Expert Review of Clinical Pharmacology最新文献

A systematic review and meta-analysis of users versus non-users: unveiling the influence of proton pump inhibitors on capecitabine efficacy in colorectal cancer. 一项使用者与非使用者的系统回顾和荟萃分析：揭示质子泵抑制剂对结直肠癌卡培他滨疗效的影响。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2025-01-25 DOI: 10.1080/17512433.2024.2443183

Francisco Cezar Aquino de Moraes, Estella Aparecida de Laia, Vitor Kendi Tsuchiya Sano, Aline Gabriele Etur Dos Santos, Caroline R M Pereira, Rommel Mario Rodríguez Burbano

{"title":"A systematic review and meta-analysis of users versus non-users: unveiling the influence of proton pump inhibitors on capecitabine efficacy in colorectal cancer.","authors":"Francisco Cezar Aquino de Moraes, Estella Aparecida de Laia, Vitor Kendi Tsuchiya Sano, Aline Gabriele Etur Dos Santos, Caroline R M Pereira, Rommel Mario Rodríguez Burbano","doi":"10.1080/17512433.2024.2443183","DOIUrl":"10.1080/17512433.2024.2443183","url":null,"abstract":"Introduction: Colorectal cancer is the second leading cause of cancer-related deaths worldwide. The impact of proton pump inhibitors (PPIs) on patients taking capecitabine, an oral fluoropyrimidine, remains uncertain, despite their use by 20 to 55% of cancer patients. We investigated how PPIs affect the effectiveness of capecitabine in treating colorectal cancer.Methods: We searched PubMed, Embase, and Web of Science databases for studies that investigated the use of PPI with capecitabine versus capecitabine alone. We used random-effects models for all endpoints. Heterogeneity was assessed using I2 statistics.Results: We included 676 patients receiving capecitabine monotherapy. The overall progression/disease-free survival favored the PPI non-users (HR 2.1372; 95% CI 1.4591-3.1306; p < 0.001). Our results show that there seems to be no difference between users of PPIs and capecitabine in the colorectal cancer patients (HR 1.5922; 95% CI 0.9718-2.6086; p = 0.065). However, after sensitivity-adjusted analysis, PPI use was negatively associated with PPI use (HR 2.14; 95% CI 1.14-4.01; p < 0.001).Conclusion: Patients with colorectal cancer undergoing oral chemotherapy, specifically capecitabine, should be monitored for the use of PPIs. Therefore, the use of PPIs should be discouraged in clinical practice in these cases.Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD42024498240.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"1-9"},"PeriodicalIF":3.6,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142846288","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}

引用次数: 0

Population pharmacokinetic modeling and exposure-response analysis of anrikefon: insights and implications in clinical analgesia. Anrikefon的人群药代动力学建模和暴露-反应分析：在临床镇痛中的见解和意义。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2025-01-23 DOI: 10.1080/17512433.2025.2449983

Kun Wang, Meixia Chen, Fengyan Xu, Fengyi Zhang, Lu Liu, Xiao Liu, Zhongyi Sun, Wanyun Zhao, Yongrui Wang, Jing Yang

{"title":"Population pharmacokinetic modeling and exposure-response analysis of anrikefon: insights and implications in clinical analgesia.","authors":"Kun Wang, Meixia Chen, Fengyan Xu, Fengyi Zhang, Lu Liu, Xiao Liu, Zhongyi Sun, Wanyun Zhao, Yongrui Wang, Jing Yang","doi":"10.1080/17512433.2025.2449983","DOIUrl":"10.1080/17512433.2025.2449983","url":null,"abstract":"Background: Anrikefon (HSK21542), a potent and selective peripheral kappa opioid receptor (KOR) agonist developed by Haisco, effectively blocks pain and itch signals.Aim: To develop a population pharmacokinetic (PK) model for anrikefon and conduct exposure-response (E-R) analysis for safety and efficacy in postoperative pain patients.Method: The Population PK analysis uses NONMEM software with data from six trials. E-R relationships were assessed using safety and efficacy data from three trials. Covariate screening and Bayesian post-hoc simulations identified relevant factors and compared exposure metrics. The fixed dosing regimen was evaluated by simulation. Safety and efficacy endpoints were evaluated using logistic regression and Emax models.Results: A three-compartment model with linear elimination accurately described anrikefon's PK, incorporating weight through allometric scaling. Significant covariates affecting clearance included creatinine clearance, total bilirubin, albumin, aspartate transaminase, and age. Fixed and weight-based dosing showed similar exposures. No apparent E-R trend was observed for safety endpoints. The Emax model indicated that most of subjects achieved over 90% of the maximum effect for SPID0-24 h at 1.0 μg/kg. Safety analysis confirmed this dose was well tolerated with no safety issues.Conclusion: This study provides valuable insights into dose selection, PK variability, and safety and efficacy endpoints.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"1-12"},"PeriodicalIF":3.6,"publicationDate":"2025-01-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143002828","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}

