Expert Opinion on Drug Safety最新文献_第2页

Analysis of the relationship between histamine H1 receptor antagonists and broad dementia events using the FAERS, JADER, and CVAR databases. 使用FAERS、JADER和CVAR数据库分析组胺H1受体拮抗剂与广泛痴呆事件之间的关系。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-10-01 Epub Date: 2025-06-12 DOI: 10.1080/14740338.2025.2517232

Jingjing Kan, Yechao Chen, Qiaoling Gu, Na Hu, Yanli Qiao, Yawen Chen, Dayu Chen, Haixia Zhang

{"title":"Analysis of the relationship between histamine H1 receptor antagonists and broad dementia events using the FAERS, JADER, and CVAR databases.","authors":"Jingjing Kan, Yechao Chen, Qiaoling Gu, Na Hu, Yanli Qiao, Yawen Chen, Dayu Chen, Haixia Zhang","doi":"10.1080/14740338.2025.2517232","DOIUrl":"10.1080/14740338.2025.2517232","url":null,"abstract":"Background: Recent studies suggest histamine H1 receptor antagonists (H1RAs) may elevate broad dementia events risk, though real-world data remain scarce.Methods: This pharmacovigilance study analyzed FDA Adverse Event Reporting System (FAERS), Japanese Adverse Drug Event Report (JADER), and Canada Vigilance Adverse Reaction (CVAR) databases from January 2004 to June 2024. Using disproportionality analyses such as the reporting odds ratio (ROR) and proportion reporting ratio (PRR), time-to-onset analysis, propensity score matching, and multivariate regression, we compared broad dementia event signals among first-generation H1RAs (FG-H1RAs), second-generation H1RAs (SG-H1RAs), and benzodiazepines (BDs).Results: According to the FAERS database, FG-H1RAs (ROR = 3.33, 95%CI 3.22-3.44; PRR = 3.11, χ2 = 5426.01), SG-H1RAs (ROR = 2.03, 95%CI 1.98-2.07; PRR = 1.97, χ2 = 3706.58), and BDs (ROR = 2.74, 95%CI 2.68-2.80; PRR = 2.6, χ2 = 8338.34) were significantly associated with broad dementia events, with FG-H1RAs having a stronger association with broad dementia events compared to SG-H1RAs (aROR = 0.60, 95%CI 0.54-0.67, p < 0.001). Analysis of the JADER and CVAR databases yielded similar results. FG-H1RAs exhibited immediate broad dementia events reporting (median = 0 days), while SG-H1RAs showed delayed onset (median = 1 day), both with early risk decay.Conclusion: This study provides evidence for the association between H1RAs treatment and broad dementia events, highlighting signaling differences among H1RAs. However, large-scale, high-quality epidemiological studies are still needed for validation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1973-1984"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274551","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

Lessons from examining the safety of drugs for COVID-19 during pregnancy. 检查妊娠期间抗COVID-19药物安全性的经验教训。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-10-01 Epub Date: 2026-03-18 DOI: 10.1080/14740338.2026.2637649

Nunzia Esposito, Antonio Riccardo Buonomo, Isabella Di Filippo, Elisabetta Forte, Emilia Trucillo, Ivan Gentile, Nicola Schiano Moriello

