Advances in Therapy最新文献

{"title":"Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease","authors":"Gerd R. Burmester,&nbsp;Atul Deodhar,&nbsp;Alan D. Irvine,&nbsp;Remo Panaccione,&nbsp;Kevin L. Winthrop,&nbsp;Ruth Ann Vleugels,&nbsp;Gweneth Levy,&nbsp;Smitha Suravaram,&nbsp;Hannah Palac,&nbsp;Lani Wegrzyn,&nbsp;Sharanya Ford,&nbsp;Sebastian Meerwein,&nbsp;Emma Guttman-Yassky","doi":"10.1007/s12325-025-03328-y","DOIUrl":"10.1007/s12325-025-03328-y","url":null,"abstract":"<div><h3>Introduction</h3><p>We report the long-term safety of upadacitinib (oral, selective, and reversible Janus kinase inhibitor) in rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), atopic dermatitis (AD), Crohn’s disease (CD), and ulcerative colitis (UC).</p><h3>Methods</h3><p>Data were analyzed from 16 studies (data cutoff August 15, 2024). Each treatment group was pooled across studies within each indication. Active comparator arms included adalimumab (RA/PsA) and methotrexate (RA). Treatment-emergent adverse events (TEAEs) were reported as exposure-adjusted incidence rates per 100 patient-years (<i>n</i>/100 PY).</p><h3>Results</h3><p>This analysis included 8632 (RA, <i>n</i> = 3209; PsA, <i>n</i> = 907; AS, <i>n</i> = 596; nr-axSpA, <i>n</i> = 286; AD, <i>n</i> = 2683; CD, <i>n</i> = 450; UC, <i>n</i> = 501) upadacitinib-treated patients over 27,164.2 patient-years (range 199.4–12,315.8 PY across indications). Rates (<i>n</i>/100 PY) of any TEAEs ranged from 112.0 (AS) to 401.1 (RA). Most frequently reported TEAEs included COVID-19, upper respiratory tract infection, nasopharyngitis, herpes zoster, urinary tract infection, and acne (primarily patients with AD). Serious TEAEs ranged from 4.5 (AD) to 11.0 (UC), and those leading to discontinuation ranged from 2.9 (AS) to 8.3 (UC). TEAEs leading to death ranged from 0 (nr-axSpA, UC) to 0.7 (RA). Among upadacitinib-treated patients across indications, rates of adverse events of special interest ranged from 1.3 to 4.6 (serious infection), 2.4–6.6 (herpes zoster), 0.2–0.9 (malignancy excluding nonmelanoma skin cancer [NMSC]), 0–1.4 (NMSC), 0–0.5 (major adverse cardiovascular event [MACE]), 0–0.9 (venous thromboembolism [VTE]), and 0–9.2 (elevated creatine kinase). In RA and PsA, herpes zoster, NMSC, and elevated creatine kinase rates were numerically higher with upadacitinib vs active comparators. Serious infection, herpes zoster, malignancy (excluding NMSC), NMSC, MACE, and VTE rates remained stable over time.</p><h3>Conclusion</h3><p>This descriptive analysis indicates a long-term safety profile of upadacitinib consistent with previous reports, further supporting long-term treatment of chronic diseases with upadacitinib. Variations in TEAE rates across indications likely reflected differences in populations and underlying comorbidities.</p><h3>Trial Registration</h3><p>ClinicalTrials.gov identifiers NCT02675426, NCT02706951, NCT02706847, NCT02629159, NCT02706873, NCT03086343, NCT03104374, NCT03104400, NCT03178487, NCT04169373, NCT03569293, NCT03568318, NCT03607422, NCT03345823, NCT02819635.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"5215 - 5237"},"PeriodicalIF":4.0,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03328-y.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144938804","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":"A New Ashwagandha Formulation (Zenroot™) Alleviates Stress and Anxiety Symptoms While Improving Mood and Sleep Quality: A Randomized, Double-Blind, Placebo-Controlled Clinical Study","authors":"Manasvi Mahadevan,&nbsp;Kumarpillai Gopukumar,&nbsp;Ruchi Gupta,&nbsp;Abhijeet Morde,&nbsp;Paras Patni,&nbsp;Sahitya Sarvamangala Srinivas,&nbsp;Arun Bhuvanendran,&nbsp;Abhijith Phanindra","doi":"10.1007/s12325-025-03327-z","DOIUrl":"10.1007/s12325-025-03327-z","url":null,"abstract":"<div><h3>Introduction</h3><p>Prolonged exposure to stress may lead to low mood, anxiety, depression, insomnia, and metabolic disorders. Ashwagandha, an established adaptogen, is known to combat stress. We studied the safety and efficacy of Ashwagandha formulation, Zenroot™ (ZEN), containing 1.5% total withanolides on stress, anxiety, mood, and sleep quality in human subjects with non-chronic mild to moderate stress.