Clinical therapeutics最新文献

{"title":"Prenatal Opioid Exposure: Have We Lost an Opportunity to Improve the Outcomes of Mothers and Their Infants?","authors":"Jonathan M. Davis MD , Lauren M. Jansson MD , Hendree E. Jones PhD","doi":"10.1016/j.clinthera.2025.05.012","DOIUrl":"10.1016/j.clinthera.2025.05.012","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 536-537"},"PeriodicalIF":3.6,"publicationDate":"2025-06-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246861","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":"Characteristics and Treatment Patterns of People Without Type 2 Diabetes Diagnoses Who Use Tirzepatide in the United States","authors":"Theresa Hunter Gibble ,&nbsp;Emily R. Hankosky ,&nbsp;Alexandra Meeks ,&nbsp;Birong Liao ,&nbsp;Jennifer Ward ,&nbsp;Ahong Huang ,&nbsp;Chanadda Chinthammit","doi":"10.1016/j.clinthera.2025.05.003","DOIUrl":"10.1016/j.clinthera.2025.05.003","url":null,"abstract":"<div><h3>Purpose</h3><div>The purpose of this study was to understand real-world use of Tirzepatide among people without type 2 diabetes (T2D) diagnoses in the United States in the Merative^TM MarketScan® Commercial (MarketScan) and Optum Clinformatics Claims (CDM) databases.</div></div><div><h3>Methods</h3><div>This retrospective, observational, descriptive study used data from the MarketScan and Optum CDM databases (index date: first-observed Tirzepatide claim) from May 2021 to September 2023. Key eligibility criteria included age ≥18 years, ≥1 Tirzepatide claim, no baseline T2D diagnosis codes or antihyperglycemic medication use (except metformin), and continuous medical and pharmacy enrollment for ≥12 months pre-index. Demographic characteristics were assessed at the index date, while clinical characteristics and treatment-related data were identified during the 12-month pre-index period. Tirzepatide persistence and utilization (6 months post index) were assessed for individuals with ≥6 months of follow-up after initiation of Tirzepatide treatment (index date). Data were analyzed separately for each database.</div></div><div><h3>Findings</h3><div>Overall, 15,534 eligible adults were identified in the MarketScan database and 6800 in the Optum CDM database; mean age was 46.2 years and 55.9 years, respectively, and in both databases, &gt;70% were female. A total of 70.6% (MarketScan) and 81.0% (Optum CDM) of individuals had at least one obesity-related complication, with the most prevalent being hypertension, dyslipidemia, and pre-diabetes. There were 8709 individuals in the MarketScan database and 3384 in the Optum CDM database with ≥6 months of follow-up. In both databases, approximately two-thirds of people were started on 2.5 mg and, by the sixth prescription fill, the most common doses of Tirzepatide were 5 mg and 7.5 mg. Tirzepatide persistence ranged from 60.6% to 75.7% across both databases, with an allowed gap between prescriptions of 45 days or 60 days. Of individuals who discontinued tirzepatide, 10.2–19.5% restarted Tirzepatide during the 6-month follow-up.</div></div><div><h3>Implications</h3><div>In both databases, most people initiating Tirzepatide without T2D diagnoses had ≥1 obesity-related complication, indicating that Tirzepatide is being used in people with multimorbidity. A high proportion of people who initiated Tirzepatide were persistent on treatment at 6 months, which is higher than that previously reported for glucagon-like peptide-1 receptor agonists.