European Journal of Clinical Pharmacology最新文献

{"title":"Administration of polyethylene glycol in critically ill patients with acute myocardial infarction: a retrospective propensity score-matched cohort study.","authors":"Linfeng Xie","doi":"10.1007/s00228-025-03892-w","DOIUrl":"10.1007/s00228-025-03892-w","url":null,"abstract":"<p><strong>Purpose: </strong>Polyethylene glycol (PEG) is commonly administered in acute myocardial infarction (AMI) cases, though its clinical efficacy remains unclear. This study investigated whether PEG treatment enhances survival outcomes in AMI patients.</p><p><strong>Methods: </strong>This retrospective study analyzed data from the American Medical Information Mart for Intensive Care (MIMIC)-IV database, examining critically ill patients with AMI. The exposure was defined as PEG administration during hospitalization. The primary endpoints were 7-day and in-hospital all-cause mortality. External validation was performed using the eICU 2.0 database.</p><p><strong>Results: </strong>The study included 2422 participants before propensity score matching (PSM) and 1730 after matching. Multivariate Cox regression analysis prior to PSM revealed that PEG administration significantly lowered 7-day (HR = 0.247, 95% CI 0.179-0.341, p < 0.001) and in-hospital (HR = 0.422, 95% CI 0.347-0.512, p < 0.001) all-cause mortality. Post-PSM analysis produced consistent findings, with PEG administration linked to reduced 7-day (HR = 0.244, 95% CI 0.168-0.354, p < 0.001) and in-hospital (HR = 0.420, 95% CI 0.337-0.524, p < 0.001) mortality. Subgroup analyses indicated PEG's protective effect persisted across all clinical subgroups (all p-interaction > 0.005). External validation using Cox regression further confirmed that PEG administration significantly reduced both in-ICU (HR = 0.353, 95% CI 0.211-0.591, p < 0.001) and in-hospital (HR = 0.403, 95% CI 0.268-0.607, p < 0.001) mortality.</p><p><strong>Conclusion: </strong>PEG administration improved survival outcomes in critically ill AMI patients, reducing both 7-day and in-hospital all-cause mortality.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1481-1491"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144759523","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 and safety of insulin sensitisers for treating type 2 diabetes: a network meta-analysis.","authors":"Gerile Huang, Yujie Li, YuQi Shang, Huiduo Wang, Wenjing Zhang, Hao Guo","doi":"10.1007/s00228-025-03882-y","DOIUrl":"10.1007/s00228-025-03882-y","url":null,"abstract":"<p><strong>Purpose: </strong>Thiazolidinediones (TZDs), including pioglitazone and rosiglitazone, and non-TZD insulin sensitisers (chiglitazar sodium) demonstrate potential; however, their comparative efficacy and safety remain unclear. We aimed to analyse the efficacy and safety of commonly used insulin sensitisers, including chiglitazar sodium, sitagliptin, pioglitazone, and rosiglitazone for treating type 2 diabetes mellitus (T2DM).</p><p><strong>Methods: </strong>A computer-based search was conducted in the China National Knowledge Infrastructure, Wanfang Data, the VIP database, PubMed, Embase, and Cochrane Library databases from the establishment date of each database to January 2025. Included study quality was evaluated using the Cochrane risk of bias tool. Surface under the cumulative ranking curve was calculated for each outcome indicator to compare the efficacy and safety of different interventions.</p><p><strong>Results: </strong>In reducing haemoglobin A1c, 8 mg of rosiglitazone was superior over 100 mg sitagliptin, 30 mg pioglitazone, and 15 mg pioglitazone (P < 0.05), with no significant differences among the remaining medications. To reduce fasting plasma glucose, 45 mg of pioglitazone was more effective than any dosage of chiglitazar sodium, sitagliptin, or rosiglitazone (P < 0.05). Regarding safety, the incidence rate of adverse reactions was higher with 45 mg of pioglitazone than with 8 mg of rosiglitazone (P < 0.05), with no significant differences in adverse events among other medications.</p><p><strong>Conclusion: </strong>Compared with placebo, all four drugs were safe and effective in the treatment of T2DM. High-dose TZDs may be more effective than mitiglinide and sitagliptin. However, 45 mg of pioglitazone was associated with a higher incidence of adverse events, warranting close monitoring of its safety profile.