European Journal of Clinical Pharmacology最新文献

{"title":"A meta-analysis and systematic review of the first Trop-2-targeting antibody-drug conjugate (sacituzumab govitecan) in treating metastatic breast cancer.","authors":"Jue Wang, Shengyou Lin, Jialin Zhang, Jingyang Su","doi":"10.1007/s00228-025-03876-w","DOIUrl":"10.1007/s00228-025-03876-w","url":null,"abstract":"<p><strong>Objectives: </strong>To assess the effectiveness and safety of sacituzumab govitecan in metastatic breast cancer (MBC), we performed a meta-analysis of randomized controlled trials comparing sacituzumab govitecan with chemotherapy.</p><p><strong>Methods: </strong>We systematically searched multiple databases for relevant studies. Primary outcomes included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), and adverse events (AEs). Data were analyzed using RevMan 5.3 software.</p><p><strong>Results: </strong>Three studies were included after rigorous screening and quality assessment. Compared with chemotherapy, sacituzumab govitecan significantly prolonged PFS [HR 0.57; 95% CI 0.43, 0.77; P = 0.0002], improved OS [HR 0.64; 95% CI 0.48, 0.85; P = 0.002], and increased ORR [RR 2.84; 95% CI 1.27, 6.37; P = 0.01]. However, sacituzumab govitecan was associated with higher incidence of AEs (P < 0.00001).</p><p><strong>Conclusion: </strong>In this study, sacituzumab govitecan demonstrated improved PFS and OS compared to chemotherapy regimens in patients with MBC. Further research is required to validate its broad applicability and long-term treatment stability.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1275-1285"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144583458","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":"Why do patients have doubts about generic drugs in Italy?","authors":"L Pasina, Sam Urru, S Mandelli","doi":"10.1007/s00228-016-2069-2","DOIUrl":"10.1007/s00228-016-2069-2","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1377-1379"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"34387517","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":"Pretomanid can significantly increase plasma rivaroxaban concentrations-a case report.","authors":"Dali Fan, Teurai Chikura, Sarah McCrostie, Paul Ken Leong Chin","doi":"10.1007/s00228-025-03871-1","DOIUrl":"10.1007/s00228-025-03871-1","url":null,"abstract":"<p><strong>Background: </strong>Rivaroxaban, a direct factor Xa inhibitor, is an oral anticoagulant used in the prevention and treatment of thromboembolic disease. The clearance of rivaroxaban involves excretion unchanged via the kidneys where it is subject to active secretion into the renal tubules, involving P-glycoprotein (P-gp) and organic anion transporter 3 (OAT3). Pretomanid, a nitroimidazole antibiotic used for multidrug-resistant tuberculosis (MDR-TB), is an OAT3 inhibitor based on in vitro data. This case report describes a \"natural experiment\" involving rivaroxaban concentration monitoring. It entails a novel pharmacokinetic interaction between rivaroxaban and pretomanid in a 61-year-old male undergoing MDR-TB treatment.</p><p><strong>Result: </strong>Following pretomanid initiation, rivaroxaban trough plasma concentration increased more than two-fold, prompting a halving of rivaroxaban dose, and subsequent restoration of trough concentration to pre-pretomanid value.</p><p><strong>Discussion: </strong>This interaction appears to be mediated by pretomanid inhibition of OAT3, which reduces renal clearance of rivaroxaban. Other components of MDR-TB regimen and pre-existing medications are unlikely to be contributory based on their pharmacokinetic profiles.</p><p><strong>Conclusion: </strong>This case highlights the potential impact of drug interactions involving pretomanid and known OAT3 perpetrators on the pharmacokinetics of rivaroxaban and other OAT3 substrates, particularly those of low therapeutic index, such as methotrexate. Given the global rise in MDR-TB, further research into pretomanid as a perpetrator of drug interactions is warranted.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1329-1332"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539615","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":"Severe drug-associated anaphylaxis: a complementary descriptive analyses of registry cases and spontaneous reports.","authors":"Patrick Christ, Diana Dubrall, Sabine Dölle-Bierke, Wojciech Francuzik, Matthias Schmid, Bernhardt Sachs, Margitta Worm","doi":"10.1007/s00228-025-03868-w","DOIUrl":"10.1007/s00228-025-03868-w","url":null,"abstract":"<p><strong>Purpose: </strong>Drugs are among the most common triggers of severe anaphylactic reactions in adults. The aim of our study was to identify the most frequently suspected drugs and associated factors of severe drug-associated anaphylactic reactions in two different data sources. Moreover, the impact of the route of administration (oral versus intravenous) was investigated.