记录了17,627,524份AE报告,其中1366份是与PLZ相关的BC。男性患者多于女性患者。患者的中位年龄为70岁。年度报告的高峰期出现在 2011 年。共有 602 例 AE 报告了发病时间(TTO),中位 TTO 为 1023 天。在这项研究中,乳腺癌和乳腺癌复发是强信号,而乳腺癌0期(原位癌)、Ⅱ期和Ⅲ期是弱信号:本研究利用FAERS数据库全面展示了PLZ诱发糖尿病患者BC的风险。结果表明,接受PLZ治疗的患者更容易罹患乳腺癌。接受PLZ治疗的患者中,与BC相关的病例报告中,男性和老年占多数。
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引用次数: 0
Safety analysis of fluoroquinolone drugs in elderly patients over 65 based on FAERS 根据 FAERS 对 65 岁以上老年患者使用氟喹诺酮类药物的安全性分析
IF 3.1 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-19 DOI: 10.1080/14740338.2024.2392862
Yanwei Li, Li Chen, Xiting Tang, Lan Luo, Chengliang Wang
This study investigates adverse drug event (ADE) reports from the FAERS related to FQs drugs in patients aged 65 and older. The findings aim to guide the rational clinical use of these drugs in eld...
本研究调查了 FAERS 中有关 65 岁及以上患者服用 FQs 药物的药物不良事件 (ADE) 报告。研究结果旨在指导老年患者在临床上合理使用这些药物。
{"title":"Safety analysis of fluoroquinolone drugs in elderly patients over 65 based on FAERS","authors":"Yanwei Li, Li Chen, Xiting Tang, Lan Luo, Chengliang Wang","doi":"10.1080/14740338.2024.2392862","DOIUrl":"https://doi.org/10.1080/14740338.2024.2392862","url":null,"abstract":"This study investigates adverse drug event (ADE) reports from the FAERS related to FQs drugs in patients aged 65 and older. The findings aim to guide the rational clinical use of these drugs in eld...","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142249017","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
From common to unreported: a real-world study of adverse events to duloxetine in the treatment of osteoarthritis. 从常见到未报告:关于度洛西汀治疗骨关节炎不良事件的真实世界研究。
IF 3.1 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-18 DOI: 10.1080/14740338.2024.2393470
Jingkai Di,Likun Qi,Lujia Liu,Xinglong Xing,Yaru Liu,Chuan Xiang
BACKGROUNDIn a review of drug guidelines published by the International Association for the Study of Osteoarthritis, it is recommended to support the conditional use of duloxetine in patients with osteoarthritis. However, there is a lack of comprehensive research on the adverse events of duloxetine for the treatment of osteoarthritis populations.RESEARCH DESIGN AND METHODSWe used the reporting odds ratio (ROR) to determine the strength of the adverse event signal. In addition, we investigated trends in the occurrence of adverse events using the Weibull shape parameter (WSP) test.RESULTSThe results showed that 50 and 14 adverse events were detected in both Asian and American populations. Four new adverse events, Mouth ulceration, femoral neck fracture, incontinence, long QT syndrome, were identified. There was a difference in the time of adverse event induction between the North American and Asian populations (p < 0.0001). The Weibull shape parameter (WSP) test showed that the incidence of AE decreased over time.CONCLUSIONOur study contributes to an in-depth understanding of the safety of duloxetine in the treatment of osteoarthritis.
背景在国际骨关节炎研究协会发布的药物指南回顾中,建议支持骨关节炎患者有条件地使用度洛西汀。然而,目前还缺乏关于度洛西汀治疗骨关节炎人群不良事件的全面研究。研究设计与方法我们使用报告几率比(ROR)来确定不良事件信号的强度。结果表明,在亚洲和美国人群中分别发现了 50 例和 14 例不良事件。发现了四种新的不良事件,即口腔溃疡、股骨颈骨折、大小便失禁和长 QT 综合征。北美和亚洲人群发生不良事件的时间存在差异(P < 0.0001)。我们的研究有助于深入了解度洛西汀治疗骨关节炎的安全性。
{"title":"From common to unreported: a real-world study of adverse events to duloxetine in the treatment of osteoarthritis.","authors":"Jingkai Di,Likun Qi,Lujia Liu,Xinglong Xing,Yaru Liu,Chuan Xiang","doi":"10.1080/14740338.2024.2393470","DOIUrl":"https://doi.org/10.1080/14740338.2024.2393470","url":null,"abstract":"BACKGROUNDIn a review of drug guidelines published by the International Association for the Study of Osteoarthritis, it is recommended to support the conditional use of duloxetine in patients with osteoarthritis. However, there is a lack of comprehensive research on the adverse events of duloxetine for the treatment of osteoarthritis populations.RESEARCH DESIGN AND METHODSWe used the reporting odds ratio (ROR) to determine the strength of the adverse event signal. In addition, we investigated trends in the occurrence of adverse events using the Weibull shape parameter (WSP) test.RESULTSThe results showed that 50 and 14 adverse events were detected in both Asian and American populations. Four new adverse events, Mouth ulceration, femoral neck fracture, incontinence, long QT syndrome, were identified. There was a difference in the time of adverse event induction between the North American and Asian populations (p < 0.0001). The Weibull shape parameter (WSP) test showed that the incidence of AE decreased over time.CONCLUSIONOur study contributes to an in-depth understanding of the safety of duloxetine in the treatment of osteoarthritis.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142248907","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
