Drugs - Real World Outcomes最新文献

{"title":"Polypharmacy and Activities of Daily Living in Older Patients Undergoing Cerebrovascular Rehabilitation: An Observational Study Using Japanese Real-World Data.","authors":"Yukari Ogawa, Takeshi Horii, Masaharu Sakoh, Kiyoshi Mihara","doi":"10.1007/s40801-026-00589-z","DOIUrl":"https://doi.org/10.1007/s40801-026-00589-z","url":null,"abstract":"<p><strong>Background: </strong>Polypharmacy is highly prevalent among older patients undergoing cerebrovascular rehabilitation and may adversely affect functional recovery.</p><p><strong>Objective: </strong>This study examined the association between polypharmacy and the extent and pace of functional recovery in older patients undergoing convalescent rehabilitation after cerebrovascular events.</p><p><strong>Methods: </strong>This retrospective observational study used a Japanese real-world claims database (Japan Medical Data Center claims database, accessed on 25 August 2025), and included patients aged ≥ 65 years admitted to convalescent rehabilitation wards for cerebrovascular diseases. Polypharmacy was defined as the use of six or more medications. Patients were categorized into four groups according to polypharmacy status at admission and discharge: persistent non-polypharmacy, polypharmacy resolved, incident polypharmacy, and persistent polypharmacy. Functional outcomes were assessed using the Functional Independence Measure (FIM). The primary outcome measure was FIM gain, and the secondary outcome measure was FIM efficiency. Multivariable linear regression analyses adjusted for patient characteristics, comorbidities, and hospital bed capacity were performed.</p><p><strong>Results: </strong>Among 44,980 patients, 48.9% had persistent polypharmacy and 14.8% developed incident polypharmacy during hospitalization. Polypharmacy status was not significantly associated with FIM gain. In contrast, FIM efficiency was significantly lower in the polypharmacy-resolved, incident polypharmacy, and persistent polypharmacy groups than in the persistent non-polypharmacy group. The strongest negative association with FIM efficiency was observed in the incident polypharmacy group (B = -0.114, p < 0.001), followed by the persistent polypharmacy group (B = -0.069, p < 0.001).</p><p><strong>Conclusions: </strong>Polypharmacy status was not significantly associated with FIM gain, the primary outcome. Although the three polypharmacy groups had lower FIM efficiency and longer hospital stays than the persistent non-polypharmacy group, the lower FIM efficiency may partly reflect differences in length of hospital stay. These observational findings do not establish a causal relationship between changes in medication burden and functional recovery.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149165996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Epidemiology of Inflammatory Bowel Disease in Italy: Treatment Patterns, Adherence, and Costs in Patients with Ulcerative Colitis Treated with Mesalazine.","authors":"Luca Degli Esposti, Chiara Veronesi, Silvia Calabria, Lisa Giannessi, Antonietta Barbieri, Fausto Bartolini, Stefania Dell'Orco, Fulvio Ferrante, Stefano Grego, Cataldo Procacci, Cristina Bezzio, Alessandro Armuzzi","doi":"10.1007/s40801-026-00591-5","DOIUrl":"https://doi.org/10.1007/s40801-026-00591-5","url":null,"abstract":"<p><strong>Background/aim: </strong>Ulcerative colitis (UC) and Crohn's disease (CD) are chronic immune-mediated conditions associated with a substantial clinical and economic burden. Italian epidemiological evidence is limited. Mesalazine remains a cornerstone of UC management. This study aimed to provide updated epidemiological estimates of inflammatory bowel disease (IBD) in Italy, and to evaluate real-world treatment patterns, adherence to oral mesalazine, and healthcare costs among patients with UC initiating mesalazine therapy.</p><p><strong>Methods: </strong>A retrospective observational analysis was conducted using Italian administrative databases covering ~4 million beneficiaries. Patients with UC and CD were identified (January 2010-May 2023) using the International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) or exemption codes. Patients with UC who were new users of mesalazine were characterized at baseline. Mesalazine treatment patterns, adherence, and direct healthcare costs were described at follow-up.