Drugs - Real World Outcomes最新文献

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Effectiveness and Safety of Long-Term Venous Thromboembolism Prophylaxis After Colorectal Cancer Surgery: A Retrospective Study. 结直肠癌术后长期静脉血栓栓塞预防的有效性和安全性:一项回顾性研究。
IF 1.9
Drugs - Real World Outcomes Pub Date : 2025-09-01 Epub Date: 2025-08-05 DOI: 10.1007/s40801-025-00510-0
Ying Zhang, Xiaozhu Zhou, Yi Wu, Shicai Chen, Xiangli Cui, Ying Zhao
{"title":"Effectiveness and Safety of Long-Term Venous Thromboembolism Prophylaxis After Colorectal Cancer Surgery: A Retrospective Study.","authors":"Ying Zhang, Xiaozhu Zhou, Yi Wu, Shicai Chen, Xiangli Cui, Ying Zhao","doi":"10.1007/s40801-025-00510-0","DOIUrl":"10.1007/s40801-025-00510-0","url":null,"abstract":"<p><strong>Background: </strong>The optimal duration for thromboprophylaxis after colorectal cancer surgery remains uncertain. We sought to compare the effectiveness and safety of long-term thromboprophylaxis to that of short-term thromboprophylaxis in preventing venous thromboembolism (VTE) after colorectal cancer surgery.</p><p><strong>Methods: </strong>In our retrospective study, patients undergoing colorectal cancer surgery were divided into the short-term (< 7 days) and long-term (≥ 7 days) thromboprophylaxis groups based on the low molecular weight heparin prophylaxis regimen. Propensity score matching was performed for both groups, and comparative analysis of the incidence of asymptomatic or symptomatic VTE and bleeding complications was conducted. Multivariable logistic regression analysis was performed in the unmatched cohort to explore the association of potential risk factors with postoperative VTE.</p><p><strong>Results: </strong>A total of 140 patients undergoing colorectal cancer surgery were included. After matching, there were 57 patients in each group. VTE occurred in 18 patients (15.8%) within 6 months after surgery, with 12 cases (21.1%) in the short-term thromboprophylaxis group and six cases (10.5%) in the long-term thromboprophylaxis group (P = 0.123). There were no significant differences in the incidence of bleeding complications between the two groups. Multivariable logistic regression analysis indicated that long-term thromboprophylaxis can reduce the risk of postoperative VTE (odds ratio 0.34, 95% confidence interval 0.12-0.95; P = 0.039).</p><p><strong>Conclusions: </strong>Long-term thromboprophylaxis (≥ 7 days) demonstrated comparable effectiveness and safety to shorter regimens (< 7 days) in preventing postoperative VTE in patients with colorectal cancer, while suggesting potential sustained protective benefits during extended follow-up periods exceeding 6 months. Whether VTE prophylaxis should be extended to 28 days post-surgery requires further research.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"479-487"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381313/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144783757","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}
引用次数: 0
Nontuberculous Mycobacterial Lung Disease Management in Belgium: A Longitudinal Pharmacy Database Study. 比利时非结核性分枝杆菌肺病管理:纵向药学数据库研究。
IF 1.9
Drugs - Real World Outcomes Pub Date : 2025-09-01 Epub Date: 2025-07-29 DOI: 10.1007/s40801-025-00507-9
Eliana Peeters, Marko Obradovic, Roald van der Laan, Rui Cai, Natalie Lorent
{"title":"Nontuberculous Mycobacterial Lung Disease Management in Belgium: A Longitudinal Pharmacy Database Study.","authors":"Eliana Peeters, Marko Obradovic, Roald van der Laan, Rui Cai, Natalie Lorent","doi":"10.1007/s40801-025-00507-9","DOIUrl":"10.1007/s40801-025-00507-9","url":null,"abstract":"<p><strong>Background and objective: </strong>Nontuberculous mycobacteria (NTM) are opportunistic pathogens that can cause lung disease (NTMLD) in susceptible individuals, but NTMLD management is challenging. This study aims to describe real-world NTMLD treatment patterns in Belgium.</p><p><strong>Methods: </strong>This retrospective study used data from the IQVIA longitudinal pharmacy database. Patients with presumed NTMLD (i.e., who initiated prespecified NTM treatments from October 2015 through September 2019) were included. Variables of interest were initiated prescribed regimens, medication possession rate (MPR), and treatment persistence, switches, and restarts.