Expert Opinion on Drug Safety最新文献

Hepatic adverse events associated with anaplastic lymphoma kinase tyrosine kinase inhibitors: a disproportionality analysis based on FAERS database and analysis of drug-gene interaction network.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-18 DOI: 10.1080/14740338.2025.2467830

Yan Huo, Minghua Ma, Weiwei Tian, Fang Wang, Xiaolan Liao

{"title":"Hepatic adverse events associated with anaplastic lymphoma kinase tyrosine kinase inhibitors: a disproportionality analysis based on FAERS database and analysis of drug-gene interaction network.","authors":"Yan Huo, Minghua Ma, Weiwei Tian, Fang Wang, Xiaolan Liao","doi":"10.1080/14740338.2025.2467830","DOIUrl":"10.1080/14740338.2025.2467830","url":null,"abstract":"Background: Anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitors (TKIs) are vital for treating ALK-positive cancers but have been associated with liver injury, necessitating further safety investigation. This study examines hepatic adverse event (AE) signals related to ALK TKIs using the U.S. FDA Adverse Event Reporting System (FAERS) and explores potential mechanisms of liver injury.Research design and methods: AE reports from FAERS (Q3 2011 to Q1 2024) related to liver injury were analyzed using the reporting odds ratio (ROR) and multi-item gamma Poisson shrinker (MGPS) methods. Pathway enrichment and drug-gene network analyses were performed to investigate underlying mechanisms.Results: This study identified 2,132 AE reports from the FAERS database linking hepatic AEs to ALK TKIs therapy. Significant signals were detected by ROR and MGPS methods, with common AEs including aminotransferase abnormalities, hyperbilirubinemia, and increased blood alkaline phosphatase, mainly occurring within the first 30 days of treatment. Gene analysis revealed key nodes in the protein-protein interaction (PPI) network, such as PIK3CA, SRC, and PTK2. Enriched KEGG pathways included the MAPK, PI3K-Akt, and Ras signaling.Conclusion: This pharmacovigilance study identifies significant AE signals linking ALK TKIs to liver injury, highlighting potential mechanisms and providing insights for clinical management and patient outcomes.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-11"},"PeriodicalIF":3.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413753","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

Drug-induced skin ulcer: real-world pharmacovigilance analysis based on the FDA adverse event reporting system.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-18 DOI: 10.1080/14740338.2025.2468854

Qiubai Jin, Jiufei Fang, Feihong Ren, Jiaqi Li, Shuanglin Zhou, Ping Song

{"title":"Drug-induced skin ulcer: real-world pharmacovigilance analysis based on the FDA adverse event reporting system.","authors":"Qiubai Jin, Jiufei Fang, Feihong Ren, Jiaqi Li, Shuanglin Zhou, Ping Song","doi":"10.1080/14740338.2025.2468854","DOIUrl":"https://doi.org/10.1080/14740338.2025.2468854","url":null,"abstract":"Background: Skin ulcer (SU) may increase the risk of systemic infections and have evolved into an important public health problem. However, there is a lack of research specifically on drug-induced SU.Research design and methods: We extracted data on adverse drug events (ADEs) associated with SU from the FDA Adverse Event Reporting System (FAERS) database. Disproportionality analysis was performed to calculate the risk signals for drugs that may induce SU. Logistic regression analysis was carried out to investigate the factors influencing the occurrence of SU.Results: 21372 cases of SU were reported in FAERS database between 2005 and 2024. Based on the frequency of ADE reports, we compiled a list of the top 50 drugs associated with SU. Only 15 drugs had explicit mentions of SU in their instructions, while 32 drugs were recognized as positive signals for SU by reporting odds ratio model. Logistic regression revealed the duration of medication was the risk factor for tocilizumab, alendronate sodium, and erlotinib usage. Females were also identified as risk factor for erlotinib.Conclusions: Our study identified 32 drugs potentially inducing SU, which provides valuable insights for targeted prevention and treatment strategies aimed at mitigating the risk of drug-induced SU.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440390","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