</p><p><strong>Results: </strong>At the end of 2023, UC and CD prevalence rates were 272 (95% confidence interval [CI] 267-278) and 166/100,000 (95% CI 162-170) inhabitants, respectively. Incidence rates in 2023 of UC and CD were 18.9 (95% CI 18-20) and 10.8/100,000 (95% CI 10-12), respectively. Among 2552 patients with UC who were new mesalazine users, 69.6% of time-dependent mesalazine users were adherent (versus 56.1% pH-dependent users). Mean annual cost per patients with UC who were new mesalazine users in 2023 was €4516, mainly driven by hospitalizations.</p><p><strong>Conclusions: </strong>This real-world analysis provides recent epidemiological estimates of UC and CD, and describes a substantial economic burden, highlighting the need for improving adherence and therapeutic pathways.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-10-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149164838","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PCSK9 inhibitors usage in South China: A Multi-Center Real-World Study.","authors":"Qiuyan Yu, Tiantian Ma, Fengmei Huang, Olivia Monteiro, Edmundo Patricio Lopes Lao, Io Chon Vong, Sam In Ung, Shasha Li, Shaorong Wu, Jinghao Wang, Joseph Edgar Blais, Kathryn Choon Beng Tan, David Tak Wai Lui, Kai Hang Yiu, Ian Chi Kei Wong, Celine Sze Ling Chui","doi":"10.1007/s40801-026-00586-2","DOIUrl":"https://doi.org/10.1007/s40801-026-00586-2","url":null,"abstract":"<p><strong>Background: </strong>Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are effective for lipid management in high-risk patients with atherosclerotic cardiovascular disease. Their inclusion in China's National Reimbursement Drug List and the Hong Kong Hospital Authority Drug Formulary in 2021 improved accessibility. The Guangdong-Hong Kong-Macau Greater Bay Area is a unique integrated economic zone in Southern China where divergent healthcare systems coexist. How these disparate policies create inequities in drug access remains unexplored for regional health integration. This study aimed to compare real-world PCSK9i utilization and effect across the Greater Bay Area.</p><p><strong>Methods: </strong>This multi-center cohort study analyzed electronic health records from five centers: Hong Kong Hospital Authority (HKHA) [Hong Kong], Macau Health Bureau (SSM) [Macau public], Macau University of Science and Technology Hospital - University Hospital (MUST-UH) [Macau private], Hong Kong-Shenzhen Hospital (HKU-SZH) [Shenzhen], and First Affiliated Hospital of Jinan University (JNUH) [Guangzhou], between August 2016 and December 2024, with center-specific start dates reflecting local PCSK9i availability. Adult (aged ≥18 years) new users of alirocumab or evolocumab were included. We investigated prescribing trends and evaluated the low-density lipoprotein cholesterol (LDL-C) goal attainment post-initiation.</p><p><strong>Results: </strong>There were total of 9828 new users (HKHA = 3296, HKU-SZH = 2529, SSM = 148, MUST-UH = 87, JNUH = 3768), agent choice varied with evolocumab most commonly prescribed in HKHA, MUST-UH, and JNUH, while alirocumab was most common in HKU-SZH and SSM. Patients were predominantly older male individuals with a high burden of atherosclerotic cardiovascular disease. Prescribing trends showed a divergent uptake, with the highest uptake in mainland centers (JNUH and HKU-SZH) post-National Reimbursement Drug List inclusion. Substantial LDL-C reductions were observed after PCSK9i initiation (median reductions of 38-56%). Approximately 60-70% of patients achieved an LDL-C <1.8 mmol/L in most centers, though attainment was slightly lower in JNUH.</p><p><strong>Conclusions: </strong>In the largest real-world study of PCSK9i in Asia, therapy was primarily used in high-risk patients, and substantial LDL-C reductions with high goal attainment were observed following its initiation. The observed regional variations in prescribing patterns highlight the impact of local healthcare policies. The findings provide a robust model for multi-jurisdictional evidence generation and highlight the need for further research on whether harmonized access policies could improve lipid management and reduce the cardiovascular burden across East Asia.