</p><p><strong>Results: </strong>Overall, 199 presumed NTMLD patients initiated 72 triple- and 130 dual-drug regimens. The average triple-drug therapy MPR was 88%, and median treatment duration was 225 days. Sixty percent and 30% of patients remained on initial therapy at 6 and 12 months, respectively. Therapy switches were common, with up to five switches per patient. Seventeen percent of initiated therapies were stopped for more than 60 days but restarted within 1 year.</p><p><strong>Conclusion: </strong>Despite inherent methodological limitations, results indicate therapy switches, premature treatment interruption, and restarting multidrug oral NTM treatment are common. These findings underscore the need for improved management of NTMLD through enhanced monitoring as well as more tolerable and effective treatment options.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"447-456"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381327/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144741580","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}
引用次数: 0
Evidence of Sex-Related Pharmacodynamic Differences in Photosensitive Epilepsy Treated with Valproate: Findings from a Retrospective, Observational, Single-Center, Within-Patient, Cohort Study. 丙戊酸治疗光敏性癫痫的性别相关药效学差异的证据:来自回顾性、观察性、单中心、患者内、队列研究的发现。
IF 1.9
Drugs - Real World Outcomes Pub Date : 2025-09-01 Epub Date: 2025-06-28 DOI: 10.1007/s40801-025-00503-z
Dorothee Kasteleijn-Nolst Trenité, Ronald C Reed, Alessandro Ferretti, Anteo Di Napoli, Pasquale Parisi
{"title":"Evidence of Sex-Related Pharmacodynamic Differences in Photosensitive Epilepsy Treated with Valproate: Findings from a Retrospective, Observational, Single-Center, Within-Patient, Cohort Study.","authors":"Dorothee Kasteleijn-Nolst Trenité, Ronald C Reed, Alessandro Ferretti, Anteo Di Napoli, Pasquale Parisi","doi":"10.1007/s40801-025-00503-z","DOIUrl":"10.1007/s40801-025-00503-z","url":null,"abstract":"<p><strong>Background and objective: </strong>Sexual dimorphism in drug efficacy, beyond pharmacokinetics (PK), remains underexplored. Significant sex differences exist in drug metabolism and adverse events, highlighting the need for personalized medicine. The objective of our study was to assess whether there are sex differences in the pharmacodynamic (PD) response to valproic acid (VPA) in photosensitive epilepsy, focusing on electroencephalographic (EEG) biomarkers (e.g., photoparoxysmal response [PPR] raw data and transformed PPR data, the standardized photosensitivity range [SPR]) that cannot be attributed to pharmacokinetics alone. On the basis of some exploratory published evidence plus our own clinical observations of VPA treatment in patients with epilepsy plus photosensitivity over time, we hypothesized that an EEG pharmacodynamic difference might exist between females and males.</p><p><strong>Methods: </strong>We conducted a retrospective, observational, single-center, within-patient EEG cohort study conducted on antiseizure medicine (ASM)-naïve photosensitive individuals before and after VPA treatment (nonrandomized). The data we reviewed had been collected from a referral hospital in the Netherlands from 1990 to 2000. Changes in EEG data, including raw PPR data (transformed into SPR), were analyzed before and after VPA therapy in 48 patients, including 27 females and 21 males, ranging in age from 8 to 50 years old for the entire cohort. Co-primary outcomes included a between-sex comparison in the distribution of within-patient SPR changes from pre-VPA to steady-state VPA therapy, and complete PPR elimination on EEG. Secondary outcomes included the comparison of percentage of males and females meaningfully responding to VPA across SPR change categories, VPA dose, potential impact of plasma [VPA] concentrations on SPR changes, and associaton of patient age with SPR values. Statistical analyses included univariate linear regression models, chi-squared tests, non-parametric Wilcoxon-Mann-Whitney tests, and Fisher's exact tests.