Assessment of adverse events of the novel antiepileptic drug lamotrigine: a real-world pharmacovigilance study based on FAERS.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-18 DOI: 10.1080/14740338.2025.2465867

Lidan Tu, Jingyang Xiao, Qingxia Hong, Aijun Ouyang, Ying Tu, Shuping Wang

{"title":"Assessment of adverse events of the novel antiepileptic drug lamotrigine: a real-world pharmacovigilance study based on FAERS.","authors":"Lidan Tu, Jingyang Xiao, Qingxia Hong, Aijun Ouyang, Ying Tu, Shuping Wang","doi":"10.1080/14740338.2025.2465867","DOIUrl":"https://doi.org/10.1080/14740338.2025.2465867","url":null,"abstract":"Background: Lamotrigine (LTG), a medication frequently prescribed for epilepsy. Despite its widespread use, there remains a lack of clarity regarding the drug's safety profile when used over extended periods in large patient populations. This study evaluated the safety profile of LTG using the FDA Adverse Event Reporting System (FAERS), aiming to enhance clinical decision-making.Research design and methods: We used disproportionate analyses, including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayes geometric mean (EBGM), to identify signals of adverse reactions associated with LTG.Results: A total of 187,024 records were reported, involving 905 adverse drug event (ADE) signals across 27 system organs classes (SOCs). We detected several known adverse event (AE) signals from the clinical trial phase, including seizures, rash, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS). Additionally, we uncovered several unforeseen and significant adverse effects that were not documented in the medication's prescribing information, encompassing suicides, atrial septal defects, Brugada syndrome, and signals associated with aortic stenosis.Conclusions: Our analysis in the post-marketing setting reveals new AE signals associated with LTG, highlighting the need for ongoing risk surveillance.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440352","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

EVALUATING BOWEL OBSTRUCTION and ILEUS EVENTS in PATIENTS on GLP-1 RECEPTOR AGONISTS: A SYSTEMATIC REVIEW and META-ANALYSIS.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-18 DOI: 10.1080/14740338.2025.2465870

Lama Alfehaid, Majed Alyami, Sumaya Almohareb, Omar Alshaya, Abdulaali Almutairi

{"title":"EVALUATING BOWEL OBSTRUCTION and ILEUS EVENTS in PATIENTS on GLP-1 RECEPTOR AGONISTS: A SYSTEMATIC REVIEW and META-ANALYSIS.","authors":"Lama Alfehaid, Majed Alyami, Sumaya Almohareb, Omar Alshaya, Abdulaali Almutairi","doi":"10.1080/14740338.2025.2465870","DOIUrl":"https://doi.org/10.1080/14740338.2025.2465870","url":null,"abstract":"Introduction: This research evaluated the association between glucagon-like peptide-1 receptor agonists (GLP-1 RA) and bowel obstruction or ileus.Methods: We searched databases, including Medline, Embase, and Cochrane, for studies on adult patients treated with GLP-1 RA. We included randomized control trials (RCT), cohort, case-control studies, and case reports. We used the Cochrane Risk of Bias tool to evaluate the quality of RCTs and the Newcastle-Ottawa Scale for cohort and case-control studies.Results: Out of 317 records identified, 14 studies were included in the systematic review. The meta-analysis included 6 studies with a combined total of 550,426 participants. The use of GLP-1 RA did not show an incremental risk of bowel obstruction or ileus compared to controls (OR 1.95, 95% CI 0.43-8.79). However, the studies had high heterogeneity (I2 = 94%). A subgroup analysis by specific medication revealed that liraglutide was associated with a significantly high risk of bowel obstruction or ileus (OR 3.0, 95% CI 2.03-4.45; I2 = 0%).Conclusions: GLP-1 receptor agonists do not significantly increase the risk of bowel obstruction or ileus. However, liraglutide is associated with a higher risk compared to semaglutide. Clinicians should remain aware of these rare events while recognizing the benefits of GLP-1 receptor agonists for glycemic control and cardiovascular health.Prospero registration: CRD42024585971.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440393","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

