European Journal of Clinical Pharmacology最新文献

{"title":"Reply to correspondence.","authors":"Omar Ismail, Karam Albdour, Yazan Jaber, Kamel Jaber, Ameen Alsaras","doi":"10.1007/s00228-025-03827-5","DOIUrl":"10.1007/s00228-025-03827-5","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"895-897"},"PeriodicalIF":2.4,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143709287","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":"https://doi.org/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":""},"PeriodicalIF":2.4,"publicationDate":"2025-05-29","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":"Signal detection of ferric carboxymaltose-induced serious adverse events: disproportionality analysis of FAERS and VigiBase data and systematic review of case reports.","authors":"Reddikumar Reddy Galigutta, Christy Thomas, Mahesh Rathod, P N Hasik, R S Ray, Jai Prakash, Krishna Undela","doi":"10.1007/s00228-025-03849-z","DOIUrl":"https://doi.org/10.1007/s00228-025-03849-z","url":null,"abstract":"<p><strong>Purpose: </strong>The recent surge in serious adverse events (SAEs) and deaths associated with ferric carboxymaltose (FCM) underscores the importance of evaluating its safety profile.</p><p><strong>Methods: </strong>We conducted a retrospective case/non-case study from Q4 of 2003 to Q4 of 2024 data on FCM in the FDA Adverse Event Reporting System (FAERS) and VigiBase databases. Signal detection was performed using proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The influence of concomitant medication on the identified signal was assessed and refined using Open Vigil 2.1. Additionally, to identify case reports on FCM-induced adverse events, a comprehensive search was performed in PubMed, Google Scholar, and Scopus databases from inception to April 12, 2025.</p><p><strong>Results: </strong>In the FAERS database, 46 deaths were reported in connection with FCM, though no significant death signal was observed (PRR = 0.3, LB (lower bound) ROR = 0.2, IC₀₂₅ = - 2.3). Nonetheless, positive safety signals emerged for SAEs such as anaphylactic shock (PRR = 3.9, LB ROR = 2.3, IC₀₂₅ = 1.0), circulatory collapse (PRR = 14.6, LB ROR = 10.5, IC₀₂₅ = 3.1), respiratory distress (PRR = 9.6, LB ROR = 7.1, IC₀₂₅ = 2.6), hypophosphatemia (PRR = 520.7, LB ROR = 530.1, IC₀₂₅ = 8.0), and arrhythmia (PRR = 3.3, LB ROR = 2.2, IC₀₂₅ = 1.0). After meticulously refining our analysis to account for the influence of concomitant medications, we observed that the strength of all signals remained unchanged, except for respiratory distress, bradycardia, hypotension, abdominal pain, and urticaria. Analysis of VigiBase data revealed 42 reported fatal cases and potential signals for hypersensitivity (PRR = 4.5, LB ROR = 4.4, IC₀₂₅ = 2.1), anaphylactic shock (PRR = 2.3, LB ROR = 1.9, IC₀₂₅ = 0.9), circulatory collapse (PRR = 7.2, LB ROR = 6.0, IC₀₂₅ = 2.5), respiratory distress (PRR = 6.9, LB ROR = 5.7, IC₀₂₅ = 2.5), and hypophosphatemia (PRR = 245.1, LBROR = 234.8, IC₀₂₅ = 7.5) with Ferinject. The systematic review of 11 case reports emphasized SAEs linked to FCM, thereby strengthening this association.</p><p><strong>Conclusion: </strong>This study reveals that FCM carries SAEs. Providers must weigh the benefits and risks on a case-by-case basis, considering patient-specific factors. Continuous monitoring and further research are crucial for the safe use of FCM in iron deficiency anemia.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-05-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144119075","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":"Purine xanthine oxidase inhibitors are not conducive to the prognosis of chronic heart failure: a meta-analysis.","authors":"Lin Ye, Anyi Xu, Jianing Huang, Yeyuan Zhang, Jie Yao, Fang Wang","doi":"10.1007/s00228-025-03848-0","DOIUrl":"https://doi.org/10.1007/s00228-025-03848-0","url":null,"abstract":"<p><strong>Background: </strong>According to previous studies, the efficacy of xanthine oxidase inhibitors (XOIs) in patients with chronic heart failure (CHF) is still controversial. Therefore, the purpose of this study was to investigate the efficacy of XOIs in patients with CHF.</p><p><strong>Methods: </strong>Up to July 2024, we searched PubMed, EMBASE, Medline, Web of Science, and Cochrane Library for studies on the efficacy of XOI in patients with CHF. The main results included all-cause mortality, cardiovascular (CV) mortality, and heart failure (HF) hospitalization rates. The results were evaluated by hazard ratio (HR) and 95% confidence interval (95% CI).