</p><p><strong>Results: </strong>Our first co-primary outcome revealed a statistically significant difference in the distribution of within-patient SPR changes from pre-VPA to steady-state VPA therapy. Males experienced a significantly greater reduction in SPR compared with females. The mean decrease in SPR was -7.0 ± 2.6 in males only versus -3.9 ± 3.3 in females only (p = 0.0018). The next co-primary outcome, the percent of patients with complete PPR elimination, or a SPR value = 0 on second EEG, was observed in ten (47.6%) males compared with four (14.8%) females, a 3.2-fold difference (p = 0.0237). One secondary outcome, the percentage of males with a VPA clinically meaningful to optimal response was 1.93-fold greater than females, at 100:51.8%, respectively (p < 0.0001). Between-sex VPA total daily milligram dose did not differ. Plasma [VPA] concentrations, although nearly twice as high in females, were not st","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"503-520"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381318/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144526855","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}
引用次数: 0
Income-Based Disparities in Opioid Prescription Dispensing Among Public Drug Plan Beneficiaries in Canada from 2010 to 2018: A Population-Based and Sex-Stratified Retrospective Study. 2010年至2018年加拿大公共药物计划受益人阿片类药物处方分配中基于收入的差异:一项基于人群和性别分层的回顾性研究
IF 1.9
Drugs - Real World Outcomes Pub Date : 2025-09-01 Epub Date: 2025-05-30 DOI: 10.1007/s40801-025-00498-7
Mhd Wasem Alsabbagh, Moad Alsefaou, Susan J Elliott, Martin Cooke, Feng Chang
{"title":"Income-Based Disparities in Opioid Prescription Dispensing Among Public Drug Plan Beneficiaries in Canada from 2010 to 2018: A Population-Based and Sex-Stratified Retrospective Study.","authors":"Mhd Wasem Alsabbagh, Moad Alsefaou, Susan J Elliott, Martin Cooke, Feng Chang","doi":"10.1007/s40801-025-00498-7","DOIUrl":"10.1007/s40801-025-00498-7","url":null,"abstract":"<p><strong>Background: </strong>Previous research in Canada has examined opioids prescription dispensing at the population level but did not examine the potential relationship with area-level income and rates of opioid dispensing.</p><p><strong>Objective: </strong>The aim was to estimate average and annual opioid dispensing rate ratios (RRs) between lowest and highest income quintile geographic areas in Canada.</p><p><strong>Methods: </strong>We performed a population-based retrospective study using the National Prescription Drug Utilization Information System (NPDUIS) between 2010 and 2018 that contains prescription records for all public drug plan beneficiaries (65+) in all Canadian provinces, excluding Quebec, Nova Scotia, and New Brunswick. We used census median household income, calculated at the Forward Sortation Area (FSA-the first three letters of the postal code) to assign income quintiles. Morphine milligram equivalent (MME) was calculated for all opioid dispensing and was divided by population of the FSA quintile. Population census year 2016 was used for population and income estimations. We calculated the average and annual RR between lowest and highest quintiles and stratified them by patients' sex. The significance of the trend of annual RR was tested by linear regression.</p><p><strong>Results: </strong>The average MME per capita for the 65+ population ranged from 2321.8 in quintile 1 to 5831.9 in quintile 5. The RR between highest and lowest quintile was 2.5 (95% confidence interval [CI] 1.3-3.7), and was more profound for males (3.2, 95% CI 1.4-4.9) than females (2.2, 95% CI 1.2-3.3). Over the study period, the RR reduced slightly from 2.7 to 2.3 (p < 0.01). However, this trend was only significant for females.</p><p><strong>Conclusion: </strong>Inequity in opioid prescriptions dispensing was persistent over time. Patients in the lowest income quintiles received higher amounts of opioids per capita, with some sex variation. Dispensing policies must take these equity issues into account.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"337-349"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12380661/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144186782","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}
