European Journal of Clinical Pharmacology最新文献

{"title":"β-blocker and clinical outcomes in patients after myocardial infarction: a systematic review and meta-analysis.","authors":"Wenxing Yang, Xuehong Sun, Yushu Zhang, Zhi Lu, Zhilong Shu, Kui Zhang","doi":"10.1007/s00228-025-03919-2","DOIUrl":"https://doi.org/10.1007/s00228-025-03919-2","url":null,"abstract":"<p><strong>Background and objective: </strong>While current clinical guidelines generally advocate for beta-blocker therapy following acute myocardial infarction (AMI), conflicting findings have surfaced through large-scale observational studies and meta-analyses. We conducted this systematic review and meta-analysis of published observational studies to quantify the long-term therapeutic impact of beta-blocker across heterogeneous AMI populations.</p><p><strong>Methods: </strong>We conducted comprehensive searches of the PubMed, Embase, Cochrane, and Web of Science databases for articles published from 2000 to 2025 that examine the link between beta-blocker therapy and clinical outcomes (last search update: March 1, 2025). We used the odds ratio (OR) with its 95% confidence interval (95% CI) to evaluate the effect of beta-blocker therapy on all-cause mortality, cardiac death, or major adverse cardiac events (MACE) in AMI patients. Our analysis stratified these effects by study type, ejection fraction (EF), sample size, follow-up duration, and patient characteristics including primary coronary revascularization, ST-segment elevation status, and comorbidities.</p><p><strong>Results: </strong>This meta-analysis incorporated 34 observational studies covering 233,303 AMI patients. Our results showed beta-blockers reduced all-cause (OR = 0.73, 95% CI = 0.64-0.82) and cardiac mortality (OR = 0.79, 95% CI = 0.70-0.89) in post-AMI patients, with no significant effect on MACE. In these patients, post-PCI and STEMI patients, beta-blockers lowered all-cause mortality but not MACE risk. Subgroup analysis revealed that beta-blockers decreased all-cause death in post-AMI patients with diabetes and COPD, but not in those with hypertension and AF. Stratified by EF, beta-blockers were beneficial for all-cause death (OR = 0.75, 95% CI = 0.60-0.93), cardiac death (OR = 0.72, 95% CI = 0.56-0.92), and MACE (OR = 0.85, 95% CI = 0.76-0.96) in post-AMI patients with reduced EF and only decreased all-cause death in those with preserved EF.</p><p><strong>Conclusions: </strong>Our meta-analysis suggests beta-blockers may offer long-term clinical benefits to AMI patients, particularly those with reduced EF. However, this is not conclusive for AMI patients with comorbidities or preserved EF.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145029281","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":"Economic evaluation of antibody-drug conjugates (ADCs) in patients with breast cancer: systematic review.","authors":"Mohammad Ali Rezaei, Hamid Pourasghari, Fereshte Karimi, Soheila Rajaie, Amirreza Shahmohammady, Masoud Behzadifar, Amir Hossein Dehqan, Samad Azari","doi":"10.1007/s00228-025-03915-6","DOIUrl":"https://doi.org/10.1007/s00228-025-03915-6","url":null,"abstract":"<p><strong>Introduction: </strong>Metastatic breast cancer (mBC) is a major global health challenge. Antibody-drug conjugates (ADCs), including trastuzumab emtansine (T-DM1), trastuzumab deruxtecan (T-DXd), and sacituzumab govitecan (SG), offer clinical benefits but are associated with high costs, making cost-effectiveness assessments essential for policy decisions.</p><p><strong>Methods: </strong>This systematic review analyzed economic evaluations comparing T-DM1, T-DXd, and SG with conventional treatments in breast cancer. A search of four databases and gray Literature up to November 2024 included studies reporting ICERs, QALYs, and LYGs. Data were extracted per PRISMA and CHEERS guidelines.</p><p><strong>Results: </strong>Twenty-nine studies from the USA, China, Brazil, Germany, Finland, Singapore, and Canada were reviewed. In the USA, ICERs for T-DXd ranged from $194,424/QALY (HR-) to $406,900/QALY, often exceeding WTP thresholds ($100K-$200K). It was cost-effective in HR- patients and those with good ECOG. In China, ICERs > $50,000/QALY exceeded the national threshold (~ $36,475/QALY). In Finland, T-DXd was cost-effective vs. T-DM1 (€55,360/QALY). T-DM1 was cost-effective in Canada (-$3,844/QALY) and select U.S. studies, but not in Brazil ($99,699/QALY) or China. Drug pricing was a key driver; U.S. results varied, perhaps due to modeling differences and sponsor bias. SG was not cost-effective in any country. ICERs ranged from $237,816/QALY (Singapore) to > $1.3 million/QALY (USA). In China, the cost-effectiveness probability was 0% at current prices.