Clinical therapeutics最新文献

{"title":"Individual, Social and Environmental Factors Influencing Medication-Taking Among Adults of Vietnamese Heritage With Type 2 Diabetes Living in Australia: A Qualitative Study","authors":"Olumuyiwa Omonaiye BPharm, MPH, PhD , Elizabeth Holmes-Truscott BPSc (Hons),PhD , Bodil Rasmussen BN, PhD , Peter S. Hamblin MBSS, MD, FRACP , Kevin Mc Namara BSc, MSc, PhD , Jane Tran MBSS , Cheryl Steele B. Nurs (Hons) , Jerry Lai BBSc (Hons), MStatSc, PhD , Elizabeth Manias BPharm, MPharm, MNStud, PhD","doi":"10.1016/j.clinthera.2025.01.012","DOIUrl":"10.1016/j.clinthera.2025.01.012","url":null,"abstract":"<div><h3>Purpose</h3><div>To explore factors influencing diabetes medication-taking among adults of Vietnamese heritage with type 2 diabetes mellitus (T2DM) residing in Australia. Barriers to and enablers of optimal medication use, as perceived by those with diabetes and health professionals working with this community, were explored via the Theoretical Domains Framework (TDF).</div></div><div><h3>Methods</h3><div>This qualitative study was conducted between November 2021 – March 2023 with input from an advisory group consisting of 4 individuals of Vietnamese heritage (a person living with T2DM, a credentialed diabetes care and education specialist, a General Practitioner, and Nephrologist). Data were collected using semistructured interviews with people with T2DM (adults, living in Australia, Vietnamese country of birth and/or language spoken at home) and focus group discussions with health professionals involved in the care of people with T2DM from Vietnamese background. Recruitment of participants was from a national diabetes registry and/or a tertiary hospital. The 14 domains of the TDF informed the development of the study aim, guided data collection, and thematic analysis. The TDF is a comprehensive framework that can be used to identify barriers and facilitators that influence health behaviors.</div></div><div><h3>Findings</h3><div>Twenty-three interviews were conducted with adults with T2DM (n = 14 women; median [IQR] age = 60 [16] years; n = 15 insulin-treated; all Vietnamese born, with n = 15 reporting Vietnamese as primary language). One focus group was undertaken with each group of health professionals (n = 7 doctors - 5 endocrinologists and 2 advanced endocrinology physician trainees, n = 6 credentialed diabetes care and education specialists, and n=3 pharmacists). A wide range of themes about the barriers and enablers [determinants] of medication taking were generated and mapped on 13 of 14 Theoretical Domains Framework domains, only excluding the domain of ``goals.'' The most important (determined through frequency and richness) domains that influenced medication-taking were: <em>Environmental Context and Resources-</em>access to subsidized medications is facilitated via the Australian Pharmaceutical Benefits Scheme, but high costs remained a significant barrier for many<em>. Emotion</em>-participants reported anxiety about diabetes complications as a motivator for medication-taking, while fears about long-term side effects created barriers. <em>Social Influences-</em>family support was an enabler of medication-taking. However, lack of support and pressure to use alternative treatments posed barriers for some participants. <em>Beliefs About Consequences-</em> belief in the negative outcomes of missed doses motivated medication-taking, while a lack of immediate side effects from missed doses reinforced perceptions that skipping medication was harmless. <em>Memory, attention, and decision making-</em>participants prioritized certain ","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 5","pages":"Pages e1-e11"},"PeriodicalIF":3.2,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476422","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tacrolimus-Induced Fever in a Lung Transplant Recipient: A Case-Report","authors":"Robin Thirionet MD , Charline Leclercq MD , Michel Dumonceaux MD , Thomas Planté-Bordeneuve MD, PhD , François M. Carlier MD, PhD","doi":"10.1016/j.clinthera.2025.01.016","DOIUrl":"10.1016/j.clinthera.2025.01.016","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 5","pages":"Pages 396-399"},"PeriodicalIF":3.2,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143472392","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effects of Thalidomide on Metabolism and Lifespan of Red Blood Cell in Patients With β-Thalassemia Major: A Post Hoc Analysis of a Randomized Controlled Trial","authors":"Huanju Yang ,&nbsp;Sichong Han ,&nbsp;Jianquan Xu ,&nbsp;Sheng He ,&nbsp;Qiyang Lu ,&nbsp;Tianying Luo ,&nbsp;Shuying Chen ,&nbsp;Lujie Dang ,&nbsp;Guizhen Wang ,&nbsp;Jinyan Li ,&nbsp;Minjie Huang ,&nbsp;Yangdong Liao ,&nbsp;Yanfang He ,&nbsp;Ning Cai ,&nbsp;Lan Huang ,&nbsp;Meiguang Zhou ,&nbsp;Yongquan Mo ,&nbsp;Weijian Zhu ,&nbsp;Zhengwei Wu MD ,&nbsp;Guangbiao Zhou PhD ,&nbsp;Jiangming Chen MD","doi":"10.1016/j.clinthera.2025.01.008","DOIUrl":"10.1016/j.clinthera.2025.01.008","url":null,"abstract":"<div><h3>Purpose</h3><div>Recent studies have shown the thalidomide's therapeutic potential in treatment of patients with β-thalassemia major. However, the effect of thalidomide on metabolism and lifespan of red blood cells (RBCs) is rarely reported.