European Journal of Clinical Pharmacology最新文献

{"title":"Cost-effectiveness of rivaroxaban plus aspirin versus aspirin alone in patients with stable coronary artery disease or peripheral artery disease: a systematic review.","authors":"Jalal Arabloo, Mohammad Ali Rezaei, Vahid Makhtoumi, Zahra Mollaei Sadiani, Aziz Rezapour","doi":"10.1007/s00228-024-03794-3","DOIUrl":"10.1007/s00228-024-03794-3","url":null,"abstract":"<p><strong>Purpose: </strong>This study aimed to systematically review the cost-effectiveness of rivaroxaban plus aspirin (RIV + ASA) versus aspirin (ASA) alone in patients with stable coronary artery disease (CAD) or peripheral artery disease (PAD).</p><p><strong>Methods: </strong>A systematic review was conducted using leading databases including PubMed, Scopus, and Web of Science core collection. The search was carried out up to June 25, 2024, focusing on identifying full economic evaluation studies comparing the cost-effectiveness of RIV + ASA versus ASA alone in patients with stable cardiovascular diseases (CVDs). The methodological quality of the included studies was assessed utilizing the validated Quality of Health Economics Studies (QHES) checklist. Subsequently, a qualitative analysis was performed to synthesize the collected data. We converted the incremental cost-effectiveness ratios (ICERs) into the equivalent amount in US dollars for the year 2024.</p><p><strong>Results: </strong>Out of 315 identified articles, 11 met inclusion criteria and were included in the review. RIV + ASA was generally found to be cost-effective, with ICERs falling within acceptable willingness-to-pay (WTP) thresholds. However, substantial variation in ICERs was observed across studies due to differences in healthcare systems, drug pricing, and WTP thresholds. In these studies, ICERs per quality-adjusted life-year (QALY) were (in 2024 US dollars) US$4939 to $29,162 for all patients, $10,385 to $85,394 for CAD, and $1013 to $40,244 for PAD in different studies. RIV + ASA was more cost-effective in high-risk subgroups, such as patients with PAD. Key drivers of cost-effectiveness included mortality rates, the cost of rivaroxaban, and utility scores.</p><p><strong>Conclusions: </strong>RIV + ASA appears to be a cost-effective treatment option for patients with CAD or PAD or both. Future research should address geographical biases, consider societal perspectives, and explore alternative treatment options to optimize resource allocation and improve patient outcomes in the management of CVDs. Future research should also consider evaluating the cost-effectiveness of alternative new oral anticoagulants (NOACs) to provide a broader perspective on treatment options for CVD.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"279-290"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142876565","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 safety and effectiveness of tolvaptan in patients with heart failure and renal impairment: a systematic review and meta-analysis.","authors":"Aashish Kumar, Umer Iqbal, Shafin Bin Amin, Syed Ali Arsal, Syed Muhammad Sinaan Ali, Muhammad Ashir Shafique, Muhammad Saad Shahid, Aimen Naz, Emediong Santhus Asuka","doi":"10.1007/s00228-024-03778-3","DOIUrl":"10.1007/s00228-024-03778-3","url":null,"abstract":"<p><strong>Purpose: </strong>Patients with heart failure and concomitant renal impairment are often prescribed loop diuretics, such as furosemide, as the primary treatment. The present meta-analysis is focused on analyzing the safety and efficacy of the implementation of tolvaptan as a novel approach in patients with renal impairment and heart failure.</p><p><strong>Methods: </strong>Two reviewers conducted a screening of articles using online databases, including PubMed, Google Scholar, and Embase. Following a comprehensive literature search, seven articles that met all inclusion criteria (patients with heart failure and renal impairment) were selected for analysis. Subsequently, various primary and secondary outcomes were evaluated.</p><p><strong>Results: </strong>The primary outcomes of our study included urine volume, worsening renal function, blood urea nitrogen (BUN) levels, and creatinine levels. Tolvaptan demonstrated superior efficacy in increasing urine output with a standardized mean difference of 2.18 (95% CI 0.62-3.75, p = 0.006) and resulted in a lower incidence of worsening renal function with odds ratio 0.41 (95% CI 0.22-0.77, p = 0.006). Additionally, there was no significant difference in the tolvaptan and conventional treatment groups in changing serum creatinine levels with a standardized mean difference of - 0.37 (95% CI - 0.86 to 0.12, p = 0.135), but tolvaptan tends to decrease blood urea nitrogen levels with a standardized mean difference - 0.18 (95% CI - 0.30 to - 0.06, p = 0.004) in comparison to conventional treatment group.