European Journal of Clinical Pharmacology最新文献

{"title":"Letter to the editor: Relevant errors in a systematic review and network meta-analysis evaluating the efficacy and safety of different pharmacological interventions in the treatment of tardive dyskinesia.","authors":"Christoph U Correll, David Rowe, Rinat Ribalov, Verena Ramirez Campos, Marco Solmi","doi":"10.1007/s00228-025-03826-6","DOIUrl":"10.1007/s00228-025-03826-6","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1099-1101"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12152080/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143990352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Post-market safety profile and suicide/self-injury risk signals of dextromethorphan/bupropion: a real-world pharmacovigilance study.","authors":"Lingjing Yuan, Jianping He, Xiangyu Li","doi":"10.1007/s00228-025-03841-7","DOIUrl":"10.1007/s00228-025-03841-7","url":null,"abstract":"<p><strong>Background: </strong>Dextromethorphan/bupropion (D/B) is an innovative pharmacological treatment for major depressive disorder. Nevertheless, the current evidence regarding the safety profile of D/B is predominantly derived from clinical trials, thus hindering the timely updating of adverse event (AE) data for this medication. Therefore, this study conducted data mining and analysis of AE signals (especially for suicide/self-injury) associated with D/B using the Food and Drug Administration Adverse Event Reporting System (FAERS) database.</p><p><strong>Methods: </strong>This study used the disproportionality method to systematically evaluate the associations between D/B and potential AEs and compared these AEs with AEs related to bupropion and esketamine by using data from the FAERS collected between the third quarter of 2022 and the second quarter of 2024.</p><p><strong>Results: </strong>A total of 2451 AE reports identifying D/B as the \"primary suspect\" were collected. From these reports, 81 preferred terms and 24 system organ classifications were identified, with a predominant focus on psychiatric disorders (22.07%) and nervous system disorders (18.77%). These AEs were mostly found in individuals aged 18-44 years. The median time to onset for D/B-related AEs was determined to be 2 days. Nearly 20 novel AEs identified during the labelling process were detected, such as a sensation of inebriation and panic attacks. Importantly, the risk signals for suicide/self-injury associated with D/B were significantly lower than those associated with bupropion and esketamine. However, these signals cannot be ignored in view of their serious consequences.</p><p><strong>Conclusion: </strong>Psychiatric and nervous system disorders, such as suicidal/self-injurious behaviours, require careful monitoring in clinical applications. It is imperative to conduct traditional pharmacoepidemiological research to evaluate whether D/B is linked to an increased risk of dissociative disorders in the future. Moreover, health care professionals should remain vigilant for AE signals not listed in package inserts.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1029-1041"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968399","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 drug-drug interaction between dolutegravir and magnesium: not all salts are the same.","authors":"Dario Cattaneo, Anna Lisa Ridolfo, Andrea Giacomelli, Nunziata Calvagna, Alberto Dolci, Andrea Gori, Cristina Gervasoni","doi":"10.1007/s00228-025-03843-5","DOIUrl":"10.1007/s00228-025-03843-5","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1097-1098"},"PeriodicalIF":2.4,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144003977","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":"Drug-eluting stent versus bare metal stent for symptomatic intracranial stenosis: a comparative systematic review and meta-analysis study.","authors":"Mohammad Sina Mirjani, Pouria Delbari, Muhammad Hussain Ahmadvand, Saba Sabet, Zahra Ardestani, Mohammad Emad Sharifi, Sina Hatami, Mansoureh Jabari, Amirali Barkhordarioon, Mohammad Taha Akbari Javar, Amirmohammad Bahri, Sina Ahmadi, Bardia Hajikarimloo, Ibrahim Mohammadzadeh, Mohammad Amin Habibi, Hamidreza Saber","doi":"10.1007/s00228-025-03846-2","DOIUrl":"10.1007/s00228-025-03846-2","url":null,"abstract":"<p><strong>Background: </strong>Intracranial atherosclerotic artery stenosis (ICAS) is a major cause of ischemic stroke globally and is associated with poor recanalization rates, high recurrence, and adverse functional outcomes. The use of stents has been explored as a treatment option to improve outcomes, despite concerns over procedure-related complications and in-stent restenosis (ISR). This study aimed to compare the efficacy and safety of drug-eluting stents (DES) versus bare metal stents (BMS) in treating patients with symptomatic ICAS (sICAS).