Drugs - Real World Outcomes最新文献

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Patient‑Reported Satisfaction in Relapsing-Remitting Multiple Sclerosis: Advantages of At‑Home Self‑Administered Subcutaneous Ofatumumab Versus Other High‑Efficacy Therapies. 复发-缓解型多发性硬化症患者报告的满意度:在家自行皮下注射Ofatumumab与其他高效疗法的优势
IF 1.9
Drugs - Real World Outcomes Pub Date : 2026-04-20 DOI: 10.1007/s40801-026-00553-x
Francesco Pastore, Emanuela Domenicone, Patrizia DellOro, Charlotte Lefort
{"title":"Patient‑Reported Satisfaction in Relapsing-Remitting Multiple Sclerosis: Advantages of At‑Home Self‑Administered Subcutaneous Ofatumumab Versus Other High‑Efficacy Therapies.","authors":"Francesco Pastore, Emanuela Domenicone, Patrizia DellOro, Charlotte Lefort","doi":"10.1007/s40801-026-00553-x","DOIUrl":"https://doi.org/10.1007/s40801-026-00553-x","url":null,"abstract":"<p><strong>Background: </strong>Multiple sclerosis is an immune-mediated disorder characterized by demyelination and neurodegeneration. Disease-modifying therapies are available with a range of mechanisms of action, efficacies, safety profiles, places and routes of administration, and degrees of patient autonomy; however, comprehensive evaluations of satisfaction with high-efficacy therapies in patients with multiple sclerosis are lacking.</p><p><strong>Objective: </strong>We aimed to evaluate satisfaction of patients treated with high-efficacy therapies for relapsing-remitting multiple sclerosis and identify factors influencing preferences and acceptance, focusing on the perceived impact of administration routes on quality of life, daily activities, and treatment burden.</p><p><strong>Methods: </strong>We conducted a cross-sectional survey of 208 adults diagnosed with relapsing-remitting multiple sclerosis who were receiving high-efficacy therapies for at least 6 months between February and April 2025 at Italian MS centers. Data were collected using a structured questionnaire designed for this study. Domains included: (I) Temporal and Organizational Burden of Therapy, (II) Perceived Impact of Therapy, (III) Therapy Administration Experience, and (IV) Decision-Making Involvement Experience.</p><p><strong>Results: </strong>A non-parametric analysis revealed that more favorable scores on the domains of (I) Temporal and Organizational Burden of Therapy, (II) Perceived Impact of Therapy, and (III) Therapy Administration Experience were associated with treatment with subcutaneous ofatumumab (n = 90), compared to the other high-efficacy therapies such as natalizumab (n = 55), ocrelizumab (n = 59), and alemtuzumab (n = 4) [all n = 118, p < 0.001]. Fewer than one in four patients recalled being offered the possibility of self-administering high-efficacy therapies at home.</p><p><strong>Conclusions: </strong>Subcutaneous ofatumumab treatment, a therapy self-administered at home, was associated with more favorable experiences compared to other high-efficacy therapies, highlighting the importance of shared decision making and organizational and logistical factors when selecting therapies for multiple sclerosis.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147728516","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}
引用次数: 0
Treatment Patterns in Patients with Late-Onset Myasthenia Gravis in Japan: An Insurance Claims Database Study. 日本迟发性重症肌无力患者的治疗模式:一项保险索赔数据库研究。
IF 1.9
Drugs - Real World Outcomes Pub Date : 2026-04-20 DOI: 10.1007/s40801-026-00552-y
Akiyuki Uzawa, Makoto Samukawa, Shingo Konno, Izumi Mishiro, Kentaro Taki, Hiroshi Todaka, Céline Quelen, Katarzyna Jabłońska, Renata Majewska, Yohei Ohashi
{"title":"Treatment Patterns in Patients with Late-Onset Myasthenia Gravis in Japan: An Insurance Claims Database Study.","authors":"Akiyuki Uzawa, Makoto Samukawa, Shingo Konno, Izumi Mishiro, Kentaro Taki, Hiroshi Todaka, Céline Quelen, Katarzyna Jabłońska, Renata Majewska, Yohei Ohashi","doi":"10.1007/s40801-026-00552-y","DOIUrl":"https://doi.org/10.1007/s40801-026-00552-y","url":null,"abstract":"<p><strong>Background and objective: </strong>This study evaluated treatment patterns and oral corticosteroid (OCS) use in Japanese patients with myasthenia gravis, comparing late-onset (mean age 79.8 years) and early/adult-onset (mean age 61.3 years) cohorts. It also explored treatment frequency rates.