</p><p><strong>Conclusion: </strong>While tolvaptan administration was related to better renal outcomes, unresolved heterogeneities and various factors could have influenced our findings. Further research is needed to evaluate the role of tolvaptan in the treatment of this patient population.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"203-216"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142695413","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The quantity, reliability, transparency, reporting, and interpretation of pharmacovigilance signal detection studies in pregnancy: a meta-epidemiological study.","authors":"Xue-Feng Jiao, Zhengyang Zhang, Lixiong Gong, Shan Lan, Songzhen Zhang, Jiang Wang, Xiubi Chen, Qiang Wei, Hailong Li, Linan Zeng, Lu Han, Lingli Zhang","doi":"10.1007/s00228-024-03790-7","DOIUrl":"10.1007/s00228-024-03790-7","url":null,"abstract":"<p><strong>Purpose: </strong>To systematically review the characteristics of the available pharmacovigilance signal detection studies in pregnancy, and comprehensively assess the reliability, transparency, reporting, and interpretation of these studies.</p><p><strong>Methods: </strong>We searched five databases from inception to February 2024 to identify the available pharmacovigilance signal detection studies in pregnancy. We extracted three aspects of information (basic information, data processing modes, signal detection analyses) to assess the reliability, transparency, and reporting of each study. Moreover, we adopted the criteria of Mouffak et al.'s study to assess the misinterpretation of signal detection results in these studies.</p><p><strong>Results: </strong>A total of 33 pharmacovigilance signal detection studies in pregnancy were identified. Among them, there were great methodological heterogeneities in the data processing modes (restriction to the population, comparator, standardization of drug names and adverse event names, the assigned roles of drugs, counting unit, etc.) and signal detection analyses (signal detection method, sensitivity analysis, subgroup analysis, adjustment for confounding factors, etc.). Moreover, 13 (39%) studies had at least one type of inappropriate interpretation and/or extrapolation of signal detection results.</p><p><strong>Conclusion: </strong>Our results reveals that the quantity of pharmacovigilance signal detection studies in pregnancy is relatively limited. Furthermore, the reliability, transparency, reporting, and interpretation of the existing studies are less optimistic. The main issues existing in the available pharmacovigilance signal detection studies in pregnancy consist of two aspects: (1) great methodological heterogeneities exist in the data processing modes and signal detection analyses among different studies and (2) inappropriate interpretation and extrapolation of signal detection results are frequent.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"309-319"},"PeriodicalIF":2.4,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846254","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":"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":" ","pages":"1-33"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11695395/pdf/","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":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effectiveness of macrolides as add-on therapy to beta-lactams in community-acquired pneumonia: A meta-analysis of randomized controlled trials.","authors":"Vitória Martins Prizão, Otavio Cosendey Martins, Beatriz Austregésilo de Athayde de Hollanda Morais, Beatriz Ximenes Mendes, Maria Luiza Rodrigues Defante, Mariana de Moura Souza","doi":"10.1007/s00228-024-03775-6","DOIUrl":"10.1007/s00228-024-03775-6","url":null,"abstract":"<p><strong>Purpose: </strong>This study aims to evaluate whether adding macrolides (MAC) to beta-lactam (BL) monotherapy in the treatment of community-acquired pneumonia (CAP) offers clinical benefits that justify the potential disadvantages or side effects.</p><p><strong>Methods: </strong>We systematically searched PubMed, Embase, and Cochrane for randomized controlled trials (RCTs) comparing BL monotherapy to combination therapy with BL and MAC for the in-hospital treatment of CAP. We pooled mean differences (MD) for continuous outcomes and risk ratio (RR) for binary outcomes, with 95% confidence intervals (CI).