</p><p><strong>Results: </strong>A total of eight studies were included in this meta-analysis, of which five were cohort studies and three were randomized controlled trials (RCTs). The total sample size was 301,345. The experimental group was exposed to allopurinol or hydroxypurinol. The all-cause mortality (HR = 1.26, 95% CI 1.05-1.51, p = 0.013) and CV mortality (HR = 1.58, 95% CI 1.17-2.14, p = 0.03) in the experimental group were higher than those in the control group. In terms of HF hospitalization, there was no difference between both groups (HR = 1.21, p = 0.292). Subgroup analysis showed that the CV hospitalization rate of the experimental group was higher than that of the control group, regardless of frequency and dose levels. The all-cause mortality in the low-dose group was higher than that in the control group (HR = 1.39, p = 0.033). The CV mortality of the low-dose group (HR = 1.55, p = 0.006) and the prevalent group (HR = 1.50, p = 0.042) was higher than that of the control group.</p><p><strong>Conclusion: </strong>Purine XOI exposure may be unfavorable for the prognosis of CHF patients and is affected by the frequency and dose of use.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-05-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143978052","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":"Pentoxifylline uses in inner ear diseases.","authors":"Ahmed Ramzi, Subhia Maya, Nadeen Balousha, Mufreh Amin, Rovan Ahmed Rouby, Ghalia Aljarrah, Dalia Gamal Elnady, Ahmed Samir, Thoria Ibrahim Essa Ghanm, Zahraa Natheer Bhaya, Abdallah Altarras, Fares Abdelsalam, Mohamed Yasser, Mahmoud Samir, Mostafa Ramzi Shiha","doi":"10.1007/s00228-025-03844-4","DOIUrl":"https://doi.org/10.1007/s00228-025-03844-4","url":null,"abstract":"<p><strong>Background: </strong>Labyrinth or the inner ear consists of the cochlea (for hearing) and vestibular system (for balance), with disorders affecting hearing, balance, or both, and symptomatology including hearing loss, tinnitus, and vertigo. Regulatory-approved medications for inner ear diseases are rare worldwide relative to the frequency of those diseases. There are no FDA-approved medications for any inner ear disease. This is due to multiple reasons, including the lack of conclusive evidence for various drugs that have been investigated. We aim to contribute to the review endeavor by addressing pentoxifylline (PTX), a medication that has been studied for cochlear and vestibular disorders, yet its efficacy and safety have not been systematically reviewed in a publication.</p><p><strong>Methods: </strong>More than a dozen databases from around the globe were systematically searched, including PubMed, EMBASE, Scopus, Web of Science, Cochrane/CENTRAL, ScienceDirect, Google Scholar, Europe PMC, ICTRP, ClinicalTrials.gov, EU-CTR, PsycInfo, LILACS, WPRIM, IBECS, SciELO, CNKI, VIP, and Wanfang, to methodically compile experimental and analytical studies. Search results are up to January 2025. This work focused on workable reports in which PTX had distinct or attributable results and organized them into overarching categories of vertigo, hearing loss, and tinnitus.</p><p><strong>Results: </strong>Forty studies, including 15 randomized controlled trials (RCTs), were included. Each condition was addressed in seven RCTs, with some overlap. Studies on inner ear vertigo reported significant outcomes for PTX. A large proportion of the literature involved idiopathic sudden sensorineural hearing loss (ISSNHL), but its results were mixed. Studies on tinnitus suggest that PTX has similar efficacy to Ginkgo biloba extract and corticosteroids, two of the most prescribed medications. Adverse events were generally mild and rarely necessitated discontinuation.</p><p><strong>Conclusion: </strong>Pentoxifylline could improve inner ear vertigo and tinnitus. In ISSNHL, results are inconsistent in the context of spontaneous recovery rates, albeit leaning toward ineffectiveness. Over a variety of regimens, it sustained good safety. The rigor and designs of the reports could not produce robust recommendations.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143976304","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":"Antithrombotic therapy for secondary stroke prevention in patients with cancer: a systematic review and network meta-analysis.","authors":"Leonardo Zumerkorn Pipek, Rafaela Farias Vidigal Nascimento, Sabrina Isabel Coronel, Mark Baker, Fernando Mayor Basto, Guilherme Diogo Silva","doi":"10.1007/s00228-025-03847-1","DOIUrl":"https://doi.org/10.1007/s00228-025-03847-1","url":null,"abstract":"<p><strong>Background: </strong>The risk of stroke among patients with cancer is two times that of the general population due to a combination of cancer-, chemotherapy-, radiotherapy-, and surgery-related factors. There is a paucity of data regarding the optimal antithrombotic therapy for secondary stroke prevention in these patients.