European Journal of Clinical Pharmacology最新文献

{"title":"Comment on: \"Genome-wide association study of direct oral anticoagulants and their relation to bleeding\".","authors":"Muhammad Umar Farooque Khoso, Muhammad Hammad Chola, Muhammad Hasan","doi":"10.1007/s00228-025-03865-z","DOIUrl":"10.1007/s00228-025-03865-z","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1229-1230"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246985","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}

{"title":"Tranexamic acid-induced anaphylaxis: a systematic review.","authors":"Pei-Shuang Lin, Yun-Tai Yao, Alparslan Turan, Daniel I Sessler","doi":"10.1007/s00228-025-03857-z","DOIUrl":"10.1007/s00228-025-03857-z","url":null,"abstract":"<p><strong>Purpose: </strong>Tranexamic acid (TXA) is a synthetic antifibrinolytic agent widely used in a diverse range of hemorrhagic scenarios. Despite documented superior safety profile, increasing reports have emerged describing anaphylactic reactions to TXA. We reviewed reported cases of anaphylactic reactions to TXA and summarize their clinical characteristics, diagnosis and treatment protocols.</p><p><strong>Methods: </strong>PubMed, Embase, Web of Science were searched with the terms \"tranexamic acid\", \"antifibrinoly*\", \"anaphylaxis\", \"anaphylactic\", \"anaphylactoid\", \"allergy\" and \"hypersensitivity\" to identify relevant case reports. Data were extracted and analyzed.</p><p><strong>Results: </strong>Our review identified 15 cases of TXA-induced anaphylaxis. Patients were 2 to 80 years old, with 60.0% adults. The most common symptoms were hypotension, hypoxia and rash in an equal 66.7%, followed by tachycardia in 60.0%. TXA was confirmed as the culprit allergen in 73.3% of cases through allergological workup. Major treatments consisted of corticosteroids (80.0%), epinephrine (73.3%) and antihistamine (60.0%). While most patients recovered, 1 patient experienced recurrent anaphylaxis and 1 patient died.</p><p><strong>Conclusions: </strong>Anaphylaxis to TXA is a rare drug adverse reaction with varying manifestations. Prompt recognition and appropriate treatment are critical in facilitating optimal outcomes.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1119-1127"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144198581","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}

{"title":"The efficacy and safety of PD-1/PD-L1 inhibitors plus chemotherapy versus chemotherapy alone in advanced or metastatic gastric or gastroesophageal junction cancer: a meta-analysis of randomized controlled trials.","authors":"Hu Piao, Li Wenping, Li Chengde, Li Haoming, Zhang Xiaohan, Liu Yingdi, Zhang Xuezheng, Mao Shumei","doi":"10.1007/s00228-025-03861-3","DOIUrl":"10.1007/s00228-025-03861-3","url":null,"abstract":"<p><strong>Background: </strong>The combination chemotherapy of alpha-PD-1/PD-L1 has become the standard treatment option for some cancer patients. However, studies have shown that not all patients benefit from improved survival rates, especially the use of PD-1/PD-L1 inhibitors in combination with chemotherapy for progression-free survival (PFS) in patients with gastric or gastroesophageal cancer (GC/GEJC) remains highly controversial. To address this issue, we conducted a meta-analysis of randomized controlled trials (RCTs) aimed at comparing the efficacy of PD-1/PD-L1 inhibitors combined with chemotherapy versus chemotherapy in GC/GEJC patients.</p><p><strong>Method: </strong>By searching relevant databases, RCTs published up to November 2024 were collected, and the hazard ratios (HR) and 95% confidence intervals (CI) of overall survival (OS) and PFS were calculated. Meanwhile, the odds ratios (OR) and 95% CI of treatment-related adverse events (TRAEs) were evaluated.</p><p><strong>Result: </strong>A total of 6842 patients were included in seven trials. In the summary analysis of OS, compared with the chemotherapy group, the PD-1/PD-L1 inhibitor combined with the chemotherapy group showed significant improvement in OS (HR = 0.80; 95% CI = 0.76-0.85; p < 0.0001) and PFS (HR = 0.86; 95% CI = 0.71-0.81; p < 0.0001). Additionally, there were significant differences in the incidence of TRAEs (OR = 1.59; 95% CI = 1.21-2.02; p = 0.0001) and grade 3-4 TRAEs (OR = 1.43; 95% CI = 1.30-1.58; p < 0.0001).</p><p><strong>Conclusion: </strong>When compared to chemotherapy, the combination of PD-1/PD-L1 inhibitors with chemotherapy improves survival but with higher toxicity risks, requiring careful benefit-risk evaluation in clinical practice.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1129-1139"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144257674","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}

