Expert Review of Clinical Pharmacology最新文献

{"title":"Is therapeutic drug monitoring a dancing partner for TNF-α inhibitors in real-world practice? Answers from an updated systematic review and meta-analysis.","authors":"Yang Hu, Zaiwei Song, Yuan Gao, Dan Jiang, Yiwen Ran, Yi Ma, Huibo Li, Rongsheng Zhao","doi":"10.1080/17512433.2024.2403641","DOIUrl":"10.1080/17512433.2024.2403641","url":null,"abstract":"<p><strong>Introduction: </strong>This systematic review aimed to determine the effect of therapeutic drug monitoring (TDM) for tumor necrosis factor-α inhibitors (TNF-αI) in immune-mediated inflammatory diseases (IMIDs) based on real-world evidence, as results from published meta-analyses based on randomized controlled trials (RCTs) may not fully capture the nuances of clinical practice due to strict criteria.</p><p><strong>Methods: </strong>We searched PubMed, Embase, and the Cochrane Library up to 1 August 2023. Cohort studies comparing TDM (proactive and reactive) with empirical management were included. Primary outcome was effectiveness [for IBDs: clinical remission; for rheumatic diseases: clinical remission or low disease activity], with certainty of evidence appraised using the GRADE approach. Secondary outcomes included treatment failure, serious adverse events (SAEs), IMIDs-related surgeries or hospitalizations, and anti-drug antibodies (ADAs) development risk.</p><p><strong>Results: </strong>Twenty-four cohort studies were included and almost all were on infliximab. For IBDs, compared with empirical management, proactive TDM significantly improved clinical remission (RR = 1.15, 95% CI = 1.04-1.28), reduced IBDs-related surgeries (RR = 0.46, 95% CI = 0.26-0.81), hospitalizations (RR = 0.60, 95% CI = 0.43-0.83), SAEs (RR = 0.23, 95% CI = 0.07-0.76), and ADAs development risk (RR = 0.34, 95% CI = 0.19-0.60). Reactive TDM significantly lowered hospitalization rates and might be cost-effective. Proactive TDM outperformed reactive TDM in secondary outcomes. For rheumatic diseases, benefits of TDM were inconclusive due to limited evidence.</p><p><strong>Conclusions: </strong>Real-world evidence supports proactive TDM of TNF-αI (particularly infliximab) in IBDs to improve effectiveness, safety, and immunogenicity. However, benefits of TDM for different TNF-αI in other IMIDs remain uncertain.</p><p><strong>Protocol registration: </strong>www.crd.york.ac.uk/ PROSPERO identifier is CRD42022370846.</p>","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"1-14"},"PeriodicalIF":3.6,"publicationDate":"2024-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142282636","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":"Effect of fasudil on clinical outcomes of pulmonary hypertension: a systematic review and meta-analysis.","authors":"Wanying Bao,Mengxin Cheng,Xiaoye Chen,Tao Wang,Dan Xu,Hualin Liao,Lei Chen,Fuqiang Wen,Junyun He,Jun Chen","doi":"10.1080/17512433.2024.2404688","DOIUrl":"https://doi.org/10.1080/17512433.2024.2404688","url":null,"abstract":"BACKGROUNDPulmonary hypertension (PH) is a life-threatening condition with high mortality, categorized into 5 Groups based on distinct etiologies. Fasudil, a potent vasodilator targeting the RhoA/Rho kinase pathway, holds promise for diverse PH pathologies. However, a comprehensive systematic evaluation of its clinical benefits remains elusive.METHODSWe conducted a systematic search across several databases. Meta-analysis using odds ratio and mean difference was performed, with an assessment of studies' quality and pooled evidence.RESULTSStudies on Group-2 and -3 PH reports eligible data for meta-analysis. Inclusion of 3269 patients with Group-3 PH demonstrated that fasudil significantly increased effective events, FEV1, 6-minute walking distance (6MWD) and arterial PaO2, and decreased mean pulmonary artery pressure (mPAP) and pulmonary artery systolic pressure (PASP); Inclusion of 197 patients with Group-2 PH suggested that fasudil significantly increased 6MWD and PaO2, and decreased PASP. Subgroup analysis revealed no significant difference between dosages of 30 and 60 mg/day, while durations and methods of fasudil administration might affect therapeutic effectiveness in patients with Group-3 PH.CONCLUSIONSBy providing comprehensive and robust evidence, our study favor the beneficial effects of fasudil by enhancing FEV1, 6MWD and PaO2, and reducing mPAP and PASP on patients with Group-3 PH, suggesting fasudil as a viable treatment recommendation for these patients and highlighting the need for further studies to inform healthcare policies.PROTOCOL REGISTRATIONwww.crd.york.ac.uk/prospero identifier is CRD42022308947.