Comparative safety analysis of Hedgehog inhibitor preparations: insights from the FAERS database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-18 DOI: 10.1080/14740338.2025.2466668

Yijiang Liu, Gen Li, Chengliang Wang, Jia Chen, Li Chen

{"title":"Comparative safety analysis of Hedgehog inhibitor preparations: insights from the FAERS database.","authors":"Yijiang Liu, Gen Li, Chengliang Wang, Jia Chen, Li Chen","doi":"10.1080/14740338.2025.2466668","DOIUrl":"10.1080/14740338.2025.2466668","url":null,"abstract":"Background: Vismodegib and sonidegib are currently the only Hedgehog inhibitors (HHIs) approved by the U.S. Food and Drug Administration (FDA) for the treatment of locally advanced BCC (laBCC). However, there is limited systematic research comparing the adverse drug events (ADEs) associated with these two inhibitors.Research design and methods: Data were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) for the period from 2019 to the second quarter of 2024. Disproportionality analysis was conducted to compare ADEs between vismodegib and sonidegib.Results: The occurrence of ADEs was notably higher among patients aged ≥ 65 years (72.98%) and males (60.17%). The most frequently reported ADEs associated with HHIs included skeletal muscle and joint diseases and nervous system disorders, particularly muscle spasms and dysgeusia. Differences in adverse reactions between vismodegib and sonidegib were observed, mainly in nervous system, gastrointestinal system, skin and subcutaneous tissue, and renal and urinary disorders.Conclusions: This analysis, using the FAERS database, enhances understanding of the ADE profiles associated with both vismodegib and sonidegib. Further research is needed to validate the hypotheses generated by this study.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-8"},"PeriodicalIF":3.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143398892","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

Post-marketing safety assessment of constipation drugs: a real-world pharmacovigilance study based on FAERS database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-18 DOI: 10.1080/14740338.2025.2467829

Wenyu Zhang, Hui Wang, Shiwei Yang, Xue Pang, Wenqi Hu, Guang Zhang, Xuezhi Xin

{"title":"Post-marketing safety assessment of constipation drugs: a real-world pharmacovigilance study based on FAERS database.","authors":"Wenyu Zhang, Hui Wang, Shiwei Yang, Xue Pang, Wenqi Hu, Guang Zhang, Xuezhi Xin","doi":"10.1080/14740338.2025.2467829","DOIUrl":"10.1080/14740338.2025.2467829","url":null,"abstract":"Background: Laxatives are widely used in the treatment of constipation, but they also have brought many adverse reactions to patients.Methods: We conducted a pharmacovigilance analysis based on the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database to analyze the adverse events of six constipation drugs (linaclotide, lubiprostone, prucalopride, naloxegol, naldemedine, and plecanatide) and to search for clinically meaningful adverse reaction signals. We used disproportionality analysis as the main analysis method to detect pharmacovigilance signals, which includes Frequentist methods and Bayesian methods.Results: Among the reports of the six drugs, more adverse reactions were reported from females than males, and the number of adverse reactions reported was higher in the group of 60-89 years. Linaclotide had the lowest proportion of serious adverse event reports (4.38%), while naldemedine had the highest proportion of serious adverse event reports (25.57%). According to the classification of system organ classification (SOC), the number of gastrointestinal adverse events (N = 8321) was the largest.Conclusions: The adverse reactions of constipation drugs were mainly gastrointestinal symptoms such as diarrhea, abdominal pain and abdominal distension. Linaclotide has the highest safety, and more studies are needed to analyze the cardiovascular safety of lubiprostone.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-12"},"PeriodicalIF":3.0,"publicationDate":"2025-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413756","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

Potential risk analysis of antipsychotics-related constipation from the FDA Adverse Event Reporting System.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-17 DOI: 10.1080/14740338.2025.2468857