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 572-580"},"PeriodicalIF":3.6,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246858","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 Nintedanib in Japanese Patients With Early-Stage Idiopathic Pulmonary Fibrosis: A One-Year Interim Analysis from a Multicenter Observational Study in Kyushu and Okinawa, Japan","authors":"Noriho Sakamoto ,&nbsp;Masaki Okamoto ,&nbsp;Kazunori Tobino ,&nbsp;Hidenori Ichiyasu ,&nbsp;Kazuya Ichikado ,&nbsp;Hiroshi Ishii ,&nbsp;Naoki Hamada ,&nbsp;Kazuhiro Yatera ,&nbsp;Taiga Miyazaki ,&nbsp;Hiroshi Ishimoto ,&nbsp;Takashi Kido ,&nbsp;Takuto Miyramura ,&nbsp;Shimpei Morimoto ,&nbsp;Naoki Hosogaya ,&nbsp;Hiroshi Mukae","doi":"10.1016/j.clinthera.2025.05.007","DOIUrl":"10.1016/j.clinthera.2025.05.007","url":null,"abstract":"<div><h3>Background</h3><div>Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive lung disease with a poor prognosis. Nintedanib, an antifibrotic agent, has been shown in clinical trials to slow the decline in forced vital capacity (FVC) and reduce acute exacerbations (AE-IPF). Long-term studies confirm its continued effectiveness, though side effects like diarrhea may affect adherence. Despite real-world data supporting nintedanib’s benefits, no prospective study has assessed its efficacy in early-stage IPF. This study evaluated the efficacy, safety, and tolerability of nintedanib in patients with early-stage IPF to assess its effectiveness outside randomized control trials.</div></div><div><h3>Methods</h3><div>A 1-year interim analysis of a prospective, multicenter observational study was conducted in Kyushu and Okinawa, Japan. This study included 215 patients with early-stage IPF (stage I/II per the Japanese IPF severity system) who were followed up for 52 weeks. Changes in FVC and diffusion capacity of carbon monoxide (DLco); incidence of adverse events, acute exacerbations, and death; and factors associated with FVC decline and nintedanib discontinuation were evaluated.</div></div><div><h3>Results</h3><div>The percentage of predicted FVC (%FVC) remained stable, from 83.2% at baseline to 83.7% at 52 weeks, while %DLco decreased from 70.8% to 64.2%. Incidences of acute exacerbation and death were both 4.7%. Nintedanib was discontinued due to adverse events in 21.9% of the patients. Risk factors for FVC decline (&gt;5%) included female sex, GAP stage II/III, low oxygen saturation (SpO₂) in the 6-minute walk test (6 MWT), and elevated biomarkers (KL-6). Significant factors for nintedanib discontinuation were advanced age, modified Medical Research Council (mMRC) grade I or higher, GAP stage II/III, low %FVC, low SpO₂ in the 6 MWT, short 6 MWT distance, and low albumin levels.</div></div><div><h3>Conclusion</h3><div>The findings of this interim analysis indicate that nintedanib has good efficacy, safety, and tolerability for early-stage IPF in real-world settings, outside randomized control trials.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 587-594"},"PeriodicalIF":3.6,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246859","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":"New Approach Combination-Dosed Therapy for Nonalcoholic Steatohepatitis Versus Vitamin E: A Randomized Controlled Trial","authors":"Amr Y. Zakaria Pharm D, MSc ,&nbsp;Rehab Badawi MD ,&nbsp;Hasnaa Osama PhD ,&nbsp;Mona A. Abdelrahman PhD ,&nbsp;Asmaa M. El-Kalaawy MD","doi":"10.1016/j.clinthera.2025.05.006","DOIUrl":"10.1016/j.clinthera.2025.05.006","url":null,"abstract":"<div><h3>Purpose</h3><div>There is currently no US Food and Drug Administration–approved remedy for nonalcoholic steatohepatitis (NASH). The present study evaluated the efficacy of N-acetyl cysteine (NAC) and rosuvastatin (RSV) compared with conventional vitamin E in patients with NASH.</div></div><div><h3>Methods</h3><div>This study was designed as a parallel, double-blinded, randomized controlled trial. Ninety patients who met the eligibility criteria were enrolled in this study. Subsequently, 45 patients were allocated to each group as follows: group 1 reported consistent administration of vitamin E 400 IU^Ⓡ (PHARCO-Pharmaceuticals) twice daily over a duration of 6 months. Group 2 included patients with NASH who received NAC, Gemacysteine 300 mg^Ⓡ (GEMA-Pharma) at 1200 mg twice daily, along with RSV, Crestor 20 mg^Ⓡ (AstraZeneca). To achieve the study’s objective, FibroScan^Ⓡ examination of liver tissue and fibrosis scores, as well as tests for liver aminotransferases, lipid profile, glycemic parameters, and hepatic and renal functions, besides health-related quality of life using the Short-Form 36 were evaluated before and after 6 months of treatment.