引用次数: 0

Person-centeredness in medication management with people living with dementia. 以人为本的痴呆患者药物管理。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2025-01-21 DOI: 10.1080/17512433.2024.2448837

Mouna Sawan, Brendan Mccormack, Danijela Gnjidic

引用次数: 0

Optimal use, combinations, and sequencing of therapies in advanced prostate cancer. 晚期前列腺癌的最佳使用、组合和治疗顺序。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2025-01-16 DOI: 10.1080/17512433.2025.2451643

Clayton K Oakley, Benjamin A Teply

引用次数: 0

Analysis of serum concentrations of metoprolol and its metabolite α-hydroxymetoprolol in patients with heart failure with reduced ejection fraction: a pilot study in routine health care. 美托洛尔及其代谢物α-羟基美托洛尔在心力衰竭伴射血分数降低患者血清浓度的分析：一项常规医疗保健的初步研究。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2025-01-16 DOI: 10.1080/17512433.2025.2450257

Ivana Kacirova, Marie Lazarova, Romana Urinovska, Jozef Dodulik, Jan Vaclavik

{"title":"Analysis of serum concentrations of metoprolol and its metabolite α-hydroxymetoprolol in patients with heart failure with reduced ejection fraction: a pilot study in routine health care.","authors":"Ivana Kacirova, Marie Lazarova, Romana Urinovska, Jozef Dodulik, Jan Vaclavik","doi":"10.1080/17512433.2025.2450257","DOIUrl":"10.1080/17512433.2025.2450257","url":null,"abstract":"Background: The cardioselective β-1 receptor antagonist metoprolol is used to treat heart failure. It is metabolized in the liver, primarily by cytochrome 2D6.Research design and methods: In this study, trough serum concentrations of metoprolol and its metabolite α-hydroxymetoprolol were measured in patients with heart failure with reduced ejection fraction.Results: Concentrations were 1.3-122.9 µg/L for metoprolol and 1.3-125.7 µg/L for α-hydroxymetoprolol, metabolic ratios were 0.11-98.32. The median weight-adjusted apparent clearance of metoprolol was 53.07 (range 3.24-500.0). Metoprolol and α-hydroxymetoprolol concentrations correlated with both daily dose and dose per kilogram of body weight. However, metoprolol concentrations at the same daily dose showed a wide variability. Patients taking 100 mg/day had significantly lower NT-proBNP values than those taking 25 or 50 mg/day. Patients with LVEF ≤ 35% versus > 35% used significantly lower daily doses and doses per kilogram of body weight, although metoprolol concentrations did not differ. A poor cytochrome 2D6 metabolizer phenotype was detected in two patients.Conclusions: Metoprolol concentrations showed a wide interindividual variability at the same daily dose. Simultaneous determination of metoprolol and α-hydroxymetoprolol concentrations could identify patients at risk of possible accumulation of metoprolol leading to intoxication or, conversely, patients at risk of underdosing. [Figure: see text].","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"1-11"},"PeriodicalIF":3.6,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142930957","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}

引用次数: 0

Efficacy and safety of triple hormone receptor agonist retatrutide for the management of obesity: a systematic review and meta-analysis. 三重激素受体激动剂利特鲁肽治疗肥胖的有效性和安全性：系统回顾和荟萃分析。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2025-01-16 DOI: 10.1080/17512433.2025.2450254

Jay Tewari, Khalid Ahmad Qidwai, Ajoy Tewari, Savneet Kaur, Vineeta Tewari, Anuj Maheshwari

{"title":"Efficacy and safety of triple hormone receptor agonist retatrutide for the management of obesity: a systematic review and meta-analysis.","authors":"Jay Tewari, Khalid Ahmad Qidwai, Ajoy Tewari, Savneet Kaur, Vineeta Tewari, Anuj Maheshwari","doi":"10.1080/17512433.2025.2450254","DOIUrl":"https://doi.org/10.1080/17512433.2025.2450254","url":null,"abstract":"Introduction: Retatrutide is a novel triple hormone receptor agonist which has shown great promise in tackling obesity in preliminary trials. We did this systematic review and meta-analysis to pool the results of all available trials and ascertain its safety and efficacy in the treatment of obesity.Material and methods: A literature search was conducted in PubMed, Cochrane Central and Embase using appropriate search terms and randomized control trials (RCTs) were identified which reported the safety and efficacy of retatrutide. Data was pooled using mean differences for continuous variables and risk ratios for the safety profile in RStudio.Results: After the initial search four RCTs were included in the analysis which compared the safety and efficacy of retatrutide versus placebo. Retatrutide showed a dose dependent relationship with the 12 mg dose causing the maximum reductions across all the outcomes considered. The safety profile of retatrutide was found to be comparable to the control group.Conclusion: In conclusion our analysis found retatrutide to be clinically and statistically better than placebo in the various studies outcomes. We eagerly await the conduction of further trials for more robust and substantial results.Protocol registration: www.crd.york.ac.uk/prospero identifier is CRD42024566153.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"1-16"},"PeriodicalIF":3.6,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143002806","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}