{"title":"Global burden of vaccine-associated Raynaud's phenomenon, 1968-2024: A comprehensive analysis of the pharmacovigilance database.","authors":"Jinyoung Jeong, Hyunjee Kim, Hyesu Jo, Jaeyu Park, Jaehyeong Cho, Hayeon Lee, Hanseul Cho, Masoud Rahmati, Ho Geol Woo, Dong Keon Yon","doi":"10.1007/s00228-025-03854-2","DOIUrl":"10.1007/s00228-025-03854-2","url":null,"abstract":"<p><strong>Purpose: </strong>Reports of Raynaud's phenomenon following vaccination have been steadily increasing; however, research on vaccine-associated Raynaud's phenomenon remains limited. This study aims to provide a comprehensive analysis of the association between Raynaud's phenomenon and various vaccines.</p><p><strong>Method: </strong>This study used data from international pharmacovigilance, which contains over 35 million adverse event cases from more than 140 countries. Two established pharmacovigilance indicators, the information component (IC) and reporting odds ratio (ROR), were employed in the analysis with 95% confidence interval (CI). The IC was derived using a Bayesian methodology to compare the reporting and non-reporting groups, while the ROR, a frequentist measure of association, was calculated using contingency tables based on the number of adverse events.</p><p><strong>Results: </strong>The signal with Raynaud's phenomenon was highest for papillomavirus vaccines (ROR: 11.49 [95% CI, 9.66-13.67]; IC: 3.45 [IC_0.25, 3.16]), followed in order by typhoid (5.86 [2.93-11.72]), hepatitis B (5.63 [4.25-7.45]; 2.42 [1.95]), COVID-19 mRNA (5.00 [4.70-5.31]; 2.00 [1.91]), and hepatitis A vaccines (4.35 [2.87-6.62]; 2.02 [1.30]). The signal was higher in females (ROR: 3.74 [95% CI, 3.54-3.95]; IC: 1.67 [IC_0.25, 1.59]) compared to males (3.44 [3.12-3.78]; 1.57 [1.43]), and it increased monotonically with age (0-11 years: IC [IC_0.25] 0.03 [-0.56]; 12-17 years: 1.54 [1.25]; 18-44 years: 1.64 [1.52]; 45-64 years: 2.00 [1.87]; ≥ 65 years: 2.12 [1.91]).</p><p><strong>Conclusion: </strong>This study suggests the potential signal association between various vaccines and Raynaud's phenomenon. Although our study does not imply causality, we propose the need to strengthen post-vaccination monitoring and establish support policies to address such adverse events.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1197-1206"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144233577","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}

{"title":"Pharmacogenomics-guided treatment versus conventional treatment in patients with Schizophrenia: Evaluation of medication adherence and switching rate.","authors":"Jiaqi Wang, Yuhang Yan, Liguang Duan, Binliang Tong, Xiaochuan Zhao, Shi Su, Mengqiang Zhao, Chaoli Chen, Yang Lun, Yueyao Luan, Qixuan Sun, Yuanyuan Zhao, Jing Yu, Xiaoying Geng, Jincheng Wang, Chunhua Zhou","doi":"10.1007/s00228-025-03858-y","DOIUrl":"10.1007/s00228-025-03858-y","url":null,"abstract":"<p><strong>Purpose: </strong>The main objective of this study was to systematically evaluate the effectiveness of pharmacogenomics-guided treatment (PGxT) and treatment-as-usual (TAU) in schizophrenia management through two key indicators: medication adherence and antipsychotic switching rate.</p><p><strong>Methods: </strong>The study cohort comprised individuals with schizophrenia who were hospitalized between April 2022 and March 2024. The cohort was stratified into two groups: the PGxT and TAU. To address potential confounding between the groups, propensity score matching (PSM) was applied. The primary outcome measures were the proportions of patients with good medication adherence (≥ 80%) at three and six months after discharge and the antipsychotic switching rate.</p><p><strong>Results: </strong>Among the 420 patients in the PGxT and TAU groups obtained through propensity score matching, the proportions of patients with good medication adherence (≥ 80%) was 49.76% at three months and 33.10% at six months, with a significant difference between the follow-up periods (P < 0.001). During the three-month observation period, the proportion of patients demonstrating good adherence were significantly different (55.24% in PGxT group vs. 44.29% in TAU group; P = 0.032). The difference was also significant after six months (44.76% in PGxT group vs. 21.43% in TAU group; P < 0.001). Furthermore, the proportion of antipsychotic switching rate was lower in the PGxT group (25.71%) than in the TAU group (41.90%) (P < 0.001).</p><p><strong>Conclusion: </strong>This study observed an association between PGxT and higher adherence as well as lower medication switching rate in patients with schizophrenia, which suggests potential clinical utility of PGx testing.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1187-1195"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144233578","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}