</p><p><strong>Methods: </strong>Severe drug-associated anaphylactic reactions from Germany were analysed in 1046 cases of the European Anaphylaxis Registry and in 1878 spontaneous reports of the European adverse drug reaction (ADR) database EudraVigilance.</p><p><strong>Results: </strong>Several analgesics, antibiotics and contrast media were among others reported most frequently in both data sources. In addition, antineoplastic and immunomodulating agents were commonly reported in spontaneous reports. As associated factors, thyroid disorders, asthma and chronic obstructive pulmonary diseases, as well as cardiovascular diseases, were frequently reported in both. Serious reactions such as cardiac arrest were more commonly reported for intravenously administered drugs, while skin reactions were more common for orally administered drugs.</p><p><strong>Conclusions: </strong>The analyses of two datasets differing regarding their data collection enables to get a more complete picture of severe anaphylactic reactions in real world settings. Our study confirms that patients with thyroid disorders, cardiovascular and respiratory diseases (e.g. asthma) might carry a higher risk to develop severe anaphylactic reaction. The more serious course of anaphylactic reactions related to intravenously compared to orally applied drugs may result from the faster availability of intravenously administered drugs or differences among the patient populations.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1301-1314"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398439/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144505217","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-marketing safety signals of imatinib: pharmacovigilance insights from the FDA Adverse Event Reporting System (FAERS) and implications for clinical practice.","authors":"Tianqin Xia, Bo Shu, Yuan Peng, Baiqiang Wang","doi":"10.1007/s00228-025-03872-0","DOIUrl":"10.1007/s00228-025-03872-0","url":null,"abstract":"<p><strong>Aims: </strong>To evaluate the safety profile of imatinib using the FDA Adverse Event Reporting System (FAERS) database, identifying both documented and undocumented adverse events.</p><p><strong>Methods: </strong>The FAERS data is widely used in drug safety surveillance studies, helping to identify potential safety issues. The FAERS data, spanning from the first quarter of 2014 to the fourth quarter of 2024, were subjected to a comprehensive analysis utilizing various disproportionality analysis methods. These methods included the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayes geometric mean (EBGM). The primary objective of this analysis was to quantify the associations between specific drugs and their corresponding adverse events (AEs). By employing these advanced statistical techniques, we aimed to identify and evaluate potential safety signals within the vast dataset, thereby providing valuable insights into the pharmacovigilance landscape over the specified decade.</p><p><strong>Results: </strong>A total of 56,364 reports (170,659 AE occurrences) were included. Imatinib exhibited expected AEs (e.g., nausea, diarrhea) consistent with summaries of product characteristics (SPCs), alongside potential novel signals such as pubertal failure, large intestine fibroma, ototoxicity, and pregnancy complications. Severe outcomes comprised 84.24% of reports (34.44% death), with 38.08% of AEs occurring > 360 days post-treatment. Malignant neoplasm progression showed a strong association.</p><p><strong>Conclusions: </strong>This study has revealed the safety issues of imatinib, particularly in terms of gastrointestinal reactions. It emphasizes the need for careful monitoring and further research in clinical applications to understand the mechanism, improve treatment efficacy, and minimize adverse events.