</p><p><strong>Method: </strong>A systematic review and meta-analysis were conducted according to PRISMA guidelines, with a comprehensive search of PubMed, Embase, and Web of Science up to March 1, 2024. Studies that reported outcomes such as technical and clinical success rates, periprocedural complications, ISR, and stroke rates were included. Statistical analysis was performed using Stata v.17.</p><p><strong>Results: </strong>A total of 44 studies involving 13,658 patients were included. DES demonstrated lower pooled rates of major stroke (3% [95% CI 2-4%]) and ISR (8% [95% CI 3-12%]) compared to BMS (5% [95% CI 3-6%] for major stroke and 19% [95% CI 14-24%] for ISR), though the difference in major stroke rate was not statistically significant. The clinical success rate was similar between DES (89% [95% CI 78-99%]) and BMS (86% [95% CI 76-97%]). Technical success rates were high and comparable for both stent types. Subgroup analyses and meta-regression identified significant factors influencing heterogeneity, including stent or wire length and diameter.</p><p><strong>Conclusion: </strong>DES showed a significant advantage over BMS in reducing ISR and major stroke rates while maintaining comparable safety and technical success. These findings support the preferential use of DES in clinical practice for managing sICAS, emphasizing their role in enhancing patient outcomes through reduced restenosis and recurrent ischemic events.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"939-954"},"PeriodicalIF":2.7,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143974848","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":"Drug-related falls: proportion and impact of hospitalizations in geriatric departments on the prescription of fall-risk increasing drugs (FRIDs).","authors":"Céline Vaesken, Véronique Lelong-Boulouard, Sophie Fedrizzi, Alexandra Muzard, Pablo Descatoire, Gilles Loggia, Guillaume Saint-Lorant, Cédric Villain, Alexandre Meurant","doi":"10.1007/s00228-025-03836-4","DOIUrl":"10.1007/s00228-025-03836-4","url":null,"abstract":"<p><strong>Purpose: </strong>The incidence of drug-related admissions in France was 8.5% in 2018, with falls being the 5 th cause of DRA. The screening of adverse drug reactions (ADRs) in old adults can be challenging. Our objective was to determine the proportion of old patients hospitalized for drug-related falls in a geriatrics department, assess their preventability and the impact of hospitalizations on the prescription of fall-risk increasing drugs (FRIDs).</p><p><strong>Methods: </strong>A retrospective observational study, including patients aged over 75 years who were admitted to an acute geriatrics medicine department from May 10, 2022, to February 2, 2023, was conducted. We used a previously published method to detect DRA and assess their preventability.</p><p><strong>Results: </strong>Of the 512 patients admitted to the department during the study period, 104 patients (20%) were hospitalized due to falls, of whom 71 (14%) were considered to be drug-related. Falls associated with drugs were categorized as more severe (p = 0.01). In 41% of drug-related falls, ADRs were considered to be definitively avoidable. The most commonly implicated FRIDs classes were beta-blockers (53%, n = 38); diuretics (47%, n = 34); antidepressants (41%, n = 29); benzodiazepines (6%, n = 20); and underuse of vitamin D in patients with a documented deficiency (65%, n = 46). In patients hospitalized for drug-related falls, the FRIDs decreased between admission (n = 314) and discharge (n = 198, p < 0.01).</p><p><strong>Conclusion: </strong>The proportion of hospitalizations for drug-related falls is notably high in geriatric department, and a substantial proportion can be prevented. These findings emphasize the importance of targeting high-risk patients for falls and implementing preventive measures, such as reassessing their medication as recommended in the latest international guidelines for falls prevention.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":"81 6","pages":"885-893"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143973726","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":"Effects of oral antidiabetic agents on the renin-angiotensin-aldosterone system.","authors":"Xifeng Yang, Yijie Qi, Jinxuan Hao, Hongxia Wei, Zhe Li, Ming Xu, Yi Zhang, Yunfeng Liu","doi":"10.1007/s00228-025-03830-w","DOIUrl":"10.1007/s00228-025-03830-w","url":null,"abstract":"<p><strong>Background: </strong>The renin-angiotensin-aldosterone system (RAAS) is a vital endocrine system that plays a crucial role in maintaining homeostasis. However, excessive activation of the RAAS can contribute to the pathogenesis of certain diseases. Prolonged hyperglycemia leads to overactivation of the RAAS through the production of inflammatory factors and other mechanisms, ultimately resulting in diabetic complications. Oral antidiabetic agents are the cornerstone of diabetes treatment, and the effects of oral antidiabetic agents on the RAAS have not been clearly summarized.