{"title":"Lessons from examining the safety of drugs for COVID-19 during pregnancy.","authors":"Nunzia Esposito, Antonio Riccardo Buonomo, Isabella Di Filippo, Elisabetta Forte, Emilia Trucillo, Ivan Gentile, Nicola Schiano Moriello","doi":"10.1080/14740338.2026.2637649","DOIUrl":"10.1080/14740338.2026.2637649","url":null,"abstract":"Introduction: Pregnant women represent a vulnerable population during the COVID-19 pandemic, facing increased risks of severe disease and adverse obstetric outcomes, yet they have been largely excluded from pivotal therapeutic clinical trials, leaving a critical evidence gap for treatment decisions.Areas covered: This review examines the available evidence on the safety and efficacy of COVID-19 therapies during pregnancy, including oral antivirals (nirmatrelvir/ritonavir, molnupiravir), intravenous remdesivir, monoclonal antibodies, corticosteroids, and immunomodulators (tocilizumab, baricitinib). A literature search was conducted using MEDLINE/PubMed for English-language articles published from March 2020 to December 2023, including studies of any design reporting maternal and neonatal outcomes.Expert opinion: The COVID-19 pandemic exposed a critical gap in clinical research through the systematic exclusion of pregnant women from therapeutic trials. Current evidence, though largely observational, supports vaccination as the primary preventive strategy, nirmatrelvir/ritonavir for outpatients at risk of progression, and remdesivir plus corticosteroids for hospitalized patients requiring oxygen supplementation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1793-1803"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147376451","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

Infection toxicity assessment of tumor necrosis factor α inhibitors in the treatment of IBD: a real-world study based on the US food and drug administration adverse events reporting system (FAERS). 肿瘤坏死因子α抑制剂治疗IBD的感染毒性评估：基于美国食品和药物管理局不良事件报告系统（FAERS）的现实世界研究。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-10-01 Epub Date: 2025-03-30 DOI: 10.1080/14740338.2025.2486309

Qian Cheng, Zeyu Yao, Xuan Shi, Shupeng Zou, Yazheng Zhao, Mengling Ouyang, Minghui Sun

{"title":"Infection toxicity assessment of tumor necrosis factor α inhibitors in the treatment of IBD: a real-world study based on the US food and drug administration adverse events reporting system (FAERS).","authors":"Qian Cheng, Zeyu Yao, Xuan Shi, Shupeng Zou, Yazheng Zhao, Mengling Ouyang, Minghui Sun","doi":"10.1080/14740338.2025.2486309","DOIUrl":"10.1080/14740338.2025.2486309","url":null,"abstract":"Background: Tumor necrosis factor α (TNF-α) inhibitors are widely used to treat inflammatory bowel disease (IBD), but systematic risk assessment of infectious toxicity is still lacking.Research design and methods: We used disproportional analysis to calculate infection-related risk signals for four TNF-α inhibitors and compared them with infection-related signals for seven other therapies.Results: There were 55,379 reports of infection-related adverse events (AEs) with TNF-α inhibitors as a 'primary suspect (PS)' therapy. The median time to onset of infection-related AEs was 113 days (interquartile range [IQR] 14-612). TNF-α inhibitors present the strongest infectious toxic signal than interleukin 12/23 (IL-12/23) inhibitors, integrin blockers, Jak inhibitors, and S1P receptor modulator. Compared with infliximab, certolizumab pegol, and adalimumab, golimumab showed the strongest signal. The strongest signal corresponding to appendicitis, pulmonary tuberculosis, pneumonia, sepsis, urinary tract infection, otitis media and herpes zoster is golimumab, infliximab, golimumab, natalizumab, certolizumab pegol, infliximab, and infliximab.Conclusions: Compared with other control therapies, TNF-α inhibitors have the strongest infectious toxicity signal. Compared with other TNF-α inhibitors, golimumab has the strongest infectious toxicity signal. When using TNF-α inhibitors to treat IBD, infection-related AEs should be vigilant.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"2007-2014"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143742689","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

Identification of drug combinations to reduce the risk of pioglitazone-related bladder cancer using the FDA adverse event reporting system database. 使用FDA不良事件报告系统数据库识别药物组合以降低吡格列酮相关膀胱癌的风险。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-10-01 Epub Date: 2025-05-06 DOI: 10.1080/14740338.2025.2492744

Jun-Jie Yang, Hui Zhao, Ming-Ming Yan, Xiang Zheng, Qian Zhang, Hai-Yan Chen, Xiao-Yan Qiu