</p><h3>Methods</h3><p>This was a prospective, randomized, double-blind, parallel, placebo-controlled, clinical interventional study with supplementation duration of 84 days. Ninety subjects were randomly assigned in a 1:1 ratio to receive 125 mg of ZEN or placebo. We measured stress using the Perceived Stress Scale (PSS) score as a primary endpoint. Various secondary endpoints included Mindfield eSense Skin Response (SCR) and Mindfield eSense PULSE Heart Rate Variability (HRV)–Root Mean Square of Successive Differences (RMSSD), and standard deviation of normal NN interval (SDNN), Beck Anxiety Inventory (BAI), Profile of Mood States (POMS), Pittsburgh Sleep Quality Index (PSQI), stress biomarkers of serum cortisol, and salivary alpha amylase (sAA) levels and safety parameters. The study assessments were performed on days 0, 14, 28, 56, and 84.</p><h3>Results</h3><p>All 90 randomized subjects completed the study. Mean ± standard error (SE) age of subjects in the ZEN group was 35.5 ± 1.3 years and in the placebo group was 34.5 ± 1.2 years. ZEN 125 mg showed significant (<i>p</i> &lt; 0.05) improvements in PSS, BAI, and PSQI scores on days 28, 56, and 84; SCR on days 14, 28, and 84 and trend (<i>p</i> &lt; 0.1) on day 56; HRV-RMSSD and SDNN on day 14; and POMS on days 56 and 84. No significant differences were observed between the two groups for serum cortisol and sAA. The study product was well tolerated without any safety concerns.</p><h3>Conclusion</h3><p>We observed significant reductions in both subjective and objective measures of stress with improvement in mood, sleep quality, and occasional anxiety symptoms. ZEN was well tolerated without any related adverse events. Future clinical studies are warranted to evaluate the effect of ZEN on chronically stressed adults.</p><p>Clinical Trial Registration Number: http://ctri.nic.in/Identifier:CTRI/2024/03/063786.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"5238 - 5254"},"PeriodicalIF":4.0,"publicationDate":"2025-08-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03327-z.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144938822","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":"Economic Evaluation and Budget Impact Analysis of Indocyanine Green Test for Preoperative Liver Function in Patients with Major Hepatectomy in Thailand","authors":"Unchalee Permsuwan,&nbsp;Pajaree Sriuttha,&nbsp;Chutwichai Tovikkai,&nbsp;Anon Chotirosniramit,&nbsp;Asara Thepbunchonchai,&nbsp;Sunhawit Junrungsee,&nbsp;Worakitti Lapisatepun,&nbsp;Kittipong Chaiyabutr,&nbsp;Tharatip Srisuk,&nbsp;Piyameth Dilokthornsakul","doi":"10.1007/s12325-025-03341-1","DOIUrl":"10.1007/s12325-025-03341-1","url":null,"abstract":"<div><h3>Introduction</h3><p>Post-hepatectomy liver failure (PHLF) remains a significant cause of morbidity and mortality following liver resections. Indocyanine green (ICG) clearance testing provides quantitative liver function assessment to improve perioperative risk stratification. However, its cost poses a concern in resource-limited settings like Thailand. This study aimed to evaluate the cost-utility and budget impact of adding ICG testing to standard diagnosis compared to standard diagnosis alone in patients undergoing first major hepatectomy.</p><h3>Methods</h3><p>A hybrid model combining a decision tree and Markov model was developed from a societal perspective over a lifetime horizon. Clinical data and cancer treatment costs were derived from 400 real-world patients admitted to four university hospitals. PHLF costs were sourced from the National Health Security Office and utility values were directly collected from patients admitted for major hepatectomy. Primary outcomes included total costs, life years, quality-adjusted life years (QALYs), and the incremental cost-effectiveness ratio (ICER). A 3% annual discount rate was applied. A variety of sensitivity analyses were conducted to test parameter uncertainty. A 5-year budget impact analysis was also performed from a payer’s perspective, calculating the net budget impact (NBI) between both strategies.