European Journal of Clinical Pharmacology最新文献

{"title":"Letter to the editor: \"Effects of dapagliflozin and empagliflozin on 6-min walk distance in heart failure with preserved and reduced ejection fraction: a systematic review and meta-analysis of randomized controlled trials involving 2624 patients\".","authors":"Kazumasa Kotake, Kazuki Adachi, Yuki Nakano","doi":"10.1007/s00228-024-03731-4","DOIUrl":"10.1007/s00228-024-03731-4","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141733757","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":"Therapeutic drug monitoring for valproate: deriving a novel formula for calculation of free concentration.","authors":"Erna Pretorius, Paulina van Zyl, Gina Joubert","doi":"10.1007/s00228-024-03741-2","DOIUrl":"10.1007/s00228-024-03741-2","url":null,"abstract":"<p><strong>Background: </strong>Monitoring free valproate concentrations, as with other highly protein-bound anticonvulsants, is essential in clinical situations where protein binding may be disrupted. Conversion of measured total concentrations to approximate free concentrations offers a cost-effective alternative. This study evaluated the relationship between total and free valproate concentrations for discordance and the impact of key determinants. A novel formula was devised that incorporates significant variables.</p><p><strong>Methods: </strong>A multicentre, cross-sectional observational analytical study included 101 subjects 18 years and older using valproate for 6 months or longer. Participants were recruited from private and public sector healthcare settings from primary to tertiary level in, South Africa, during 2017-2019.</p><p><strong>Results: </strong>Free valproate concentrations could be measured for 84 subjects. Discordance for concomitant total and free valproate concentrations was 79.1%. Among 19 participants with elevated free concentrations, 15 (78.9%) had total valproate concentrations within the recommended reference range. Calculations based on the study-derived formula were more accurate in predicting free valproate concentration than previously proposed methods.</p><p><strong>Conclusion: </strong>This study proposes that the novel formula for calculating free valproate enables more accurate prediction.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11458675/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141987670","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":"Neuronal toxicity of monoclonal antibodies (mAbs): an analysis of post-marketing reports from FDA Adverse Event Reporting System (FAERS) safety database.","authors":"Nitin Kumar, Vivekanandan Kalaiselvan, Mandeep Kumar Arora","doi":"10.1007/s00228-024-03727-0","DOIUrl":"10.1007/s00228-024-03727-0","url":null,"abstract":"<p><strong>Background: </strong>Monoclonal antibodies (mAbs) are pivotal in treating various diseases, including cancers and autoimmune disorders. Despite their therapeutic benefits, mAb therapy has been associated with neurological toxicity.</p><p><strong>Objectives: </strong>This study aimed to assess the occurrence of neuronal toxicity associated with mAbs, utilizing data from the FDA Adverse Event Reporting System (FAERS) safety database. The study also sought to delineate the medical characteristics of the reported cases.</p><p><strong>Methods: </strong>A comprehensive analysis of neurological adverse events reported in the FAERS database was conducted, employing computational methodologies such as proportional relative risk (PRR), information component (IC₀₂₅), and chi-square (χ²). Individual case safety reports (ICSRs) pertaining to neurological disorders linked to mAbs from the date of first global marketing authorization until June 30, 2023, were meticulously examined.</p><p><strong>Results: </strong>The FAERS safety database contains 79,022 ICSRs linking mAbs to nervous system disorders. Rituximab, bevacizumab, denosumab, nivolumab, and trastuzumab were frequently cited. Reported adverse events include headache, peripheral neuropathy, dizziness, and cerebrovascular accident. Most ICSRs (85.81%) were serious, mainly affecting females (57.04%) with a 14.09% fatality rate. Panitumumab, atezolizumab, bevacizumab, and trastuzumab showed strong drug-event associations. Signal disproportionate reporting (SDR) analysis flagged myasthenia gravis, peripheral neuropathy, and neurotoxicity across multiple mAbs, suggesting potential signals.</p><p><strong>Conclusions: </strong>Interdisciplinary collaboration between oncologists and neurologists is crucial for safe mAb use. Our study enhances understanding of mAb neurological safety. Disproportionality signal analysis provides valuable evidence for risk mitigation.