Drugs - Real World Outcomes最新文献

{"title":"Opioid Therapy Discontinuation in General Practice: Associations with Adjunct Therapies and Somatoform Pain Disorders.","authors":"Sabrina Brinkmöller, Regina Poß-Doering, Cornelia Straßner, Gunter Laux","doi":"10.1007/s40801-026-00573-7","DOIUrl":"10.1007/s40801-026-00573-7","url":null,"abstract":"<p><strong>Background: </strong>Chronic non-cancer pain is a common reason for consultation in primary care. Although opioid therapy may be considered a treatment option for selected patients, guideline-recommended discontinuation can be challenging for both patients and general practitioners. This study investigated predictors of opioid discontinuation in primary care.</p><p><strong>Methods: </strong>We analyzed German claims data (2021) from patients aged ≥ 18 years with at least one oral or transdermal opioid prescription from general practitioners in the first three quarters of 2021. Exclusion criteria were malignant diseases or palliative care. Opioid discontinuation was operationalized as the absence of an opioid prescription in the fourth quarter. Multivariable logistic regression was used to examine associations between prespecified predictors and the absence of an opioid prescription in the fourth quarter.</p><p><strong>Results: </strong>The cohort included 94,125 patients (mean age 65 years; 62% female). Weak, long-acting opioids were most commonly prescribed. In multivariable regression analyses, adjunct therapy prescriptions were associated with higher odds of the absence of an opioid prescription (OR 1.834), whereas somatoform pain disorders (OR 0.801) and substance use disorders (OR 0.814) were associated with lower odds of the absence of an opioid prescription (all p < 0.001).</p><p><strong>Conclusions: </strong>These findings are consistent with current guideline recommendations emphasizing the use of adjunct therapies in chronic non-cancer pain management in general practice. Caution is warranted when prescribing opioids to patients with somatoform pain disorders or concurrent substance use disorders. Further research with longer observation periods is needed to confirm these associations and better understand their underlying mechanisms.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"475-486"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570869/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148668774","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}

{"title":"Complications and Occurrence of Exacerbations in Patients with Myasthenia Gravis Treated with Oral Corticosteroids.","authors":"Zhiwen Liu, Louis Jackson, Jacqueline Pesa, Alicia K Campbell, Zia Choudhry, Nizar Souayah","doi":"10.1007/s40801-026-00565-7","DOIUrl":"10.1007/s40801-026-00565-7","url":null,"abstract":"<p><strong>Background: </strong>Myasthenia gravis is a rare disease characterized by autoantibody-driven impairment of neuromuscular junction activity. Standard-of-care therapy includes oral corticosteroids (OCS), despite associated complications. This study describes OCS-related complications and exacerbations in a real-world myasthenia gravis population.</p><p><strong>Methods: </strong>This retrospective longitudinal cohort study leveraged US claims data (January 2016-March 2023; Optum's de-identified Clinformatics^® Data Mart Database) to identify patients with myasthenia gravis (International Classification of Diseases, Tenth Revision, Clinical Modification: G70.00/01). Patients were classified into non-OCS and OCS cohorts; the OCS cohort was further stratified into < 6-month, 6-month, and 12-month exposure groups (≥ 5 mg/day prednisone-equivalent; 12-month follow-up). Inverse probability treatment weighting balanced baseline characteristics. Weighted prevalence ratios of select complications (e.g., diabetes, fracture, hyperlipidemia, hypertension, infection, myocardial infarction, osteoporosis, stroke, glaucoma) and rate/risk ratios for exacerbations were calculated.</p><p><strong>Results: </strong>The weighted population included 3297 patients in the non-OCS cohort and 418, 872, and 1243 patients in the <  6-month, 6-month, and 12-month OCS exposure groups, respectively. During follow-up, the <  6-month, 6-month, and 12-month OCS exposure groups had significantly higher infection risk versus non-OCS: weighted prevalence ratios (95% confidence interval) 1.6 (1.1-2.1), 1.5 (1.2-2.0), and 1.6 (1.3-2.0), respectively. Osteoporosis risk was similar in the <  6-month group but higher in the 6- and 12-month groups versus non-OCS: weighted prevalence ratios (95% confidence interval) 1.2 (0.9-1.6), 1.5 (1.2-1.8), and 1.7 (1.4-2.0), respectively. Oral corticosteroid exposure groups had more myasthenia gravis exacerbations during follow-up versus non-OCS.</p><p><strong>Conclusions: </strong>After adjusting for observable confounders, OCS exposure within the 12-month initiation period was associated with a higher burden of complications and exacerbations among patients with myasthenia gravis.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"373-382"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570864/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148411026","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}

