Advances in Therapy最新文献

{"title":"Correction: Expert Consensus on the Clinical Application of Sulodexide in Vascular Diseases.","authors":"Yongjun Li, Yu Zhao, Wei Ye","doi":"10.1007/s12325-026-03777-z","DOIUrl":"https://doi.org/10.1007/s12325-026-03777-z","url":null,"abstract":"","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149001133","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":"Impact of Uncontrolled Motor Fluctuations in Parkinson's Disease: Real-World Insights from the PROSPECT Observational Study.","authors":"Alberto J Espay, Luc Defebvre, Oriol de Fabregues, Drew Falconer, Kazuko Hasegawa, David Houghton, David Ledingham, Alexander Lehn, Tiago A Mestre, Tomoko Oeda, Fabienne Ory-Magne, Justyna R Sarna, Delaram Safarpour, Sam Colman, Lars Bergmann, Pavnit Kukreja, Koray Onuk, Connie H Yan, Pilar Sanchez Alonso","doi":"10.1007/s12325-026-03793-z","DOIUrl":"https://doi.org/10.1007/s12325-026-03793-z","url":null,"abstract":"<p><strong>Introduction: </strong>Limited real-world data exist around the long-term impact of uncontrolled motor fluctuations in Parkinson's disease (PD). With this first-ever, prospective, observational study, we sought to describe real-world treatment patterns and longitudinal outcomes of patients with PD and motor fluctuations inadequately controlled by oral medications.</p><p><strong>Methods: </strong>PROSPECT was a 24-month multicountry observational study that included 229 adults with idiopathic PD and uncontrolled motor fluctuations (≥ 2.5 h/day \"off\" time) on optimized oral PD medications who were device-aided therapy-naive. Treatment modifications, including adding device-aided therapy, were made as part of routine clinical care and were not assigned by the study. Assessments included change from baseline (CFB) in motor and non-motor symptoms, activities of daily living (ADL; MDS-UPDRS Part II), and quality of life (QoL; EQ-5D-5L, PDQ-39). Outcomes were adjusted for baseline differences using linear regression. Subgroup analyses were performed among those who remained on oral PD medications only and those who initiated device-aided therapy.</p><p><strong>Results: </strong>Most patients (80.3%, n = 184) remained solely on oral PD medications due to clinician not offering or patient refusal, and showed a small reduction in \"off\" time (CFB - 0.7 h/day, p = .006) at 24 months, with nominal decline in ADL (CFB = 1.5, p = .010) and QoL (PDQ-39 CFB = 2.6, p = .010; EQ-5D-5L CFB = - 0.04, p = .017). Approximately half (49.8%, n = 114) were offered device-aided therapy, of whom 44.7% (n = 51/114) declined, mainly citing needing time to decide or perception as unnecessary. Patients who initiated device-aided therapy (19.7%, n = 45) showed a meaningful \"off\" time reduction (CFB = - 2.2 h/day, p < .0001) and no change in ADL and QoL at 24 months, versus slight worsening with oral medications only.</p><p><strong>Conclusion: </strong>Despite device-aided therapy eligibility, most patients with PD remained exclusively on oral medications. Device-aided therapy initiation was associated with improved motor symptoms, while those who remained on oral medications showed no meaningful change.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148987843","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: Vutrisiran Health Care Resource Utilization, Costs, Discontinuation, and Mortality: A Real-World Claims Analysis.","authors":"Nicole K Bart, Daniel P Judge, Margarita Udall, Liana Hennum, Melissa Allison, Avinash Dash, Shradha Sanghi, Rakesh Ramesh, Richard Wright","doi":"10.1007/s12325-026-03764-4","DOIUrl":"10.1007/s12325-026-03764-4","url":null,"abstract":"","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148982155","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":"Patient and Healthcare Professional Attitudes and Trial Experiences with a Subcutaneous Long-Acting Injectable Olanzapine (TV-44749) for Schizophrenia Treatment.","authors":"Andrew J Cutler, Alma Gonzalez, Mark Suett, Ken Shulman, Kelli R Franzenburg, Jane Lazar Tucker, Elizabeth Costa, Sangtaeck Lim","doi":"10.1007/s12325-026-03697-y","DOIUrl":"https://doi.org/10.1007/s12325-026-03697-y","url":null,"abstract":"<p><strong>Introduction: </strong>Long-acting injectable (LAI) antipsychotics improve schizophrenia treatment adherence compared with oral antipsychotics but remain underused. TV-44749 is an innovative, once-monthly, subcutaneous (SC) LAI olanzapine designed to provide sustained efficacy through controlled olanzapine release over the monthly dosing interval without oral supplementation or complex initiation regimens. This survey assessed patients' and healthcare professionals' (HCPs) attitudes and experiences with TV-44749 during the phase 3 SOLARIS trial.