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":"5 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142250019","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":"Analyzing the clinical efficacy and safety of levocetirizine based on its receptor occupancy, intraclass comparison and role in the treatment of CSU: an AROG consensus statement.","authors":"Kabir Sardana, C R Srinivasan, Mukesh Girdhar, Neirita Hazarika, Krina Patel, Narayan Rao, Akshay Jain, Jaspriya Sandhu, Shivani Bansal, Sunil Ghate, Rizwan Haq, Dhruv Premy Agarwal","doi":"10.1080/17512433.2024.2401093","DOIUrl":"10.1080/17512433.2024.2401093","url":null,"abstract":"<p><strong>Introduction: </strong>Chronic spontaneous urticaria (CSU) is characterized by urticaria persisting for more than 6 weeks. Antihistamines, notably sgAH (second generation antihistamines) are the first line of treatment for CSU.</p><p><strong>Areas covered: </strong>This consensus aimed to review the existing research on receptor occupancy of antihistamines, including levocetirizine, and translate its implications in the treatment of CSU. The consensus deliberations were under the banner of the Antihistamine Receptor Occupancy Group (AROG) from India, an expert panel of 12 dermatologists with a mix of institutional and practitioner backgrounds. This group analyzed the existing translational research on the receptor occupancy of levocetirizine to establish the clinical efficacy and safety of levocetirizine in the treatment of CSU using the grading of recommendations assessment, development, and evaluation (GRADE) method vis-a-vis the varied SGAH.</p><p><strong>Expert opinion: </strong>SGAH constitute the first step in the therapeutic ladder for managing CSU. Levocetirizine has high bioavailability, high affinity and occupancy of the H1 receptor, rapid onset of action, limited distribution and minimal hepatic metabolism. It exhibits significant anti-inflammatory effects at clinically relevant concentrations. The marked receptor occupancy translates to enhanced efficacy as compared to similarly dosed SGAH with the lower cost making it an appropriate drug for chronic use. Receptor occupancy should be the basis of intra-class head-to-head trials in CSU.</p>","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"1-15"},"PeriodicalIF":3.6,"publicationDate":"2024-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142125239","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Oral complement factor D inhibitor danicopan for paroxysmal nocturnal hemoglobinuria.","authors":"Bo Xu,Jiecan Zhou","doi":"10.1080/17512433.2024.2403638","DOIUrl":"https://doi.org/10.1080/17512433.2024.2403638","url":null,"abstract":"INTRODUCTIONParoxysmal nocturnal hemoglobinuria (PNH) is a rare hematological disorder characterized by episodic hemolysis, with additional clinical manifestations including thrombosis and bone marrow failure. The US FDA approved a complement factor D inhibitor, danicopan (Voydeya™), previously known as ACH-4471, for the treatment of extravascular hemolysis in adults with PNH on March 29, 2024. The primary purpose of this review is to examine the clinical efficacy and safety of danicopan.AREAS COVEREDWe systematically searched for articles on PubMed, Web of Science, and three publishers Springer, Elsevier, Wiley up to May 6, 2024.EXPERT OPINIONDanicopan acts on the alternative pathway of the complement cascade, preferentially controlling C3 fragment-mediated extravascular hemolysis. Recommended dosage is 150 mg orally three times a day, which can be increased to 200 mg three times a day when necessary. Vaccination is required before administration to prevent infections by encapsulated bacteria. In a pivotal phase 3 trial ALPHA, danicopan significantly increased hemoglobin levels compared to placebo (P<0.0001), 60% of patients experienced an increase in hemoglobin levels of at least 2 g/dL, compared to none in the placebo group (adjusted difference of 47%; P<0.0001). Common adverse events during danicopan treatment include headache and upper respiratory tract infection.","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":"7 