</p><p><strong>Methods: </strong>We conducted a retrospective analysis of the DeSC Healthcare claims database (2014-21). Adults with myasthenia gravis starting immunosuppressant therapy and with ≥ 2 years of follow-up were included. Patients were stratified by age group (< 75 and ≥ 75 years) and by exposure to early fast-acting treatment (EFT). Outcomes included OCS dose trajectories, time to achieve a maintenance dose of ≤ 5 mg/day, and the frequency of myasthenia gravis cases treated with immunotherapy.</p><p><strong>Results: </strong>Early fast-acting treatment use was lower in the late-onset cohort (31/148 patients; 20.9%) than in the early-onset cohort (42/180; 28.0%). Initial and maximum OCS doses and time spent > 20 mg/day tended to be lower in late-onset patients. The OCS target was achieved more often and sooner in late-onset patients (median 5.1 vs 14.9 months), particularly in those without EFT. The frequency of treated myasthenia gravis cases was higher in late-onset patients (7.09 vs 3.97 per 100,000).</p><p><strong>Conclusions: </strong>Late-onset patients were less likely to receive EFT, received lower OCS doses yet reached the OCS target earlier, which may reflect physician caution with OCS exposure and good response to treatments. The findings highlight timely identification of the need for EFT, safer OCS-sparing strategies, and clearer clinical guidance in patients with late-onset myasthenia gravis.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147728508","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}
引用次数: 0
The Relevance of Lenvatinib in Advanced Hepatocellular Carcinoma: Insights from a Prospective Observational Cohort in South India. Lenvatinib在晚期肝细胞癌中的相关性:来自印度南部前瞻性观察队列的见解。
IF 1.9
Drugs - Real World Outcomes Pub Date : 2026-04-20 DOI: 10.1007/s40801-026-00554-w
Joe Jose, Shibu V Ignatious, Thattungal Manoharan Anoop
{"title":"The Relevance of Lenvatinib in Advanced Hepatocellular Carcinoma: Insights from a Prospective Observational Cohort in South India.","authors":"Joe Jose, Shibu V Ignatious, Thattungal Manoharan Anoop","doi":"10.1007/s40801-026-00554-w","DOIUrl":"https://doi.org/10.1007/s40801-026-00554-w","url":null,"abstract":"<p><strong>Background and objective: </strong>Lenvatinib is a multi-kinase inhibitor approved as a first-line therapy for advanced hepatocellular carcinoma. In India and other low- and middle-income countries, immune checkpoint inhibitor-based regimens are not universally accessible, and real-world data on lenvatinib are limited. We evaluated the effectiveness, safety, and predictors of outcomes of first-line lenvatinib in Indian patients with advanced hepatocellular carcinoma.</p><p><strong>Methods: </strong>This prospective observational cohort included consecutive patients with advanced hepatocellular carcinoma treated with first-line lenvatinib at the Regional Cancer Centre, Kerala, India, between March 2021 and May 2024. Lenvatinib was started at 8 or 12 mg once daily based on weight. Overall survival and progression-free survival were estimated using the Kaplan-Meier method. Cox regression analysis identified independent predictors of outcomes. Toxicities were graded using Common Terminology Criteria for Adverse Events Version 5.0.</p><p><strong>Results: </strong>A total of 112 patients were enrolled; median age was 62 years, and 88% were male. The predominant etiologies were non-viral (83%), mainly non-alcoholic steatohepatitis and alcohol-related liver disease. Most patients (79 %) had Barcelona Clinic Liver Cancer stage C disease, with nearly half showing macroscopic portal vein invasion. At a median follow-up of 30.8 months, median overall survival was 13.3 months (95% confidence interval [CI] 10.6-16.6) and median progression-free survival was 8.1 months (95% CI 6.5-9.8). Multivariate analysis showed improved overall survival with non-viral etiology (hazard ratio [HR] 0.49, 95% CI 0.28-0.86, p = 0.014), radiological response (HR 0.40, 95% CI 0.22-0.71, p = 0.002), and subsequent therapy (HR 0.36, 95% CI 0.22-0.60, p < 0.001), whereas portal vein invasion predicted worse overall survival (HR 1.67, 95% CI 1.06-2.61, p = 0.026). Grade ≥3 toxicities occurred in 38% of patients, mainly dermatologic, and no treatment-related deaths occurred.</p><p><strong>Conclusions: </strong>Lenvatinib demonstrated favorable survival outcomes and manageable toxicity in advanced hepatocellular carcinoma in our cohort, with superior effectiveness in non-viral disease. Given some evidence suggesting that immune checkpoint inhibitors may be less effective in non-viral hepatocellular carcinoma, along with the high costs and lack of accessibility, lenvatinib could still be a viable first-line option for non-viral hepatocellular carcinoma in resource-constrained settings. This is even more relevant with the rising trend of non-viral related hepatocellular carcinoma in low- and middle-income countries.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147728495","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}