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1493-1506"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144759524","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":"Dose-dependent efficacy and safety of Filgotinib in moderate to severe Crohn's disease: a grade-assessed systematic review and meta-analysis of randomized controlled trials.","authors":"Mohamed S Elgendy, Ahmed Raza, Mohamed Rifai, Wajeeh Ur Rehman, Ahmed Emara, Muhammad Haris Khan, Ayiz Jan, Muhammad Younas, Anum Nawaz, Ubaid Khan","doi":"10.1007/s00228-025-03891-x","DOIUrl":"10.1007/s00228-025-03891-x","url":null,"abstract":"<p><strong>Background: </strong>Crohn's disease is a chronic inflammatory condition that can relapse and can impact any part of the digestive tract. Janus kinase (JAK) inhibitors, like Filgotinib, have surfaced as a promising treatment option. This meta-analysis evaluates its dose-dependent effects (100 mg or 200 mg) in moderate-to-severe cases.</p><p><strong>Methods: </strong>A comprehensive search was conducted in PubMed, CENTRAL, Web of Science, Scopus, and EMBASE up to March 2025. Risk ratio (RR) was used for dichotomous outcomes, with 95% confidence intervals (CI).</p><p><strong>Prospero id: </strong>CRD420251032985.</p><p><strong>Results: </strong>Four RCTs with 1681 patients were included. Filgotinib 200 mg compared to placebo had a higher rate of mucosal remission at 24 to 58 weeks (wk) (14.9% vs 6%, RR = 2.51, 95% CI [1.06:5.95], P = 0.0370), two-item patient'sreported outcome (PRO2) clinical remission at 10 wk (35.7% vs 22.5%, RR = 1.48, 95% CI [1.21:1.81], P = 0.0002), and Crohn's Disease Activity Index (CDAI) clinical remission at 10 wk (33.4% vs 17.8%, RR = 1.77, 95% CI [1.42:2.21], P < 0.0001). However, there was no significant difference between Filgotinib 100 mg and placebo in rates of CDAI clinical remission at 10 wk (P = 0.7490) and mucosal remission at 24 to 58 wk (P = 0.5850). In both doses, there was no significant difference in total treatment adverse events (TEAEs) at 20 to 58 wk (P = 0.4576, P = 0.2354) and serious TEAEs at 20 to 58 wk (P = 0.992, P = 0.2354).</p><p><strong>Conclusions: </strong>Filgotinib 200 mg demonstrated superior short-term clinical benefits and medium-term mucosal remission compared to placebo in moderate-to-severe CD. However, Filgotinib 100 mg showed no significant efficacy. Both doses have acceptable safety profiles, necessitating further long-term multicenter RCTs.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1517-1531"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144768524","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 drug-based model to predict hyponatremia in outpatients of a geriatric clinic.","authors":"Anne Claire B van Orten-Luiten, Elske M Brouwer-Brolsma, André Janse, Renger F Witkamp","doi":"10.1007/s00228-025-03890-y","DOIUrl":"10.1007/s00228-025-03890-y","url":null,"abstract":"<p><strong>Purpose: </strong>Chronic hyponatremia in older people is associated with adverse outcomes including gait disturbances, falls, osteoporosis, fractures, cognitive impairment, and cardiovascular disease. Diagnosis in outpatient settings is challenging due to the non-specific nature of its symptoms. While hyponatremia is well-studied in hospitalized patients, little research has focused on outpatient settings. This study aimed to develop a drug-based model to non-invasively predict hyponatremia in older adults attending a geriatric outpatient clinic.</p><p><strong>Methods: </strong>Cross-sectional data from 2181 outpatients aged ≥ 55 were analysed using logistic regression. Polypharmacy, 27 specific drug groups, sex, age, and BMI were considered as potential risk factors. Predictors were selected using stepwise backward logistic regression for the complex model and LASSO regression for the simple model. Internal validation was performed through bootstrapping, and model performance was evaluated by constructing a receiver operating characteristic (ROC) curve.</p><p><strong>Results: </strong>The prevalence of hyponatremia was 10.5%, with higher occurrence in women. The complex model identified predictors including sex, age, BMI, polypharmacy, and 11 drug groups, achieving an area under the curve (AUC) of 0.75, [95% CI 0.72-0.79], indicating a reasonably good ability to distinguish between hypo- and normonatremia. The simple model, including only polypharmacy, had limited predictive performance (AUC = 0.64 [95% CI 0.60-0.68]).