</div></div><div><h3>Findings</h3><div>In group 1, a statistically significant decrease in the mean value of steatosis was observed after 6 months by 6.05% (<em>P</em> = 0.017), whereas treated group 2 exhibited a reduction of 16.49% (<em>P</em> = 0.001). Group 2 reported a statistically significant decrease in the mean fibrosis value of approximately 19.5% (<em>P</em> = 0.001). Fibrosis-4 Index score’s significance stated a reduction in the mean values within treatment group 2, with decreases of 51.70%. MACK-3 score which is a combination of homeostatic model assessment, aspartate aminotransferase, and cytokeratin-18, exhibited a notable reduction in mean values within treatment group 2 by 25.06% (<em>P</em> = 0.001). Concerning biological markers, malondialdehyde, both groups reported significant reductions in mean values of 11.90% (<em>P</em> = 0.006) and 27.43% (<em>P</em> = 0.001), respectively. Group 2 exhibited substantial reductions in mean levels of all biological markers: NOD-like receptor-associated protein 3 inflammasome decreased by 24.40%, tumor necrosis factor-α by 9.64%, tissue inhibitor of metalloproteinases 1 by 10.28%, N-terminal propeptide of procollagen type III by 14.58%, cytokeratin-18 by 23.44%, and fibroblast growth factor-21 by 15.08% (<em>P</em> &lt; 0.05), whereas group 1 did not demonstrate significant differences. Group 2 has substantial improvement in various metabolic parameters and health-related quality of life with accepted safety profile parameters.</div></div><div><h3>Implications</h3><div>Patients in group 2 treated with the combination of NAC/RSV exhibited tolerability and efficacy in improving liver steatosis and fibrosis, besides metabolic parameters, indicating a new combination approach to the management of NASH. C","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages e19-e30"},"PeriodicalIF":3.6,"publicationDate":"2025-06-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144246860","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":"Sex differences in time to testing for pulmonary embolism in the emergency department: a survival analysis","authors":"Brandon C. Maughan MD, MHS, MSHP ,&nbsp;Alexa Redmond MD, MPH ,&nbsp;Yoona Shim BS ,&nbsp;Nick Patrick MD ,&nbsp;Mike J. Hildebrand ,&nbsp;Bory Kea MD ,&nbsp;Esther K. Choo MD, MPH ,&nbsp;Angela F. Jarman MD, MPH","doi":"10.1016/j.clinthera.2025.04.014","DOIUrl":"10.1016/j.clinthera.2025.04.014","url":null,"abstract":"<div><h3>Study Objective</h3><div>Female patients experience delays in diagnostic testing for major cardiovascular diseases such as myocardial infarction and stroke. The objective of this study was to assess sex differences in the time to initial diagnostic testing among emergency department (ED) patients evaluated for pulmonary embolism (PE).</div></div><div><h3>Methods</h3><div>The sample included 15,038 adult patients evaluated for PE in 3 EDs from 2017 to 2023. The primary outcome was the time from ED arrival to the first order of a diagnostic test. Secondary outcomes included time to CT scan completion and time to admission for patients diagnosed with PE. Data on patient demographics, medical history, diagnostic test orders, and ED-operational factors were extracted from the electronic medical record. We performed survival analysis with a Cox proportional hazards model using an elastic net regression strategy for variable selection. Poisson regression with robust standard errors was used to measure the average marginal association of female sex with time to first PE test order.