{"title":"Comparative efficacy and adverse effects of β3-agonists and antimuscarinics in overactive bladder: a network and component network meta-analysis.","authors":"Wenlin Huang, Xueqin Zheng, Jinyang Luo, Yongxiu Chen, Yong Xu","doi":"10.1007/s00228-025-03855-1","DOIUrl":"10.1007/s00228-025-03855-1","url":null,"abstract":"<p><strong>Background: </strong>To assess and compare the efficacy and adverse effects of β3-adrenergic receptor agonists (vibegron and mirabegron), alone and with antimuscarinic agents, in treating overactive bladder (OAB) via network meta-analysis (NMA) and component network meta-analysis (cNMA).</p><p><strong>Materials and methods: </strong>A search across multiple databases was done for Phase II/III RCTs from Jan. 2010 to June 2024. Adults with OAB or overactive bladder symptom score (OABSS) ≥ 3 were included. Trials evaluating vibegron (monotherapy/combination) and mirabegron combination therapies were eligible. Excluded were nonrandomized studies, secondary OAB, and long-term cardiovascular disease cases. Primary outcomes included micturition frequency (MF), urgency episodes (UE), urge urinary incontinence (UUI), and mean voided volume (MVV). Secondary outcomes were adverse events leading to treatment discontinuation (AELTD), adverse events (AEs), serious adverse events (sAEs), dry mouth, and constipation. Data analysis used the netmeta R package with both NMAs and cNMA.</p><p><strong>Results: </strong>Twelve studies (11,374 participants) were included. Vibegron outperformed mirabegron and antimuscarinics in reducing micturition frequency, with 100 mg vibegron showing the greatest reduction (SMD =  - 0.87, 95% CI - 1.16 to - 0.59). Combination therapies generally had better efficacy in improving UE and UUI than monotherapies, except mirabegron 50 mg + tamsulosin. No significant MVV differences between treatments and controls. For AEs, there were no significant differences in overall AEs or AELTD between treatments and controls. But higher doses and combination therapies had higher risks of dry mouth and constipation. Component network meta-analysis (cNMA) showed greater reductions in micturition frequency, suggesting possible negative interactions, whereas standard NMA showed synergistic effects on urgency episodes (UE) and mean voided volume (MVV).</p><p><strong>Conclusion: </strong>β3-agonists, especially vibegron, are effective for OAB symptoms (MF and UUI), both alone and with antimuscarinics. For short-term treatment, combination therapies seem superior to monotherapies in symptom control.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1217-1227"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246986","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}