{"title":"Identification of drug combinations to reduce the risk of pioglitazone-related bladder cancer using the FDA adverse event reporting system database.","authors":"Jun-Jie Yang, Hui Zhao, Ming-Ming Yan, Xiang Zheng, Qian Zhang, Hai-Yan Chen, Xiao-Yan Qiu","doi":"10.1080/14740338.2025.2492744","DOIUrl":"10.1080/14740338.2025.2492744","url":null,"abstract":"Background: Emerging studies have uncovered the innovative pharmacological characteristics of pioglitazone (PLZ). However, concerns regarding the potential link to an increased risk of bladder cancer (BC) had constrained its clinical application.Research design and methods: BC reports associated with PLZ and drug combinations containing PLZ from 1 January 2004 to 30 September 2024 were identified from the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Reporting odds ratio (ROR) and Bayesian confidence propagation neural network (BCPNN) method was applied to mine adverse drug event signals.Results: Of 144 combinations, 15 showed an IC025 greater than 3, denoting a strong signal; 44 had an IC025 between 1.5 and 3, indicating moderate signal intensity; 36 had an IC025 between 0 and 1.5, pointing to a weak signal; and 49 had an IC025 less than 0, suggesting no apparent related signal. Importantly, the IC025 values for all drug combinations did not surpass the value observed when PLZ was used as monotherapy.Conclusions: Through comprehensive data mining, 14 PTs associated with BC were identified, indicating that specific medication combinations might mitigate the risk of PLZ-related BC. Our findings offer valuable insights for guiding decisions on PLZ combination therapies.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1889-1898"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143964951","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

Comprehensive post-marketing safety analysis of tildrakizumab: insights from the FDA adverse event reporting system. 全面的Tildrakizumab上市后安全性分析：来自FDA不良事件报告系统的见解

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-10-01 Epub Date: 2025-06-17 DOI: 10.1080/14740338.2025.2520422

Kaidi Zhao, Shengxiang Xiao, Yang Zhao, Chen Tu

{"title":"Comprehensive post-marketing safety analysis of tildrakizumab: insights from the FDA adverse event reporting system.","authors":"Kaidi Zhao, Shengxiang Xiao, Yang Zhao, Chen Tu","doi":"10.1080/14740338.2025.2520422","DOIUrl":"10.1080/14740338.2025.2520422","url":null,"abstract":"Background: Tildrakizumab is a biologic agent approved for the treatment of moderate to severe psoriasis. Although its safety has been established in clinical trials, its real-world safety profile remains to be further investigated.Research design and methods: This study analyzed adverse events (AEs) from the FDA Adverse Event Reporting System (FAERS) database between the first quarter of 2018 and the first quarter of 2024. Four disproportionality analysis methods were applied: Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-item Gamma Poisson Shrinker (MGPS). Subgroup analyses, sensitivity analyses, and Weibull distribution modeling were conducted.Results: A total of 1,263 reports involving 2,344 AEs were included. Several known AEs were confirmed, and unexpected AEs such as urinary tract infections, herpes zoster, atrial fibrillation, and basal cell carcinoma were identified. Sensitivity analysis further confirmed the reliability of the overall findings.Conclusions: This study confirmed some known AEs and identified several unexpected AEs, highlighting the importance of early-stage monitoring. These findings may provide preliminary insights into the safe use of tildrakizumab. However, the FAERS database has limitations, including reporting bias, incomplete clinical information, and the inability to establish causality. These findings warrant further validation through prospective studies.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1943-1950"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144283150","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

Risk of musculoskeletal disorders associated with Bruton's tyrosine kinase inhibitors: a disproportionality analysis of FAERS database and meta-analysis. 与布鲁顿酪氨酸激酶抑制剂相关的肌肉骨骼疾病风险：FAERS数据库的歧化分析和荟萃分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-10-01 Epub Date: 2025-06-18 DOI: 10.1080/14740338.2025.2521358