</p><p><strong>Conclusion: </strong>T-DXd and T-DM1 may be cost-effective in select groups and high-income countries. SG is not cost-effective anywhere. Drug prices are the main determinant of value, highlighting the need for price negotiations and more regional studies.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145029102","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":"Influence of ultrafiltration conditions on the unbound fraction of phenytoin and valproic acid.","authors":"Pjotr P Temme, Matthijs van Luin, Maarten J Deenen, Ron Meijer, Nynke G L Jager, Mirte M Malingré","doi":"10.1007/s00228-025-03918-3","DOIUrl":"https://doi.org/10.1007/s00228-025-03918-3","url":null,"abstract":"<p><strong>Purpose: </strong>This study was designed to analyse the influence of temperature, pH and storage time on unbound fractions of PHT and VPA.</p><p><strong>Methods: </strong>The influence of ultrafiltration (UF) temperature on measured unbound fractions of PHT and VPA in spiked samples was evaluated in a single laboratory experiment and in data from a national external quality control (EQC) database. The influence of pH adjustment with phosphate buffered saline (PBS) on measured unbound fractions of PHT and VPA was investigated in patient samples. The influence of storage time on unbound fractions of PHT and VPA was examined in patient samples by performing UF at various time points.</p><p><strong>Results: </strong>Performing UF at a temperature of 37 °C compared to 20 °C significantly increased (p < 0.05) the measured unbound fractions for both PHT (range 14.8-26.3%) and VPA (range 5.7-16.0%) in the single laboratory experiment. Consistent with these findings, reported unbound fractions in the ECQ database of PHT were significantly higher with UF at 37 °C compared to room temperature. For VPA, this was not the case. However, for both drugs, the number of laboratories performing UF at 37 °C was limited (n = 2-4). Adjustment of pH with PBS was unfeasible. After 4 days of storage at 5 °C, the unbound fraction of PHT seemed to remain stable whereas the unbound fraction of VPA appeared to increase (27.4%) (n = 3).</p><p><strong>Conclusion: </strong>Higher UF temperatures led to an increase in measured unbound fractions of both PHT and to a lesser extent VPA. Storage time of plasma samples might influence the unbound fraction of VPA.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145023082","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":"A real-world pharmacovigilance study of FDA Adverse Event Reporting System events for gefitinib and docetaxel.","authors":"Chengqian Cui, Bingge Li, Xiaoxia Zhang","doi":"10.1007/s00228-025-03905-8","DOIUrl":"https://doi.org/10.1007/s00228-025-03905-8","url":null,"abstract":"<p><strong>Background: </strong>In recent years, gefitinib and docetaxel, as targeted and chemotherapeutic agents, respectively, have been widely used in the treatment of non-small cell lung cancer (NSCLC). However, the safety of these drugs remains a significant concern in clinical practice. Comparative studies on the safety of these two drugs have yet to be fully explored. This study aimed to analyze adverse event (AE) signals associated with gefitinib and docetaxel in the treatment of NSCLC using the FDA Adverse Event Reporting System (FAERS), providing insights for clinical practice and package insert.</p><p><strong>Methods: </strong>Adverse events for gefitinib and docetaxel were retrieved from the FDA Adverse Event Reporting System (FAERS) from the first quarter of 2004 (2004 Q1) through the fourth quarter of 2024 (2024 Q4). The reporting odds ratio method was used to identify risk signals. The results were standardized and classified using the System Organ Class (SOC) and Preferred Terms (PT) in the 26.1 version of the Medical Dictionary for Regulatory Activities (MedDRA) and compared with the package insert.