</p><p><strong>Results: </strong>Six RCTs with 2661 participants (52% receiving combination therapy), revealed no significant difference in in-hospital mortality (RR 0.99; 95% CI 0.78 to 1.25; p = 0.94; I2 = 0%), 90-day mortality (RR 1.03; 95% CI 0.82 to 1.29; p = 0.83; I2 = 13%), or 30-day mortality (RR 0.90; 75% CI 0.63 to 1.29; p = 0.58; I2 = 54%). Additionally, no significant differences were observed in the length of hospital stay (MD 0.51; 95% CI - 0.50 to 1.51; p = 0.33; I2 = 63%) or respiratory insufficiency (RR 0.63; 95% CI 0.29 to 1.35; p = 0.24; I2 = 74%). However, combination therapy significantly improved the treatment success rate (RR 1.17; 95% CI 1.04 to 1.32; p = 0.009; I2 = 0%).</p><p><strong>Conclusion: </strong>Our findings suggest that BL + MAC therapy should not be used in all cases of hospitalized patients with CAP.</p><p><strong>Prospero id: </strong>CRD42024516383 - Data of registration: 03/03/2024.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"83-91"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142647082","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":"Racial/ethnic differences in survival and treatment response with PD-1/PD-L1 inhibitors in resectable non-small cell lung cancer: a meta-analysis of randomized controlled trials.","authors":"Francisco Cezar Aquino de Moraes, Eric Pasqualotto, Anna Luíza Soares de Oliveira Rodrigues, Rommel Mario Rodríguez Burbano","doi":"10.1007/s00228-024-03777-4","DOIUrl":"10.1007/s00228-024-03777-4","url":null,"abstract":"<p><strong>Background: </strong>The optimal treatment for resectable Non-Small Cell Lung Cancer (NSCLC) remains under investigation, particularly about its effectiveness across different ethnicities. This meta-analysis aims to investigate the potential benefits of adding PD1/PD-L1 inhibitors for treatment, stratified by ethnicity.</p><p><strong>Methods: </strong>We searched PubMed, Embase, and Cochrane databases for randomized controlled trials (RCTs) that investigated the use of PD1/PD-L1 inhibitors to treat patients with resectable NSCLC. The outcomes evaluated were disease-free survival/event-free survival (DFS/EFS), major pathological response (MPR), and pathological complete response (pCR). Hazard ratios (HRs) or risk ratios (RRs) with 95% confidence intervals (CIs) were computed for all endpoints using DerSimonian and Laird random-effects models. Statistical analyses were performed with R Software, version 4.2.3.</p><p><strong>Results: </strong>A total of six RCTs comprising 3,827 patients with NSCLC were included. In populations of Asian descent, PD1/PD-L1 significantly improved DFS/EFS (HR 0.59; 95% CI 0.44-0.78), MPR (RR 5.76; 95% CI 3.58-9.28), and pCR (RR 25.00; 95% CI 6.17-101.36). Similarly, patients of European ancestry experienced significantly improved DFS/EFS (HR 0.77; 95% CI 0.65-0.90), MPR (RR 2.75; 95% CI 2.00-3.77), and pCR (RR 4.53; 95% CI 2.69-7.6) with PD1/PD-L1 therapy. Notably, patients with mixed ethnicity also demonstrated significant improvement in MPR (RR 4.05; 95% CI 2.60-6.33) and pCR (RR 8.44; 95% CI 3.75-19.00) when receiving PD1/PD-L1 inhibitors.</p><p><strong>Conclusion: </strong>This comprehensive meta-analysis suggests that incorporating PD1/PD-L1 inhibitors into treatments offers a promising benefit for patients with resectable NSCLC, regardless of ethnicity. Future studies with in-depth molecular characterization of patients can further refine these findings and potentially guide the development of personalized treatment strategies based on individual ethnic backgrounds.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"139-150"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142616635","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":"Risk prediction models for adverse drug reactions and adverse drug events in older adults-a systematic review and meta-analysis.","authors":"Nicole Cosgrave, Sooad Saleh, Woei Shan Ong, Juliane Frydenlund, David J Williams, Caitriona Cahir","doi":"10.1007/s00228-024-03774-7","DOIUrl":"10.1007/s00228-024-03774-7","url":null,"abstract":"<p><strong>Background: </strong>Adverse drug reactions (ADRs) are common and result in significant morbidity, mortality, and associated hospital costs. Models predicting ADRs in older adults were previously found to lack reliability and validity. This systematic review and meta-analysis aim to provide an updated, comprehensive quality assessment and analysis of ADR-risk prediction tools in older adults.