</p><p><strong>Objective: </strong>To review the effects of various types of oral antidiabetic agents on the components of the RAAS.</p><p><strong>Results: </strong>Sodium-glucose cotransporter inhibitors (SGLT2i) inhibit glucose and sodium reabsorption, which increases the flow of Na⁺ to the macula densa, thereby inhibiting tubuloglomerular feedback (TGF) and subsequently decreasing renin production. GLP-1 receptor agonists (GLP-1RA) and dipeptidyl peptidase-4 inhibitors (DPP-4i) can directly inhibit angiotensin II (Ang II) or indirectly suppress it by modulating TGF. These agents also affect Ang II type 1 receptors (AT1R) and Ang II type 2 receptors (AT2R) to mitigate Ang II and can indirectly interact with Ang II through Na⁺/H⁺ exchanger isotope 3 (NHE3). Thiazolidinediones (TZDs), as PPAR-γ agonists, can enhance the expression of the renin gene, inhibit the production of angiotensin-converting enzyme (ACE), regulate the levels of AT1R and AT2R, and decrease aldosterone production. Metformin also inhibits the production of renin and aldosterone in patients with polycystic ovary syndrome (PCOS).</p><p><strong>Conclusions: </strong>These oral agents, which exhibit diverse effects on the components of the RAAS, modulate the activity of these components to exert antihypertensive, anti-inflammatory, cardioprotective, and renoprotective effects, thereby offering several beneficial outcomes in the management of diabetes.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"801-813"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751777","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":"Gambling disorders and drugs: a disproportionality analysis in the WHO pharmacovigilance database.","authors":"Jean-Louis Montastruc","doi":"10.1007/s00228-025-03828-4","DOIUrl":"https://doi.org/10.1007/s00228-025-03828-4","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":"81 6","pages":"907-909"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143985041","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":"Effect of dapagliflozin on malignant ventricular arrhythmias in elderly after acute myocardial infarction: a propensity score-matched cohort study.","authors":"Li Deng, Jingyi Wang, Ye Deng, Jianya Huang, Qingqing Gu, Qianwen Chen, Lu Pan, Jun Wei, Qingjie Wang, Ling Sun","doi":"10.1007/s00228-025-03832-8","DOIUrl":"10.1007/s00228-025-03832-8","url":null,"abstract":"<p><strong>Objective: </strong>This study aims to evaluate the effect of dapagliflozin (DAPA) on malignant ventricular arrhythmias (MVA) after acute myocardial infarction (AMI).</p><p><strong>Methods: </strong>A single-center, prospective and observational cohort study was conducted. We enrolled AMI patients from the ChangZhou Acute Myocardial Infarction Registry between January 2018 and November 2023. They were divided into two groups according to the use of dapagliflozin. The median follow-up time was 211 days. The primary endpoint of the study was the incidence of MVA during hospitalization, and the secondary endpoint was all-cause mortality rate during the follow-up period. Kaplan-Meier survival analysis and multifactorial logistic regression analysis were performed to assess the association between DAPA and the risk of MVA. Enrolled patients were matched on a 1:1 propensity score.</p><p><strong>Results: </strong>Of the 2607 AMI patients enrolled, MVA were reported postoperatively in 123 (4.7%)patients. Cardiovascular death occurred in 93 (3.6%) patients. The average age of the enrolled patients was 65.03 ± 0.27 years. Of participants assigned to dapagliflozin, 8 out of 363 patients (2.2%) experienced MVA compared with 115 out of 2244 patients (5.1%) in the control group (odds ratio, OR = 0.392; 95% confidence interval, 95% CI: 0.171-0.900; P = 0.027). After 1:1 propensity score matching, DAPA remained able to reduce the risk of MVA in patients with AMI. (OR = 0.340; 95% CI: 0.121-0.960; P = 0.042). At a median follow-up of 211 days, all-cause mortality remained lower in the DAPA group than in the control group after matching (P = 0.033).</p><p><strong>Conclusion: </strong>Dapagliflozin may attenuate the risk of MVA and all-cause mortality in elderly AMI patients, highlighting its potential as a therapeutic adjunct. However, these findings require validation in large-scale randomized trials.