引用次数: 0
Treatment Patterns and Characteristics of Patients with Hereditary Angioedema Treated with Lanadelumab: A US Retrospective Chart Review. Lanadelumab治疗遗传性血管性水肿患者的治疗模式和特征:美国回顾性图表回顾。
IF 1.9
Drugs - Real World Outcomes Pub Date : 2025-09-01 Epub Date: 2025-07-16 DOI: 10.1007/s40801-025-00505-x
Maureen Watt, Rose Chang, Louise Huafeng Yu, Louise Clear, Maral DerSarkissian
{"title":"Treatment Patterns and Characteristics of Patients with Hereditary Angioedema Treated with Lanadelumab: A US Retrospective Chart Review.","authors":"Maureen Watt, Rose Chang, Louise Huafeng Yu, Louise Clear, Maral DerSarkissian","doi":"10.1007/s40801-025-00505-x","DOIUrl":"10.1007/s40801-025-00505-x","url":null,"abstract":"<p><strong>Background and objective: </strong>Hereditary angioedema presents as recurrent, unpredictable, and often debilitating attacks of cutaneous/submucosal swelling. This study assessed the characteristics and treatment patterns of patients receiving long-term prophylaxis with the plasma kallikrein inhibitor lanadelumab in US clinical practice.</p><p><strong>Methods: </strong>This retrospective longitudinal study, based on a physician panel-based medical chart review, included patients with a diagnosis of hereditary angioedema due to C1 esterase inhibitor deficiency/dysfunction (HAE-C1INH-Type1/2), initiating lanadelumab in/after August 2018 (index date), and with ≥ 3 months' post-index follow-up (Part 1, N = 186) and, additionally, a dosing interval extension after initiating lanadelumab 300 mg every 2 weeks (Part 2, N = 75).</p><p><strong>Results: </strong>Patients in Part 1 were predominantly aged ≥ 18 years (95.7%) with HAE-CINH-Type1 (90.3%); Part 2 included a higher proportion of patients with HAE-C1INH-Type2 (28.0% vs 9.7%). In Part 1, 115/165 (69.7%) patients with hereditary angioedema attack information experienced 371 attacks in the 3 months pre-index; these were mostly mild/moderate (60.4%) and most commonly affected the lips (38.0%) and hands (32.9%). In total, 19/155 (12.3%) patients had 39 attacks during the post-index period (mean ± standard deviation [interquartile range] attack rate: 0.1 ± 0.3 [0.0, 0.0] per month). In Part 2, a dosing interval extension was enabled by well-controlled disease (74/75, 98.7%); most patients (86.7%) transitioned from every 2 weeks to every 4 weeks dosing. Among patients with attack information, 7/72 (9.7%) experienced a hereditary angioedema attack while receiving an initial every 2 weeks dosing regimen and 4/75 (5.3%) after an extended-interval dosing regimen.</p><p><strong>Conclusions: </strong>Lanadelumab dosing intervals can be individualized to maintain effective disease control. A dosing interval extension may be considered in well-controlled disease.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"351-365"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381329/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144641984","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}
引用次数: 0
Effectiveness of Glipizide and Glipizide Plus Metformin Formulation among Asian Indians with Type 2 Diabetes: a Real-World, Retrospective Electronic Medical Record Analysis. 格列吡嗪和格列吡嗪加二甲双胍治疗2型糖尿病的有效性:一项真实世界的回顾性电子病历分析
IF 1.9
Drugs - Real World Outcomes Pub Date : 2025-09-01 Epub Date: 2025-07-10 DOI: 10.1007/s40801-025-00502-0
Thyparambil Aravindakshan PramodKumar, Rajendra Pradeepa, Saravanan Jebarani, Sadasivam Ganesan, Abhijit Pednekar, Routray Philips, Suraparaju Pavan Kumar, Ranjit Unnikrishnan, Ranjit Mohan Anjana, Viswanathan Mohan