{"title":"Tolerability, Drug Utilization Pattern and Effectiveness of Minocycline Oral Formulations in India: A Real-World Retrospective Study from Electronic Medical Records.","authors":"Sanjiv Kandhari, Jayakar Thomas, K Yogiraj, Rakhesh Sv, Rathish T Pillai, Anupam Das, Geetanjali Shetty, Pranav Sheth, Bhavesh Lalan, Shruti Dharmadhikari, Chintan Khandhedia, Prashant Devkare, Amey Mane, Suyog Mehta","doi":"10.1007/s40801-026-00577-3","DOIUrl":"10.1007/s40801-026-00577-3","url":null,"abstract":"<p><strong>Background: </strong>Minocycline, a second-generation tetracycline, is widely used for the management of several dermatologic and infectious conditions. Large-scale real-world studies demonstrating its tolerability, utilization patterns, and effectiveness in Indian clinical practice remain limited.</p><p><strong>Objectives: </strong>The aim of this study was to evaluate real-world tolerability, utilization patterns, and effectiveness of oral minocycline formulations.</p><p><strong>Methods: </strong>This retrospective, real-world, observational, multicentric electronic medical records (EMR)-based study analyzed anonymized patient data retrieved from the HealthPlix EMR database between January 2017 and February 2023. Patients of either gender aged ≥12 years prescribed oral minocycline with at least one follow-up visit were included. The primary endpoint was tolerability, assessed as the proportion of patients with physician-documented complaints. Secondary outcomes included assessment of prescribing patterns and effectiveness.</p><p><strong>Results: </strong>A total of 2161 patients from 189 centers across India met the eligibility criteria. The mean age ± standard deviation (SD) was 30.15 ± 12.50 years, and 62.56% (1352) of the patients were females. Acne was the most common indication, documented for 1230 patients (56.92%), with acne vulgaris being the most predominant subtype. Minocycline 100 mg once daily was the most frequently prescribed regimen. The most common prescription duration at baseline was 11-20 days. Adverse events were documented in a smaller proportion of patients (n = 29; 1.34%).</p><p><strong>Conclusion: </strong>In routine real-world practice, oral minocycline was prescribed for a range of indications, predominantly acne, with prescription patterns largely aligned with contemporary recommendations. These findings suggest that oral minocycline was rationally utilized, well tolerated and associated with positive clinical outcomes in routine clinical practice. Despite inherent limitations of the retrospective design, the study provides robust real-world evidence supporting the continued use of oral minocycline in Indian clinical practice. These findings should be interpreted cautiously in the view of the retrospective design and inherent limitations of EMR-based data. REGISTRY AND THE REGISTRATION NO.</p><p><strong>Of the study: </strong>The study was registered with the Clinical Trials Registry-India (CTRI) under the registration number CTRI/2023/08/056338-Retrospectively registered.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"487-497"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570871/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148721054","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}

{"title":"Association Between Follow-Up Therapeutic Drug Monitoring and Vancomycin-Induced Nephrotoxicity: A Claims Database Study.","authors":"Tomoyuki Yamada, Shungo Imai, Kenta Minami, Taku Ogawa, Akira Ukimura, Masami Nishihara, Masashi Neo","doi":"10.1007/s40801-026-00575-5","DOIUrl":"10.1007/s40801-026-00575-5","url":null,"abstract":"<p><strong>Background: </strong>In vancomycin treatment, follow-up therapeutic drug monitoring (TDM) within 1 week after the initial TDM is recommended in patients with dose change after the initial TDM or high risk of vancomycin-induced nephrotoxicity (VIN); however, the effectiveness of follow-up TDM implementation remains unclear. This study aimed to delineate outcomes of follow-up TDM after the initial assessment under real-world conditions in Japan and clarify its association with VIN.</p><p><strong>Methods: </strong>Retrospective data analysis was conducted using a Japanese health insurance claims database. Approval was granted by the Ethics Committee of Osaka Medical and Pharmaceutical University (protocol number: 2022-105). Adult patients who received intravenous vancomycin, excluding those without a dose change after the initial TDM and without risk of VIN between January 2020 and December 2021, were included. Follow-up TDM was defined as conducting TDM within 1 week after the initial assessment. The association between performing follow-up TDM and the occurrence of VIN was assessed in patients with dose change after the initial TDM or high risk of VIN.</p><p><strong>Results: </strong>Among 492 patients who underwent the initial TDM, 403 (81.9%) had follow-up TDM performed. Cox proportional hazards model analysis revealed that follow-up TDM was associated with a lower occurrence of VIN after adjustment for estimated glomerular filtration rate <30 mL/min/1.73 m², concomitant nephrotoxic drugs, vasopressors, loop diuretics, initial vancomycin trough concentration >15 mg/L (hazard ratio 0.47; 95% confidence interval (CI) 0.25-0.86, p = 0.015). In a sensitivity analysis using inverse probability of treatment weighting, which additionally adjusted for institutional characteristics and baseline clinical risk factors, the association was attenuated and did not reach statistical significance (hazard ratio 0.62; 95% CI 0.31-1.23; p = 0.167), with residual imbalance remaining for some covariates after weighting. An exploratory receiver operating characteristic (ROC) analysis suggested a TDM frequency of 1.009 per week with a modest area under the ROC curve of 0.673 (95% CI 0.597-0.749), sensitivity of 0.618, and specificity of 0.661 (p < 0.001).</p><p><strong>Conclusion: </strong>This study found that follow-up TDM was associated with a lower occurrence of VIN, supporting guidelines recommending follow-up TDM in vancomycin therapy. Health providers should consider conducting follow-up TDM to potentially lower the occurrence of VIN, although further prospective studies are warranted to clarify its independent effect.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"383-394"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570862/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148789395","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}