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"839-851"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751775","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":"Psychotropic polypharmacy impairs walking independence in post-stroke patients.","authors":"Ayaka Matsumoto, Yoshihiro Yoshimura, Fumihiko Nagano, Sayuri Shimazu, Takahiro Bise, Yoshifumi Kido, Ai Shiraishi, Aomi Kuzuhara, Takenori Hamada, Kouki Yoneda","doi":"10.1007/s00228-025-03833-7","DOIUrl":"10.1007/s00228-025-03833-7","url":null,"abstract":"<p><strong>Purpose: </strong>Psychotropic drugs are associated with adverse outcomes in older adults. However, evidence on the effect of psychotropic use on walking ability in post-stroke patients is lacking. This study examined the association between psychotropic medication use and walking independence in post-stroke patients.</p><p><strong>Methods: </strong>This retrospective cohort study included stroke patients admitted for convalescent rehabilitation at a Japanese hospital between 2020 and 2022. Psychotropic medications (benzodiazepines, hypnotics, antipsychotics, and antidepressants) prescribed at admission were recorded. The primary outcome was walking independence at discharge, defined as a Functional Independence Measure (FIM) walk score ≥ 6. Logistic regression analyses examined the association between the number of psychotropic drugs and walking independence, adjusting for potential confounders.</p><p><strong>Results: </strong>Of the 709 patients enrolled, 559 (mean age 75.5 years, 52.8% male) were included in the analysis. At admission, 25.4% of patients used psychotropic drugs. In the adjusted analysis, the number of psychotropic medications was independently associated with lower walking independence at discharge (OR 0.620, 95% CI 0.428-0.897, P = 0.011). Hypnotic use specifically showed a negative impact on walking independence (OR 0.331, 95% CI 0.154-0.708, P = 0.004). However, psychotropic drug use was not significantly associated with improvement in FIM-motor scores.</p><p><strong>Conclusion: </strong>Psychotropic polypharmacy at admission, particularly with hypnotics, was associated with reduced likelihood of achieving walking independence after stroke rehabilitation. Judicious use of psychotropic medications may be warranted when ambulation is a critical goal for older post-stroke patients.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"831-838"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143751780","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":"Efficacy of cyclophosphamide for skin fibrosis in systemic sclerosis: a systematic review and single-arm meta-analysis.","authors":"Xin Tian, PengJiao An, RongJi Liu, Wei Zuo, Xin Liu, ZaiWei Song, Yang Hu, RongSheng Zhao, Bo Zhang","doi":"10.1007/s00228-025-03837-3","DOIUrl":"10.1007/s00228-025-03837-3","url":null,"abstract":"<p><strong>Purpose: </strong>Systemic sclerosis (SSc) is a chronic connective tissue disorder characterized by skin thickening with vascular and visceral involvements. The efficacy of cyclophosphamide for SSc-related skin fibrosis remains controversial. The aim of this study was to evaluate the effectiveness of cyclophosphamide for skin fibrosis in SSc.</p><p><strong>Methods: </strong>PubMed, Embase, the Cochrane Library, and ClinicalTrials.gov databases were systematically searched for all published clinical trials on the treatment of SSc with cyclophosphamide until January 15, 2025.The outcome of interest was the extent of skin fibrosis, measured by the modified Rodnan skin score (mRSS). Two authors independently screened studies, extracted data, and evaluated the risk of bias. Meta-analysis was conducted with Stata/SE software.</p><p><strong>Results: </strong>A total of 20 articles involving 869 patients met the inclusion criteria. Cyclophosphamide reduced mRSS score by 2.30 (95% CI 0.72-3.88), 4.53 (95% CI 2.91-6.14), 6.72 (95% CI 2.74-10.70), 5.70 (95% CI 4.04-7.36), and 4.60 (95% CI 3.18-6.02) at 6-, 12-, 18-, 24- and 36-month, respectively. The estimated effect size, obtained by pooling mRSS from all studies at the follow-up endpoint, decreased by 4.71 (95% CI 2.72-6.70). In diffuse cutaneous SSc (dcSSc) subtype, the pooled mRSS decreased by 3.02 (95% CI 1.46-4.58), 6.45 (95% CI 5.02-7.87), 8.03 (95% CI 5.26-10.80), and 6.34 (95% CI 6.00-6.68) at 6-, 12-, 18-, and 24-month, respectively. And the overall reduction in mRSS at the end of follow-up in dcSSc was 7.30 (95% CI 5.61-8.99) across 11 studies. Significant heterogeneity was observed among these studies, and subgroup analysis revealed that study size and disease subtype partially explained the heterogeneity. Sensitivity analysis indicated good study stability.</p><p><strong>Conclusion: </strong>Cyclophosphamide effectively reduced mRSS scores in SSc, particularly in dcSSc. While skin thickness improvement diminishes after 24 months, it remains a viable option for patients with worsening skin fibrosis.</p><p><strong>Trial registration: </strong>PROSPERO registration number: CRD42024502283. Registered on 25 January 2024.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"863-874"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143810864","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}