Mohammed Zuber, Christy Thomas, Shifa Taj, Muhammed Rashid, Krishna Undela, Jeyanthi Ramanarayanan, Francisco J Hernandez-Ilizaliturri, Lorenzo Villa Zapata

{"title":"Risk of musculoskeletal disorders associated with Bruton's tyrosine kinase inhibitors: a disproportionality analysis of FAERS database and meta-analysis.","authors":"Mohammed Zuber, Christy Thomas, Shifa Taj, Muhammed Rashid, Krishna Undela, Jeyanthi Ramanarayanan, Francisco J Hernandez-Ilizaliturri, Lorenzo Villa Zapata","doi":"10.1080/14740338.2025.2521358","DOIUrl":"10.1080/14740338.2025.2521358","url":null,"abstract":"Background: Randomized controlled trials (RCTs) have reported an increased risk of musculoskeletal disorders with BTK inhibitors (BTKis). We conducted a disproportionality analysis using the FDA Adverse Event Reporting System (FAERS) and a meta-analysis of RCTs to further investigate.Research design and methods: A retrospective case/non-case study was performed using FAERS reports through Q2 2024. Disproportionality analysis calculated Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), and Information Component (IC) to identify signals (PRR ≥2, lower bound ROR > 1, IC025 > 0). A meta-analysis calculated risk ratios (RR) for musculoskeletal outcomes.Results: In FAERS, ibrutinib was associated with increased reports of muscle spasms [PRR: 2.2 (χ2 : 521.9), LB ROR: 2.1, IC025 = 1.0]. Acalabrutinib showed higher risks for myalgia [PRR: 2.4, LB ROR: 2.0, IC025 = 0.9] and bone pain [PRR: 2.2, LB ROR: 1.6, IC025 = 0.6]. In the meta-analysis, ibrutinib was associated with higher risks of arthralgia (RR: 1.46, 95% CI 1.21-1.76), muscle spasm (RR: 2.32, 95% CI 1.72-3.12), and back pain (RR: 1.22, 95% CI 0.75-1.96).Conclusions: Findings from FAERS and meta-analysis suggest a stronger association between BTKis, particularly ibrutinib, and musculoskeletal adverse events.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1935-1942"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301476","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Safety profile of letrozole in the real world: a disproportionality analysis of FAERS database and systematic review of case reports. 来曲唑在现实世界中的安全性：对FAERS数据库的不相称性分析和对病例报告的系统回顾。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-10-01 Epub Date: 2025-07-09 DOI: 10.1080/14740338.2025.2527964

Chunsu Liang, Yizhou Zhang, Pengjiao An, Wei Zuo, Bo Zhang

{"title":"Safety profile of letrozole in the real world: a disproportionality analysis of FAERS database and systematic review of case reports.","authors":"Chunsu Liang, Yizhou Zhang, Pengjiao An, Wei Zuo, Bo Zhang","doi":"10.1080/14740338.2025.2527964","DOIUrl":"10.1080/14740338.2025.2527964","url":null,"abstract":"Background: Letrozole is an aromatase inhibitor for breast cancer. Most of the safety data of letrozole came from clinical trials, while real-world information is insufficient.Research design and methods: FAERS data were analyzed using OpenVigil 2 for disproportionality signals. A systematic review of PubMed, Embase, and CINAHL identified letrozole-related ADR case reports, evaluated by Naranjo Scale.Results: The analysis of FAERS (2004 Q1-2023 Q4) identified 1,165 ADR signals from 29,631 cases, with general disorders, gastrointestinal, and musculoskeletal connective tissue disorders being the most frequent system organ classes (SOCs). Fatigue (3,431 cases), nausea (2,421), diarrhea (1,943), arthralgia (1,756), and alopecia (1,640) were the top reported signals. Novel signals included nitrituria and retinal phototoxicity, with 14 SOCs identified in the top 20 high-PRR signals. The systematic review included 45 cases from 40 publications, with skin/subcutaneous (13 cases) and musculoskeletal disorders (9 cases) most common. Notably, 26.67% of ADRs (12/45) were unreported in labeling, including rhabdomyolysis, systemic sclerosis, and acute kidney injury.Conclusions: Clinicians need to pay attention to rhabdomyolysis when letrozole combined with catecholaminergic agents. Patient education on urine output monitoring is essential due to potential kidney injury. Bone marrow suppression and reproductive toxicity risks require clinical attention.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1985-1995"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539752","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