Drugs causing prostate-specific antigen changes: the food and drug administration adverse event reporting system combined with Mendelian randomization analysis. 导致前列腺特异性抗原变化的药物:食品药品管理局不良事件报告系统与孟德尔随机分析相结合。
IF 3.1 3区 医学 Q2 PHARMACOLOGY & PHARMACY Pub Date : 2024-09-18 DOI: 10.1080/14740338.2024.2405577
Wei Zhang,Xin Jiang,Zhisheng Jia,Hua Tian,Renjie Wang,Yuepeng Ma,Zhifang Ma,Xin Wang,Caoyang Hu
BACKGROUNDProstate cancer is one of the most common malignancies in men worldwide, and prostate-specific antigen (PSA) screening is widely used for its early detection. Drug use may affect PSA levels, but the effect for most drugs is currently unknown.METHODSThis study first investigated drugs related to PSA changes through the Food and Drug Administration Adverse Event Reporting System (FAERs) database, and then used a Mendelian randomization (MR) method to explore the causal relationship between specific drugs and PSA changes using a genome-wide association study (GWAS) data. The statistical analysis software SAS and R were used in the study.RESULTSThrough analysis of the FAERs database, 22 drugs were found to be associated with an increase in PSA, and 14 drugs were associated with a decrease in PSA. MR analysis showed that the use of tamsulosin may lead to an increase in PSA. Heterogeneity test, horizontal pleiotropy test and leave-one-out Analysis verified the stability of the results. MR analyses for other drugs did not show statistical significance.CONCLUSIONThis study provided a basis for better understanding the impact of medications on prostate health, helping to avoid overdiagnosis or underdiagnosis of high-risk patients. However, research still requires larger-scale validation and in-depth exploration.
背景前列腺癌是全球男性最常见的恶性肿瘤之一,前列腺特异性抗原(PSA)筛查被广泛用于早期检测。本研究首先通过食品药品管理局不良事件报告系统(FAERs)数据库调查了与PSA变化有关的药物,然后使用孟德尔随机化(MR)方法,利用全基因组关联研究(GWAS)数据探讨了特定药物与PSA变化之间的因果关系。结果通过分析 FAERs 数据库,发现 22 种药物与 PSA 升高有关,14 种药物与 PSA 降低有关。MR分析表明,使用坦索罗辛可能会导致PSA升高。异质性检验、水平多向性检验和leave-one-out分析验证了结果的稳定性。结论这项研究为更好地了解药物对前列腺健康的影响提供了依据,有助于避免对高危患者的过度诊断或诊断不足。然而,研究仍需要更大规模的验证和深入探索。
{"title":"Drugs causing prostate-specific antigen changes: the food and drug administration adverse event reporting system combined with Mendelian randomization analysis.","authors":"Wei Zhang,Xin Jiang,Zhisheng Jia,Hua Tian,Renjie Wang,Yuepeng Ma,Zhifang Ma,Xin Wang,Caoyang Hu","doi":"10.1080/14740338.2024.2405577","DOIUrl":"https://doi.org/10.1080/14740338.2024.2405577","url":null,"abstract":"BACKGROUNDProstate cancer is one of the most common malignancies in men worldwide, and prostate-specific antigen (PSA) screening is widely used for its early detection. Drug use may affect PSA levels, but the effect for most drugs is currently unknown.METHODSThis study first investigated drugs related to PSA changes through the Food and Drug Administration Adverse Event Reporting System (FAERs) database, and then used a Mendelian randomization (MR) method to explore the causal relationship between specific drugs and PSA changes using a genome-wide association study (GWAS) data. The statistical analysis software SAS and R were used in the study.RESULTSThrough analysis of the FAERs database, 22 drugs were found to be associated with an increase in PSA, and 14 drugs were associated with a decrease in PSA. MR analysis showed that the use of tamsulosin may lead to an increase in PSA. Heterogeneity test, horizontal pleiotropy test and leave-one-out Analysis verified the stability of the results. MR analyses for other drugs did not show statistical significance.CONCLUSIONThis study provided a basis for better understanding the impact of medications on prostate health, helping to avoid overdiagnosis or underdiagnosis of high-risk patients. However, research still requires larger-scale validation and in-depth exploration.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.1,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142249019","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
期刊
Expert Opinion on Drug Safety
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