引用次数: 0

Closing the gaps in the access to quality-assured medicines for global health: The case for oxytocin for postpartum haemorrhage. 为全球卫生缩小在获得有质量保证的药品方面的差距：产后出血使用催产素的案例。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2025-01-09 DOI: 10.1080/17512433.2024.2447775

C C Lee, Luther Gwaza, Karin Rombouts, Peter Hu, Rutendo Kuwana, Bart Remmerie, Chioma Ejekam, Kehinde Okunade, Pete Lambert

{"title":"Closing the gaps in the access to quality-assured medicines for global health: The case for oxytocin for postpartum haemorrhage.","authors":"C C Lee, Luther Gwaza, Karin Rombouts, Peter Hu, Rutendo Kuwana, Bart Remmerie, Chioma Ejekam, Kehinde Okunade, Pete Lambert","doi":"10.1080/17512433.2024.2447775","DOIUrl":"https://doi.org/10.1080/17512433.2024.2447775","url":null,"abstract":"Introduction: Access to quality-assured medicines remains unequal between high-income and low-income countries. To bridge this gap, product development and supply in low- and middle-income countries (LMICs) should follow World Health Organization (WHO)'s policies and recommendations whilst aligning with international standards.Areas covered: We reviewed two cases on oxytocin access for postpartum hemorrhage (PPH), a condition that disproportionately affects mothers in low-income countries. The first case examines the challenges in ensuring quality-assured oxytocin injections in LMICs. International technical guidelines allow different storage conditions for oxytocin, which can cause confusion in countries with weak regulatory oversight. WHO and partners recommend a common storage and management of oxytocin to resolve this issue. The second case explores the design of clinical studies for inhaled oxytocin, a promising candidate for PPH aiming for rapid registration and inclusion in WHO's therapeutic recommendations. Aligning scientific, regulatory, and WHO policy requirements early in the development process can expedite access to new effective medicines in LMICs, and we described the potential clinical challenges in meeting this.Expert opinion: Robust partnerships between stakeholders, to streamline medicine development and regulatory approval, are essential to close access gaps and ultimately prevent unnecessary deaths due to PPH in LMICs.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"1-9"},"PeriodicalIF":3.6,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142946842","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}

引用次数: 0

Updates in innovation of the treatment of pyoderma gangrenosum. 坏疽性脓皮病治疗创新进展。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2025-01-06 DOI: 10.1080/17512433.2024.2447776

Heejo Keum, Elina V Zhivov, Alex G Ortega-Loayza

{"title":"Updates in innovation of the treatment of pyoderma gangrenosum.","authors":"Heejo Keum, Elina V Zhivov, Alex G Ortega-Loayza","doi":"10.1080/17512433.2024.2447776","DOIUrl":"10.1080/17512433.2024.2447776","url":null,"abstract":"Introduction: Pyoderma gangrenosum (PG) is a rare neutrophilic dermatosis characterized by rapidly enlarging, painful ulcers with undermined borders. The management of PG is challenging due to the lack of standardized evidence-based treatments.Areas covered: This review examines recent efforts to establish standardized outcomes for clinical trials to facilitate the drug development process for PG. It explores new therapeutics in development and evaluates advanced options for wound and pain management. Literature available on the pathogenesis, treatment, and pain management of PG from database inception to April 2024 was searched in PubMed, Embase, and Cochrane. ClinicalTrials.gov and the EU Clinical Trials Register were searched for clinical trials on PG.Expert opinion: New therapeutics such as interleukin 36 inhibitor and complement component C5a inhibitor more specifically target key pathways in the pathogenesis of PG have shown promise and can greatly benefit patients with PG, which still lacks an FDA-approved treatment. In addition to systemic therapy, local wound care and pain management should be carried out simultaneously to achieve successful wound healing.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"1-11"},"PeriodicalIF":3.6,"publicationDate":"2025-01-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142885048","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}

引用次数: 0

FLOT vs CROSS in localized esophageal adenocarcinoma: what is the current best strategy? FLOT vs CROSS治疗局限性食管腺癌：目前的最佳策略是什么？

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2025-01-02 DOI: 10.1080/17512433.2024.2447779

Jane E Rogers, Michael Leung, Jaffer A Ajani

引用次数: 0

Gene therapy in cardiology: pioneering a new era in medical ethics and patient care. 心脏病学中的基因治疗：开创医学伦理和病人护理的新时代。

IF 3.6 3区医学

Expert Review of Clinical Pharmacology Pub Date : 2025-01-01 DOI: 10.1080/17512433.2024.2448523

Maria Sara Mauro, Davide Capodanno

引用次数: 0