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149105432","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Pharmacist-Led Polypharmacy Management on Prescribing Patterns in Older Inpatients: A Real-World Study in a Chronic Care Hospital.","authors":"Takefumi Miyake, Yu Nakamura, Kana Masui, Hideko Iwasaki, Fumiyasu Nakamura, Mai Hashimoto, Daisuke Kadowaki","doi":"10.1007/s40801-026-00584-4","DOIUrl":"https://doi.org/10.1007/s40801-026-00584-4","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Polypharmacy is a major challenge in geriatric pharmacotherapy and is associated with increased risks of adverse drug events, functional decline, and increased healthcare costs. Although pharmacist-led medication reviews improve prescription appropriateness, evidence regarding the sustained implementation of such interventions in chronic care hospitals remains limited.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aimed to evaluate the impact of a stepwise pharmacist-led polypharmacy management program on prescription patterns and medication costs among older inpatients in a chronic care hospital.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;We conducted a single-center, retrospective observational study at a chronic care hospital in Japan, and included all inpatients hospitalized between January 2023 and December 2025. A multidisciplinary polypharmacy management program was introduced in 2024, followed by pharmacist-led comprehensive medication evaluation and management in 2025. The study period was categorized into three phases: preintervention (2023), implementation (2024), and comprehensive management (2025). The primary outcome was the monthly average number of regularly prescribed oral medications. The secondary outcomes included the prevalence of polypharmacy, defined as the concurrent use of ≥ 6 regularly prescribed medications, and hyperpolypharmacy, defined as ≥ 10 medications. The threshold of ≥ 6 medications was adopted because it is used as the criterion for polypharmacy management in the Japanese national healthcare reimbursement system. The threshold of ≥ 10 medications corresponds to our hospital's institutional criterion for identifying patients eligible for pharmacist-led comprehensive medication review.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Approximately 320 inpatients were included monthly during the study period. The average number of prescribed medications decreased from 6.44 ± 3.37 in 2023 to 6.23 ± 3.52 in 2024 and 6.05 ± 3.47 in 2025. Regarding the rate of polypharmacy, the proportion of patients taking ≥ 6 or ≥ 10 medications decreased from 54.3% to 46.5% and from 18.4% to 15.5%, respectively. In contrast, the total annual medication costs showed no significant changes across the 3 years. Analysis according to therapeutic class demonstrated decreased costs for hypnotics/anxiolytics and nonsteroidal antiinflammatory drugs/paracetamol, whereas antithrombotic drug costs increased. The prescription volume measured by defined daily dose per 100 patients per day (DPD) remained generally stable, although intergroup differences were observed in 2025.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;Pharmacist-led polypharmacy management was associated with changes in prescribing patterns and reductions in medication burden in this chronic care hospital. However, the reductions in the number of medications did not translate into short-term reductions in medication costs. These findings suggest that pharmacist-led interventions in ","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149105475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Correction: Real-World Evidence for Drug Value Assessment in China: Learning from International Experiences.","authors":"Abraham G Hartzema, Adel Gehchan, Jennifer D Guo, Jianwei Xuan","doi":"10.1007/s40801-026-00572-8","DOIUrl":"https://doi.org/10.1007/s40801-026-00572-8","url":null,"abstract":"","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149024144","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Characteristics and Treatment Patterns of Early Stage Melanoma: Results from a Multisite Chart Review.","authors":"Collin M Costello, Maria L Wei, James Isaacs, Elizabeth M Gaughan, Adina Greene, Alexandra So, Xiaochen Zhong, Jara Majuelos-Melguizo, Kavita Gandhi, Claudia Rey, Alicia Delibes, Rosemarie Barnett, Mizuho Fukunaga-Kalabis, Nawab Qizilbash, Irene M Shui, Xiang-Lin Tan","doi":"10.1007/s40801-026-00583-5","DOIUrl":"https://doi.org/10.1007/s40801-026-00583-5","url":null,"abstract":"<p><strong>Background: </strong>Early stage melanomas are clinically heterogeneous and real-world treatment patterns in early stage cutaneous melanoma are poorly characterized.