</div></div><div><h3>Methods</h3><div>This study was a post hoc analysis of a randomized controlled trial (Chinese Clinical Trial Registry, ChiCTR1800015702). One hundred patients with β-thalassemia major were randomly assigned 1:1 to treatment with a placebo or thalidomide. The primary outcomes were the differences in RBC lifespan, reticulocyte count, and peripheral nucleated RBC count of patients after treatment of 12 weeks. Other indicators of hemolytic reaction were also analyzed.</div></div><div><h3>Findings</h3><div>Compared with the placebo group after treatment of 12 weeks, the thalidomide group showed a longer RBC lifespan (16.29 ± 6.42 vs 12.90 ± 4.98 days; <em>P</em> = 0.004), smaller mean corpuscular volume (68.34 ± 7.79 vs 78.01 ± 6.33 fl; <em>P</em> &lt; 0.001), smaller mean corpuscular hemoglobin (21.62 ± 2.85 vs 24.68 ± 2.69 pg; <em>P</em> &lt; 0.001), and lower lactate dehydrogenase (190.00 [148.00 - 305.00] vs 251.00 [199.20 - 327.80]; <em>P</em> = 0.014). Meanwhile, thalidomide significantly increased the RBC lifespan at 24 weeks (21.24 ± 8.30 days; <em>P</em> &lt; 0.001) and 48 weeks (23.21 ± 8.42 days; <em>P</em> &lt; 0.001) when compared with baseline (12.8 ± 6.0 days).</div></div><div><h3>Implications</h3><div>Thalidomide increases the RBC lifespan and reduces hemolytic reactions in patients with β-thalassemia major. Chinese Clinical Trial Registry identifier: ChiCTR1800015702.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 4","pages":"Pages 252-260"},"PeriodicalIF":3.2,"publicationDate":"2025-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143457179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Crenessity (crinecerfont)","authors":"Paul Beninger MD, MBA","doi":"10.1016/j.clinthera.2025.01.010","DOIUrl":"10.1016/j.clinthera.2025.01.010","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 4","pages":"Pages 335-336"},"PeriodicalIF":3.2,"publicationDate":"2025-02-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"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 First-line Targeted Therapies in Physically Fit Patients With Chronic Lymphocytic Leukemia: A Systematic Review and Network Meta-analysis","authors":"Anita Stożek-Tutro MSc ,&nbsp;Monika Reczek MPharm ,&nbsp;Paweł Kawalec MD, PhD","doi":"10.1016/j.clinthera.2025.01.009","DOIUrl":"10.1016/j.clinthera.2025.01.009","url":null,"abstract":"<div><h3>Purpose</h3><div>Targeted therapies are promising treatment options for fit patients with untreated chronic lymphocytic leukemia (CLL). However, there is a lack of data on their relative efficacy and safety. The aim of this systematic review was to assess the relative efficacy and safety of first-line targeted therapies (including venetoclax [VEN], obinutuzumab [OBI], ibrutinib [IBR], and other options) for physically fit patients with untreated CLL.</div></div><div><h3>Methods</h3><div>A systematic literature review of major medical databases (MEDLINE, Embase, and Cochrane Central Register of Controlled Trials) and additional data sources was conducted to identify randomized controlled trials providing data of interest. Progression-free survival (PFS) and undetectable minimal residual disease (MRD(-)) in peripheral blood (PB) were analyzed, along with other end points. A Bayesian network meta-analysis was used for data analysis. The study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines, and its protocol was registered in the International Prospective Register of Systematic Reviews (CRD42023393903).</div></div><div><h3>Findings</h3><div>The network meta-analysis results reported no significant differences between targeted therapies for PFS. However, IBR + VEN and VEN + OBI + IBR reported the highest probability of being the most effective options based on surface under the cumulative ranking curve values. For MRD(-)PB, VEN + OBI + IBR reported a significant advantage over other therapies, with surface under the cumulative ranking curve values confirming it as the most effective option in this term.