Adverse event profiles of four monomethyl auristatin E-conjugated antibody drug conjugates: a disproportionality analysis based on the US FDA adverse event reporting system (FAERS) database. 四种单甲基auristatin e偶联抗体药物偶联物的不良事件概况：基于美国FDA不良事件报告系统（FAERS）数据库的歧化分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-10-01 Epub Date: 2025-07-04 DOI: 10.1080/14740338.2025.2526790

Yohei Doi, Ichiro Ieiri, Mayako Uchida, Takeshi Hirota

{"title":"Adverse event profiles of four monomethyl auristatin E-conjugated antibody drug conjugates: a disproportionality analysis based on the US FDA adverse event reporting system (FAERS) database.","authors":"Yohei Doi, Ichiro Ieiri, Mayako Uchida, Takeshi Hirota","doi":"10.1080/14740338.2025.2526790","DOIUrl":"10.1080/14740338.2025.2526790","url":null,"abstract":"Background: Antibody-drug conjugates (ADCs) with monomethyl auristatin E (MMAE) have recently become prevalent in cancer treatment. This study aimed to comprehensively examine the adverse events (AEs) associated with regulatory-approved MMAE-conjugated ADCs using the FDA Adverse Event Reporting System (FAERS).Research design and methods: A disproportionality analysis of reports from July 2011 to September 2024 was conducted to detect AE signals in adult patients with cancer receiving any of the four MMAE-conjugated ADCs (brentuximab vedotin, enfortumab vedotin, polatuzumab vedotin, and tisotumab vedotin) using reporting odds ratio and information component.Results: FAERS yielded 12,655 reported cases with 4,958 drug-AE pairs. Positive signals observed across the four MMAE-ADCs included 'blood and lymphatic system disorders' and 'metabolism and nutrition disorders' at the system organ class, and anemia, febrile neutropenia, hypokalemia, peripheral neuropathy, and pneumonitis for individual AEs, with 54 other overlapping AEs shared by at least three of the ADCs.Conclusions: FAERS analysis revealed overlapping safety signals in MMAE-conjugated ADCs. Although further research is necessary to clarify causal relationships, our findings provide a basis for understanding the characteristics of possible AEs in MMAE-ADCs, aiding clinical decision-making for patient safety management.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1951-1964"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505278","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 analysis of adverse events between sacubitril/valsartan and valsartan using the FAERS database: a disproportionality analysis. 使用FAERS数据库对苏比里尔/缬沙坦和缬沙坦不良事件进行比较分析：歧化分析。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-10-01 Epub Date: 2025-11-22 DOI: 10.1080/14740338.2025.2591388

Da Li, Yunfeng Li, Lei Yao, Jianhua Li, Xunjie Zhou, Mingtai Gui, Bo Lu, Xiaozhe Chen, Yidan Dong, Deyu Fu, Mingzhu Wang