</p><p><strong>Objective: </strong>The purpose of this study was to characterize real-world treatment patterns among patients with early stage cutaneous melanoma.</p><p><strong>Methods: </strong>A retrospective chart review was conducted at four US sites. Adult patients with histologically confirmed stage IB-IIC melanoma diagnosed between 1 January 2018 and 24 months before the start of data collection at each site (latest 3 July 2024) were included. Data on treatment patterns, recurrence, and lines of treatment (LOTs) were collected using a case report form (CRF). Treatment patterns were analyzed for specific sequences given within the same LOT. Chi-squared or Fisher's exact tests were used to assess associations.</p><p><strong>Results: </strong>Among 398 enrolled patients, 224 (56.3%) were stage IB, 84 (21.1%) IIA, 65 (16.3%) IIB, and 25 (6.3%) IIC. Overall, 366 (92.0%) received sentinel lymph node biopsy, 392 (98.5%) received surgery, 135 (33.9%) watchful waiting, 49 (12.3%) systemic drug therapy, and 10 (2.5%) radiotherapy. Radiotherapy and systemic drug therapy use was significantly greater in patients with higher stages or recurrence. The most frequent systemic drug therapies were anti-PD-1 (81.6%) and anti-CTLA-4 (30.6%). A total of 394 (99.0%) patients received at least one LOT. Almost all patients (99.5%) received surgery alone or in combination as the first LOT. Systemic drug therapy was included in most second LOTs (57.8%). Overall, 64 (16.1%) patients received ≥ 2 LOTs (stage IB 8.9%, IIA 22.7%, IIB 23.1%, IIC 40.0%) and 25 (6.3%) received ≥ 3 LOTs (stage IB 3.1%, IIA 7.2%, IIB 10.8%, IIC 20.0%).</p><p><strong>Conclusions: </strong>In alignment with National Comprehensive Cancer Network (NCCN) guidelines, management of early stage cutaneous melanoma was predominantly surgical. Patients with higher disease stages received more LOTs, and some patients received up to four systemic drug therapies. This highlights a need for novel therapies and optimization of treatment sequences for high-risk early stage melanoma.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149008015","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Estimated Acquisition Cost Differences between Fixed and Simulated Body Weight-Based Nivolumab Dosing Using Real-World Claims Data in Japan.","authors":"Tomohiko Harada, Yoshihiro Noguchi, Ai Ohnishi, Rikuto Masuda, Tomoya Sugimoto, Tomoaki Yoshimura","doi":"10.1007/s40801-026-00582-6","DOIUrl":"https://doi.org/10.1007/s40801-026-00582-6","url":null,"abstract":"<p><strong>Background: </strong>Nivolumab was initially approved with body weight-based dosing; however, fixed-dose regimens were later adopted based on pharmacokinetic evidence supporting comparable benefit-risk profiles. Nevertheless, the acquisition cost impact of fixed dosing relative to a body weight-based counterfactual remains unclear in Japanese real-world data.</p><p><strong>Objectives: </strong>The purpose of this study was to estimate drug acquisition cost differences at the index administration by comparing observed fixed-dose quantities with a simulated body weight-based counterfactual using nationwide Japanese claims data.</p><p><strong>Methods: </strong>We retrospectively analyzed nationwide Japanese claims data. Fixed-dose regimens of 80, 240, 360, and 480 mg were mapped to corresponding body weight-based regimens of 1, 3, 4.5, and 6 mg/kg, respectively, and patient-specific body weight-based doses were calculated using recorded body weight. The index administration was the first nivolumab administration observed for each patient during the database observation period. Costs were estimated at the index administration using official Japanese drug prices. Sensitivity analyses examined alternative body weight measurement windows and simulated measurement error. Bootstrap resampling was used to estimate uncertainty in the median cost difference.</p><p><strong>Results: </strong>Among 3243 patients, estimated drug acquisition costs based on observed fixed-dose quantities were higher than those calculated for the simulated body weight-based counterfactual at the index administration. The median cost difference was 89,540 Japanese yen (bootstrap 95% confidence interval 86,945-92,135 Japanese yen). Median costs were 311,443 and 251,750 Japanese yen for observed fixed-dose quantities and the simulated body-weight-based counterfactual, respectively. The direction of the estimated cost difference remained consistent across sensitivity analyses, although its magnitude varied across simulated body weight measurement-error scenarios.