</p><p><strong>Objectives: </strong>Our goal was to review the stroke recurrence in patients treated with different antithrombotic therapies (antiplatelets, warfarin, heparin, and direct oral anticoagulants). Our secondary objective was to review the bleeding risk across different antithrombotic therapies.</p><p><strong>Methods: </strong>A review of the literature was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Articles that adequately assessed secondary prevention of stroke in patients with cancer were selected from the PubMed, Embase, and Scopus databases from inception until March 2, 2025. We performed a network meta-analysis for stroke recurrence, major bleeding, and mortality. The treatments were ranked by P-SCORE. Subgroup analyses were conducted based on median D-dimer levels, multiple territories of stroke, and exclusion of studies with high risk of bias.</p><p><strong>Results: </strong>We included 11 studies (four RCTs, six retrospective studies, and one case series) with a total of 1319 patients. In the primary analysis, antiplatelets were the highest-ranked treatment for reducing stroke recurrence (RR 0.44 [0.20; 0.96]), followed by LMWH (RR 0.50 [0.26; 0.96]), both significantly superior to no treatment. However, LMWH consistently ranked higher than antiplatelets in all subgroup analyses. There was no difference regarding major bleeding or mortality.</p><p><strong>Conclusion: </strong>Antiplatelets can be considered an option for secondary prevention of stroke in patients with cancer, especially in patients with a higher bleeding risk. Future research with high-quality studies is needed to confirm our preliminary findings and should focus on identifying subgroups of patients with cancer who may benefit most from specific antithrombotic therapies.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143974047","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":"https://doi.org/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":""},"PeriodicalIF":2.4,"publicationDate":"2025-05-06","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":"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":"https://doi.org/10.1007/s00228-025-03843-5","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.4,"publicationDate":"2025-05-05","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":"The effect of colchicine on coagulation in patients with chronic coronary disease who use vitamin K antagonists.","authors":"Jeroen P A Houwen, Arief Lalmohamed, Jochem Zwaan, Toine C G Egberts, Michiel Duyvendak, Aernoud T L Fiolet, Arend Mosterd","doi":"10.1007/s00228-025-03815-9","DOIUrl":"10.1007/s00228-025-03815-9","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Low-dose (0.5 mg/day) colchicine improves cardiovascular outcomes in patients with stable coronary disease. Around 10-15% of these patients simultaneously use anticoagulant therapy, including vitamin-K antagonists (VKAs). In vitro studies and case reports have described a possible interaction between colchicine and VKAs leading to increased INR, but controlled studies are lacking.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;The aim of this study was to investigate if there is a drug-drug interaction between low-dose colchicine and VKAs in patients with chronic coronary disease.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This study was a sub-analysis of the randomized low-dose colchicine for secondary prevention of cardiovascular disease 2 (LoDoCo2) trial. This placebo-controlled trial investigated efficacy of colchicine 0.5 mg once daily in patients with chronic coronary disease. For the current study, we included a selection of Dutch patients who concomitantly used a VKA. Following a 30 days open-label colchicine run-in phase, patients were randomized to colchicine or placebo. The primary outcome was the intra-patient difference in international normalized ratio (INR) during the first month after starting or stopping colchicine as compared to the preceding month. Secondary outcomes included changes in VKA daily dosage, assessed in the same pattern and before and after randomization, and time in therapeutic range (TTR), assessed before and after randomization to reflect long-term effects. INR measurements were part of routine clinical care.