{"title":"Effectiveness of Glipizide and Glipizide Plus Metformin Formulation among Asian Indians with Type 2 Diabetes: a Real-World, Retrospective Electronic Medical Record Analysis.","authors":"Thyparambil Aravindakshan PramodKumar, Rajendra Pradeepa, Saravanan Jebarani, Sadasivam Ganesan, Abhijit Pednekar, Routray Philips, Suraparaju Pavan Kumar, Ranjit Unnikrishnan, Ranjit Mohan Anjana, Viswanathan Mohan","doi":"10.1007/s40801-025-00502-0","DOIUrl":"10.1007/s40801-025-00502-0","url":null,"abstract":"<p><strong>Background: </strong>In low- and middle-income countries, sulfonylureas are commonly prescribed due to cost-effectiveness. However, data comparing their real-world impact, especially when used alone versus in combination with metformin, remain limited.</p><p><strong>Objective: </strong>This study aimed to assess the effectiveness of glipizide and glipizide plus metformin in individuals with type 2 diabetes (T2D) using real-world data.</p><p><strong>Methods: </strong>Data was obtained from 11,949 individuals with T2D who were prescribed either glipizide or glipizide+metformin and had at least one follow-up within 1 year at a tertiary diabetes care centre in India. The primary outcome was the change in glycated hemoglobin (HbA1c) levels from baseline to follow-up. Secondary outcomes included changes in fasting plasma glucose (FPG), postprandial glucose (PPG), body mass index (BMI), and estimated glomerular filtration rate (eGFR).</p><p><strong>Results: </strong>The mean age of participants was 56 ± 11 years, 59% (n = 7008) were male, and the mean diabetes duration was 10.2 ± 8 years. In the glipizide group (n = 6034), HbA1c decreased from 8.8% to 7.9% (p < 0.001), FPG decreased by 16 mg/dL (p < 0.001), and PPG decreased by 29 mg/dL (p < 0.001). In the glipizide + metformin group (n = 5915), HbA1c levels declined from 8.9% to 7.8% (p < 0.001), and FPG and PPG declined by 23 mg/dL and 44 mg/dL, respectively (p < 0.001). BMI remained stable in the glipizide group, while a reduction of 0.2 kg/m<sup>2</sup> was observed among overweight/obese individuals in the glipizide + metformin group. The use of glipizide and glipizide + metformin effectively improved glycemic control without adverse anthropometric changes. C-peptide levels were preserved across all treatment groups, demonstrating sustained β-cell function. HbA1c reductions were observed consistently across all eGFR categories. Furthermore, as glipizide plus metformin is one of the least expensive antidiabetic drugs in India (₹1460/year [$16.87]) it can help improve accessibility to treatment even among those in lower socio-economic statuses.</p><p><strong>Conclusions: </strong>Glipizide as monotherapy or in combination with metformin, significantly improved glycemic control even in those with decreasing renal function, with no adverse effects on weight and with preservation of β-cell function. While long-term studies are needed to assess the sustainability of these benefits, glipizide can be considered a cost-effective therapeutic option for T2D in low- and middle-income countries.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"457-466"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381306/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144599693","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}
引用次数: 0
The Economic Burden, Epidemiological Insights, and Treatment Patterns of Wilson's Disease: A Real-World Study in Italy. 威尔逊病的经济负担、流行病学见解和治疗模式:意大利的现实世界研究。
IF 1.9
Drugs - Real World Outcomes Pub Date : 2025-09-01 Epub Date: 2025-07-31 DOI: 10.1007/s40801-025-00506-w
Paolo Sciattella, Matteo Scortichini, Nora Cazzagon, Georgios Loudianos, Massimo Zuin, Pier Maria Battezzati, Giuseppe Maggiore, Antonio Grieco, Eugenio Baglione, Marco Senzolo, Silvia Mazza, Claudia Della Corte, Annalisa Tortora, Fabiola Di Dato, Margherita Matarazzo, Raffaele Iorio
{"title":"The Economic Burden, Epidemiological Insights, and Treatment Patterns of Wilson's Disease: A Real-World Study in Italy.","authors":"Paolo Sciattella, Matteo Scortichini, Nora Cazzagon, Georgios Loudianos, Massimo Zuin, Pier Maria Battezzati, Giuseppe Maggiore, Antonio Grieco, Eugenio Baglione, Marco Senzolo, Silvia Mazza, Claudia Della Corte, Annalisa Tortora, Fabiola Di Dato, Margherita Matarazzo, Raffaele Iorio","doi":"10.1007/s40801-025-00506-w","DOIUrl":"10.1007/s40801-025-00506-w","url":null,"abstract":"<p><strong>Background: </strong>Wilson's disease (WD) is an autosomal recessive disorder characterized by abnormal copper accumulation, leading to multi-organ damage. The economic impact of WD in Italy has not been comprehensively studied.