</div></div><div><h3>Results</h3><div>Female sex was associated with a slower time to first PE test (hazard ratio (HR) 0.92 [95% confidence interval (CI) 0.88, 0.95], p&lt;0.001) with an average delay of 7.2 minutes [95% CI 4.6, 9.8] compared to male patients. Secondary outcomes noted similar delays to CT scan completion (HR 0.85 [95% CI 0.8, 0.89], average 14.1 minutes [95% CI 9.3, 18.8]) and hospital admission (HR 0.83 [95% CI 0.71, 0.98], average 18.7 minutes [95% CI 1, 36.4]) for female patients compared to males.</div></div><div><h3>Conclusions</h3><div>Female patients experience slower times to diagnostic testing for PE in the emergency department. Future research should examine sex-associated delays to anticoagulation and other treatments.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 581-586"},"PeriodicalIF":3.6,"publicationDate":"2025-06-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144224626","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 Efficacy and Safety of Antibiotic Regimens in Sepsis-Induced Acute Kidney Injury: A Retrospective Cohort Study","authors":"Yiheng Zhou MM ,&nbsp;Yan Sun MM","doi":"10.1016/j.clinthera.2025.05.001","DOIUrl":"10.1016/j.clinthera.2025.05.001","url":null,"abstract":"<div><h3>Purpose</h3><div>Acute kidney injury (AKI) is a prevalent and serious complication in septic patients, potentially exacerbated by certain medications, which significantly affects morbidity and mortality rates. This study aims to evaluate the comparative efficacy and safety of different antibiotic regimens for treating sepsis-induced AKI.</div></div><div><h3>Methods</h3><div>This retrospective cohort study analyzed adult patients with AKI resulting from sepsis between 2022 and 2024. Patients were divided into three groups: Group 1 received beta-lactam monotherapy (e.g., piperacillin-tazobactam); Group 2 was treated with non-beta-lactam antibiotics (e.g., fluoroquinolones, macrolides); and Group 3 received combination therapy (e.g., betalactam plus vancomycin for MRSA). Data on demographics, clinical parameters, and outcomes—including in-hospital mortality, length of stay, and renal function—were collected.</div></div><div><h3>Findings</h3><div>A total of 552 patients were included, with no significant differences in baseline characteristics among the groups. The combination therapy group experienced a shorter duration of fever (1.33 ± 0.57 days, <em>P</em> = 0.001), lower 30-day mortality, and shorter ICU stays (4.36 = 0.81 days, <em>P</em> = 0.001). Serum creatinine levels rose significantly across all groups (<em>P</em> = 0.005), with the highest levels observed in the combination therapy group. AKI incidence was 25.3% in fluoroquinolone patients, 15.7% in beta-lactam patients, and 18.9% in the combination therapy group. Renal replacement therapy was required for 11.2% of betalactam and 16.5% of fluoroquinolone patients.</div></div><div><h3>Implications</h3><div>This study underscores significant differences in renal outcomes associated with various antibiotic regimens in septic patients with AKI. While combination therapy may improve infection control, it also poses risks to renal function. Clinicians should consider these findings when selecting antibiotic regimens for septic patients, particularly those with preexisting renal impairment.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 546-553"},"PeriodicalIF":3.6,"publicationDate":"2025-06-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144224625","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 Safety and Efficacy of Intravenous Ibuprofen in Older Patients: A Retrospective Subgroup Analysis","authors":"Tong J. Gan MD ,&nbsp;Breanne Gibson PhD ,&nbsp;Emily Durr PharmD ,&nbsp;Andrew Abad PhD ,&nbsp;Beth Zaborny ,&nbsp;Sergio Bergese MD ,&nbsp;Stephen Southworth MD","doi":"10.1016/j.clinthera.2025.04.021","DOIUrl":"10.1016/j.clinthera.2025.04.021","url":null,"abstract":"<div><h3>Purpose</h3><div>Intravenous ibuprofen (IVIB) is safe and effective for the management of pain and fever in children and adults, but requires evaluation in older patients. This retrospective study aimed to evaluate the safety and efficacy of IVIB in older patients (age ≥60 years).