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141763966","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":"Reliability and validity of the Turkish version of the medication practical barriers to adherence questionnaire in patients with chronic diseases.","authors":"Nora Samuelyan, Pınar Ay, Zoe Moon, Mesut Sancar, Rob Horne, Betul Okuyan","doi":"10.1007/s00228-024-03735-0","DOIUrl":"10.1007/s00228-024-03735-0","url":null,"abstract":"<p><strong>Purpose: </strong>The aim of this study was to evaluate the validity and reliability of the Turkish version of the Medication Practical Barriers to Adherence Questionnaire (MPRAQ-TR).</p><p><strong>Methods: </strong>This is a validation study conducted between August 2022 and March 2023 in the ambulatory services of a secondary care private hospital located in Istanbul, Türkiye, among patients (18 years of age and older) with chronic diseases. After the Turkish translation and cultural adaptation of the MPRAQ, and a pilot think-aloud study, the following psychometric properties were assessed: internal consistency by calculating the Cronbach's alpha coefficient, 2-week test-retest reliability, convergent validity by calculating Spearman's rank correlation between the MPRAQ-TR and the Turkish version of Medication Adherence Report Scale (MARS), and predictive validity by evaluating the association between the MPRAQ-TR score and nonadherence to medications.</p><p><strong>Results: </strong>Among the 380 patients (response rate = 89.6%), 72.1% were nonadherent to their medications. The intraclass correlation coefficient was 0.99 for MPRAQ-TR scores (95% CI, 0.98-0.99; p < 0.001). The Cronbach's alpha of the MPRAQ-TR was 0.853. There was a moderate negative correlation between the scores on the MARS and the MPRAQ-TR (Spearman's rho = - 0.525; p < 0.01), supporting the convergent validity of the MPRAQ-TR. In the univariate analysis, the total score of MPRAQ-TR was associated with increased odds of nonadherence to medications (p < 0.01).</p><p><strong>Conclusion: </strong>MPRAQ-TR shows good psychometric properties and can be used to evaluate the practical adherence barriers of patients with chronic diseases.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141897083","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 ramucirumab for gastric or gastro-esophageal junction adenocarcinoma: a systematic review and meta-analysis.","authors":"Ruiqi Ren, Zhewei Zhang, Shaokun Zhai, Jiahui Yang, BaihaiTihan Tusong, Jingzhou Wang","doi":"10.1007/s00228-024-03734-1","DOIUrl":"10.1007/s00228-024-03734-1","url":null,"abstract":"<p><strong>Purpose: </strong>Based on the comparison of ramucirumab monoclonal antibody with control treatments in randomized controlled trials, this study aims to elucidate the role of ramucirumab monoclonal antibody in cancer therapy and its potential side effects, providing scientific evidence for clinical treatment.</p><p><strong>Methods: </strong>PubMed, Embase, Cochrane, and Web of Science were searched systematically to obtain the trials on ramucirumab in the treatment of gastric or gastroesophageal junction (GEJ) adenocarcinoma up to April 13, 2023. We included randomized controlled trials (RCTs) evaluating the efficacy and safety of ramucirumab as monotherapy and in combination with other chemotherapy agents as interventions for treating gastric or gastroesophageal junction (GEJ) adenocarcinoma.</p><p><strong>Results: </strong>After screening 2200 studies, we finally included 8 eligible studies (involving a total of 3,283 participants). Meta-analysis results showed that compared to the control group, ramucirumab monotherapy significantly improved overall survival (OS) (hazard ratio [HR] = 0.77, 95% confidence interval [CI] [0.67, 0.89]) and progression-free survival (PFS) (HR = 0.48, 95% CI [0.40, 0.58]). Similar results were obtained for ramucirumab combined with paclitaxel. In the treatment combining ramucirumab with paclitaxel, compared to monotherapy, three severe adverse reactions (grade ≥ 3) were observed with significantly increased risks (OR > 2). These include proteinuria (OR = 5.37, 95% CI [1.22, 23.54]), hypertension (OR = 4.02, 95% CI [2.63, 6.14]), and gastrointestinal perforation (OR = 4.64, 95% CI [1.00, 21.60]). Subgroup analysis further indicated that ramucirumab is effective in both non-East Asian and East Asian populations, with East Asian patients more prone to developing proteinuria, while having a lower incidence of hypertension. Additionally, ramucirumab demonstrated comparable efficacy between first-line and second-line treatments, with a higher incidence of proteinuria observed in second-line therapy.</p><p><strong>Conclusion: </strong>Ramucirumab significantly improves the prognosis of patients with gastric or gastroesophageal junction adenocarcinoma. When used in combination with paclitaxel, close monitoring of adverse reactions such as proteinuria (especially in East Asian populations), hypertension (especially in non-East Asian populations), and gastrointestinal perforation is essential.