{"title":"The Long-Term Sequelae and Clinical Workload Resulting from Toxicities of Immune Checkpoint Inhibitor (ICI) Therapy in Patients with Cancer.","authors":"Veera Nurmela, Anni Juntunen, Satu Tiainen, Janne Martikainen, Sanna Pasonen-Seppänen, Aino Rönkä","doi":"10.1007/s40801-026-00561-x","DOIUrl":"10.1007/s40801-026-00561-x","url":null,"abstract":"<p><strong>Background: </strong>Up to half of cancer patients treated with immune checkpoint inhibitors (ICIs) develop immune-related adverse events (irAEs). However, the long-term consequences of irAEs remain poorly characterized.</p><p><strong>Objective: </strong>This study investigated the likelihood of chronic irAEs, challenges related to their corticosteroid treatment and clinical workload associated with their management.</p><p><strong>Methods: </strong>We retrospectively analyzed 230 patients who received ICIs at Kuopio University Hospital, Finland, between the years 2015 and 2024.</p><p><strong>Results: </strong>IrAEs were chronic in 60.9% of patients who developed toxicities. Thyroiditis was the most common chronic AE (40%). Of the patients with irAE+, 42.9% were treated with systemic corticosteroids and steroid-related AEs were observed in 58% of them. Corticosteroid usage for ≥ 3 months was associated with an increased risk of steroid-related AEs (< 3 months 38.2% vs ≥ 3 months 78.8%, p < 0.001). An average of 5.3 contacts with a medical oncologist was needed for the management of an irAE, with the highest workload associated with hepatitis (10.0 contacts/irAE) and colitis (6.1 contacts/irAE).</p><p><strong>Conclusions: </strong>The characterization of the long-term sequelae of irAEs and the associated clinical workload is crucial for proper patient education and clinical resource planning.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"353-362"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570838/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148307430","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}

{"title":"Characteristics and Future Perspectives of Available Electronic Health Record Databases in Japan.","authors":"Yi Piao, Yuya Kimijima, Michihiko Nakamura, Nobutomo Matsui","doi":"10.1007/s40801-026-00562-w","DOIUrl":"10.1007/s40801-026-00562-w","url":null,"abstract":"<p><p>The global use of real-world data (RWD) for drug approval and post-marketing surveillance has increased significantly. During 2023 and 2024, the US Food and Drug Administration issued industry guidance, and the European Medicines Agency released real-world evidence framework reports to support regulatory decision making. In Japan, the Pharmaceuticals and Medical Devices Agency promotes the use of RWD, with collective efforts from the government and related industries. This report focuses on electronic health record (EHR) databases in Japan, aiming to (1) organize the characteristics of data generated from such databases, and (2) identify the challenges when using EHR databases for regulatory decision making. This report conducted an internet-based Google search using the keywords 'electronic medical record database' with the condition that the results include any of the keywords 'Japan' or 'real-world data'. Online interviews were conducted with representatives from eight EHR database companies identified as being utilized in Japan, focusing on the characteristics of each EHR database, challenges in their utilization, and future perspectives. The characteristics and limitations of current EHR databases were summarized; they offer broad coverage in terms of patient backgrounds and easier access to clinical laboratory values but are unable to track patients who transfer between hospitals due to lack of data linkage, and there may be loss of information during data abstraction. Data collection methods were mostly retrospective. Critically, there is no overall standardization between the EHR databases. Currently, EHR studies are primarily observational to verify efficacy and safety in real clinical practice and are gradually being used for post-marketing surveillance to support regulatory decision making in Japan. Addressing operational, technical, and methodological challenges in using EHR databases for regulatory approval applications requires efforts from multiple stakeholders, including industry, academia, and government.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"317-327"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570837/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148307463","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}