</div></div><div><h3>Methods</h3><div>A post hoc subgroup analysis was performed with data from four prospective clinical studies in which IVIB was administered for the treatment of pain and/or fever in hospitalized patients every 6 hours for up to 5 days. Efficacy was assessed using total morphine requirement and the visual analogue scale to evaluate pain. Safety was assessed by adverse event (AE) monitoring.</div></div><div><h3>Findings</h3><div>Of 1041 patients treated, 757 patients were 18 to 59 years old and 284 were ≥60 years old. Among older patients, 61 received placebo, and 223 received IVIB. All patients were included in the safety assessment; 591 patients from two placebo-controlled trials were included in the efficacy analysis. In both age cohorts, the incidence of AEs was higher in the placebo group, and the incidence of serious AEs was similar between treatment groups. In older patients, IVIB treatment resulted in a 24.0% reduction in pain at rest (<em>P</em> = 0.008), a 20.0% reduction in pain with movement (<em>P</em> = 0.001) between 6 and 24 hours postsurgery, and a 23.2% reduction in total morphine requirement (<em>P</em> = 0.031) compared with placebo.</div></div><div><h3>Implications</h3><div>IVIB was well-tolerated and reduced postoperative opioid consumption and pain severity in older patients. These findings suggest IVIB is a safe and effective nonopioid analgesic for perioperative pain management in older individuals.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 538-545"},"PeriodicalIF":3.6,"publicationDate":"2025-05-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144172881","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 Efficacy and Safety of Short- Versus Standard-course Fluoroquinolone Treatment in Acute Exacerbations of Chronic Obstructive Pulmonary Disease: A Meta-analysis of Double-blind Studies","authors":"Salma Messous PhD ,&nbsp;Achraf Rekik MD ,&nbsp;Lynn Keraani MD ,&nbsp;Rym Hamed MD ,&nbsp;Marwa Toumia MD ,&nbsp;Randa Dhaoui MD ,&nbsp;Adel Sekma MD ,&nbsp;Khaoula Bel Haj Ali MD ,&nbsp;Sarra Sassi MD ,&nbsp;Cyrine Kouraichi MD ,&nbsp;Riadh Boukef MD ,&nbsp;Wahid Bouida MD ,&nbsp;Hamdi Boubaker MD ,&nbsp;Mohamed Amine Msolli MD ,&nbsp;Semir Nouira MD","doi":"10.1016/j.clinthera.2025.04.020","DOIUrl":"10.1016/j.clinthera.2025.04.020","url":null,"abstract":"<div><h3>Purpose</h3><div>The objective of this meta-analysis is to determine whether a short course (≤5 days) of fluoroquinolone treatment is as effective as a long course (7 days) in the treatment of patients with an acute exacerbation of chronic obstructive pulmonary disease (COPD).</div></div><div><h3>Methods</h3><div>PubMed, Embase, Cochrane library, and Web of Science were searched to 2021. Studies considered eligible for inclusion were randomized trials of antibiotic intervention involving adult patients &gt;18 years of age with a diagnosis of acute exacerbation of COPD, no antimicrobial at the time of the diagnosis and who received treatment with fluoroquinolones in 2 different course duration. The primary outcome analyzed was the clinical cure rate at early follow-up in an intention-to-treat.</div></div><div><h3>Findings</h3><div>Nine studies with a total of 3951 patients met the inclusion criteria. The methodological quality of the study was high or very high with &gt;77% of the studies having a Jadad score of at least 4. At early (&lt;21 days) and late follow-up, there was no significant difference in clinical cure between the short course of fluoroquinolones therapy and the conventional course (odds ratio [OR] = 1.00; 95% CI, 0.97–1.04; <em>P</em> = 0.82). Similar results were found for both antibiotic regimens regarding bacteriologic clearance (OR = 0.96; 95% CI, 0.75–1.22; <em>P</em> = 0.73). Short course was not inferior to the long course when using the same quinolone (OR = 1.00; 95% CI, 0.95–1.04; <em>P</em> = 0.73) and it had significantly reduced adverse effects (OR = 0.76; 95% CI, 0.64–0.89; <em>P</em> &lt; 0.05).