1","pages":""},"PeriodicalIF":4.4,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142222504","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":"Association between sodium-glucose cotransporter 2 inhibitors and eye disorders: a systematic review and meta-analysis.","authors":"Bo Xu, Bo Kang, Fan Tang, Jiecan Zhou, Zunbo He","doi":"10.1080/17512433.2024.2399073","DOIUrl":"10.1080/17512433.2024.2399073","url":null,"abstract":"<p><strong>Introduction: </strong>Lowering blood glucose is important to prevent long-term microvascular complications in adults with type 2 diabetes mellitus (T2DM). Various evidence suggests that sodium-glucose cotransporter 2 (SGLT2) inhibitors are beneficial for microvascular diseases. This study was designed to investigate whether SGLT2 inhibitors have an effect on eye disorders.</p><p><strong>Methods: </strong>We searched PubMed, Web of Science, and ClinicalTrials.gov for randomized, double-blind, placebo-controlled trials with at least 24 weeks of follow-up up to 20 December 2023. Mantel-Haenszel statistical method, risk ratios (RRs) and 95% confidence intervals (CIs) were used to analyze the binary variables.</p><p><strong>Results: </strong>We included a total of 40 studies covering 104,586 participants. T2DM was present in 84.5% of the subjects. SGLT2 inhibitors had no significant effect on overall eye events compared to placebo (RR 0.99; 95%CI 0.86-1.15; <i>p</i> = 0.91), nor did subgroup analysis. We did not observe significant heterogeneity (I² = 0; <i>p</i> = 0.99). Analysis of all secondary outcomes showed that SGLT2 inhibitors did not cause a significantly different effect from placebo. Meta-analysis in the entire T2DM population showed results consistent with those in the overall population.</p><p><strong>Conclusion: </strong>SGLT2 inhibitors did not have a significant effect on eye disorders during treatment, regardless of baseline conditions and duration of treatment.</p>","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"1-9"},"PeriodicalIF":3.6,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105883","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.","authors":"","doi":"10.1080/17512433.2024.2402165","DOIUrl":"https://doi.org/10.1080/17512433.2024.2402165","url":null,"abstract":"","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"1"},"PeriodicalIF":3.6,"publicationDate":"2024-09-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142153523","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":"Drug related adverse event assessment in neonates in clinical trials and clinical care.","authors":"Nadir Yalcin, John van den Anker, Samira Samiee-Zafarghandy, Karel Allegaert","doi":"10.1080/17512433.2024.2390927","DOIUrl":"10.1080/17512433.2024.2390927","url":null,"abstract":"<p><strong>Introduction: </strong>Assessment of drug-related adverse events is essential to fully understand the benefit-risk balance of any drug exposure, weighing efficacy versus safety. This is needed for both drug labeling and clinical decision-making. Assessment is based on seriousness, severity and causality, be it more difficult to apply in neonates. Adverse event detection or prevention in the neonatal clinical setting is also more complicated because of polypharmacy, and off-label or unlicensed pharmacotherapy.</p><p><strong>Areas covered: </strong>Tools became available to assess severity and causality of adverse events in neonates recruited in clinical trials. The first version of the Neonatal Adverse Event severity score (NAESS) reduced the inter-observer variability. Causality tools like the Naranjo score were also tailored to neonates. These tools are also instrumental to support proactive pharmacovigilance in clinical care, while multidisciplinary care teams and computerized pharmacovigilance using advanced data analysis, like machine learning are emerging approaches to develop effective decision strategies.</p><p><strong>Expert opinion: </strong>All stakeholders involved in development of medicines or its clinical use should be aware of the limitations of the currently available assessment tools. Extension and optimization of these tools, advanced data analysis approaches, and capturing the variability in time-dependent physiology are warranted to improve pharmacovigilance in neonates.</p>","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"803-816"},"PeriodicalIF":3.