{"title":"Signal detection between 5-alpha reductase inhibitors and the risk of suicidality and depression: an international pharmacovigilance analysis.","authors":"Soyun Lee, Hyesu Jo, Guillaume Fond, Laurent Boyer, Lee Smith, André Hajek, Dong Keon Yon","doi":"10.1007/s00228-025-03851-5","DOIUrl":"10.1007/s00228-025-03851-5","url":null,"abstract":"<p><strong>Objective: </strong>This study aims to investigate the signal detection between the use of finasteride and dutasteride and the occurrence of suicidality, including suicidal ideation, attempts, and completed suicide, as well as the development of depression.</p><p><strong>Methods: </strong>This study utilized data from a global pharmacovigilance database encompassing over 35 million adverse event reports from more than 140 countries. Suicidality and depression were defined by MedDRA terms version 26.0. To analyze the data, two well-established pharmacovigilance indicators were applied: the information component (IC) and the reporting odds ratio (ROR).</p><p><strong>Results: </strong>A total of 395 and 1299 reports of suicidality and depression, respectively, were identified in signal detection with finasteride and dutasteride. Reporting trends showed that cases first emerged in 1992, with a notable increase after 2010. The main analysis identified signal detections between finasteride use and both suicidality (ROR, 7.28 [95% CI, 6.57-8.06]; IC, 2.82 [IC_0.25, 2.65]) and depression (ROR, 28.18 [95% CI, 26.57-29.89]; IC, 4.68 [IC_0.25, 4.58]), whereas dutasteride showed no significant signal for suicidality and a weaker signal with depression (ROR, 3.23 [95% CI, 2.61-4.00]; IC, 1.66 [IC_0.25, 1.30]). In subgroup analysis, younger individuals (18-44 years) had particularly strong signals for suicidality (IC, 3.54 [IC_0.25, 3.27]), and depression (IC, 5.25 [IC_0.25, 5.05]) associated with finasteride, suggesting a heightened susceptibility in this age group. The time to onset of suicidality and depression was predominantly reported after 3 months of drug administration, with suicidality occurring at an average of 114.92 days and depression at 93.31 days.</p><p><strong>Conclusions: </strong>Although our study does not imply causality, this findings suggest a statistically significant disproportionality in reports of suicidality and depression associated with finasteride use and increased signal risks of suicidality and depression highlighting the need for further large-scale epidemiological studies to confirm these findings and investigate the underlying mechanisms.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1177-1185"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144233579","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}

{"title":"Tegoprazan: a novel, highly selective, and potent potassium-competitive acid blocker (P-CAB).","authors":"Wenlu Wang, Hafiza Sidra Yaseen, Xiaoji Li, Muhammad Zia Ahmad, Yaowu Chen, Guorong Li, Muhammad Naveed, Hafiz Muhammad Zubair, Jannat Bibi","doi":"10.1007/s00228-025-03850-6","DOIUrl":"10.1007/s00228-025-03850-6","url":null,"abstract":"<p><p>Few decades back, researchers have been paid attention to overcome limitations of PPIs, thus explored an innovative drug class \"potassium-competitive acid blockers (P-CABs)\" to achieve rapid, potent, and prolonged gastric acid inhibition. Tegoprazan is first self-developed P-CAB in China.</p><p><strong>Purpose: </strong>We aim to review the published articles on pharmacology, pharmacokinetics, drug interactions, clinical efficacy, and Tegoprazan's safety profile.</p><p><strong>Methodology: </strong>We conducted a comprehensive search of literature before August 2024. We reviewed all published articles, including pharmacology, pharmacodynamics, pharmacokinetics, mechanisms of action, drug interactions, clinical efficacy, and safety of Tegoprazan.</p><p><strong>Results: </strong>Multiple studies have exhibited promising gastric acid-suppressing effect of Tegoprazan by competing with H⁺-K⁺-ATPase potassium-binding site. Compared to PPIs, Tegoprazan exhibits a more potent and durable acid-suppressive effect that remains unaffected by food intake or CYP2C19 gene polymorphism. Tegoprazan can be used to treat all gastric acid-related disorders, i.e., GERD, ulcer and H. pylori. Multiple clinical trials exhibited substantial acid-suppressing effects of Tegoprazan at 50, 100, and 200 mg doses (p < 0.001) and relatively lower levels of gastrin. The most reported adverse events for Tegoprazan are gastrointestinal disorders (2-4.9%) and headaches (1-4.9%) and can disappear spontaneously without medical intervention.</p><p><strong>Conclusion: </strong>Tegoprazan is a novel PCAB having well-documented tolerance and safety profile thus can be administered for gastric acid diseases. However, current research on Tegoprazan is limited and primarily focuses on Asian regions. This is insufficient; we hope future studies will shed more light on other ethnic groups.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1103-1117"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144183663","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}