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1343-1353"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398436/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144583459","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":"Delayed psychotropic toxicity after switching from nevirapine to bictegravir: the role of enzyme de-induction in people with HIV and polypharmacy.","authors":"Giacomo Pozza, Andrea Giacomelli, Annalisa Ridolfo, Maria Vittoria Cossu, Andrea Gori, Dario Cattaneo, Cristina Gervasoni","doi":"10.1007/s00228-025-03873-z","DOIUrl":"10.1007/s00228-025-03873-z","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1375-1376"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144539614","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":"Response commentary: genome‑wide association study of direct oral anticoagulants and their relation to bleeding.","authors":"Sofia Attelind, Niclas Eriksson, Mia Wadelius, Pär Hallberg","doi":"10.1007/s00228-025-03864-0","DOIUrl":"10.1007/s00228-025-03864-0","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1373"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144309764","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":"Comparison between clopidogrel and ticagrelor in CYP2C19 loss-of-function alleles coronary artery disease and stroke patients: a meta-analysis.","authors":"Mahmoud Elsayed, Mostafa Hossam El Din Moawad, Mohammed Elkholy, Yousr Ahmed, Younes Nabgouri, Gulnaz Bahtiyarova, Ibraheem M Alkhawaldeh, Mohamed Abouzid, Reham M Wagih","doi":"10.1007/s00228-025-03860-4","DOIUrl":"10.1007/s00228-025-03860-4","url":null,"abstract":"<p><strong>Background: </strong>It is suggested that in patients with coronary artery diseases (CAD) and stroke, the use of ticagrelor and aspirin may perform better than clopidogrel and aspirin regarding the risk of thrombosis/embolism, including recurrent myocardial infarction (MI) and cardiovascular death, especially in those carrying CYP2C19 loss-of-function (LOF) alleles. Therefore, we conducted the present systematic review and meta-analysis to investigate the effect of clopidogrel and ticagrelor in CAD and stroke patients with CYP2C19 LOF alleles (poor metabolizers of clopidogrel).</p><p><strong>Methods: </strong>We performed the current systematic review and meta-analysis by searching for all eligible publications on PubMed, Web of Science, and Scopus from inception to November 2024. A search strategy employing three primary keywords in conjunction with their corresponding Medical Subject Headings (MeSH) terms: \"Ticagrelor\" AND \"Clopidogrel\" AND \"CYP2C19\" (PROSPERO ID CRD420251050533). We implemented the odds ratio (OR) as an effect estimate for the dichotomous variables. The analysis was done at 95% confidence intervals (CI), and the p-value was significant if it was less than or equal to 0.05.</p><p><strong>Results: </strong>Using clopidogrel was associated with an increased risk of thrombosis/embolism compared with ticagrelor, showing OR = 1.78 (95%CI, 1.08, 2.95; p = 0.02). Also, clopidogrel led to an increased risk of stroke, whether when used in stroke or CAD patients with CYP2C19 LOF alleles, compared with ticagrelor, with an overall OR = 1.43 (95%CI, 1.23, 1.66; p < 0.00001) and a higher rate of MI with OR = 1.53 (95%CI, 1.22, 1.92; p = 0.0003). No significant difference was observed between the two groups (clopidogrel and ticagrelor) in stroke or CAD patients with OR = 0.98 (95%CI, 0.79, 1.22; p = 0.87). Also, no significant difference was observed between both groups regarding the risk of minor bleeding in stroke or CAD patients with OR = 0.66 (95%CI, 0.42, 1.05; p = 0.08) and any types of bleeding (major or minor bleeding) with overall OR = 0.81 (95%CI, 0.54, 1.21; p = 0.3) and I² = 88%, p < 0.00001.</p><p><strong>Conclusion: </strong>The meta-analysis of the selected articles indicated a preference for ticagrelor over clopidogrel in patients with stroke or CAD possessing CYP2C19 LOF alleles. The reduced incidence of thrombosis/embolism and associated events, such as stroke and MI, was noted in individuals administered ticagrelor in comparison to those receiving clopidogrel. Bleeding remains a concern with ticagrelor; however, current studies indicate its safety since there are no significant changes in the risk of minor and major bleeding and ICH compared to clopidogrel.