</div></div><div><h3>Implications</h3><div>A short course of fluoroquinolones proved to be as effective as and safer than conventional course in the treatment of patients diagnosed with acute exacerbation of COPD. Further research is encouraged to clarify the long-term outcomes in patients receiving short course of quinolones compared with the conventional course (NCT05380375).</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages 631-637"},"PeriodicalIF":3.6,"publicationDate":"2025-05-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141567","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":"Diagnostic and Prognostic Roles of Inflammatory Biomarkers in Patients With Coronary Heart Disease and Heart Failure Treated With Empagliflozin","authors":"Ahmed A. El-Sherbeni PhD ,&nbsp;Naglaa F. Khedr PhD ,&nbsp;Ibtsam Khairat PhD ,&nbsp;Rehab H. Werida PhD","doi":"10.1016/j.clinthera.2025.04.019","DOIUrl":"10.1016/j.clinthera.2025.04.019","url":null,"abstract":"<div><h3>Purpose</h3><div>Coronary artery disease (CAD) and heart failure (HF) are leading causes of global morbidity and mortality and pose economic burden. This study aims to examine the diagnostic and prognostic significance of biomarkers in patients with CAD and HF treated with empagliflozin.</div></div><div><h3>Methods</h3><div>In a prospective, case-control study, 180 participants were divided into 3 groups: patients with stable angina (CAD) and patients with HF on empagliflozin 10 mg daily for 6 months compared with healthy controls. Biomarker levels were measured at baseline, with hospital readmission rates monitored over 30 and 90 days. Stepwise logistic regression was used to predict hospital readmissions with and without participant clinical features. All relevant independent variables were then included in a single model using multiple logistic regression.</div></div><div><h3>Findings</h3><div>Significant differences in biomarker profiles were observed across groups, indicating the differential significance of these biomarkers in diagnostic and prognostic aspects. Multinomial logistic regression identified 3 biomarkers as key diagnostic markers for CAD and HF: homocysteine (relative risk ratio [RRR] = 16.5 for CAD), fetuin A (RRR = 1.1 for HF), and visfatin (RRR = 30.4 and 23.1 for CAD and HF, respectively). Prognostic analysis by multiple logistic regression identified visfatin (odds ratio = 6.5) and high-sensitivity C-reactive protein (odds ratio = 1.9) as significant predictors of hospital readmission for patients with CAD and HF, respectively.</div></div><div><h3>Implications</h3><div>The study underscores the promising role of selected biomarkers in the diagnosis and prognosis of CAD and HF diseases. These findings suggest the integration of biomarker profiling into clinical protocols to enhance patient care and outcomes in cardiovascular disease, especially in those treated with empagliflozin. Even if these indicators have potential, further larger size, long-term research is required to confirm their use in clinical settings. ClinicalTrials.gov identifier: NCT05911724.</div></div>","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 8","pages":"Pages e1-e11"},"PeriodicalIF":3.6,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141568","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":"Interview with Dr. Mandi Pratt-Chapman: The Impact of Restrictions on Lesbian, Gay, Bisexual, Transgender, Queer and Intersex Research on Oncology","authors":"Mandi Pratt-Chapman PhD, MA ,&nbsp;Jill L. Maron MD, MPH","doi":"10.1016/j.clinthera.2025.04.018","DOIUrl":"10.1016/j.clinthera.2025.04.018","url":null,"abstract":"","PeriodicalId":10699,"journal":{"name":"Clinical therapeutics","volume":"47 7","pages":"Pages 465-468"},"PeriodicalIF":3.2,"publicationDate":"2025-05-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144141679","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}