</p><p><strong>Methods: </strong>This study complemented the SOLARIS trial, which assessed the efficacy, safety, and tolerability of TV-44749 in adults with schizophrenia (NCT05693935). Separate online surveys were developed and sent to patients and HCPs.</p><p><strong>Results: </strong>Overall, 70 patients (66% male; mean [SD] age, 44 [10.7] years) and 35 HCPs (11 physicians and 24 nurses) completed the survey. Patient characteristics mirrored the larger SOLARIS population. Patients preferred SC versus intramuscular injections (79% vs. 21%, respectively), primarily due to the shorter/thinner needle (67%). For HCPs, injection route preference was balanced. Most patients (90%) indicated that an LAI without a post-injection monitoring period would be helpful. Most physicians (> 90%) and nurses (> 66%) reported that the post-injection monitoring requirements present potential treatment barriers and clinical challenges that could impact LAI use. Most respondents (> 81%) indicated that injection type, initiation regimen, and dosing schedule were important treatment attributes. Patients attributed a higher degree of value than HCPs to dosing schedule and injection type. Respondents (> 72%) had favorable responses (satisfied or very satisfied) regarding TV-44749's initiation regimen, dosing schedule, and the trial medication overall, and answered favorably regarding continuing TV-44749 treatment.</p><p><strong>Conclusion: </strong>Overall, this study highlights the differential value of TV-44749 and where it may address barriers associated with IM LAI olanzapine pamoate use. Additionally, these results provide insight into differences in attitudes and experiences among patients and HCPs regarding use of LAIs and help to identify opportunities where education could improve LAI adoption. Graphical plain language summary available for this article.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148975362","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":"Evinacumab Across Different Lipid Phenotypes: A Systematic Review and Meta-Analysis.","authors":"Walter Masson, Martín Lobo, Mara Mansur, Carla Solis, Juan Patricio Nogueira","doi":"10.1007/s12325-026-03783-1","DOIUrl":"https://doi.org/10.1007/s12325-026-03783-1","url":null,"abstract":"<p><strong>Introduction: </strong>Evinacumab, a monoclonal antibody targeting angiopoietin-like protein 3 (ANGPTL3), has emerged as a promising therapeutic option for severe dyslipidemias. We have conducted a systematic review to evaluate its efficacy across different clinical settings.</p><p><strong>Methods: </strong>This systematic review and meta-analysis was conducted in accordance with PRISMA guidelines and registered in PROSPERO (CRD42026142022). Eligible studies included randomized controlled trials, open-label extension studies, single-arm studies, and observational cohorts involving healthy individuals and patients with hypercholesterolemia or hypertriglyceridemia. Due to the small number of available studies and the absence of the data required for quantitative pooling in other clinical settings, a single-arm meta-analysis was performed exclusively in patients with hypercholesterolemia receiving evinacumab 15 mg/kg every 4 weeks.</p><p><strong>Results: </strong>Overall, 17 studies were included in the systematic review. In hypercholesterolemia, evinacumab consistently reduced LDL-C levels by approximately 50%, with reductions ranging from 42% to 82% across studies. Long-term extension and real-world data confirmed sustained efficacy. Meta-analysis of seven studies including 357 patients receiving evinacumab 15 mg/kg intravenously every 4 weeks demonstrated significant reductions in LDL-C [mean difference (MD) - 48.56%], non-HDL-C (MD - 50.19%), apolipoprotein B (MD - 40.51%), and triglycerides (MD - 53.13%). In hypertriglyceridemia, qualitative evidence showed marked triglyceride lowering, particularly in multifactorial chylomicronemia syndrome, with reductions frequently exceeding 60-80%, whereas responses were limited in familial chylomicronemia syndrome.