</p><p><strong>Aims: </strong>The objectives were to determine the economic burden of WD, describe the demographic and clinical characteristics, and estimate the treatment distribution over time, using real-world data from Italy.</p><p><strong>Methods: </strong>A retrospective multicenter longitudinal chart review study was conducted across six Italian reference centers for WD management. Patients with at least one visit for WD in 2019-2020 were included. Demographic, clinical, and treatment data were collected from medical records, and healthcare resource utilization and related costs were estimated over a 12-month follow-up. Treatment patterns from diagnosis to 2021 were also described.</p><p><strong>Results: </strong>A total of 243 patients with WD were included (183 adults, 60 minors). Median age at diagnosis was 11 years in adults and 7 years in minors. At enrollment, hepatic involvement was the most frequent clinical manifestation (84.7% of adults; 80% of minors), while 13.1% of adults and 16.7% of minors were asymptomatic. In adults, use of D-penicillamine and zinc decreased, while trientine tetrahydrochloride use increased over time. In minors, treatment remained stable. The average annual cost per patient was €10,394 for adults (mainly driven by pharmacological treatment) and €1351 for minors. Costs increased with the number of disease manifestations.</p><p><strong>Conclusion: </strong>The economic burden of WD in Italy varies with disease severity and treatment strategy, highlighting the need for optimized management practices to mitigate costs while enhancing patient care.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"391-398"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381324/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144759452","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}
引用次数: 0
Assessment of Burden of Partial Response to Standard Doses of Proton Pump Inhibitors in Patients with Clinically Diagnosed Gastroesophageal Reflux Disease: A Real-World Evidence Study in India. 临床诊断为胃食管反流病的患者对标准剂量质子泵抑制剂部分反应负担的评估:印度的一项真实世界证据研究
IF 1.9
Drugs - Real World Outcomes Pub Date : 2025-09-01 Epub Date: 2025-06-19 DOI: 10.1007/s40801-025-00497-8
Yogesh Garje, Rajiv Saikia, Sunil Gupta, Soujanya Peri, Praveen Sharma, Shruti Dharmadhikari, Ashwini Satpathy, Chintan Khandhedia, Neeraj Markandeywar, Amey Mane, Suyog Mehta, Sadhna Joglekar
{"title":"Assessment of Burden of Partial Response to Standard Doses of Proton Pump Inhibitors in Patients with Clinically Diagnosed Gastroesophageal Reflux Disease: A Real-World Evidence Study in India.","authors":"Yogesh Garje, Rajiv Saikia, Sunil Gupta, Soujanya Peri, Praveen Sharma, Shruti Dharmadhikari, Ashwini Satpathy, Chintan Khandhedia, Neeraj Markandeywar, Amey Mane, Suyog Mehta, Sadhna Joglekar","doi":"10.1007/s40801-025-00497-8","DOIUrl":"10.1007/s40801-025-00497-8","url":null,"abstract":"<p><strong>Background: </strong>Partial response to standard-dose proton pump inhibitors (PPIs) in gastroesophageal reflux disease (GERD) is common, yet real-world data on its burden and management in Indian settings remain limited.</p><p><strong>Objective: </strong>This study aimed to understand the burden, clinical profile, drug utilization patterns across specialties, the effectiveness of Pantoprazole 80 mg dual delayed-release (DDR) formulation, and management strategies used in the treatment of partial responders with clinically diagnosed GERD in Indian settings.</p><p><strong>Methods: </strong>This was a multicentric, retrospective observational study. Data on adult patients with GERD with a follow-up duration of at least 4 weeks from baseline were extracted from electronic medical records (EMR) of outpatient settings from five centers, which included drug utilization patterns, clinical and treatment profiles, and effectiveness of PPIs.