</p><h3>Results</h3><p>Compared to standard diagnosis alone, adding ICG testing increased costs by 3600 Thai baht (THB) [102 US dollars ($)] and gained 0.001 QALYs, yielding an ICER of 2,763,973 THB/QALY ($78,321). The probability of cost-effectiveness at the ceiling threshold of 160,000 THB/QALY ($4,534) was 6.3%. The ICER would fall below this threshold if PHLF risk exceeded 10.1% or if ICG test cost decreased by at least 88%. The 5-year NBI was 39.5 million THB ($1.1 million), reduced by 47.3% with dose-sharing.</p><h3>Conclusion</h3><p>Although not cost-effective at current thresholds, ICG reduces PHLF-related costs and maintains an acceptable NBI per year.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"5202 - 5214"},"PeriodicalIF":4.0,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03341-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144938820","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":"Efficacy and Safety of Triple Fixed Dose Combination of Dapagliflozin + Sitagliptin + Metformin IR in Indian Patients with Type 2 Diabetes Mellitus: A Randomized, Phase 3 Study in Comparison with Dual FDC Sitagliptin + Metformin IR","authors":"Mahendra Pal Singh,&nbsp;Sandeep Gupta,&nbsp;Manish Singh,&nbsp;C. Ambrish,&nbsp;Prakash Kurmi,&nbsp;Dinesh Kumar Gangwani,&nbsp;J. Naganna,&nbsp;Ravikumar Sethuraman,&nbsp;Vrindavani Dhumal,&nbsp;Sapan Behera,&nbsp;Piyush M. Patel,&nbsp;Dipak M. Patil,&nbsp;Lalit K. Lakhwani,&nbsp;Pravin S. Ghadge,&nbsp;Suyog C. Mehta,&nbsp;Sadhna J. Joglekar","doi":"10.1007/s12325-025-03323-3","DOIUrl":"10.1007/s12325-025-03323-3","url":null,"abstract":"<div><h3>Introduction</h3><p>This study aims to evaluate the efficacy and safety of a triple fixed-dose combination (FDC) of dapagliflozin, sitagliptin, and immediate-release metformin (DAPA + SITA + MET IR) compared to dual FDCs in patients with type 2 diabetes mellitus (T2DM).</p><h3>Methods</h3><p>This Phase 3, randomized, open-label study included eligible patients with T2DM who were randomly assigned in a 1:1 ratio to receive either a triple FDC of DAPA + SITA + MET IR (5 + 50 + 500/1000 mg) or a dual FDC of sitagliptin and MET IR (SITA + MET IR; 50 + 500/1000 mg), administered twice daily for 16 weeks. The primary endpoint was the mean change in glycated haemoglobin (HbA1c) from baseline to Week 16.</p><h3>Results</h3><p>The mean baseline HbA1c was ~ 9% in both arms. Adjusted mean reduction in HbA1c from baseline to Week 16 was significantly greater in triple FDC of DAPA + SITA + MET IR (– 2.08%) versus dual FDC of SITA + MET IR  (– 1.38%) <i>P</i> &lt; 0.0001. A significantly greater reduction in HbA1c was observed with triple FDC compared to the dual FDC at Week 12 (<i>P</i> &lt; 0.0001). At Week 16, a significantly higher proportion of patients achieved HbA1c &lt; 7% with triple FDC than with dual FDC (48.9% versus 31.1%; <i>P</i> = 0.0029). Both treatments were well tolerated.</p><h3>Conclusion</h3><p>Triple FDC of DAPA + SITA + MET IR demonstrated superior efficacy in achieving glycaemic control in patients with T2DM compared to dual FDC. There were no major safety concerns.</p><h3>Clinical trial registration number</h3><p>CTRI/2022/04/041817.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"5187 - 5201"},"PeriodicalIF":4.0,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03323-3.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144870863","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":"Identifying Treatable Traits of Patients with Asthma Prescribed an ICS/LABA: A Descriptive Analytic Database Study in England","authors":"Jennifer K. Quint,&nbsp;Adrian Rendon,&nbsp;Richard Stanford,&nbsp;Bilun Gemicioglu,&nbsp;Leandro Fritscher,&nbsp;Watchara Boonsawat,&nbsp;Elke Rottier,&nbsp;Anurita Majumdar,&nbsp;Mohamed Hamouda","doi":"10.1007/s12325-025-03332-2","DOIUrl":"10.1007/s12325-025-03332-2","url":null,"abstract":"<div><h3>Introduction</h3><p>We aimed to understand predictors of moderate-to-severe asthma exacerbations and high short-acting β₂-agonist (SABA) use in adults with asthma newly initiating single-inhaler twice-daily inhaled corticosteroids/long-acting β₂-agonists (ICS/LABAs) in England.