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1241-1256"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398434/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144324851","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":"Efficacy and safety of colchicine post myocardial infarction: a systematic review, meta-analysis and meta-regression analysis of randomized clinical trials.","authors":"Farhan Naeem, Shehroze Tabassum, Muhammad Burhan, Elsayed Balbaa, Ahmed Ibrahim, Shrouk Ramadan, Usama Qamar, Fatima Saeed, Mohamed Abuelazm, Dmitry Abramov, Timir K Paul, Yasar Sattar","doi":"10.1007/s00228-025-03869-9","DOIUrl":"10.1007/s00228-025-03869-9","url":null,"abstract":"<p><strong>Background: </strong>Myocardial infarction (MI) triggers inflammation that affects post-MI outcomes. Colchicine shows potential in treating cardiovascular (CV) conditions; however, its role in reducing adverse CV events post-MI remains uncertain.</p><p><strong>Methods: </strong>We conducted a thorough search across PubMed, Embase, Web of Science from inception to February 2025 for randomized controlled trials (RCTs) comparing colchicine and control in MI patients. Outcomes were analyzed using a random-effects model to pool relative risks (RRs) and mean differences (MD) with 95% confidence intervals (CIs).</p><p><strong>Results: </strong>A total of 14 RCTs incorporating 14,326 patients were included. The incidence of adverse CV events, all-cause mortality, cardiac-specific mortality, non-cardiac specific mortality, recurrent MI, repeat revascularization and post-MI heart failure (HF), post-MI atrial fibrillation (AF), and stroke were comparable between colchicine and control groups. In both colchicine and control groups, a similar change in high-sensitivity C-reactive protein (hs-CRP) from the baseline was observed. Regarding the safety profile, both colchicine and control had overall comparable any adverse effects; however, gastrointestinal adverse events (RR: 1.74, 95% CI [1.20, 2.51], P = 0.003) were higher in the colchicine group. The incidence of myelotoxicity or infections was comparable between both groups.</p><p><strong>Conclusions: </strong>Colchicine was not beneficial in reducing adverse CV events, mortality, recurrent MI, repeat revascularization, post-MI HF, post-MI AF, and stroke following acute MI compared to control. However, colchicine use was associated with a higher incidence of gastrointestinal adverse events, with no notable increase in any adverse effects, myelotoxicity, or infections.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1257-1274"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144474379","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":"Understanding attitudes towards psychiatric medications: a comparative study of patients, healthcare professionals, and general population perspectives.","authors":"Seda Yavuz, Yavuz Yılmaz, Erdi Bahadır","doi":"10.1007/s00228-025-03879-7","DOIUrl":"10.1007/s00228-025-03879-7","url":null,"abstract":"<p><strong>Background: </strong>In recent years, with the increasing challenges in living conditions, there has been a rise in individuals seeking psychiatric support. This situation may lead to changes in attitudes and perceptions towards psychiatric medication treatments.</p><p><strong>Aim: </strong>This study aims to examine the attitudes of stable psychiatric patients, healthcare professionals, and the general population toward psychiatric medication treatments.</p><p><strong>Method: </strong>The study included 311 stable psychiatric patients, 200 healthcare professionals, and 274 participants from the general population. Participants were administered a data form that questioned sociodemographic and clinical characteristics, the Drug Attitude Inventory-10, and the Beliefs about Medicines Questionnaire.</p><p><strong>Results: </strong>The study reveals significant differences in attitudes towards medication among stable psychiatric patients, non-psychiatric healthcare professionals, and the general population. Stable psychiatric patients tend to have a stronger belief in the positive effects of medication and are more likely to internalize medications in their daily lives. However, this group experiences side effects more intensely compared to other groups. Healthcare professionals maintain a balanced stance regarding the benefits and side effects of medications, while the general population exhibits a more negative attitude towards medications and expresses greater concern about the addictive potential of these drugs.</p><p><strong>Conclusion: </strong>Considering these differences may contribute to more effective management of treatment processes and improve attitudes toward medications.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1355-1363"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144599766","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}