</div></div><div><h3>Implications</h3><div>Targeted therapies may offer a promising treatment option for fit patients with previously untreated CLL. Among the therapies assessed, IBR + rituximab and VEN + OBI + IBR emerge as the most effective therapeutic options for prolonging PFS, while VEN + OBI + IBR and VEN + OBI reported favorable outcomes in achieving MRD(-)PB. However, further research is needed to validate these findings.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 5","pages":"Pages e12-e20"},"PeriodicalIF":3.2,"publicationDate":"2025-02-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425040","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Thalidomide: Following Tragedy, a Repurposed Molecule With Continuing Opportunities for Clinical Benefit","authors":"Paul Beninger MD, MBA","doi":"10.1016/j.clinthera.2025.01.011","DOIUrl":"10.1016/j.clinthera.2025.01.011","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 4","pages":"Pages 249-251"},"PeriodicalIF":3.2,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413701","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Effectiveness of Sotrovimab in Ambulatory Patients With COVID-19: A Retrospective Cohort Study Using a Large Administrative Claims Database in the United States","authors":"Christopher F. Bell PhD ,&nbsp;Tasneem Lokhandwala PhD ,&nbsp;Daniel C. Gibbons PhD ,&nbsp;Myriam Drysdale PhD ,&nbsp;Jane Wang PhD ,&nbsp;Emily J. Lloyd PhD","doi":"10.1016/j.clinthera.2025.01.003","DOIUrl":"10.1016/j.clinthera.2025.01.003","url":null,"abstract":"<div><h3>Purpose</h3><div>To assess real-world effectiveness of sotrovimab for reducing severe clinical outcomes in patients with coronavirus disease 2019 (COVID-19) versus no treatment during the Delta/early Omicron variant periods.</div></div><div><h3>Methods</h3><div>Patients diagnosed with COVID-19 between May 26, 2021, and April 5, 2022, were identified from US administrative claims data (Komodo Health). Cohorts included early treatment (sotrovimab, other monoclonal antibodies, or antivirals), prophylaxis monoclonal antibody treatment, and untreated for COVID-19. Patient characteristics and severe clinical outcomes (assessed in the 29-day post-treatment period, including hospitalization, mortality, ventilatory support/extracorporeal membrane oxygenation [ECMO], and hospital length of stay) were described for all cohorts, with comparative effectiveness analysis conducted among matched cohorts of sotrovimab-treated and untreated patients.</div></div><div><h3>Findings</h3><div>In the descriptive analysis (<em>N</em> = 434,766 early treated; <em>N</em> = 2015 prophylaxis treated; <em>N</em> = 4,231,748 untreated), differences in age, comorbidity, and high-risk status were observed. Clinical outcomes occurred at low frequencies in all cohorts. In the effectiveness analysis (<em>N</em> = 34,160 sotrovimab treated; <em>N</em> = 68,320 untreated), treatment with sotrovimab significantly (<em>P</em> &lt; 0.001 for all) reduced hospitalization (4.0% vs 4.7%), hospitalization and/or mortality (4.0% vs 5.2%), ventilatory support and/or ECMO (3.6% vs 6.5%), and length of inpatient stay (4.8 vs 6.2 days) versus no treatment. Stratification by age showed the significant reduction in the likelihood of 29-day all-cause hospitalization was only observed in patients aged &gt;55 years, with greatest benefit observed among patients aged ≥65 years (odds ratio [OR] 0.56; 95% confidence interval [CI] 0.49–0.63). Likelihood of all-cause hospitalization was lower among sotrovimab-treated versus untreated patients during the Delta (OR 0.66; 95% CI 0.57–0.76), Omicron BA.1 (OR 0.88; 95% CI 0.81–0.95), and BA.2 (OR 0.58; 95% CI 0.43–0.79) variant predominant periods.</div></div><div><h3>Implications</h3><div>Sotrovimab was associated with a reduced risk of severe clinical outcomes in patients with COVID-19 at high risk of progression during the Delta and early Omicron (BA.1 and BA.2) variant periods.