</p><p><strong>Results: </strong>The FAERS received 8214 and 42,453 AE reports for gefitinib and docetaxel, respectively. An analysis of the top 100 AEs ranked by signal strength revealed 64 positive PTs for gefitinib, spanning 14 SOCs, 45 of which were not mentioned in the package insert. For docetaxel, 61 positive PTs were identified, involving 15 SOCs, with 33 AEs not mentioned in the package insert. The top 5 PTs with the highest signal strength for gefitinib were PRIDE syndrome, drug resistance, lymphangiosis carcinomatosa, xeroderma, and skin disorder. For docetaxel, the top 5 PTs were lacrimal structure injury, madarosis, hair disorder, variations in hair color, and psychological trauma.</p><p><strong>Conclusion: </strong>The potential adverse reactions of gefitinib and docetaxel are not fully covered in their package insert. The newly identified AE signals provide critical evidence for the improvement of the package insert. These findings have significant implications for individualized clinical treatment.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145006022","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":"Imeglimin systematic review: a novel therapeutic approach for type 2 diabetes-unveiling benefits on β-cell function, insulin sensitivity, and potential long-term glycaemic control (HbA1c).","authors":"S Murshidha Shireen, E Bhavya, R Parthiban","doi":"10.1007/s00228-025-03902-x","DOIUrl":"https://doi.org/10.1007/s00228-025-03902-x","url":null,"abstract":"<p><strong>Background: </strong>The prevalence of diabetes mellitus has surged fourfold globally over the past 30 years, creating a major health concern. Imeglimin, a novel oral antidiabetic agent, has shown promising results in the management of type 2 diabetes mellitus (T2DM).</p><p><strong>Objectives: </strong>This systematic review aimed to evaluate the efficacy and safety of imeglimin in patients with T2DM based on available clinical studies.</p><p><strong>Methodology: </strong>A total of 15 studies, including randomised clinical trials, observational studies, and retrospective analyses, were included in this review. These studies involved 2332 participants, predominantly with T2DM, aged 18 to 84 years. Imeglimin was administered at doses ranging from 500 to 3000 mg/day, either as monotherapy or in combination with other antidiabetic agents. The primary outcomes assessed were changes in glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), and insulin sensitivity.</p><p><strong>Results: </strong>Imeglimin (500 to 3000 mg/day) demonstrated significant reductions in HbA1c levels, ranging from 0.44 to 1.1%, compared to placebo. FPG and glycated albumin also decreased significantly with imeglimin treatment. Improvements in insulin sensitivity and β-cell function were observed in both animal and human studies. Imeglimin was generally well tolerated, with no significant adverse effects on cardiac safety. However, gastrointestinal side effects, such as nausea, vomiting, and diarrhoea, were reported in some studies using imeglimin at doses above 2000 mg/day.</p><p><strong>Conclusion: </strong>Imeglimin appears to be an effective and safe treatment option for T2DM, offering a unique mechanism of action and the potential for use as monotherapy or in combination with other antidiabetic agents. Further long-term studies are needed to establish its sustained efficacy and safety profile.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144991850","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":"Oral Melatonin for Pain Relief During Venepuncture in Neonates- a Pilot Randomized Control Trial.","authors":"Sushree Smita Behura, Santosh Kumar Panda, Subhrajyoti Tripathy, Ipsa Kujur, Swaranjika Sahoo, Deepti Damayanty Pradhan","doi":"10.1007/s00228-025-03914-7","DOIUrl":"https://doi.org/10.1007/s00228-025-03914-7","url":null,"abstract":"<p><strong>Purpose: </strong>This study aims to compare the analgesic efficacy of oral melatonin with placebo in neonates during venepuncture.</p><p><strong>Methods: </strong>This open-level, pilot randomized controlled trial was conducted in a tertiary care neonatal unit. Sixty eligible, non-sick neonates (gestational age ≥ 34 weeks) scheduled for venepuncture were randomized into the melatonin group (MG, n = 30) and the placebo group (PG, n = 30). MG received oral melatonin (1 mg/kg), and PG received 2 ml of normal saline. Pain intensity was measured by the Premature Infant Pain Profile-Revised (PIPP-R) during the procedure and at 1 min and 2 min post-procedure. Scores were compared between both groups using the Mann-Whitney U test, and the effect size was calculated with the rank-biserial correlation coefficient.