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141916492","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 evolution of clinical trials for pediatric pulmonary hypertension: are the needs of patients and their caregivers being met?","authors":"Julie Wacker, Raphael Joye, Leon Genecand, Frederic Lador, Maurice Beghetti","doi":"10.1080/17512433.2024.2396119","DOIUrl":"10.1080/17512433.2024.2396119","url":null,"abstract":"<p><strong>Introduction: </strong>Pediatric pulmonary hypertension is a rare condition. Survival remains poor in the current management era. There is a lack of data regarding the medical management of pediatric pulmonary hypertension and most pulmonary vasodilators are used off-label in children.</p><p><strong>Areas covered: </strong>Pediatric pulmonary hypertension clinical trials' design and realization face many hurdles, including poor recruitment, limited available pharmacologic and physiologic data in children of various ages, ethical issues, and the lack of validated trial endpoint. Innovative clinical trial designs have emerged and may allow us to overcome some of these issues. Extrapolation of adult data to children, with additional pharmacokinetic and safety data, remains extremely important and valid in etiologies where the pediatric and the adult pathophysiologies are believed to be similar.</p><p><strong>Expert opinion: </strong>Close collaboration between sponsors, regulators, patients, caregivers, physicians and researchers is necessary to develop efficacious and safe drugs for pediatric pulmonary hypertension. The increasing involvement of patients' and caregivers' participation in the development of clinical trials should help shape future research that is feasible and meaningful to the patients.</p>","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"793-801"},"PeriodicalIF":3.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142016830","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":"Sodium-glucose co-transporter 2 inhibition and acute myocardial infarction: the DAPA-MI and EMPACT-MI trials.","authors":"Muhammad Adnan Zaman, Sidra Kalsoom","doi":"10.1080/17512433.2024.2390921","DOIUrl":"10.1080/17512433.2024.2390921","url":null,"abstract":"","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"771-775"},"PeriodicalIF":3.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901441","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":"Hydroxyurea in the sickle cell disease modern era.","authors":"Chazmyn Riley, Walter K Kraft, Robin Miller","doi":"10.1080/17512433.2024.2390915","DOIUrl":"10.1080/17512433.2024.2390915","url":null,"abstract":"<p><strong>Introduction: </strong>Sickle cell disease is an inherited disorder characterized by hemoglobin S polymerization leading to vaso-occlusion and hemolytic anemia. These result in a variety of pathological events, causing both acute and chronic complications. Millions around the world are affected by sickle cell disease with predominance in sub-Saharan Africa. Hydroxyurea was the first drug approved for use in sickle cell disease to reduce the occurrence of painful crises and blood transfusions in patients with frequent, moderate to severe painful crises.</p><p><strong>Areas covered: </strong>With the development of new therapeutics, the role of hydroxyurea is evolving. This narrative review aims to provide clinical data, safety information, and supplementary evidence for the role of hydroxyurea in the current era of sickle cell disease. A comprehensive literature search of databases, including PubMed and Cochrane Library, was conducted from 1963 to 2024.</p><p><strong>Expert opinion: </strong>Even though new medications have been approved for sickle cell disease, hydroxyurea remains the gold standard. Hydroxyurea is not only a disease modifier but it has additional clinical benefits, it is affordable, and its longevity has prompted expanded research in areas such as underutilization and pharmacogenomics. As the treatment landscape evolves, hydroxyurea's long-standing record of efficacy and safety continues to support its role as a key agent in disease management.</p>","PeriodicalId":12207,"journal":{"name":"Expert Review of Clinical Pharmacology","volume":" ","pages":"777-791"},"PeriodicalIF":3.6,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11428029/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141970931","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}