{"title":"Residual Burden in Adalimumab-Treated Patients with Hidradenitis Suppurativa: An Observational Cohort Study Based on Insurance Claims in the USA.","authors":"Maria A Aleshin, Tanja Tran, Ingrid Pansar, Aijing Shang, David Friesen, Alexa B Kimball","doi":"10.1007/s40801-026-00564-8","DOIUrl":"10.1007/s40801-026-00564-8","url":null,"abstract":"<p><strong>Introduction: </strong>Hidradenitis suppurativa (HS), a chronic, inflammatory skin disease, causes significant morbidity. Until 2023, adalimumab was the only US-approved biologic for patients with moderate to severe HS.</p><p><strong>Aim: </strong>This study describes the clinical profile, treatment utilization, and residual disease burden in patients with HS initiating adalimumab in the USA.</p><p><strong>Methods: </strong>This observational cohort study used data from the Merative MarketScan^® Commercial, Medicare, and Multi-State Medicaid claims databases. Adult patients who initiated adalimumab treatment between 2015 and 2018 were included (main cohort). Patients required continuous insurance enrolment during the year prior to adalimumab initiation (baseline period). Patients were followed until adalimumab discontinuation or study end (2022) to examine treatment patterns, discontinuation rates, predictors of discontinuation, and healthcare resource utilization (HCRU). Study objectives were repeated from the onset of the coronavirus 2019 (COVID-19) pandemic (COVID-19 cohort; 2020-2022). Statistical methods included Kaplan-Meier estimates and a multivariable proportional hazard regression model.</p><p><strong>Results: </strong>The main cohort included 2367 adult patients (70.4% Commercial/Medicare-insured and 29.6% Medicaid-insured). Overall, 60.3% of patients discontinued adalimumab and 6.5% of patients switched from adalimumab to other biologics; the drug survival at 6 and 12 months was 68.4% and 48.0%, respectively. Discontinuation predictors (based on baseline characteristics) included female sex, younger age, Medicaid insurance, and undergoing excision surgery. Despite a decrease in HCRU events during adalimumab treatment, the need for interventions such as antibiotics and surgeries persisted. The COVID-19 cohort showed similar trends in adalimumab drug survival and HCRU.</p><p><strong>Conclusion: </strong>While adalimumab improved certain outcomes in HS, residual burden and high discontinuation rates indicate the need for accessible and durable therapies.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"451-464"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570863/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148618784","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}

{"title":"Correction: Drug Utilization Pattern of Proton Pump Inhibitors in Patients with Acid Peptic Disease and Comorbidities in India: A Real-World Electronic Medical Records-Based Study.","authors":"Yogesh Garje, Tanish Modi, Mudit Sabharwal, Sunil Gupta, Rajiv Saikia, Ashwini Satpathy, Shruti Dharmadhikari, Neeraj Markandeywar, Chintan Khandhedia, Amey Mane, Suyog Mehta, Sadhna Joglekar","doi":"10.1007/s40801-026-00569-3","DOIUrl":"10.1007/s40801-026-00569-3","url":null,"abstract":"","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"525"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570845/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148789347","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}