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;In total, 73 patients were included (35 colchicine and 38 in the placebo group). No significant intra-patient change in INR was observed after starting colchicine during the open-label run-in phase (mean INR: 2.60 before vs. 2.67 during run-in, difference 0.07, 95% CI - 0.13 to 0.26; p = 0.50). Similarly, stopping colchicine treatment (i.e., randomization to placebo) did not significantly alter INR levels (mean INR: 2.70 during run-in vs. 2.81 after randomization, difference 0.11, 95% CI - 0.12 to 0.33; p = 0.34). The change in mean VKA daily dosage was - 0.01 mg (95% CI - 0.03 to 0.01; p = 0.35) when starting colchicine and - 0.01 mg (95% CI - 0.03 to 0.01; p = 0.41) when switching to placebo. TTR in patients allocated to active treatment was 65.8% in the year prior to the start of colchicine and 73.4% in the year after randomization to colchicine (change in TTR 7.56%, 95% CI - 0.14 to 15.26%; p = 0.05). Mean VKA dosage remained similar (change in VKA dosage of 0.01 mg; 95% CI - 0.11 to 0.13 mg; p = 0.84).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusion: &lt;/strong&gt;No significant changes in INR, VKA dosage, or TTR in patients using VKAs after starting or stopping colchicine were observed. These results suggest that there is no need for additional INR monitoring beyond the standard of care when using low-dose colchicine, though further studies in larger populations would help to confirm this ","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"719-725"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12003603/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143572584","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":"Unveiling cardiovascular and respiratory toxicities with monoclonal antibodies in multiple myeloma: disproportionality analysis from the FDA Adverse Event Reporting System.","authors":"Maria Antonietta Barbieri, Giulia Russo, Giuseppe Cicala, Giuseppe Andò, Tindara Franchina, Nicola Silvestris, Mariacarmela Santarpia, Edoardo Spina","doi":"10.1007/s00228-025-03824-8","DOIUrl":"10.1007/s00228-025-03824-8","url":null,"abstract":"<p><strong>Introduction: </strong>Monoclonal antibodies (mAbs) have revolutionized the treatment of multiple myeloma (MM), demonstrating remarkable effectiveness, despite potential adverse events (AEs). This study aims to identify unexpected signals of disproportionate reporting (SDRs) for cardiovascular (CV) and respiratory AEs associated with mAbs in MM treatment.</p><p><strong>Methods: </strong>From January 2015 to December 2023, reports involving suspected drugs (daratumumab, elotuzumab, elranatamab, isatuximab, belantamab mafodotin, teclistamab, and talquetamab) were analyzed in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database. Descriptive analysis was followed by disproportionality analyses first comparing mAbs to all other drugs (reference group, RG1), and subsequently conducting a sensitivity analysis against other MM drugs (RG2).</p><p><strong>Results: </strong>Out of 13,496,241 reports, 31,052 (0.2%) were associated with MM, with 6574 (0.1%) linked to CV and respiratory adverse events, primarily involving older population (n = 3441; 52.3%) and male (n = 3338; 50.8%) patients. Disproportionality analyses identified unexpected SDRs for daratumumab, including cardiac failure (n = 322; RG1: ROR = 4.74, CI 95% = 4.24-5.29; RG2: ROR = 4.42, 95% CI = 3.91-4.99), embolic and thrombotic event, such as pulmonary embolism (162; RG1: 2.44, 2.09-2.85), deep vein thrombosis (126; RG1: 2.95, 2.47-3.52), and respiratory failure (192; RG1: 4.06, 3.52-4.68; RG2: 4.2, 3.59-4.91). Isatuximab was linked to cardiac arrhythmia, such as atrial fibrillation (46; RG1: 2.54, 1.9-3.4; RG2: 1.35, 1.01-1.81), embolic and thrombotic event, including deep vein thrombosis (26; RG1: 2.93, 1.99-4.3) and pulmonary embolism (89; RG1: 6.56, 5.32-8.1; RG2: 2.93, 2.37-3.63). Elotuzumab showed also SDRs for atrial fibrillation (56; RG1: 3.68, 2.82-4.79; RG2: 1.96, 1.5-2.56) and deep vein thrombosis (41; RG1: 5.49, 4.03-7.47).</p><p><strong>Conclusion: </strong>Unexpected CV and respiratory AEs with clinical relevance not previously reported in literature have been identified underlining the importance of pharmacovigilance.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"755-770"},"PeriodicalIF":2.4,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143647741","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}