{"title":"Comparative analysis of adverse events between sacubitril/valsartan and valsartan using the FAERS database: a disproportionality analysis.","authors":"Da Li, Yunfeng Li, Lei Yao, Jianhua Li, Xunjie Zhou, Mingtai Gui, Bo Lu, Xiaozhe Chen, Yidan Dong, Deyu Fu, Mingzhu Wang","doi":"10.1080/14740338.2025.2591388","DOIUrl":"10.1080/14740338.2025.2591388","url":null,"abstract":"Background: This study conducts a comprehensive comparative analysis of adverse event (AE) signals between sacubitril/valsartan and valsartan, two pivotal cardiovascular drugs for heart failure and hypertension, utilizing the FAERS database to identify differential safety risks and optimize clinical monitoring.Research design and methods: Data from the FAERS database (2004Q1-2024Q2) were analyzed using disproportionality analysis and Bayesian methods to detect and evaluate AE signals associated with sacubitril/valsartan and valsartan, enabling a comparative assessment.Results: A total of 102,678 adverse event reports (AERs) were linked to sacubitril/valsartan, compared to 24,318 AERs for valsartan. Sacubitril/valsartan demonstrated the strongest association with cardiac disorders (ROR 4.13), while valsartan exhibited the highest association with vascular disorders (ROR 2.67). Common AE signals aligned with the respective drug labels. Unexpected AEs for sacubitril/valsartan included myocardial infarction (n = 2,909, ROR 6.45), arrhythmia (n = 1,691, ROR 4.07), decreased activity (n = 544, ROR 11.13), and fluid imbalance (n = 44, ROR 11.98). Unique AEs for valsartan included fear of disease (n = 137, ROR 47.57), thrombotic stroke (n = 31, ROR 25.60), merycism (n = 30, ROR 79.41), and eosinophilic colitis (n = 11, ROR 20.62).Conclusions: Sacubitril/valsartan and valsartan exhibit distinct AE risk profiles in cardiovascular disease treatment, underscoring the need for large-scale clinical trials and mechanistic studies on sacubitril to validate these findings.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1907-1917"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145539714","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

Bridging evidence gaps in dravet syndrome: real-world safety insights from under-reported antiseizure therapies. 弥合草稿综合征的证据差距：从报道不足的抗癫痫治疗中获得的真实世界安全性见解。

IF 3 3区医学

Expert Opinion on Drug Safety Pub Date : 2026-10-01 Epub Date: 2026-04-28 DOI: 10.1080/14740338.2026.2666178

Alessandro Ferretti, Antonella Riva, Lorenzo Perilli, Pasquale Parisi, Pasquale Striano

{"title":"Bridging evidence gaps in dravet syndrome: real-world safety insights from under-reported antiseizure therapies.","authors":"Alessandro Ferretti, Antonella Riva, Lorenzo Perilli, Pasquale Parisi, Pasquale Striano","doi":"10.1080/14740338.2026.2666178","DOIUrl":"10.1080/14740338.2026.2666178","url":null,"abstract":"Introduction: Dravet syndrome is an early-onset developmental and epileptic encephalopathy in which management must extend beyond seizure control to include the monitoring and treatment of neurodevelopmental and systemic comorbidities.Areas covered: Well-established treatments, together with recently approved agents, are discussed alongside under-reported therapies. Safety profiles, clinically relevant pharmacokinetic interactions, and practical aspects of dose titration and monitoring are reviewed. Emerging targeted pharmacological and genetic strategies are also briefly considered as potential disease-modifying approaches.Expert opinion: In clinical practice, valproate-based regimens remain central to seizure management, with adjunctive therapies tailored to seizure type, comorbidities, tolerability, and drug interactions. While stiripentol, clobazam, fenfluramine, and cannabidiol are supported by the strongest evidence, less frequently reported therapies, including perampanel, topiramate, levetiracetam, cenobamate, and ketogenic dietary therapies, may benefit selected patients but require cautious use due to heterogeneous efficacy and safety data. The complexity of available options highlights the need for individualized, dynamic treatment strategies. Although emerging targeted and genetic therapies may represent a future paradigm shift beyond symptomatic seizure control, their clinical impact remains to be established, warranting careful implementation and long-term safety evaluation.","PeriodicalId":12232,"journal":{"name":"Expert Opinion on Drug Safety","volume":" ","pages":"1805-1817"},"PeriodicalIF":3.0,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147766797","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