</p><p><strong>Results: </strong>Among EMRs of 5205 patients with GERD, 38.0% were on rabeprazole and 36.6% on pantoprazole (mean age: 53.3 years; standard deviation: 14.3 years), and 55.0% were male. Heartburn was the primary complaint in 76.0% of cases. Cardiovascular co-morbidities with dyslipidemia were reported in 66.7% (1742/2610) patients. Pantoprazole and rabeprazole were preferred across specialties, where 31.1% (592/1906) and 17.7% (350/1979) adhered to treatment, respectively. Total burden of partial responders was 41.7%, including patients who switched PPIs, changed PPI dosage, or added other medications. Pantoprazole 40 mg twice daily (BD) showed 49.1% improvement in heartburn and 50.9% in abdominal pain. Pantoprazole 80 mg DDR once daily demonstrated significantly higher symptom relief, with a 60.2% reduction in heartburn (p < 0.001) and a 66.1% reduction in abdominal pain (p < 0.001). These findings suggest that higher-dose pantoprazole therapy may be a clinically effective strategy for managing partial responders to standard-dose PPIs.</p><p><strong>Conclusions: </strong>A significant proportion of patients with GERD were partial responders to PPIs. Pantoprazole and rabeprazole had high patient adherence across disciplines. Both pantoprazole DDR 80 mg once daily (OD) and 40 mg BD demonstrated significant symptom reduction in partial responders, supporting their use in optimizing GERD management in Indian clinical settings.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"411-424"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381319/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144332580","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}
引用次数: 0
Prevalence and Patterns of Use of Natural Health Products and Medicines in New Zealand: A Pilot Study Using an Online Market Research Panel. 新西兰天然保健产品和药品的流行程度和使用模式:一项使用在线市场研究小组的试点研究。
IF 1.9
Drugs - Real World Outcomes Pub Date : 2025-06-01 Epub Date: 2025-03-19 DOI: 10.1007/s40801-025-00482-1
E Lyn Lee, Jeff Harrison, Joanne Barnes
{"title":"Prevalence and Patterns of Use of Natural Health Products and Medicines in New Zealand: A Pilot Study Using an Online Market Research Panel.","authors":"E Lyn Lee, Jeff Harrison, Joanne Barnes","doi":"10.1007/s40801-025-00482-1","DOIUrl":"10.1007/s40801-025-00482-1","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Traditional, complementary and alternative medicine (TCAM), including natural health products (NHPs), are used by many consumers to address their [perceived] health needs. While many developed countries have national data on NHPs use, limited information is available for New Zealand (NZ). Current, robust data on the prevalence and patterns of NHPs use in NZ are required.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This project explored the feasibility of conducting a national study and collecting preliminary data on the prevalence and patterns of use of NHPs, including access to and expenditure on NHPs, and of the use of conventional medicines in NZ using a newly designed bespoke questionnaire.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;An online cross-sectional survey was administered to a sample of the adult population in NZ via an online market research panel in November 2021. Self-reported data on participants' use of NHPs (including photographs of products), consultations with TCAM practitioners and use of conventional medicines were collected. Data on the prevalence and patterns of use of NHPs were analysed and reported using descriptive statistics. Multivariable logistic regression was applied to assess the impact of sociodemographic variables on NHPs, TCAM practitioners and conventional medicines use.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The final sample comprised 992 participants. Sociodemographic data for these participants were comparable to those reported for the NZ Census 2018. The frequency of missing data was &lt; 10% for most of the questions; data quality for broad-level prevalence analysis was good, but was moderate to poor for analysis at the specific NHP or TCAM practitioner level. The specific product(s) and their respective ingredient list(s) could not be determined for most NHPs described as photographs were not uploaded, rendering product names unverifiable. Preliminary data indicate that 57.6% of participants have used NHPs and 22.9% consulted a TCAM practitioner in the last 12 months. Among current NHP users, 71.1% concurrently used one or more conventional medicines. Over half (53%) of the NHPs were self-selected (not recommended by a health practitioner). The median daily cost per NHP was NZD 0.28 (interquartile range NZD 0.14-0.50) and the median cost for visits to a TCAM practitioner over the last 12 months was NZD 120 (interquartile range NZD 40-270). Female participants, younger individuals and conventional medicine users were more likely to use NHPs/consult a TCAM practitioner/use any TCAM. Higher-income participants were more inclined to consult a TCAM practitioner. Individuals born overseas were more likely to use any type of TCAM.