Sidi He, Chuanwei Li

{"title":"Potential risk analysis of antipsychotics-related constipation from the FDA Adverse Event Reporting System.","authors":"Sidi He, Chuanwei Li","doi":"10.1080/14740338.2025.2468857","DOIUrl":"https://doi.org/10.1080/14740338.2025.2468857","url":null,"abstract":"Background: Antipsychotics-related constipation is a frequently neglected and poorly researched adverse effects in patients in clinical practice. Constipation not only affects the physical health of patients, but also increases the psychological stress to their disease burden, so it requires our more attention.Methods: We queried adverse event reports of antipsychotics-related constipation from the FDA Adverse Event Reporting System (FAERS) database between January 2017 and December 2022.The report odds ratio(ROR) and 95% confidence intervals(CIs) were calculated using case/non-case methods.Results: A total of 562 constipation cases were attributed to atypical antipsychotics (AAPs) during the study period. Except for aripiprazole and ziprasidone, the p values of the other drugs were all less than 0.05. The RORs values in descending order:amisulpride(ROR = 4.07),paliperidone(ROR = 2.73),quetiapine(ROR = 1.83),clozapine(ROR = 1.61), olanzapine(ROR = 1.50), risperidone(ROR = 0.71).Conclusion: This study found that clozapine, olanzapine, amsulpride, quetiapine and paliperidone were correlated with constipation, while risperidone had the least effect on gastrointestinal function. Future analysis of the FAERS database in conjunction with other data sources will be essential for continuous monitoring of antipsychotics-related constipation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440409","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

Hepatic Adverse Events with CDK4/6 Inhibitors: A systematic review combining meta-analysis and FAERS Database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-17 DOI: 10.1080/14740338.2025.2468357

Yuyao Tang, Yongxin Li, Chengrong Zhang, Yinyin Ye, Tianlei Qiu, Zijun Zhu, Jiuda Zhao

{"title":"Hepatic Adverse Events with CDK4/6 Inhibitors: A systematic review combining meta-analysis and FAERS Database.","authors":"Yuyao Tang, Yongxin Li, Chengrong Zhang, Yinyin Ye, Tianlei Qiu, Zijun Zhu, Jiuda Zhao","doi":"10.1080/14740338.2025.2468357","DOIUrl":"https://doi.org/10.1080/14740338.2025.2468357","url":null,"abstract":"Background: Cell cycle protein-dependent kinase 4 and 6 inhibitors (CDK4/6is) in combination with endocrine therapy (ET) are widely used in patients with early and advanced breast cancer (BC). CDK4/6is also lead to numerous side effects. This study aims to elucidate the relationship between CDK4/6is and hepatotoxicities.Research design and methods: As of 31 March 2024, we conducted a systematic search of PubMed, Embase, and the Cochrane Library databases, as well as several oncology conference proceedings. We included 20 randomized controlled trials (RCTs) with 24,342 breast cancer (BC) patients and 400 cases from the FDA Adverse Event Reporting System (FAERS). Fixed-effect and random-effect models were used to calculate odds ratios (ORs) of hepatotoxicity in the RCTs, while Reporting Odds Ratios (RORs) were calculated for the FAERS data.Results: Overall, CDK4/6 inhibitors (CDK4/6is) were associated with significant hepatotoxicities compared to controls (OR = 1.76, 95%CI 1.40-2.22, I2 = 75%). Palbociclib, ribociclib, and abemaciclib exhibited significant hepatotoxicities, while dalpiciclib did not. FAERS data showed significant liver enzyme and organ toxicity signals for ribociclib and abemaciclib but not for palbociclib.Conclusions: CDK4/6is increase the risk of hepatotoxicities in patients with BC. Palbociclib, ribociclib, and abemaciclib caused liver damage, while dalpiciclib did not. The most common manifestations were elevated ALT and AST levels.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440395","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

Assessing the risk of acute kidney injury associated with a four-drug regimen for heart failure: a ten-year real-world pharmacovigilance analysis based on FAERS events.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-17 DOI: 10.1080/14740338.2025.2467822

Sen Lin, Ruiqi Zhao, Huimin Zhang, Yanwen Liang, Jiansuo Lin, Mengjiao Yu, Danfei Li, Bei Zhang, Lanyue Ma, Lisheng Peng