</p><h3>Methods</h3><p>This non-interventional, longitudinal, retrospective study used medical record data (Clinical Practice Research Datalink Aurum; Hospital Episode Statistics) in England. Eligible patients with diagnosed asthma were ≥ 18 years old 12 months before the first observed single-inhaler twice-daily ICS/LABA prescription date (December 1, 2017–March 31, 2019). Patients were stratified by occurrence of moderate-to-severe exacerbation and SABA use during 12 months’ follow-up. Study outcomes included exacerbation occurrence and SABA use. Latent class cluster (LCC) analysis distinguished clusters of predictors with high importance (≥ 0.70) identified from random forest analysis and confirmed on clinical relevance. Treatment characteristics were described within each cluster.</p><h3>Results</h3><p>Most of 23,567 patients meeting study criteria (80.4%) were white and female (60.3%); mean index age was 50.0 years. Overall, 21 variables were distinguished as key predictors of moderate-to-severe exacerbation (top predictors: comorbid cardiac disease, diabetes, depression, smoking, body mass index [BMI]) and 22 as key predictors of high SABA use (top predictors: comorbid upper respiratory tract infection, cardiac disease, prior SABA use, age, sex). Five clusters each were observed among patients who experienced an exacerbation and those who did not. Among patients with high or lower SABA use, five and six clusters were observed, respectively. Treatment characteristics were similar across clusters.</p><h3>Discussion</h3><p>This study distinguished treatable and non-treatable predictors of exacerbation and high SABA use. Distinct asthma phenotypes were detected via LCC analysis. Distinguished treatable traits including comorbidities, smoking status and BMI, may be targeted by healthcare professionals.</p><h3>Conclusion</h3><p>Our findings reinforce the importance of personalized asthma treatments with the goal of improving clinical outcomes.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"5164 - 5186"},"PeriodicalIF":4.0,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03332-2.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144870866","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":"Association Between Surrogate Endpoints and Clinical Outcomes in Immunoglobulin A Nephropathy: A Systematic Literature Review","authors":"Maria Lorenzi,&nbsp;Sarah N. Ali,&nbsp;Sarah Cadarette,&nbsp;Stephen Ebohon,&nbsp;Vakaramoko Diaby,&nbsp;Mohit Mathur,&nbsp;Ancilla W. Fernandes","doi":"10.1007/s12325-025-03331-3","DOIUrl":"10.1007/s12325-025-03331-3","url":null,"abstract":"<div><h3>Introduction</h3><p>At least 50% of patients with immunoglobulin A nephropathy (IgAN) reach kidney failure within 12 years of diagnosis. Delayed progression to kidney failure remains the gold standard treatment endpoint in IgAN, but the prolonged time course limits feasibility as a primary endpoint in clinical trials. Earlier measurable endpoints may serve as surrogate endpoints for clinically important long-term kidney outcomes. Regulatory bodies recognize surrogate endpoints like proteinuria reduction. However, other stakeholders, like payers, health technology assessment agencies, and policymakers, may require additional evidence. This literature review assessed data on associations between surrogate endpoints, including proteinuria and estimated glomerular filtration rate (eGFR), and long-term kidney outcomes in IgAN.</p><h3>Methods</h3><p>A systematic search of IgAN studies conducted in any country was performed in MEDLINE, Embase, and CENTRAL via Ovid (January 1, 2006–September 1, 2023), supplemented by conference abstracts (2019–2023) and relevant literature reviews and meta-analyses. Eligible studies evaluated the association of surrogate endpoints of kidney disease progression with long-term outcomes in IgAN.