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;There was a high prevalence of use of NHPs and of consultations with TCAM practitioners, which may reflect the extent of use in the general NZ population. Recognising the potential impact on patients' health outcomes, there is a need for a larger","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"237-265"},"PeriodicalIF":1.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12174004/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662752","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}
引用次数: 0
Evaluation of the Association Between Postpartum Hemorrhage and Antidepressant Use: A Mendelian Randomization Study. 产后出血与抗抑郁药使用之间关系的评估:孟德尔随机研究。
IF 1.9
Drugs - Real World Outcomes Pub Date : 2025-06-01 Epub Date: 2025-04-16 DOI: 10.1007/s40801-025-00490-1
Zhenzhen Chen, Qingqing Lv, Shiteng Lin, Wanlong Lin, Wei Zhuang
{"title":"Evaluation of the Association Between Postpartum Hemorrhage and Antidepressant Use: A Mendelian Randomization Study.","authors":"Zhenzhen Chen, Qingqing Lv, Shiteng Lin, Wanlong Lin, Wei Zhuang","doi":"10.1007/s40801-025-00490-1","DOIUrl":"10.1007/s40801-025-00490-1","url":null,"abstract":"<p><strong>Background: </strong>The relationship between antidepressants, depression, and the incidence of postpartum hemorrhage (PPH) has been reported in observational studies, but the causal link between these factors remains unknown. Clarifying this relationship is important for treating depression during pregnancy and managing PPH.</p><p><strong>Objective: </strong>We aimed to assess the causal relationship between antidepressants, depression, and PPH using a two-sample Mendelian randomization method.</p><p><strong>Methods: </strong>Single nucleotide polymorphisms were identified from publicly available genetics summary databases (FinnGen database, access date: 28 December, 2023, version R9, phenocode: ANTIDEPRESSANTS, 195,321 participants; the genome-wide association studies [GWAS] catalog, access date: 3 April, 2024, GWAS ID: ebi-a-GCST90016607; Integrative Epidemiological Unit database, access date: 3 April, 2024, GWAS ID: ieu-a-1187) as alternative exposure factors for antidepressants and depression. Subsequently, inverse variance weighting, Mendelian randomization-Egger regression, weighted median, simple method, and weighted method were employed for Mendelian randomization analyses, and the results were validated for pleiotropy, heterogeneity, and sensitivity.</p><p><strong>Results: </strong>The analyses employed three sets of genetic tools, comprising two sets of 9 and 32 single nucleotide polymorphisms that are strongly associated with depression and another set of 26 single nucleotide polymorphisms that are associated with antidepressants. The inverse variance weighting indicated that antidepressants are associated with PPH (odds ratio = 1.36, 95% confidence interval 1.10-1.69, p = 0.005). Conversely, none of the five methods of Mendelian randomization analysis identified an effect of depression on PPH.</p><p><strong>Conclusions: </strong>This Mendelian randomization analysis indicated that antidepressant use is associated with PPH. However, the evidence does not support a causal relationship between depression and PPH.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"325-333"},"PeriodicalIF":1.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12173970/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968910","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}
引用次数: 0
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