</p><p><strong>Conclusion: </strong>The complex, drug-based model predicts hyponatremia risk in outpatients of a geriatric clinic. Timely recognition may prevent inappropriate treatments for undiagnosed cases and associated harms. The model merits further development for clinical use.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1507-1515"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12443923/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144759522","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":"Long-term results of a multidisciplinary medication optimization program for older adults including primary care and hospital team.","authors":"Camille Guerin, Romain Leguillon, Albane Cherel, Lucie Valembois, Gwladys Brochard, Mélissa Pierre, Antoine Bourderont, Bérénice Gaillot, Claire Bernardeau, Céline Vaesken, Ines Tebourski, Pablo Descatoire, Guillaume Saint-Lorant, Cédric Villain, Alexandre Meurant","doi":"10.1007/s00228-025-03889-5","DOIUrl":"10.1007/s00228-025-03889-5","url":null,"abstract":"<p><strong>Background: </strong>Therapeutic optimization and deprescribing in older adults face multiple barriers, whereas drug-related hospitalization increased from 3.6% to 8.5% between 2006 and 2018. The OPTIMEDOC program aims to optimize older adults' prescriptions through clinical medication review conducted by a multidisciplinary team including clinical pharmacist, geriatrician, and general practitioner (GP). This collaboration between primary care and hospital team aims to enable appropriate and sustainable prescriptions.</p><p><strong>Purpose: </strong>This study aimed to assess the implementation of therapeutic optimizations at least 6 months after the intervention. The secondary objective was to document the most frequently deprescribed and newly introduced medications and their long-term implementation rate.</p><p><strong>Methods: </strong>This observational study was conducted in a university hospital, including patients who benefited from the OPTIMEDOC program from April 2022 to April 2024. The primary outcome was the long-term implementation rate of recommendations. The secondary outcome was a description of the optimized drugs according to ATC2 classes.</p><p><strong>Results: </strong>Among 1580 validated therapeutic recommendations for 143 patients included with an average age of 86.4 years old, 1473 were followed up (93.2%). Of these, 1017 were successfully implemented over 1 year (69.0%). Specifically, 81.8% of deprescriptions, 58.3% of introductions, and 70.5% of modifications were implemented. Although vaccine introductions were the most frequently recommended (n = 222), only 41% were implemented. Regarding deprescribing, psycholeptics, psychoanaleptics, and drugs for acid-related disorders had a long-term implementation rate of over 75%.</p><p><strong>Conclusion: </strong>These results validate the OPTIMEDOC program as an effective strategy for sustainable therapeutic optimization, especially for deprescribing. Engaging community pharmacists could further enhance the implementation of therapeutic recommendations.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"1461-1471"},"PeriodicalIF":2.7,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144728938","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":"Population pharmacokinetic characteristics of tacrolimus in Chinese lung transplant recipients and optimisation of dosing regimen during the early post-transplantation phase.","authors":"Shouning Zhou, Qiaoyan Lian, Huilong Luo, Hui Xie, Yanping Guan, Jianxing He, Li Wei, Chunrong Ju","doi":"10.1007/s00228-025-03920-9","DOIUrl":"https://doi.org/10.1007/s00228-025-03920-9","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to establish a population pharmacokinetic model and optimise tacrolimus dosing regimens in Chinese lung transplant recipients.</p><p><strong>Methods: </strong>A total of 988 tacrolimus trough concentrations and clinical data of 142 adult lung transplant recipients were collected. Population pharmacokinetic analysis was performed using a nonlinear mixed effects model. A Monte Carlo simulation was conducted to determine the optimal dosing regimen.