引用次数: 0
An Observational Study to Determine the Real-Life Effectiveness of MP-AzeFlu in Asian Patients with Allergic Rhinitis. 一项观察性研究确定MP-AzeFlu对亚洲变应性鼻炎患者的实际疗效。
IF 1.9
Drugs - Real World Outcomes Pub Date : 2026-04-17 DOI: 10.1007/s40801-026-00546-w
Pongsakorn Tantilipikorn, Yau Kay Chung Julian, Te-Huei Yeh, Yap Yoke Yeow, George Chow, Hans Christian Kuhl, Duc Tung Nguyen, Rajesh Kumar Ramalingam
{"title":"An Observational Study to Determine the Real-Life Effectiveness of MP-AzeFlu in Asian Patients with Allergic Rhinitis.","authors":"Pongsakorn Tantilipikorn, Yau Kay Chung Julian, Te-Huei Yeh, Yap Yoke Yeow, George Chow, Hans Christian Kuhl, Duc Tung Nguyen, Rajesh Kumar Ramalingam","doi":"10.1007/s40801-026-00546-w","DOIUrl":"https://doi.org/10.1007/s40801-026-00546-w","url":null,"abstract":"<p><strong>Background: </strong>Allergic rhinitis (AR) is highly prevalent in Asia, but limited data exist on the real-world effectiveness of MP-AzeFlu (azelastine/fluticasone combination nasal spray) in Asian populations.</p><p><strong>Objective: </strong>To evaluate the real-world effectiveness of MP-AzeFlu in Asian patients with moderate-to-severe AR.</p><p><strong>Methods: </strong>This prospective, multicenter, noninterventional study enrolled patients with moderate-to-severe AR in Thailand, Taiwan, Malaysia, and Hong Kong. The patients received MP-AzeFlu and completed visual analog scale (VAS) assessments for AR symptoms over 28 days. The primary outcome was the proportion of responders (VAS score < 50 mm at least once during follow-up).</p><p><strong>Results: </strong>Of the 916 patients included in the safety population, 329 (35.92%) were males and 587 (64.08%) were females. Significant improvements were observed in the overall AR and nasal and ocular symptoms from day 1 through day 28 (p < 0.0001 for all). Asthma symptoms improved significantly in patients with comorbid asthma (11.7%), and 60% reduced use of asthma reliever medication was reported. Quality of life measures, including sleep quality and daily activities, also improved significantly. MP-AzeFlu was well-tolerated, with only six patients reporting mild adverse events.</p><p><strong>Conclusions: </strong>In this real-world study, MP-AzeFlu provided rapid and sustained improvement in AR symptoms and quality of life in Asian patients with moderate-to-severe AR. MP-AzeFlu has also shown beneficial effects in patients with comorbid asthma. These results support the effectiveness of MP-AzeFlu in AR management in Asian populations.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147716341","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}
引用次数: 0
First Real-World Data of Olaparib Combination Treatment with Abiraterone and Prednisone or Prednisolone in First-Line Metastatic Castration-Resistant Prostate Cancer (mCRPC): Descriptive Analysis of 154 Patients Enrolled in the Early Access Program in France. 奥拉帕尼联合阿比特龙、强的松或泼尼松治疗一线转移性去势抵抗性前列腺癌(mCRPC)的首个真实世界数据:法国早期准入项目154例患者的描述性分析。
IF 1.9
Drugs - Real World Outcomes Pub Date : 2026-04-13 DOI: 10.1007/s40801-026-00551-z
Louis Marie Dourthe, Aline Guillot, Cécile Vassal, Eyad Kazan, David Coeffic, Christine Rebischung, Delphine Suau, Amir Lahouegue, Sofia Aboulabbes, Amélie Falabrègues, Hassiba Ould Lahsen