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 4","pages":"Pages 284-292"},"PeriodicalIF":3.2,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143254826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Hearing All Voices Through Patient-Focused Drug and Device Development Programs","authors":"Jill L. Maron MD, MPH","doi":"10.1016/j.clinthera.2025.01.004","DOIUrl":"10.1016/j.clinthera.2025.01.004","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 3","pages":"Pages 179-180"},"PeriodicalIF":3.2,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The Effect of Intermittent Fasting Diet in Comparison With Low-Calorie Diet on Inflammation, Lipid Profile, Glycemic Index, Liver Fibrosis in Patients With Metabolic-Associated Fatty Liver Disease (MAFLD): A Randomized Controlled Trial","authors":"Mehdi Karimi MSc ,&nbsp;Camellia Akhgarjand PhD ,&nbsp;Hirad Houjaghani MD ,&nbsp;Maryam Mofidi Nejad MSc ,&nbsp;Amir Ali Sohrabpour MD ,&nbsp;Hossein Poustchi MD ,&nbsp;Hamed Mohammadi PhD ,&nbsp;Maryam Chamari PhD ,&nbsp;Hossein Imani PhD","doi":"10.1016/j.clinthera.2025.01.007","DOIUrl":"10.1016/j.clinthera.2025.01.007","url":null,"abstract":"<div><h3>Background</h3><div>Metabolic-associated fatty liver disease (MAFLD) is a prevalent condition with significant health and economic burdens. Dietary interventions, such as intermittent fasting (IF) and low-calorie diets (LCD), have shown promise in managing MAFLD, but their comparative efficacy remains unclear.</div></div><div><h3>Methods</h3><div>This 10-month, parallel, single-blind randomized controlled trial compared the effects of a 16:8 IF diet with an LCD on 52 patients with MAFLD. Anthropometric, biochemical, liver enzyme, steatosis, fibrosis, inflammatory, and oxidative status parameters were assessed before and after the interventions.</div></div><div><h3>Results</h3><div>Both diets led to improvements in anthropometric measures and liver enzyme levels, with no significant differences between groups. However, the LCD group showed superior outcomes in reducing liver steatosis (–52.40 vs –44.63 dB/m; <em>P</em> &lt; 0.001) and fibrosis (–0.74 vs –0.004 Kpa; <em>P</em> = 0.01) compared to the IF group. LCD also led to a significant decrease in serum triglycerides (–24.08 vs 11.22 mg/dL; <em>P</em> = 0.02), while neither intervention significantly affected inflammatory markers or oxidative status.</div></div><div><h3>Conclusion</h3><div>While both IF and LCD can be effective in managing MAFLD, LCD may offer additional benefits in terms of liver fat reduction and improvement in certain lipid parameters. These findings highlight the complexity of dietary interventions in MAFLD and the need for personalized approaches.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 4","pages":"Pages e9-e16"},"PeriodicalIF":3.2,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364212","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparative safety of JAK inhibitors versus TNF or IL-17 inhibitors for cardiovascular disease and cancer in psoriatic arthritis and axial spondyloarthritis","authors":"Sizheng Steven Zhao MD, PhD ,&nbsp;David Riley MD ,&nbsp;Gema Hernandez PhD ,&nbsp;Uazman Alam MD, PhD","doi":"10.1016/j.clinthera.2025.01.005","DOIUrl":"10.1016/j.clinthera.2025.01.005","url":null,"abstract":"<div><h3>Objectives</h3><div>To compare the risk of cardiovascular disease (CVD) and common solid cancers between JAK inhibitors (JAKi) versus TNF or IL-17 inhibitors, among people with psoriatic arthritis (PsA) or axial spondyloarthritis (axSpA).</div></div><div><h3>Methods</h3><div>We used real-world electronic health records data from a predominantly North American population of PsA or axSpA. Initiators of JAKi (tofacitinib or upadacitinib) and TNFi were 1:1 propensity score matched. Cox models were used to compare time to CVD (acute myocardial infarction, stroke or revascularization) or common solid cancers (breast, colorectal, lung or prostate) over 3 years. Analyses were repeated for JAKi versus IL-17i. We performed sensitivity analyses with follow-up over 1 or 5 years, in those aged ≥65 years, or those initiating treatment before 2021.</div></div><div><h3>Results</h3><div>The JAKi vs TNFi comparison included 2,200 matched individuals in each group over 3,092 and 4,618 person-years, respectively. Compared to TNFi, JAKi was not associated with higher risk of CVD (HR 0.977; 95% 0.632, 1.510) or cancer (HR 0.710; 0.462, 1.091) over 3 years’ follow-up. JAKi vs IL-17i comparison included 2,287 individuals over 3,190 and 4,312 person-years, respectively. Compared to IL-17i, JAKi was not associated with risk of CVD (HR 1.114; 0.720,1.722) or cancer (HR 0.737; 0.484,1.122). Results across stratified analyses were directionally concordant.</div></div><div><h3>Conclusions</h3><div>These results are reassuring that among a large population of people with PsA or axSpA, JAKi was not associated with increased risk of CVD or common solid cancers, compared to TNFi or IL-17i initiators. Ongoing monitoring of cardiovascular and cancer risks is needed.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 4","pages":"Pages 293-297"},"PeriodicalIF":3.2,"publicationDate":"2025-02-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364191","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}