</p><p><strong>Conclusions: </strong>Evinacumab provides substantial and sustained lipid-lowering effects, particularly in homozygous familial hypercholesterolemia. Emerging evidence also supports a potential role in severe hypertriglyceridemia, although further studies are needed to define its clinical benefits in this setting.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148975415","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":"CONTROL-IHD Study: 24-h BP Control with Metoprolol-Telmisartan FDC in Hypertension and Stable Ischemic Disease.","authors":"Kamal Sharma, Gaurav Chhaya, Manojkumar Chopda, Upendra Kaul, Manish Agarwal, Prabhakar Dorairaj, Selvamani Sethuraman, Prakadeesh Bharathi, Shruti Dharmadhikari, Prachi Ahire, Chintan Khandhedia, Neeraj Markandeywar, Amey Mane, Suyog Mehta, Sadhna Joglekar","doi":"10.1007/s12325-026-03779-x","DOIUrl":"https://doi.org/10.1007/s12325-026-03779-x","url":null,"abstract":"<p><strong>Introduction: </strong>Optimal blood pressure (BP) control is essential in ischemic heart disease (IHD) to reduce cardiovascular risk. Current guidelines recommend fixed-dose combinations (FDCs) to enhance efficacy, patient adherence, and compliance. The study aimed to evaluate the efficacy and tolerability of metoprolol succinate extended-release 25/50 mg and telmisartan 40 mg FDC (Metosartan®) in patients with essential hypertension and stable IHD, using ambulatory BP monitoring (ABPM).</p><p><strong>Methods: </strong>This open-label, single-arm, multicentric, Phase IV study enrolled 88 patients who received Metosartan® once daily (OD) for 8 weeks. Primary endpoint was change in mean 24-h systolic and diastolic BP (SBP, DBP) on ABPM from baseline to week 8. Secondary endpoints included responder rates, changes in mean heart rate (HR), short-term BP variability (BPV), 24-h distribution of BP reduction, and safety outcomes.</p><p><strong>Results: </strong>Seventy-two patients completed the study. The FDC significantly reduced 24-h mean ABPM-measured SBP (143.38 ± 12.55 mmHg to 129.03 ± 11.77 mmHg) and DBP (88.84 ± 8.12 mmHg to 79.34 ± 7.93 mmHg) over 8 weeks. Mean reductions were - 14.41 ± 14.69 mmHg and - 9.52 ± 9.96 mmHg, for SBP and DBP, respectively (p < 0.0001). The ABPM-based responder rate was 36.62% (26/71). HR and 24-h BP indices improved significantly. From Weeks 2-4 to Week 8, the smoothness index increased by 0.15 (SBP) and 0.11 (DBP), while the treatment on variability index increased (TOVI) by 0.20 (SBP) and 0.16 (DBP) (all p < 0.0001). Short-term BPV showed mixed findings. Treatment was well tolerated, with only mild adverse events reported.</p><p><strong>Conclusion: </strong>Metosartan® demonstrated effective and sustained 24-h BP reduction and good tolerability in Indian patients with hypertension and stable IHD. The reductions observed during the early post-application and late dosing-interval periods suggest sustained BP lowering over 24 h.</p><p><strong>Trial registration: </strong>Clinical Trials Registry India, CTRI/2022/09/045464.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148975354","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":"Antihypertensive Medication Patterns in Patients with Hypertension that is Harder to Control: Insights from the EnligHTN Study.","authors":"Jesper N Bech, Terry McCormack, Vivek Bhalla, Naomi R Ben Dor, Julian Segura, Søren Hougaard Christiansen, Ina T Andersen, Clement Erhard, Kirsty M Rhodes, Tom Norris, Esteban Coto, Joachim Weil","doi":"10.1007/s12325-026-03771-5","DOIUrl":"https://doi.org/10.1007/s12325-026-03771-5","url":null,"abstract":"<p><strong>Introduction: </strong>Many patients with hypertension have hypertension that is harder to control (defined as needing ≥ 2 antihypertensive medications) and fail to achieve adequate blood pressure (BP) control. We assessed treatment patterns and BP outcomes in a large, multinational cohort of patients initiating a third antihypertensive class whilst remaining on a stable regimen of two antihypertensives from different classes.</p><p><strong>Methods: </strong>EnligHTN is an observational, longitudinal cohort study on hypertension management and outcomes. Data from the USA, UK, Germany, Spain, and Israel from 2018 to 2023, and Denmark from 2018 to 2024, were extracted from de-identified electronic medical records, claims data, and health registry sources. Adult patients with diagnosed hypertension were included if they initiated a third antihypertensive (index date) whilst remaining on a stable two-drug regimen. Baseline demographics and clinical characteristics, treatment patterns from index to 24 months, and BP control at 12 and 24 months from index were described.