</p><h3>Results</h3><p>Among 1833 unique citations screened, 23 publications met inclusion criteria. Proteinuria was associated with progression to kidney failure (<i>p</i> &lt; 0.001–0.021; <i>n</i> = 5 studies), reaching a composite kidney event (<i>p</i> &lt; 0.001–0.02; <i>n</i> = 6), doubling of serum creatinine (<i>p</i> = 0.009; <i>n</i> = 1), and long-term eGFR decline (<i>p</i> &lt; 0.001–0.910; <i>n</i> = 5); absolute eGFR at months 3 and 6 was associated with composite kidney events (<i>p</i> ≤ 0.001–0.03; <i>n</i> = 2); and eGFR slope was associated with kidney failure (<i>p</i> &lt; 0.001; <i>n</i> = 1) and doubling of serum creatinine (<i>p</i> &lt; 0.001–0.007; <i>n</i> = 1).</p><h3>Conclusion</h3><p>The literature supports associations of proteinuria and eGFR with long-term clinical outcomes in IgAN across multiple studies and geographic regions. Despite regional variability in standard of care, which introduces heterogeneity in the strength of associations, the consistency of findings across regions supports the utility of proteinuria and eGFR as surrogate endpoints for clinically important long-term kidney outcomes.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"4824 - 4865"},"PeriodicalIF":4.0,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03331-3.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144870861","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":"Identifying Parameters Associated with Delayed Diagnosis in Thrombotic Antiphospholipid Syndrome: Data from China Prospective APS Cohort","authors":"Ruijie Mo,&nbsp;Yuan Zhao,&nbsp;Hui Jiang,&nbsp;Yangzhong Zhou,&nbsp;Can Huang,&nbsp;Qian Wang,&nbsp;Xinping Tian,&nbsp;Mengtao Li,&nbsp;Xiaofeng Zeng,&nbsp;Jiuliang Zhao","doi":"10.1007/s12325-025-03317-1","DOIUrl":"10.1007/s12325-025-03317-1","url":null,"abstract":"<div><h3>Introduction</h3><p>The aim of this study was to  evaluate the rate of delayed diagnosis in patients with thrombotic antiphospholipid syndrome (tAPS) and explore potential risk factors and prognosis of delayed diagnosis.</p><h3>Methods</h3><p>This single-center, prospective study included consecutive patients with tAPS fulfilling the 2006 Sydney Revised Classification Criteria referred to Peking Union Medical College Hospital from June 2012 to September 2022. Patients diagnosed after more than two aPL-related clinical events had occurred were defined as having delayed diagnosis. Logistic regression analysis was used to identify risk factors, and survival analysis was employed to assess prognosis.</p><h3>Results</h3><p>A total of 379 patients were enrolled in the study. The mean age was 32.35 ± 13.86 years old, and 221 were female (58.31%), with venous thromboembolism occurring in 174 (45.91%) patients as the first event and arterial thrombosis in 107 (28.23%). Two hundred fifty-four (67.02%) patients had delayed diagnosis. Three high-frequency contributors for delay were obstetric morbidity (39.68%), deep vein thrombosis (26.38%), and thrombocytopenia (19.69%). Multivariate logistic regression indicated that patients with cardiovascular risk factors were more likely to receive delayed diagnosis (odds ratio [OR] = 1.767, 95% confidence interval [CI] 1.129–2.767, <i>P</i> = 0.013). Thrombocytopenia as first events (OR = 2.277, 95% CI 1.159–4.474, <i>P</i> = 0.017) was also a risk factor. Survival analysis showed that APS-related clinical manifestations and thrombotic recurrence were more likely to occur in delayed diagnosis group.</p><h3>Conclusion</h3><p>Delayed diagnosis of tAPS is common, which may lead to poor prognosis. For patients with cardiovascular risk factors and non-criteria manifestations, physicians should be alert to the possibility of APS.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"5255 - 5267"},"PeriodicalIF":4.0,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144870865","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":"Epidemiology Landscape and Impact of Overweight and Obesity in Adults: Multi-country Results from the IMPACT-O Study","authors":"Esther Artime,&nbsp;Erik Spaepen,&nbsp;Sarah Zimner-Rapuch,&nbsp;Anastasia Lampropoulou,&nbsp;Atif Adam,&nbsp;Xiaoyu Lin,&nbsp;Mengyuan Shang,&nbsp;Sarah Seager,&nbsp;Carel W. Le Roux,&nbsp;Dror Dicker","doi":"10.1007/s12325-025-03333-1","DOIUrl":"10.1007/s12325-025-03333-1","url":null,"abstract":"<div><h3>Introduction</h3><p>To estimate the recording rates and impact of overweight/obesity across selected countries in Europe and Asia–Pacific.