</p><p><strong>Results: </strong>The demographic characteristics were comparable between the two groups. The median (Q1-Q3) PIPP-R score in MG and PG during the procedure was 10 (9-10) and 13 (12-14), respectively, r = 0.8, p < 0.001; at 1 min [3 (2-3) and 5.5 (4-7)], r = 0.69, p < 0.001; and at 2 min [0 (0-0) and 1 (0-2)], r = 0.3, p = 0.003. Melatonin improved autonomic stability during (lower heart rates and higher oxygen saturation) and after venepuncture (higher oxygen saturation). Although procedural facial expressions were similar, fewer neonates in the melatonin group showed pain-related facial cues post-procedure compared to placebo. No significant adverse effect was noted in either group.</p><p><strong>Conclusion: </strong>Oral melatonin showed autonomic modulation and reduced PIPP-R scores in neonates during venepuncture compared to placebo, with no adverse effects, supporting its use as an analgesic. CLINICAL TRIAL REGISTRY OF INDIA: (CTRI) number- CTRI/2023/07/055046 on dated 11.07.2023.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144947475","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":"Variation in uptake of sodium glucose cotransporter 2 inhibitors and glucagon-like peptide-1 receptor analogues in adults with type 2 diabetes at high cardiovascular risk.","authors":"Juliana de Oliveira Costa, Jialing Lin, Tamara Y Milder, Alys Havard, Jerry R Greenfield, Richard O Day, Brendon L Neuen, Alice A Gibson, Jedidiah I Morton, Julian W Sacre, Sallie-Anne Pearson, Michael O Falster","doi":"10.1007/s00228-025-03870-2","DOIUrl":"10.1007/s00228-025-03870-2","url":null,"abstract":"<p><strong>Purpose: </strong>We quantified variation in the uptake of sodium-glucose co-transporter 2 inhibitors (SGLT2i) and glucagon-like peptide-1 receptor analogues (GLP-1RA) across sociodemographic, behavioural and clinical characteristics of people with type 2 diabetes (T2D) at high cardiovascular risk.</p><p><strong>Methods: </strong>We used the 45 and Up Study survey data (2018-2020) linked to dispensing and service claims for 10,171 people with T2D (56% male, median age of 72 years, median diabetes duration of 11 years). We calculated the prevalence of GLP-1RA and SGLT2i use within 1 year and used logistic regressions to assess associations with each participant characteristic.</p><p><strong>Results: </strong>We found that 2270 (22.3%) people with T2D used SGLT2i and 679 (6.7%) used GLP-1RA. Use of these medicines was higher in people diagnosed with diabetes for a longer period, a high number of comorbidities and survey year, decreased in older people, and varied by sex. After adjusting for these factors, utilisation of these medicines was lower among people who consume alcohol (versus non-drinkers) and higher among those with overweight or obesity. SGLT2i use was also higher in people who were less physically active or had established cardiovascular disease and lower in people with anxiety or depression. GLP-1RA use was higher among people with poorer health and lower in people born outside Australia/New Zealand.</p><p><strong>Conclusion: </strong>Prevalent use of SGLT2i and GLP-1RA was suboptimal and varied across clinical characteristics and behavioural risk factors. While some variation reflects complexities in prescribing for this older population, there remains opportunity for optimised prescribing within this high-risk population.