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141888827","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of olanzapine in the improvement of body weight and appetite in patients with cancer or receiving chemotherapy: a systematic review and meta-analysis.","authors":"Lu Yuan, Xin-Yu Li, Lu Xu, Si-Jie Quan, Yan-Bing Huang, Hui Zheng","doi":"10.1007/s00228-024-03770-x","DOIUrl":"https://doi.org/10.1007/s00228-024-03770-x","url":null,"abstract":"<p><strong>Objective: </strong>We aimed to assess the effects of olanzapine in the improvement of body weight and appetite in patients with cancer or receiving chemotherapy through a systematic review and meta-analysis.</p><p><strong>Methods: </strong>We searched the following databases from their inception to April 23, 2024: Embase, PubMed, Web of Science, and the Cochrane Library. The mean difference (MD) and risk ratios were used to calculate by random effects models. The primary outcome was the proportion of patients with > 5% weight gain.</p><p><strong>Results: </strong>Seventeen studies with 3457 participants were included. For primary outcomes, 1 study with 124 participants showed olanzapine increased the proportion of patients with > 5% weight gain compared with placebo (60% vs. 9%, P < 0.001). Versus active controls (3 studies, 439 participants), no significant difference in the proportion of patients with > 5% weight gain (RR = 1.69, 95%CI: 0.91 to 3.13, I² = 27%, P = 0.10), with moderate-quality evidence. Olanzapine increased appetite scores compared to both placebo (1 study, 112 participants; MD = 3, 95%CI: 2.3 to 3.7, P < 0.001) and active controls (2 studies, 106 participants; MD = 4.96, 95%CI: 4.61 to 5.30, I² = 0%, P < 0.01). For mean weight change, olanzapine showed no significant differences versus placebo (2 studies, 164 participants, MD = 2.78 kg, 95%CI: - 1.60 to 7.17, I² = 48%, P = 0.21) or active controls (2 studies, 480 participants, MD = 0.44 kg, 95%CI: - 1.04 to 1.91, I² = 58%, P = 0.56).</p><p><strong>Conclusions: </strong>Olanzapine appears to be a potential option for improving appetite and weight gain in cancer patients. Future trials need to focus on the optimal target dose and use durations of olanzapine. Registered: https://archive.org/details/osf-registrations-kpv4h-v .</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142521433","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":"Use of dipyrone during pregnancy and risk of congenital anomalies: a systematic review.","authors":"Karine Duarte Curvello, Helana Ortiz Garcia, Tatiana da Silva Sempé, Raimunda Alyne Maciel Feitosa da Silva, Luana Giongo Pedrotti, Fernanda Sales Luiz Vianna, Tatiane da Silva Dal Pizzol","doi":"10.1007/s00228-024-03769-4","DOIUrl":"https://doi.org/10.1007/s00228-024-03769-4","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to summarize the evidence on the teratogenic effects of dipyrone used during pregnancy.</p><p><strong>Methods: </strong>Databases (MEDLINE, EMBASE, Cochrane Library, CINAHL, Web of Science, Lilacs, SciELO, SCOPUS, OasisBR, and OpenGray) were reviewed until September 2023. We included studies that compared pregnant women who used dipyrone during any gestational period with those who used other analgesics or did not use any analgesics during the same gestational period. The outcome assessed was the presence of any congenital anomaly. Two reviewers independently conducted the review process, and a third reviewer resolved any disagreements. The risk of bias was assessed using the Joanna Briggs Institute tool for observational studies. The reviewed data synthesis is presented in narrative form.</p><p><strong>Results: </strong>The search retrieved 2045 results, of which seven studies were included in the review, four were case‒control studies, and three were cohort studies involving 153,562 participants. The congenital anomalies evaluated varied across studies, with unspecified congenital anomalies predominating. Five of seven studies found no association between dipyrone and congenital anomalies. In a case‒control study, a positive association was found between dipyrone use and isolated congenital cataracts compared to two control groups; in another study, a positive association for unspecified congenital anomalies was observed in only one of the two control groups analyzed. In all studies, a high risk of bias was identified, especially regarding measuring the exposure, outcome, and assessment of confounding factors.</p><p><strong>Conclusion: </strong>There is not enough evidence to define the risk of congenital anomalies associated with dipyrone use during pregnancy.</p><p><strong>Registration: </strong>CRD 42022333041.