</p><h3>Methods</h3><p>IMPACT-O was a retrospective cohort study of electronic medical records and claims databases from France, Germany, Italy, Spain, the UK, Australia, and Japan. Recording levels and the number of adults with overweight/obesity [based on diagnostic codes and/or body mass index (BMI)] during 2018–2022 were estimated. BMI thresholds/categories and obesity-related complications (ORCs) were described for adults with ≥ 1 BMI record of ≥ 25.0 kg/m² and ≥ 12 months observation before the index date.</p><h3>Results</h3><p>The number of active subjects across databases ranged from 1,203,674 to 22,413,902. BMI was recorded for 4.8–38.9% of active patients. The number of adults with overweight/obesity ranged from 3.5% in Australia to 24.9% in the UK. The percentage of individuals with BMI &gt; 25 to &lt; 30 kg/m² ranged from 43.6% in Spain to 77.9% in Japan; the percentage with BMI ≥ 30.0 kg/m² ranged from 22.1% in Japan to 54.8% in Spain. Among those with overweight/obesity, the percentage with diagnosis codes in their records ranged from 2.9% in France to 50.1% in Germany. Most (59.6–85.0%) individuals had ≥ 1 ORC; 35.9–65.8% had multimorbidity. The most frequently recorded ORCs were hypertension, dyslipidemia, depression, and type 2 diabetes.</p><h3>Conclusion</h3><p>Only a small proportion of people with overweight/obesity are formally diagnosed in healthcare databases. Most present with ≥ 1 ORC, commonly hypertension, dyslipidemia, depression, and type 2 diabetes.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"5148 - 5163"},"PeriodicalIF":4.0,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03333-1.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144870864","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":"Economic Burden of Self-Reported Tobacco Smoking Compared with Non-Smoking: Systematic Review and Meta-Analysis of Direct Health Care Costs","authors":"Nadia J. Sweis,&nbsp;Zane Z. Elfessi,&nbsp;Israel Rubinstein,&nbsp;Rachel Caskey","doi":"10.1007/s12325-025-03318-0","DOIUrl":"10.1007/s12325-025-03318-0","url":null,"abstract":"<div><h3>Background</h3><p>Tobacco smoking remains a global public health challenge, contributing to preventable mortality and morbidity and imposing substantial burdens on health care costs. We investigated whether direct health care costs differ substantially between self-reported tobacco smokers and non-smokers.</p><h3>Methods</h3><p>This systematic literature review was conducted in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Medline PubMed, Embase, PubMed Central, and Scopus were searched to identify studies of direct health care costs between smokers and non-smokers for participants aged ≥18 years. All observational, prospective, retrospective, and non-randomized comparative studies were considered. Data extraction included mean annual health care costs (± SD) for both groups. Mean differences (MD) in annual health care costs between smokers and non-smokers, expressed in 2025 US dollars, were compared and adjusted for a 12-month period and inflated to 2025 using consumer price indices.</p><h3>Results</h3><p>Of 873 studies identified, 11 were included in quantitative synthesis, which compared 19,759,529 smokers with 206,913,108 non-smokers for direct health care costs. Mean age ranged from 34.5–60.6 years for smokers and 34.3–65.1 years for non-smokers. Mean annual health care costs ranged from $65,640–$1297.1 for smokers and $54,564–$724.4 for non-smokers. Annual incremental direct health care costs for smokers versus non-smokers ranged from –$458 (95% CI [confidence interval]: –2011.0 to 1,095.0) to $11,076 (95% CI: 10,211.9 to 11,940.1) in 2025 US dollars. Meta-analysis revealed smoking generally incurred greater health care costs than non-smoking, with a mean annual incremental cost of $1916.5 (95% CI: –439.9 to 4,272.9). The result was not statistically significant (MD = 1,916.5; <i>p</i> = 0.111). Substantial heterogeneity was observed (<i>I</i>² = 99.9%). Sensitivity analysis excluding studies of chronic disease yielded a reduced incremental cost for the general population, with a statistically significant difference (MD = 583.9, <i>p</i> = 0.02), although heterogeneity remained high (<i>I</i>² = 98.0%).