{"title":"Association between antidepressant use and gynecological cancer risk: a systematic review and meta-analysis.","authors":"Francisco Cezar Aquino de Moraes, Pedro Henrique de Souza Wagner, Luana Izabela Azevedo de Carvalho, Rommel Mario Rodríguez Burbano","doi":"10.1007/s00228-025-03853-3","DOIUrl":"10.1007/s00228-025-03853-3","url":null,"abstract":"<p><strong>Purpose: </strong>The potential carcinogenic effects of antidepressants (ADs) have been debated, with some preclinical studies suggesting associations with tumor promotion. However, clinical evidence regarding their impact on the risk of gynecological cancers remains limited and inconclusive, necessitating further investigation. Therefore we conducted a comprehensive search in PubMed, Embase, and Web of Science for studies examining the correlation between AD use and the risk of gynecological cancers.</p><p><strong>Methods: </strong>The DerSimonian and Laird random-effects model was applied to calculate odds ratios (ORs) with 95% confidence intervals (CIs). Heterogeneity was assessed using the I-squared and Tau-squared statistics. Statistical analyses were performed using R software (version 4.4.1), with a significance threshold of p < 0.05.</p><p><strong>Results: </strong>Our meta-analysis included 10 case-control studies, with a total of 965,834 participants, of whom 45,998 were AD users. The findings revealed a significant association between AD use and a reduced overall risk of gynecological cancers (OR = 0.9518; 95% CI: 0.9206 to 0.9841; P = 0.004; I² = 19%). Subgroup analyses demonstrated a decreased risk for ovarian cancer (OR = 0.9316; 95% CI: 0.9105 to 0.9531; P < 0.001; I² = 0%) and endometrial cancer (OR = 0.9264; 95% CI: 0.8683 to 0.9927; P = 0.030; I² = 19%). Additionally, selective serotonin reuptake inhibitors (SSRIs) were associated with a lower risk compared to non-AD users (OR = 0.9216; 95% CI: 0.8855 to 0.9591; P < 0.001; I² = 18.2%), as well as for ovarian cancer (OR = 0.9377; 95% CI: 0.8991 to 0.9780; P = 0.003; I² = 16%) and endometrial cancer (OR = 0.9078; 95% CI: 0.8251 to 0.9989; P = 0.047; I² = 35%).</p><p><strong>Conclusions: </strong>Our meta-analysis indicates that AD use may serve as a protective factor against the development of gynecological cancers. However, potential biases and confounders should be considered, highlighting the need for balanced prescribing, taking into account the potential side effects of each AD and its suitability for individual patients.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1141-1154"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144173244","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}

{"title":"Literature-based case analysis of serious adverse drug events associated with edoxaban.","authors":"Xuanyu Luan, Dongyang Zhou, Qingxia Zhang","doi":"10.1007/s00228-025-03863-1","DOIUrl":"10.1007/s00228-025-03863-1","url":null,"abstract":"<p><strong>Background: </strong>Edoxaban, a direct oral factor Xa inhibitor, is widely used for stroke prevention in non-valvular atrial fibrillation and for the treatment of deep vein thrombosis and pulmonary embolism. Compared with warfarin, edoxaban offers non-inferior thromboembolic protection with a lower risk of major bleeding. However, with the increasing clinical use of edoxaban, reports of serious adverse events (AEs) have emerged, necessitating a comprehensive safety assessment.</p><p><strong>Methods: </strong>A comprehensive systematic literature search of 6 databases was conducted until December 2024. Case reports of serious AEs were included. Data extraction was performed using a structured Excel-based data collection form. Descriptive statistical analyses were performed to summarize the characteristics of the cases.</p><p><strong>Results: </strong>41 cases of serious AEs met the inclusion criteria. 26 involved severe bleeding events, whereas 2 cases involved thrombotic events. 7 patients had medication errors. P-glycoprotein inhibitors were co-administered in 9 cases, contributing to increased bleeding risk, while P-gp inducers were used in 2 cases, potentially reducing edoxaban efficacy. The median time to AE onset was within one month in 18 cases, but 1 case occurred after four years of therapy. 6 patients died, of whom 4 deaths were attributed to AEs.</p><p><strong>Conclusion: </strong>This study highlights the clinical risks associated with edoxaban, particularly in elderly patients, those with impaired renal function, and those receiving concomitant P-gp inhibitors. In addition to confirming previously known risk factors, this study provides practical prescribing insights by synthesizing real-world evidence on medication errors, inappropriate co-administration, and off-label use. These findings are of direct relevance to prescribers and underscore the importance of individualized risk assessment and continuous pharmacovigilance.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1207-1216"},"PeriodicalIF":2.4,"publicationDate":"2025-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144247059","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}