</p><p><strong>Results: </strong>The pharmacokinetics of tacrolimus could be best described by a one-compartment model with first-order absorption and elimination. The typical population parameter estimates of apparent clearance and apparent volume of distribution were 7.58 L·h^-1 and 701.39 L, respectively. The clearance of tacrolimus in rapid and intermediate metabolisers of CYP3A5 was 2.72-fold and 1.87-fold higher, respectively, than in poor metabolisers of CYP3A5. The concurrent use of voriconazole, posaconazole, and itraconazole led to a reduction in tacrolimus clearance by 38.21%, 26.30%, and 57.98%, respectively. Recommended dose regimens were obtained by Monte Carlo simulation based on the established model.</p><p><strong>Conclusion: </strong>Recipients with the CYP3A5*3/*3 genotype, elevated haematocrit levels, short postoperative days, and concurrent administration of azole antifungal drugs needed a reduced maintenance dose to reach the therapeutic window, which provided a reference for the formulation of individualised tacrolimus regimen during the early post-transplantation phase.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":""},"PeriodicalIF":2.7,"publicationDate":"2025-09-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145124540","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: 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/s00228-025-03917-4","DOIUrl":"https://doi.org/10.1007/s00228-025-03917-4","url":null,"abstract":"","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":"145029157","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":"Safety and efficacy of fondaparinux use in hemodialysis patients with heparin-induced thrombocytopenia: a systematic review.","authors":"Milorad Stojadinovic, Slobodan Jankovic, Radica Zivkovic-Zaric, Marko Baralic, Svetlana Jovicic-Pavlovic, Ana Bontic, Nemanja Petrovic, Ana Pejcic","doi":"10.1007/s00228-025-03913-8","DOIUrl":"https://doi.org/10.1007/s00228-025-03913-8","url":null,"abstract":"<p><strong>Background: </strong>Heparin-induced thrombocytopenia (HIT) is a severe primary hypercoagulable disorder, particularly concerning in hemodialysis (HD) patients frequently exposed to heparin. Fondaparinux has emerged as a potential alternative anticoagulant, though supporting evidence is limited. This systematic review aimed to evaluate the safety and efficacy of fondaparinux in HD patients with HIT.</p><p><strong>Methods: </strong>We searched PubMed/MEDLINE, Web of Science, Scopus, CENTRAL, ClinicalTrials.gov, and SCIndeks up to March 2, 2025. Eligible studies included clinical trials, observational studies, and case reports/series on fondaparinux use in adult HD patients with HIT. Data on demographics, clinical characteristics, diagnostics, dosing, administration routes, and outcomes were extracted and narratively synthesized.</p><p><strong>Results: </strong>Seventeen studies with 37 patients (aged 38-88 years) were included. Dosing regimens and monitoring strategies varied widely across dialysis modalities, with the most common initial fondaparinux dose being 2.5 mg/day. Platelet recovery was observed in most cases. Bleeding occurred in 10.8% of patients, thrombotic events in 5.4%, and overall mortality was 16.2%. Vascular access thrombosis was reported in two patients (5.4%) following the initiation of fondaparinux. Some clotting of the extracorporeal circuit was reported during select sessions in 7 patients undergoing non-continuous dialysis modalities (18.9%), including five on high-flux HD, one on unspecified intermittent HD, and one on post-dilution hemodiafiltration.</p><p><strong>Conclusions: </strong>Fondaparinux may be a potential alternative anticoagulant in HD patients with HIT, especially when first-line agents are unavailable. However, its use should be approached with caution and tailored to individual clinical circumstances, pending confirmation of its safety, efficacy, and optimal dosing and monitoring through larger prospective 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":"145029111","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":"Hair analysis for monitoring adherence to inhaled respiratory medications: possibilities and limitations.","authors":"Liz J A Cuperus, Wouter Ahmed, Johannes C C M In 't Veen, Huib A M Kerstjens, Tanja R Zijp, Jasper Stevens, A Mireille A Wessels, Daan J Touw, Job F M van Boven","doi":"10.1007/s00228-025-03903-w","DOIUrl":"https://doi.org/10.1007/s00228-025-03903-w","url":null,"abstract":"<p><strong>Purpose: </strong>Non-adherence to inhaled medication poses a significant clinical and economic burden on patients with respiratory diseases. This narrative review provides an overview of key aspects of hair analysis, in general and specific for inhaled medications, and explores the potential of hair analysis as a novel tool to monitor adherence to inhaled medications.