Pub Date : 2024-10-01Epub Date: 2024-07-19DOI: 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.
{"title":"Assessment of adverse events of the novel cardiovascular drug vericiguat: a real-world pharmacovigilance study based on FAERS.","authors":"Jin Rao, Xiangyu Chen, Yudi Liu, Xuefu Wang, Pengchao Cheng, Zhinong Wang","doi":"10.1080/14740338.2024.2382226","DOIUrl":"10.1080/14740338.2024.2382226","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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).</p><p><strong>Results: </strong>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 (<i>n</i> = 86, ROR 25.92, PRR 24.11, IC 4.59, EBGM 24.07), followed by dizziness (<i>n</i> = 52, ROR 6.44, PRR 6.20, IC 2.63, EBGM 6.20), malaise (<i>n</i> = 25, ROR 3.59, PRR 3.54, IC 1.82, EBGM 3.54), blood pressure decreased (<i>n</i> = 23, ROR 20.00, PRR 19.64, IC 4.29, EBGM 19.61), and anemia (<i>n</i> = 21, ROR 6.67, PRR 6.57, IC 2.72, EBGM 6.57).</p><p><strong>Conclusions: </strong>This study extended the adverse reactions documented in the FDA instruction and provided supplementary evidence regarding the clinical safety of vericiguat.</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":"141633104","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}
Pub Date : 2024-10-01Epub Date: 2024-07-22DOI: 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.
{"title":"Safety assessment of sildenafil use in neonates: a real-world data analysis based on the FDA adverse event reporting system (FAERS).","authors":"Bo Wang, Jia Zhang, Rui Cheng","doi":"10.1080/14740338.2024.2383710","DOIUrl":"10.1080/14740338.2024.2383710","url":null,"abstract":"<p><strong>Background: </strong>The safety of neonatal sildenafil use remains uncertain. This study aimed to investigate adverse events (AEs) associated with sildenafil use in neonates.</p><p><strong>Research design and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</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":"141747801","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}
Pub Date : 2024-10-01Epub Date: 2024-09-16DOI: 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.
{"title":"Identifying factors influencing clinicians' reporting of medication errors: a systematic review and qualitative evidence synthesis using the theoretical domains framework.","authors":"Neda J Takhtinejad, Derek Stewart, Zachariah Nazar, Anas Hamad, Muhammad A Hadi","doi":"10.1080/14740338.2024.2396397","DOIUrl":"10.1080/14740338.2024.2396397","url":null,"abstract":"<p><strong>Introduction: </strong>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.</p><p><strong>Areas covered: </strong>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).</p><p><strong>Expert opinion: </strong>The review analyzed fourteen high-quality studies across various regions. Facilitators of reporting were identified in the TDF domains of <i>beliefs about consequences knowledge</i> and <i>social/professional role and identity</i>. More themes emerged as barriers, mapped to the domains of <i>beliefs about consequences</i>, <i>emotions</i>, <i>environmental context and resources</i> and <i>knowledge</i>. 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.</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":"142079766","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}
Pub Date : 2024-10-01Epub Date: 2024-09-12DOI: 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.
{"title":"Treatment-emergent Candida infections in patients with psoriasis, psoriatic arthritis, and axial spondyloarthritis treated with ixekizumab: an integrated safety analysis of 25 clinical studies.","authors":"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","doi":"10.1080/14740338.2024.2399092","DOIUrl":"10.1080/14740338.2024.2399092","url":null,"abstract":"<p><strong>Background: </strong>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).</p><p><strong>Research design and methods: </strong>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.</p><p><strong>Results: </strong>Candida infections had an IR of 1.9 per 100 PY in patients with PsO (<i>N</i> = 6892; total PY = 18025.7), 2.0 per 100 PY in patients with PsA (<i>N</i> = 1401; total PY = 2247.7), and 1.2 per 100 PY in patients with axSpA (<i>N</i> = 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.</p><p><strong>Conclusions: </strong>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.</p><p><strong>Trial registration: </strong>A comprehensive list of the clinical trials and their registration numbers is reported in Table S1 of the supplemental material.</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":"142132265","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}
Pub Date : 2024-10-01Epub Date: 2024-08-27DOI: 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}
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.
{"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}
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.
{"title":"Reassessment of pioglitazone and bladder cancer based on FAERS database.","authors":"Hai-Yan Chen, Hui Zhao, Jun-Jie Yang, Qian Zhang, Ming-Ming Yan, Xiao-Yan Qiu","doi":"10.1080/14740338.2024.2390000","DOIUrl":"https://doi.org/10.1080/14740338.2024.2390000","url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Research design and methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":null,"pages":null},"PeriodicalIF":3.0,"publicationDate":"2024-09-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282662","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}
Pub Date : 2024-09-19DOI: 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...
{"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}
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.
{"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}
Pub Date : 2024-09-18DOI: 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.
{"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}