</p><p><strong>Conclusions: </strong>Using real-world Japanese claims data and official drug prices, this study estimated higher acquisition costs based on observed fixed-dose quantities than those calculated for a simulated body-weight-based counterfactual at the index administration. The body-weight-based comparator was simulated for the same patients and did not represent an observed treatment group.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148988485","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trends in the Use and Costs of Medications for Respiratory Management Included in the 2022 Benefit Plan of the Colombia Health System.","authors":"Manuel Enrique Machado-Duque, Luis Fernando Valladales-Restrepo, Andrés Gaviria-Mendoza, Juan Pablo Albanes-Beltrán, Giovanny Mesa-Escobar, Ana Camila Delgado-Araujo, María Camila Oyuela-Gutiérrez, Santiago Rubio-Londoño, Jorge Enrique Machado-Alba","doi":"10.1007/s40801-026-00581-7","DOIUrl":"https://doi.org/10.1007/s40801-026-00581-7","url":null,"abstract":"<p><strong>Background: </strong>The Colombian Ministry of Health updated the Health System Benefit Plan (BP) as of 2022. The subsequent economic impact on medicines for respiratory management remains unknown.</p><p><strong>Objective: </strong>To describe the dispensing trends and costs of medicines for respiratory management included in the 2022 Health System Benefit Plan in Colombia.</p><p><strong>Methods: </strong>The aim of this longitudinal observational study was to quantify the trends in the use and costs of medicines for respiratory management included in the new BP. Dispensations from January 2021 to June 2023 from the database of a pharmaceutical manager with information on 9.2 million members of the Colombian Health System were analyzed, and descriptive analyses were performed.</p><p><strong>Results: </strong>Medications were dispensed to 42,370 patients, who had a mean age of 60.8 <math><mo>±</mo></math> 26.2 years. Among these medications, the greatest increases in the percentages of patients to whom they were dispensed were observed for the combinations formoterol/budesonide (+156.1%), vilanterol/fluticasone (+239.7%), and vilanterol/umeclidinium (+292.1%). The total cost estimated for the October-December quarter of 2021 was USD$2,404,035, whereas that estimated for the April-June quarter of 2023 was USD$4,651,828, representing an increase of 94% in the invoiced value; this increase was attributable primarily to the invoicing of long-acting β-agonists/inhaled glucocorticoids (LABAs/ICSs) (+190%) and LABAs/LAMAs (long-acting antimuscarinics) (+119%).</p><p><strong>Conclusions: </strong>After the 2022 Benefit Plan update for respiratory conditions such as asthma and chronic obstructive pulmonary disease, increases in the dispensing and direct pharmaceutical costs of the newly included therapies were observed. These temporal changes suggest modifications in prescribing and dispensing patterns, potentially reflecting greater access to recommended first-line therapies, although causal attributions to the Benefit Plan update cannot be established, given the descriptive nature of this study.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148967229","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of Sotatercept in France since Its Availability in June 2024: A Nationwide Study from the French Health Data System (SNDS).","authors":"Nazoiri Charifa, Alain Weill, Mahmoud Zureik, Jérémie Botton, Nadia Haddy","doi":"10.1007/s40801-026-00579-1","DOIUrl":"https://doi.org/10.1007/s40801-026-00579-1","url":null,"abstract":"<p><strong>Background: </strong>Pulmonary arterial hypertension (PAH) is a rare, severe and progressive disease associated with poor quality of life and high mortality. Sotatercept, a first-in-class fusion protein, has recently been shown to provide substantial clinical benefit as add-on therapy in PAH and was made available in France in 2024 through an early access program, with eligibility criteria that progressively broadened over time.</p><p><strong>Objectives: </strong>We aimed to describe the characteristics of the first patients treated with sotatercept in France, its real-world administration patterns, and associated changes in background PAH therapy.