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497380","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":"Evaluating the impact of loperamide on irinotecan-induced adverse events: a disproportionality analysis of data from the World Health Organization pharmacovigilance database (VigiBase).","authors":"Tomoaki Akagi, Hirofumi Hamano, Hirotaka Miyamoto, Tatsuaki Takeda, Yoshito Zamami, Kaname Ohyama","doi":"10.1007/s00228-024-03767-6","DOIUrl":"https://doi.org/10.1007/s00228-024-03767-6","url":null,"abstract":"<p><strong>Purpose: </strong>SN-38, the active metabolite of irinotecan, may cause adverse events necessitating treatment discontinuation and management. Diarrhea, which is treated with loperamide, is one such event. However, loperamide may delay SN-38 elimination, causing more adverse events. Therefore, understanding the adverse events caused by symptomatic drugs is crucial for safe drug therapy. This study aimed to assess the association between loperamide and irinotecan-induced adverse events.</p><p><strong>Methods: </strong>We analyzed data up to December 2022 from VigiBase, the World Health Organization's adverse event database. The study used reporting odds ratios (RORs) to evaluate the associations between concomitant medications and irinotecan-induced adverse events. Fisher's exact probability test was used to analyze the adverse events. Logistic regression analysis was performed to identify associated adverse event signals.</p><p><strong>Results: </strong>Of the 32,520,983 cases analyzed, 57,454 involved the use of irinotecan. Among these, 1589 (2.8%) patients were co-treated with loperamide. Signals for neutropenia (ROR 1.37, 95% confidence interval (CI) 1.20-1.57, p < 0.001), anemia (ROR 1.81, 95% CI 1.43-2.30, p < 0.001), and alopecia (ROR 1.89, 95% CI 1.30-2.74, p < 0.01) were detected with concomitant loperamide. Multivariate logistic regression analysis confirmed that concomitant loperamide use was associated with signals for neutropenia, anemia, and alopecia.</p><p><strong>Conclusion: </strong>Our results suggest that loperamide increases the risk of irinotecan-induced adverse events and enhances irinotecan toxicity. The study methodology may be useful for predicting adverse event risk when choosing symptomatic therapy drugs during irinotecan use.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-10-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142497379","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":"Curcumin as a complementary treatment in oncological therapy: a systematic review.","authors":"Lisa C Gutsche, Jennifer Dörfler, Jutta Hübner","doi":"10.1007/s00228-024-03764-9","DOIUrl":"https://doi.org/10.1007/s00228-024-03764-9","url":null,"abstract":"<p><strong>Purpose: </strong>Curcumin, the active ingredient in turmeric, is employed by numerous cancer patients to support conventional cancer therapy. This systematic review aims to summarize the existing clinical evidence and to provide an overview of the potential benefits and risks associated with curcumin supplementation.</p><p><strong>Methods: </strong>In January 2024, we conducted a systematic search of five electronic databases (Embase, Cochrane, PsycInfo, CINAHL, and Medline) using a complex search strategy. We included randomized controlled trials on the use, effectiveness, and potential harm of additional curcumin therapy in adult patients under cancer treatment. The risk of bias was assessed using Cochrane revised Risk of Bias Tool 2.0.</p><p><strong>Results: </strong>This systematic review included 34 randomized controlled trials involving 2580 patients out of 11143 search results. Included patients were primarily diagnosed with head and neck cancer, followed by breast, prostate, and colorectal cancer. Therapy concepts encompassed topical or systemic curcumin administration. The studies reported heterogeneous results concerning oral and skin symptoms, pain, weight alteration and changes in body composition, survival, and disease progression. Significant findings were reported for oral mucositis and weight loss. Considering risk of bias, all studies had moderate to high risk of bias. Regarding side effects, one study reported significantly more vomiting in the curcumin group.</p><p><strong>Conclusion: </strong>Although the results suggest promise in reducing mucositis and weight loss, a clear statement regarding the effectiveness of curcumin therapy on cancer patients cannot be made due to heterogeneous results and methodological limitations of the involved studies. Further investigations of higher quality are necessary to derive a definite recommendation for action.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460944","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":"Correction to: Effects of an intraoperative intravenous Bolus Dose of Dexmedetomidine on postoperative catheter-related bladder discomfort in male patients undergoing transurethral resection of bladder tumors: a randomized, double-blind, controlled trial.","authors":"Tianhua Zhang, Huiting Li, Chunnan Lin, Rui An, Wenqian Lin, Hongying Tan, Longhui Cao","doi":"10.1007/s00228-024-03768-5","DOIUrl":"https://doi.org/10.1007/s00228-024-03768-5","url":null,"abstract":"","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":null,"pages":null},"PeriodicalIF":2.4,"publicationDate":"2024-10-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142460943","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}