</p><p><strong>Methods: </strong>PubMed searches were conducted to explore four aspects: (1) mechanisms of (inhaled) drug's systemic absorption and deposition in hair; (2) quantification of drugs in hair; (3) factors impacting (inhaled) drug hair concentrations; and (4) clinical studies assessing inhaled medication adherence through hair analysis.</p><p><strong>Results: </strong>Systemic absorption, deposition, quantification, and interpretation of drug concentrations in hair are complex phenomena and are influenced by various factors. Analysing drug concentrations in hair segments provides insights into adherence variability over up to 3 months. While studies suggest effective incorporation of several inhaled drugs into hair, inter-individual variability is influenced by external (e.g. UV-exposure), drug- (e.g. lipophilicity) and patient-specific (e.g. hair colour) factors, not just by adherence. The impact of these confounding factors on absolute hair concentrations is still unclear. Intra-individual variability unrelated to adherence appears, however, minimal.</p><p><strong>Conclusion: </strong>Although hair analysis shows promise as a novel objective bioanalytical method for assessing long-term inhaled medication adherence, until further analytical refinement, clinical validation and a clearer understanding of confounding factors, it should not be relied upon as the sole measure of adherence.</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":"145023092","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 and safety of nitazoxanide and escitalopram as adjuvant therapies in patients with rheumatoid arthritis: a randomized controlled study.","authors":"Tarek M Mostafa, Abeer A El-Sayed, Abdel Moaty A Afifi, Dalia R El-Afify","doi":"10.1007/s00228-025-03911-w","DOIUrl":"https://doi.org/10.1007/s00228-025-03911-w","url":null,"abstract":"<p><strong>Objective: </strong>This research aimed at evaluating the effectiveness and safety of nitazoxanide and escitalopram as adjuvant therapies in patients with rheumatoid arthritis (RA).</p><p><strong>Methods: </strong>In this randomized controlled parallel study, 90 patients with active RA were randomized into three groups; group 1 (control group; n = 30) which received traditional therapy, group 2 (Nitazoxanide group; n = 30) which received traditional therapy plus 1 gm/day oral nitazoxanide, and group 3 (Escitalopram group; n = 30) which received traditional therapy plus 10 mg/day oral escitalopram for three months. At baseline and 3 months after treatment, clinical and functional assessments were done through the 28-joint count disease activity score using C-reactive protein (DAS28-CRP), the health assessment questionnaire-disability index (HAQ-DI), and the patient's global assessment (PGA). Also, serum levels of high-sensitivity C-reactive protein (hs-CRP), signal transducer and activator of transcription-3 (STAT-3), Janus kinase-2 (JAK-2), toll-like receptors 4 (TLR-4), interleukin-1 beta (IL-1β), and malondialdehyde (MDA) were assessed. Data were analyzed using paired t-test and one-way analysis of variance, followed by Tukey's HDS test.</p><p><strong>Results: </strong>Three months after treatment and as compared to the control group, the nitazoxanide group showed a significant decline in PGA (P = 0.042), and serum levels of STAT-3 (P < 0.001), JAK-2 (P < 0.001), TLR-4 (P < 0.001), and IL-1β (P < 0.001). On the other hand, the escitalopram group produced a significant decrease in DAS28-CRP score (P = 0.029), HAQ-DI score (P = 0.001), and serum levels of JAK-2 (P = 0.001), TLR-4 (P < 0.001), IL-1β (P < 0.001), and MDA (P < 0.001). As compared to nitazoxanide group, the escitalopram group produced a significant decline in fatigue score (P < 0.001) and serum levels of both IL-1β (P = 0.023) and MDA (P < 0.001). Both medications were safe; however, chromaturia was the only significant nitazoxanide-related adverse effect.</p><p><strong>Conclusion: </strong>Nitazoxanide and escitalopram could serve as potential adjuvant therapies for patients with RA based on their effectiveness and safety data.</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":"145029154","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}