{"title":"First Real-World Data of Olaparib Combination Treatment with Abiraterone and Prednisone or Prednisolone in First-Line Metastatic Castration-Resistant Prostate Cancer (mCRPC): Descriptive Analysis of 154 Patients Enrolled in the Early Access Program in France.","authors":"Louis Marie Dourthe, Aline Guillot, Cécile Vassal, Eyad Kazan, David Coeffic, Christine Rebischung, Delphine Suau, Amir Lahouegue, Sofia Aboulabbes, Amélie Falabrègues, Hassiba Ould Lahsen","doi":"10.1007/s40801-026-00551-z","DOIUrl":"https://doi.org/10.1007/s40801-026-00551-z","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Olaparib, a poly ADP-ribose polymerase inhibitor, was approved by the European Commission in December 2022 and for which the Health for technology Assessment (HtA body) issued a favorable opinion for reimbursement in France on 5 April, 2023, following the results of the PROpel phase III clinical trial, for the first-line treatment of metastatic castration-resistant prostate cancer in combination with abiraterone and prednisone or prednisolone in adult men for whom chemotherapy is not clinically indicated.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This publication aimed to report the first real-world data of patients with metastatic castration-resistant prostate cancer who received a combination of first-line olaparib with abiraterone, plus prednisone or prednisolone in the funded Early Access (fEA) for olaparib in France, from 30 March, 2023, to 25 September, 2024.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;Eligible patients were adult men with first-line metastatic castration-resistant prostate cancer. Olaparib 300-mg twice-daily tablets was given in combination with abiraterone plus prednisone or prednisolone regardless of the homologous recombination repair gene mutation status. Characteristics of the population, treatment duration, reasons for discontinuation, and safety data were collected during the fEA period. Patients could continue to receive olaparib after the end of the fEA.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;A total of 84 physicians spread over 72 hospitals in metropolitan France requested a fEA for 176 patients, 154 (87.5%) of whom were eligible to be included in the early access program. In total, 118 (76.6%) patients had an unknown homologous recombination repair status. Half of the patients (76, 49.7%) had very aggressive cancer with a Gleason score of 8 while 11 (7.2%) of them had a low-grade cancer with a Gleason score of 6 at the diagnosis. The most common metastatic sites were bone (107 patients, 69.5%) and distant (60, 39.0%) or regional (42, 27.3%) lymph nodes. Among the 154 patients, 84 (54.5%) had medical history, 47 (56.0%) of whom had arterial hypertension. All included patients had received at least one prior treatment prior to the metastatic castration resistance stage. Most patients (145, 94.2%) had received androgen suppression and 70 (45.5%) had been treated with androgen receptor pathway inhibitors. Of the 154 patients, 153 (99.4%) had at least one concomitant treatment with abiraterone and prednisone or prednisolone. Data confirming administration of olaparib treatment were provided for 149 patients (exposed patients), of whom 140 (94.0%) received olaparib at initiation at the dose of 300 mg twice daily. Fifty-seven patients experienced a total of 60 adverse events (36 serious adverse events and 24 non-serious adverse events). Over this period, three fatal and five life-threatening events were reported. The three fatal adverse events were one death assessed as a suspected adverse reaction (pancytopenia) ","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147671306","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}
引用次数: 0
Regional Trends in the Opioid Epidemic Using Safety Signals of Drug Abuse and Dependence: A Disproportionality Analysis Using VigiBase. 使用药物滥用和依赖安全信号的阿片类药物流行的区域趋势:使用VigiBase进行歧化分析。
IF 1.9
Drugs - Real World Outcomes Pub Date : 2026-04-09 DOI: 10.1007/s40801-026-00550-0
Bohyun Suh, Hyung Suk Oh, Ju-Young Shin, Ju Hwan Kim
{"title":"Regional Trends in the Opioid Epidemic Using Safety Signals of Drug Abuse and Dependence: A Disproportionality Analysis Using VigiBase.","authors":"Bohyun Suh, Hyung Suk Oh, Ju-Young Shin, Ju Hwan Kim","doi":"10.1007/s40801-026-00550-0","DOIUrl":"https://doi.org/10.1007/s40801-026-00550-0","url":null,"abstract":"<p><strong>Background: </strong>The opioid epidemic, once a major concern in the United States, has escalated worldwide through three waves driven by prescription and synthetic opioids like oxycodone and fentanyl. Regional patterns of misuse and dependence remain unclear due to data heterogeneity. To address this, we compared adverse events reporting for these opioids using VigiBase.