</p><p><strong>Results: </strong>Data from 64,501 patients were included. Across countries and common third antihypertensive classes, the proportion of patients who discontinued their third medication after index ranged from 54% to 100% at 12 months and from 67% to 100% at 24 months. Among a subcohort of patients with BP measurements at 12 months from index, BP was below target in 23-89%.</p><p><strong>Conclusions: </strong>Many patients with harder-to-control hypertension discontinued their third class of antihypertensive within 1 year, and numerous did not achieve adequate BP control. These findings highlight a significant gap in current hypertension management and underscore the need for adherence-focused treatment strategies to improve treatment persistence and BP outcomes in these patients.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148943759","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":"Characteristics of Medicare and Medicaid Patients Initiating Volara Respiratory Therapy: A Medical Claims Study.","authors":"Wendy M Qi, Suhui Evelyn Li, Jocelyn M Klabnik, Stanley H Dietz, Gwen M Warling, Noah Lechtzin, Michael J Barna","doi":"10.1007/s12325-026-03762-6","DOIUrl":"https://doi.org/10.1007/s12325-026-03762-6","url":null,"abstract":"<p><strong>Introduction: </strong>Volara is a novel respiratory device that delivers oscillation, lung expansion, and aerosolized medication. This study explores healthcare resource utilization (HCRU) and costs among Medicare and Medicaid enrollees who initiated Volara, providing the first real-world characterization of their HCRU patterns.</p><p><strong>Methods: </strong>We conducted a descriptive study using administrative claims data to identify Medicare and Medicaid enrollees who initiated Volara. Respiratory-related HCRU, including emergency department (ED) visits and hospitalizations, and associated costs were summarized for the 12-month pre-initiation and 12-month post-initiation periods as annualized rates and per-member-per-month (PMPM) costs. Analyses were stratified by disease segment based on principal diagnosis as of initiation and patient characteristics, including clinical risk, social risk, and age. No formal statistical comparisons between periods were conducted because of small samples and the exploratory nature of the analysis.</p><p><strong>Results: </strong>Among Medicare enrollees, ED visit rates and costs for respiratory exacerbations were 58% and 39% lower, respectively, in the post-initiation period compared with the pre-initiation period (26.3 vs 11.0 visits per 100 patients; $21 vs $12 PMPM). Hospitalization rates and costs were also lower post-initiation (41.2 vs 30.4 per 100 patients, 26% lower; $512 vs $456 PMPM, 11% lower). ED visits and costs were lower across subgroups, whereas differences in hospitalization rates were more pronounced among patients with higher clinical risk, higher social risk, and older age. Among Medicaid enrollees, ED utilization patterns were mixed, with similar rates but higher costs post-initiation (31.4 vs 29.6 per 100 patients, 5% lower; $135 vs $168 PMPM, 24% higher). In contrast, hospitalization rates and costs were lower post-initiation overall, though subgroup patterns were heterogeneous.</p><p><strong>Conclusion: </strong>These findings provide an initial characterization of real-world utilization and cost patterns among Volara users. Observed patterns varied across populations and subgroups, underscoring the need for further research using comparative designs and appropriate adjustment for confounding to understand these relationships.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148943973","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":"Comparing Pneumonia Risks of Budesonide with Fluticasone Among Patients with Asthma in Hong Kong: A Territory-Wide Retrospective Study.","authors":"Wang Chun Kwok, Lu Zhou, Ting Fung Ma, Shuk Man Ngai, Raymond Yau Hang Leung, Terence Chi Chun Tam, James Chung Man Ho","doi":"10.1007/s12325-026-03776-0","DOIUrl":"https://doi.org/10.1007/s12325-026-03776-0","url":null,"abstract":"<p><strong>Introduction: </strong>Interclass difference in pneumonia risks between budesonide (BUD) and fluticasone were not well studied in asthma.