</p><h3>Conclusion</h3><p>This meta-analysis supports the assertion that smoking substantially increases direct health care costs compared with non-smoking, particularly for the general population.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"5134 - 5147"},"PeriodicalIF":4.0,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s12325-025-03318-0.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144870862","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":"Contralateral Randomized Comparison Between Intracameral Extended-Release Dexamethasone 9% Suspension Placed in the Capsular Bag with the Established Post-Cataract Regimen","authors":"Vasilios F. Diakonis,&nbsp;George D. Kymionis,&nbsp;Konstantinos T. Tsaousis,&nbsp;Renee C. Bondurant,&nbsp;Caroline C. Watson,&nbsp;Konstantina G. Koulotsiou,&nbsp;Robert J. Weinstock","doi":"10.1007/s12325-025-03306-4","DOIUrl":"10.1007/s12325-025-03306-4","url":null,"abstract":"<div><h3>Introduction</h3><p>This study aimed to compare the safety and efficacy of intracameral dexamethasone 9% single-dose sustained-release suspension with the established pharmaceutical regimen after cataract surgery.</p><h3>Methods</h3><p>This prospective self-controlled study included consecutive patients with bilateral visually significant cataracts. Patients received bilateral cataract extraction in the Eye Institute of West Florida by the same experienced surgeon (RJW). One randomly selected eye of every patient received a sustained-release dexamethasone 9% suspension placed in the capsular bag at the optic–haptic junction of the intraocular lens (study group); post-cataract topical regimen included topical antibiotic and NSAID. The other eye (control group) received only topical pharmaceutical agents after cataract extraction, which included the same antibiotic and NSAID as the fellow eye along with a steroid. All patients were followed at day 1, 7, and 30 after cataract surgery and visual acuity, manifest refraction, subjective anterior chamber inflammation grading, subjective patient pain score (questionnaire) along with specular microscopy of the cornea and optical coherence tomography of the macula were evaluated.</p><h3>Results</h3><p>Forty-eight eyes of 24 patients (16 female and 8 male), aged 69.54 ± 7.36 (range 54–85 years), were included in the study. All patients completed the follow-up, while none of the study eyes required additional topical treatment for inflammation control. Anterior chamber inflammation, assessed using the Summed Ocular Inflammation Score (SOIS), demonstrated a mild inflammatory response postoperatively, which resolved over time in both groups. On postoperative day 1, SOIS was slightly higher in the study eyes (1.12 ± 0.23) compared to the control eyes (0.92 ± 0.34, <i>p</i> = 0.054). By day 7, inflammation had significantly decreased (study: 0.16 ± 0.23; control: 0.17 ± 0.20, <i>p</i> = 0.88), with no residual inflammation at the final follow-up.</p><p>Uncorrected and corrected distance visual acuity, intraocular pressure, anterior chamber inflammation, corneal endothelial cell density, and central retinal thickness demonstrated no significant difference between the study and control group throughout the follow-up (<i>p</i> &gt; 0.05). None of the patients reported pain after either procedure, while no intra- or postoperative complications were noted in any of the eyes.</p><h3>Conclusions</h3><p>The use of intracameral dexamethasone 9% sustained-release suspension placed in the capsular bag at the time of cataract surgery seems to offer similar safety and efficacy as the established post-cataract topical regimen. Furthermore, no signs of iris atrophy were evident in any of the eyes up to 1 month post cataract surgery.</p></div>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":"42 10","pages":"5124 - 5133"},"PeriodicalIF":4.0,"publicationDate":"2025-08-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144844064","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}