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1315-1327"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398476/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144526935","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":"Optimization of vitamin K antagonist treatment: Near patient monitoring versus standard of care a parallel group clinical trial in older patients with atrial fibrillation.","authors":"Margriet van Elp, Maarten Beinema, Jacobus R B J Brouwers, Esther van 't Riet, Sjef van de Leur, Ildiko Schreiber, Frank G A Jansman","doi":"10.1007/s00228-025-03878-8","DOIUrl":"10.1007/s00228-025-03878-8","url":null,"abstract":"<p><strong>Purpose: </strong>Atrial fibrillation (AF) is common in the elderly population and is associated with a high risk of thromboembolic events. Although non-vitamin K oral anticoagulants (NOACs) are the preferred drugs in antithrombotic therapy for AF, Vitamin K Anticoagulant drug (VKA) treatment is still used in a considerable proportion of patients with AF. Moreover, recent findings revealed that switching VKA to NOAC is associated with more bleeding complications in frail older patients with AF. Standard of care (SOC) monitoring of VKA treatment consists of venous blood sampling and back office dosage advice with a chain of processes and involvement of several health care professionals. We have designed a new procedure for monitoring (Near Patient Therapeutic Monitoring / NPTM) in order to improve the quality and safety of VKA treatment. NPTM consists of INR measurement with a point-of-care (POC) device in the home setting of a patient, performed by one professional and with an instant dosage advice.</p><p><strong>Methods: </strong>This is a cluster-randomised, parallel group, open label study to compare SOC with NPTM of VKA treatment in patients in a home setting. The follow-up period was one year. The primary outcome was time in therapeutic range (TTR), and secondary outcomes were adverse events (deaths, bleeding and thromboembolic events).</p><p><strong>Results: </strong>555 Patients were included in the study. After randomisation, 271 patients received SOC and 284 patients received NPTM. The TTR did not differ significantly: 63.71% versus 62.47% (p > 0.05) for SOC and NPTM, respectively. Significant differences were found for all-cause death (SOC n = 34 versus NPTM n = 16, p < 0.05, OR 0.47, 95% CI: 0.25-0.87), total number of minor bleedings (79 events in SOC vs 52 in NPTM, p < 0.05, OR 64 (95%CI: 0,37-0,81) and all non-major bleedings (100 events in SOC vs 67 in NPTM, p < 0.05, OR 0.62 (95% CI: 043-0.90).</p><p><strong>Conclusions: </strong>NPTM of VKA treatment in AF-patients does not result in an improved TTR when compared to SOC. All-cause death, total number of minor bleedings and all non-major bleedings may be reduced in NPTM, although the study was not powered for these secondary outcomes. Future studies are needed to determine the cost-effectiveness of NTPM versus SOC.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1365-1371"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398432/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144616886","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":"Real-life impact of cefiderocol in carbapenem-resistant Acinetobacter baumannii infections (CRAb): a narrative review.","authors":"Francesco Ferrara, Lorenzo Martellone, Marcello Vaccaro, Adriana Coluccia, Manlio Scognamiglio, Roberto Langella, Andrea Zovi, Giacomo Polito","doi":"10.1007/s00228-025-03866-y","DOIUrl":"10.1007/s00228-025-03866-y","url":null,"abstract":"<p><strong>Introduction: </strong>Healthcare-associated infections (HAIs) represent one of the most serious complications in medical care, with a substantial global burden. The emergence and spread of antibiotic resistance, particularly among multidrug-resistant organisms such as carbapenem-resistant Acinetobacter baumannii (CRAb), have significantly complicated infection management.</p><p><strong>Objectives: </strong>The aim of this review is to provide an updated perspective on its clinical use and to explore novel therapeutic strategies for combating multidrug-resistant bacterial infections.</p><p><strong>Methods: </strong>A narrative review was performed in accordance with PRISMA 2020 guidelines, including real-world, comparative, and longitudinal observational studies that assessed cefiderocol efficacy, safety, and associated clinical outcomes.</p><p><strong>Results: </strong>The findings suggest that cefiderocol is a promising therapeutic agent for CRAb infections, demonstrating lower mortality rates compared to colistin-based regimens. Comparative studies also report a superior safety profile, particularly regarding reduced nephrotoxicity. Cefiderocol unique siderophore-mediated mechanism facilitates efficient bacterial uptake, enabling activity even against carbapenem-resistant strains.