{"title":"Treatment Patterns and Healthcare-Related Costs in Patients with Atherosclerotic Cardiovascular Disease: Insights from a Large US Healthcare Insurer.","authors":"Joseph L Smith, Laetitia N'Dri, Zhengzheng Jiang, Mukul Singhal, Joaquim Cristino, Batul Dahodwala","doi":"10.1007/s40801-026-00559-5","DOIUrl":"10.1007/s40801-026-00559-5","url":null,"abstract":"<p><strong>Background and objective: </strong>Atherosclerotic cardiovascular disease (ASCVD) is a leading cause of death in the USA. We evaluated lipid-lowering therapy (LLT) and the impact of adherence on healthcare costs among patients with ASCVD.</p><p><strong>Methods: </strong>This observational cohort study used payor claims and outpatient laboratory data. Adults with ASCVD diagnosed from 1 October 2015 to 31 December 2019 were observed 12 months before, and up to 24 months after, first LLT use (index; categorized as any LLT, statin monotherapy, ezetimibe monotherapy, or anti-proprotein convertase subtilisin/kexin type 9 monoclonal antibody [PCSK9 mAb] monotherapy). Treatment patterns, low-density lipoprotein cholesterol (LDL-C) measurements, LLT adherence (proportion of days covered ≥ 0.80), and healthcare resource utilization and costs were reported.</p><p><strong>Results: </strong>Of patients with 12 months' follow-up post-ASCVD diagnosis, 35% did not receive LLT within 12 months. Among those receiving any LLT, 95.4% received statin monotherapy at index, 1.6% ezetimibe monotherapy, and 0.3% anti-PCSK9 mAb monotherapy. In the cohort with 12 months' follow-up post-index (N = 417,625), the proportion of adherent patients was 66.0% for statin monotherapy, 58.0% for ezetimibe, and 54.9% for anti-PCSK9 mAb users. Among adherent patients, 25.0% of statin, 13.5% of ezetimibe, and 37.7% of anti-PCSK9 mAb users achieved LDL-C < 70 mg/dL within 12 months. ASCVD-related 12-month per patient per month medical costs were higher for nonadherent patients across LLT categories except ezetimibe.</p><p><strong>Conclusions: </strong>The high proportion of patients not reaching their LDL-C goal, including those adherent to LLT, demonstrates persistent gaps in care. Adherent patients had lower LDL-C and lower ASCVD-related costs.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"339-351"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570846/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148249487","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}

{"title":"Real-World Effectiveness and Safety of Dotinurad in Chinese Patients with Gout: A Comparative Analysis.","authors":"Guanqun Yi, Xuechan Huang, Yukai Huang, Zhixiang Huang, Shaoling Zheng, Zhengping Huang, Weiming Deng, Chun Zheng, Tianwang Li","doi":"10.1007/s40801-026-00574-6","DOIUrl":"10.1007/s40801-026-00574-6","url":null,"abstract":"<p><strong>Background: </strong>Dotinurad, a novel selective uric acid (UA) reabsorption inhibitor, exerts its hypouricemic effect through the selective inhibition of urate transporter 1 (URAT1). The present study aimed to investigate the short-term effectiveness and safety of dotinurad in the treatment of Chinese patients with gout, while also conducting a comparative analysis with febuxostat.</p><p><strong>Methods: </strong>This retrospective study enrolled 70 consecutive eligible inpatients and outpatients with gout from the Department of Rheumatology and Immunology, The Affiliated Guangdong Second Provincial General Hospital of Jinan University, were screened during the period from 1 January 2025 to 30 December 2025. Treatment was prescribed at the discretion of the treating clinician: 35 patients receiving dotinurad and 35 receiving febuxostat. The primary analyses focused on serum uric acid (UA) target attainment (≤ 360 μmol/L or ≤ 300 μmol/L) for patients with dotinurad or febuxostat) and short-term urate-lowering effectiveness after 4 weeks of treatment. Short-term changes in hepatic and renal function parameters were also evaluated.</p><p><strong>Results: </strong>After one month of treatment, the attainment rates for UA ≤ 360 μmol/L in the dotinurad group and the febuxostat group were 60.0% and 45.7%, respectively. The attainment rates for UA ≤ 300 μmol/L were 45.7% and 14.3%, respectively. While baseline UA levels did not differ significantly between the two groups (P = 0.227), a significant difference was observed after 4 weeks of treatment (The serum UA levels at week-4 after treatment in the dotinurad group and febuxostat group were 294.47 ± 19.31 and 380.85 ± 21.43, respectively; P = 0.003). After one month of treatment, significant intergroup differences were observed in the changes from baseline of UA and serum creatinine (SCR) (P = 0.003 and P = 0.029, respectively), whereas no statistically significant intergroup differences were found in the changes from baseline of serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) (P = 0.761 and P = 0.551, respectively).</p><p><strong>Conclusions: </strong>It was found that 2 mg/day of Dotinurad was superior to 40 mg/day of febuxostat in achieving serum UA levels ≤ 360 μmol/L or ≤ 300 μmol/L after 4 weeks in Chinese patients with gout and exerted superior short-term urate-lowering effectiveness to febuxostat. Additionally, dotinurad is not associated with a risk of hepatic or renal injury in the short term, whereas febuxostat may increase SCR levels over the short course. The conclusions are only applicable to the clinical medication setting where febuxostat is initiated at a dose of 40 mg in Chinese patients with gout.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"465-473"},"PeriodicalIF":2.0,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13570847/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148648459","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}