</p><p><strong>Methods: </strong>Using the French National Early Access and Expensive Drugs Cohort (AP-MO), derived from the French Health Data System (SNDS), we included all patients who initiated sotatercept since the start of the early access program and followed them until 31 October 2025. Baseline characteristics included sex, age, social deprivation index, comorbidities, and time since treatment initiation. Changes in background PAH therapy were also described.</p><p><strong>Results: </strong>We identified 257 patients treated with sotatercept (median age 53 years; 75.5% women; median follow-up 8.9 months). Among patients with ≥ 90 days follow-up (n = 205), background therapy remained unchanged in 67% of patients. Most administrations followed the expected 21-day interval, and 94.2% received at least one dose renewal. Thirteen deaths occurred during follow-up (0.55 per 100 person-months), and two patients underwent lung transplantation.</p><p><strong>Conclusions: </strong>These findings provide the first real-world, nationwide insights into sotatercept use in routine clinical practice, showing treatment patterns broadly consistent with initial recommendations, including maintenance of background therapy and adherence to the recommended dosing interval. Further studies are warranted to assess the long-term effectiveness and safety of sotatercept.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":2.0,"publicationDate":"2026-09-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148967256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Long-Term Antidepressant Use and Dementia Risk: A Propensity Score-Matched Study of Swiss Older Adults, with an Anticholinergic-Specific Analysis.","authors":"Melanie A Amrein, Michael P Hengartner, Markus Näpflin, Renato Farcher, Carola A Huber","doi":"10.1007/s40801-026-00560-y","DOIUrl":"10.1007/s40801-026-00560-y","url":null,"abstract":"<p><strong>Background: </strong>Antidepressants are widely prescribed, with increasing use among older adults. However, evidence on their association with dementia remains inconsistent.</p><p><strong>Objective: </strong>This study examines the association between long-term antidepressant use and dementia risk in older adults using a propensity score-matched design, with a separate analysis of long-term tricyclic antidepressant (TCAs) use, given their anticholinergic properties.</p><p><strong>Methods: </strong>A retrospective cohort study was conducted using Swiss healthcare claims data (2013-2023) from older adults aged 65 years and above. Long-term antidepressant users (> 2 years) and long-term TCAs users were separately matched to nonusers using variable ratio propensity score matching. The primary outcome was incident dementia, defined by a recorded dementia diagnosis or antidementia drug prescription. Covariates were derived from inpatient and/or outpatient records, depending on the respective variable.</p><p><strong>Results: </strong>A final sample of 19,155 long-term antidepressant users were compared with 20,648 propensity score matched nonusers. After adjusting for covariates, long-term antidepressant use was significantly associated with dementia (odds ratio [OR] 1.92, 95% confidence interval [CI] 1.72-2.15, p < 0.001). Long-term TCAs users also had higher odds of developing dementia compared with nonusers (OR 1.73, 95% CI 1.33-2.25, p < 0.001). Sensitivity analyses largely confirmed these results: long-term antidepressant users had higher odds of developing dementia compared with short-term users (OR 1.23, 95% CI 1.11-1.35, p < 0.001), but for TCA, the difference between long-term and short-term users was not statistically significant (OR 1.25, 95% CI 0.99-1.57, p = 0.059).</p><p><strong>Conclusions: </strong>These findings suggest that long-term antidepressant and long-term TCAs use is associated with an increased risk of dementia in older adults, even after accounting for various comorbidities. This study adds to the ongoing debate on the link between antidepressants and dementia. Future research is needed to further clarify underlying mechanisms and guide clinical practice.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"329-338"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570850/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148216839","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}