</p><p><strong>Conclusions: </strong>Although emerging evidence supports cefiderocol efficacy and safety, concerns persist about the potential for resistance development. Further randomized controlled trials are needed to clarify its role in the daily clinical practice and establish definitive treatment guidelines. In this context, the inclusion of reference intervals for resistance emergence during therapy is recommended, underscoring the need for vigilant monitoring throughout treatment.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1231-1240"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144274484","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":"Trends in adverse drug reaction reporting in eight selected countries after the implementation of new pharmacovigilance regulation in 2012: a joinpoint regression analysis.","authors":"Greta Masiliūnienė, Edgaras Stankevičius, Edmundas Kaduševičius","doi":"10.1007/s00228-025-03862-2","DOIUrl":"10.1007/s00228-025-03862-2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background and purpose: &lt;/strong&gt;Underreporting of adverse drug reactions (ADRs) remains to be a challenge in modern health care. Major reforms in the EU pharmacovigilance system in 2012 introduced the legal basis for consumers to report suspected ADRs. This study was designed to determine trends in overall ADR reporting, the ratio of health care professional (HCP)-to-consumer ADR reporting, and the ratio of serious-to-nonserious ADR reporting for an 11-year period in the selected non-EU and EU countries that had implemented systems for consumers' reporting before the 2012 EU pharmacovigilance legislation and those that did not have.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Materials and methods: &lt;/strong&gt;The national competent authorities of 15 countries (11 EU countries, former EU member the UK, Australia, Canada, and the USA) were contacted via e-mail and asked to provide the total number of ADR reports, numbers of ADRs reported by consumers and HCPs, numbers of serious and nonserious ADRs, and top 5 medication groups causing ADRs by the Anatomical Therapeutic Chemical (ATC) classification system during the period of 2012-2022. Eight countries, namely Belgium, Canada, Finland, Lithuania, the Netherlands, Portugal, Sweden, and the UK, responded and provided the data. The trends of ADR reporting were evaluated with the joinpoint regression analysis method. The annual percent change (APC) and the average annual percent change (AAPC) were estimated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Over the study period, the overall rates of ADR reporting increased significantly in all the countries except for Belgium, with the greatest AAPC being in Lithuania (AAPC of 32.34) and the lowest, in Canada (AAPC of 10.3). The ratios of HCP-to-consumer ADR reporting were significantly decreasing in all the countries (AAPC range, -43.7 to -24.9) except for Canada where an opposite significant trend toward an increasing HCP reporting rate (AAPC of 3.9) for 2012-2020 was observed. The ratios of serious-to-nonserious ADR reporting were significantly decreasing in more than half of the countries, namely Canada, Finland, Lithuania, the Netherlands, and Portugal, with the greatest negative AAPC being in Lithuania (AAPC of -32.9) and the smallest, in Canada (AAPC of -6.8). Vaccines (J07), immunosuppressants (L04), antineoplastic agents (L01), antibacterials for systemic use (J01), and antithrombotic agents (B01) were found to be the top 5 most frequently reported medications.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study shows the significant upward trends in overall ADR reporting not only in the countries that implemented consumer ADR reporting systems after the 2012 EU pharmacovigilance legislation but also in countries that had consumer reporting systems before 2012. Moreover, significant downward trends in the ratios of HCP-to-consumer ADR reporting were documented for all EU countries, confirming increasing consumers' involvement in ADR reporting. Further, larger scale studies with the in","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1287-1299"},"PeriodicalIF":2.7,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12398448/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144316244","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}