</p><p><strong>Methods: </strong>A territory-wide retrospective cohort study was conducted in Hong Kong among adult patients with Global Initiative for Asthma (GINA) step 3 to 5 asthma to examine pneumonia risks among those prescribed BUD or fluticacone (fluticasone furoate (FF) or fluticasone propionate (FP)).</p><p><strong>Results: </strong>There were 16,170 patients included with 7169 (44.3%), 7853 (48.6%), and 1148 (7.1%) of them prescribed BUD, FP, and FF, respectively. Using BUD as the reference group, the adjusted odds ratio (aOR), adjusted incidence rate ratio (aIRR), and adjusted hazard ratio (aHR) for all pneumonia events were 0.95 (0.85-1.06, p = 0.32), 1.05 (95% CI 0.99-1.12, p = 0.14), and 0.94 (95% CI 0.86-1.04, p = 0.23) for fluticasone (FF/FP), respectively. The aOR, aIRR, and aHR for hospitalized pneumonia were 0.95 (95% CI 0.84-1.07, p = 0.39), 1.15 (95% CI 0.63-2.08, p = 0.65), and 1.03 (95% CI 0.96-1.16, p = 0.39) for fluticasone (FF/FP). The aOR, aIRR, and aHR for pneumonia requiring ICU admissions were 1.08 (95% CI 0.58-2.00, p = 0.50), 1.15 (95% CI 0.63-2.08, p = 0.65), and 1.06 (95% CI 0.57-1.97 p = 0.85) for fluticasone (FF/FP), respectively. No significant difference in pneumonia risks for BUD and fluticasone (FF/FP) were observed.</p><p><strong>Conclusion: </strong>There was no significant difference in pneumonia risks for BUD and fluticasone (FF/FP) among patients with moderate to severe asthma.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148943989","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":"Evolution of Real-World Treatment Patterns over Time in Patients with HER2-Negative Advanced Gastric Cancer: A Retrospective Database Cohort Study from Japan.","authors":"Shuichi Hironaka, Yuya Kimijima, Yusuke Shinno, Eiji Nishiyama, Yorifumi Kikko, Yuko Matsuda, Tsunehisa Yamamoto, Bruno Casaes Teixeira, Takaki Yoshikawa","doi":"10.1007/s12325-026-03763-5","DOIUrl":"https://doi.org/10.1007/s12325-026-03763-5","url":null,"abstract":"<p><strong>Introduction: </strong>The treatment paradigm for patients with human epidermal growth factor receptor 2 (HER2)-negative advanced gastric cancer (aGC) has shifted after the introduction of new regimens.</p><p><strong>Methods: </strong>This retrospective analysis of hospital-based administrative claims data included adults (aged ≥ 20 years) who received guideline-recommended first-line treatment for HER2-negative aGC from January 1, 2012 to December 31, 2023. The primary objective was to examine the evolution of real-world treatment patterns in these patients across six eras, each spanning two calendar-year intervals from 2012 to 2023 (era 1, 2012-2013; era 2, 2014-2015; era 3, 2016-2017; era 4, 2018-2019; era 5, 2020-2021; era 6, 2022-2023).</p><p><strong>Results: </strong>Among 16,573 patients (72.1% male, 27.9% female; median age 70 years), tegafur-gimeracil-oteracil (S-1) plus cisplatin (SP) was the most common first-line regimen in 2012-2013 (94.0%). S-1 plus oxaliplatin (SOX) use increased from 22.4% in 2014-2015 to 66.3% in 2020-2021. Capecitabine plus oxaliplatin (CapeOX) and folinic acid-fluorouracil plus oxaliplatin (FOLFOX) use also increased in 2020-2021 (to 6.0% and 10.5%, respectively), whereas SP decreased (to 14.8%). In 2022-2023, first-line nivolumab plus chemotherapy (SOX, FOLFOX, or CapeOX) became the most common regimens (48.1%, 11.0%, and 2.6%, respectively), while SOX and SP decreased (to 26.2% and 2.0%, respectively). The proportion of patients aged ≥ 75 years increased over time. Median overall duration of therapy (DoT) also increased from 2012-2013 (8.5 months) to 2022-2023 (12.5 months). DoT did not change in the second- and third-line setting. In 2022-2023, median first-line DoT was longer with nivolumab plus chemotherapy versus chemotherapy alone (6.3 vs 5.0 months).</p><p><strong>Conclusion: </strong>Use of newly introduced first-line regimens for HER2-negative aGC in Japanese clinical practice has increased over time, with an increase in the overall DoT.</p>","PeriodicalId":7482,"journal":{"name":"Advances in Therapy","volume":" ","pages":""},"PeriodicalIF":4.7,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148944034","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}