</p><p><strong>Methods: </strong>Standard databases and citations were searched (2012 to 2023) and studies which developed and/or validated an ADR prediction model for use in older adults were included. Four studies from a previous systematic review were also included. The TRIPOD (transparent reporting of a multivariable prediction model for individual prognosis or diagnosis) checklist was used to evaluate each study. Random effects models were used to derive a pooled discrimination estimate (area-under-the-receiver-operation curve; AUROC) for model development and validation studies.</p><p><strong>Results: </strong>Eight studies, describing 6 ADR-risk prediction models met the inclusion criteria). In the meta-analysis, the pooled AUROC was 0.75 (95% CI 0.57, 0.87; I-squared = 96.88%) for model development studies and 0.73 (95% CI 0.52, 0.87; Isquared = 90.19%) for externally validated studies. Studies had poor adherence (range 34-50%; median 46.5%; IQR 12%) to TRIPOD guidelines.</p><p><strong>Conclusion: </strong>The studies identified through this systematic review exhibit poor adherence to TRIPOD guidelines which may question the investigational rigor and the usability of the models. This underscores the urgent need to develop a validated, robust, and reliable tool worthy of implementation and testing in a real-world setting to gauge its impact and usability effectively.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"93-110"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142667597","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":"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":" ","pages":"129-137"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","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":"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":"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":" ","pages":"45-63"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","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":"Towards streamlined product information: reporting of transporter-mediated drug interactions.","authors":"Valeria Asmar, Erik Bergman, Elin Lindhagen, Kim Sherwood, Gabriel Westman, Fabienne Zdenka Gaugaz","doi":"10.1007/s00228-024-03772-9","DOIUrl":"10.1007/s00228-024-03772-9","url":null,"abstract":"<p><strong>Purpose: </strong>The purpose of this study is to investigate the reporting of risks associated with transporter-mediated drug-drug interactions (DDIs) in medicinal product information and to identify suitable wording for future standardisation of summaries of product characteristics (SmPCs).</p><p><strong>Methods: </strong>The SmPCs of medicinal products approved in the European Union from 2012 to 2023 were screened for warnings on Organic Anion Transporting Polypeptide 1B1 and 1B3 (OATP1B1 and OATP1B3), and Breast Cancer Resistance Protein (BCRP). An in-house search engine for product information was used. Warnings were categorised into different DDI scenarios based on the SmPC texts.</p><p><strong>Results: </strong>A total of 192 out of 859 approved medicinal products had SmPC text pertaining to OATP1B1, 1B3 and/or BCRP. The majority of products had text for all three transporters Most texts were located in SmPC Sect. 5.2, followed by Sect. 4.5. Numerous interaction-texts either concluded that the interaction lacked clinical relevance or lacked information on the clinical relevance of the finding. The highest number of SmPC texts indicating a clinically relevant interaction with outlined clinical consequences was found for BCRP. The article also presents SmPC texts for each DDI scenario, which the authors consider as examples of explicit wordings with actionable recommendations.</p><p><strong>Conclusion: </strong>A potential for improvement of SmPC text for transporter-mediated DDI was identified: Warnings without clinical relevance could be omitted, and some warnings with clinical relevance could be updated to provide actionable recommendations to the prescribers. A selection of unambiguous texts was identified as starting point to generate standard texts.</p>","PeriodicalId":11857,"journal":{"name":"European Journal of Clinical Pharmacology","volume":" ","pages":"151-161"},"PeriodicalIF":2.4,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11695577/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142638600","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}