{"title":"Assessing the risk of acute kidney injury associated with a four-drug regimen for heart failure: a ten-year real-world pharmacovigilance analysis based on FAERS events.","authors":"Sen Lin, Ruiqi Zhao, Huimin Zhang, Yanwen Liang, Jiansuo Lin, Mengjiao Yu, Danfei Li, Bei Zhang, Lanyue Ma, Lisheng Peng","doi":"10.1080/14740338.2025.2467822","DOIUrl":"10.1080/14740338.2025.2467822","url":null,"abstract":"Background: The four-drug regimen for heart failure with reduced ejection fraction (HFrEF) significantly reduces the risks of hospitalization and mortality. To identify key adverse drug events (ADEs) warranting attention with this regimen, we conducted a real-world pharmacovigilance analysis based on the FDA Adverse Event Reporting System (FAERS) events.Research design and methods: We collected ADE reports of the four-drug regimen from FAERS that matched this regimen over a 10-year period. Disproportionality analysis and subgroup analysis were performed using four algorithms. Time-to-onset (TTO) analysis was used to assess the temporal risk patterns of ADE occurrence. Lastly, logistic regression was applied to investigate the relationship-value between patient characteristics and ADEs.Results: A total of 1,237 cases with 6,580 ADE reports were collected. Disproportionality analysis identified the most frequent ADEs as hypotension, acute kidney injury (AKI), and hyperkalemia. TTO analysis revealed a median TTO of 39 days for all important medical events, and the median TTO for AKI was 28 days, both fitting an early failure curve.Conclusion: In the comprehensive management of HFrEF with the four-drug regimen, in addition to routine monitoring of ADEs such as hypotension and hyperalemia, early-onset AKI should be a particular focus.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1-10"},"PeriodicalIF":3.0,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413746","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

Novel insights into post-marketing AEs associated with bempedoic acid: A comprehensive analysis utilizing the FAERS database.

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2025-02-17 DOI: 10.1080/14740338.2025.2468868

Xinzhe Wang, Yang Liu, Huawei Han, Jingyun Ma, Ningsheng Tian, Rui Zhu, Xiuwen Shi, Jing Jin, Huifang Zhou

{"title":"Novel insights into post-marketing AEs associated with bempedoic acid: A comprehensive analysis utilizing the FAERS database.","authors":"Xinzhe Wang, Yang Liu, Huawei Han, Jingyun Ma, Ningsheng Tian, Rui Zhu, Xiuwen Shi, Jing Jin, Huifang Zhou","doi":"10.1080/14740338.2025.2468868","DOIUrl":"https://doi.org/10.1080/14740338.2025.2468868","url":null,"abstract":"Background: Bempedoic acid is anew agent for lowering low-density lipoprotein cholesterol. This study used theUnited States Food and Drug Administration (FDA)Adverse Event Reporting System (FAERS) database to retrospectively mine adverseevents of oral bempedoic acid in the real world.Research design andmethods: The FAERS database wassearched to extract the adverse reactions of bempedoic acid from the third quarterof 2020 to the fourth quarter of 2023. After data standardization, theReporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), BayesianConfidence Propagation Neural Network (BCPNN), and Multi-item Gamma PoissonShrinker (MGPS) methods were used to comprehensively evaluate the adversereaction signals.Results: A total of 1091adverse reaction reports were identified, and 70 adverse reaction terms wereobtained, involving 22 system categories. According to the ROR signal ranking,the most affected System Organ Classes (SOCs) were\"musculoskeletal and connective tissue disorders,'\"hepatobiliary disorders,\" and 'investigation.\" PreferredTerms (PTs)withhigh signal intensity had low density lipoprotein abnormality, elevated blooduric acid, biliary colic, etc. New adverse reaction signals such as esophagealspasm, angina, apathy were reported.Conclusions: This study providesupport for clinical monitoring and risk identification of bempedoic acid.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":""},"PeriodicalIF":3.0,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143440397","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