</p><p><strong>Methods: </strong>We analyzed \"drug abuse and dependence\" adverse events using VigiBase, a global pharmacovigilance database containing more than 40 million Individual Case Safety Reports (ICSRs). A regional comparison of opioid-related adverse event reporting was performed, with oxycodone and fentanyl as the primary drugs and morphine and tramadol as comparators. Adverse events were defined by Standardized MedDRA Query (SMQ) criteria and cases were stratified by three periods (1990-2009, 2010-2012, 2013-2024) and regions (Americas, Western Pacific, Europe). Opioid-related death was additionally assessed as a secondary outcome. Disproportionality analysis was conducted to identify safety signals, using the reporting odds ratio (ROR). Signals were considered significant if ROR > 2, χ<sup>2</sup> > 4, and more than three reports were observed.</p><p><strong>Results: </strong>Oxycodone-related reports peaked in 2005 (n = 8395), 2011 (n = 10,444), and 2021 (n = 45,025), while fentanyl peaked in 2011 (n = 11,451) and 2017 (n = 32,704). The safety signals for oxycodone were found across all predefined periods in the Americas (1990-2009: ROR 4.40, n = 9102; 2010-2012: ROR 2.13, n = 2299; 2013-2024: ROR 5.20, n = 108,068), and in two periods in the Western Pacific (2010-2012: ROR 6.53, n = 81; 2013-2024: ROR 5.94, n = 1066). No signals were detected for oxycodone in Europe, and fentanyl did not meet signal criteria in any region or period in the primary analyses.</p><p><strong>Conclusions: </strong>Oxycodone showed consistent safety signals in the Americas and Western Pacific. The absence of signals for fentanyl and in Europe may reflect under-reporting, highlighting the need for improved surveillance of illicit opioid use.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147638369","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}
引用次数: 0
Prevalence, Clinical Characteristics, and Factors Associated with Capecitabine-Induced Hand-Foot Syndrome in Patients with Cancer: Evidence from Sudan. 癌症患者卡培他滨诱发手足综合征的患病率、临床特征和相关因素:来自苏丹的证据
IF 1.9
Drugs - Real World Outcomes Pub Date : 2026-04-03 DOI: 10.1007/s40801-026-00549-7
Ola K Obeid, Bashir A Yousef, Yousif B Hamadalneel, Mawahib A Mustafa, Amani Abdelaziz Mahmoud, Elkhanssa Abdelhameed Ahmed Elhag
{"title":"Prevalence, Clinical Characteristics, and Factors Associated with Capecitabine-Induced Hand-Foot Syndrome in Patients with Cancer: Evidence from Sudan.","authors":"Ola K Obeid, Bashir A Yousef, Yousif B Hamadalneel, Mawahib A Mustafa, Amani Abdelaziz Mahmoud, Elkhanssa Abdelhameed Ahmed Elhag","doi":"10.1007/s40801-026-00549-7","DOIUrl":"https://doi.org/10.1007/s40801-026-00549-7","url":null,"abstract":"<p><strong>Background: </strong>Hand‒foot syndrome (HFS) is a common cutaneous toxicity of capecitabine that can impair treatment continuity and quality of life. This study aimed to assess the prevalence, clinical characteristics, and factors associated with capecitabine-induced HFS.</p><p><strong>Methods: </strong>A cross-sectional analytical study was conducted at Khartoum Oncology Hospital, Sudan (June-October 2022), among adult patients with cancer receiving capecitabine monotherapy. Hand‒foot syndrome was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events and a modified Black Patient Scale. Multivariable logistic regression was used to identify factors associated with HFS, with adjusted odds ratios (aORs) and 95% confidence intervals (CIs) reported. Data analysis was performed using SPSS version 27.</p><p><strong>Results: </strong>A total of 135 patients were included in the analysis, 90 (66.7%) of whom were female and 52 (38.5%) were aged 56-70 years. The most common cancer type was breast cancer (n = 56) [41.5%]. The overall prevalence of HFS was 74 (54.8%), with 37 (50.0%) involving the hands only and 28 (37.8%) involving both the hands and feet. Onset occurred within 7-21 days in 47 (63.5%) patients. Pain was reported by 41 (30.4%), predominantly moderate by 20 (48.8). Grade I was the most frequent by National Cancer Institute criteria (n = 33) [44.5%] and the Black Patient Scale (n = 33) [44.5%]. Hand‒foot syndrome was more prevalent in female patients (n = 58) [64.4%, p = 0.001], patients with breast cancer (n = 35) [62.5%] (p = 0.049), and those receiving > 6 cycles (n = 6) [75%] (p = 0.006). After adjustment, female sex (aOR = 0.224, 95% CI 0.074-0.681; p = 0.008), patients without concomitant diseases (aOR = 2.389, 95% CI 1.011-5.646; p = 0.047), and patients receiving 4-6 cycles compared with those receiving 1-3 cycles (aOR = 0.359, 95% CI 0.155-0.828; p = 0.016) were independent predictors.</p><p><strong>Conclusions: </strong>Capecitabine-induced HFS affects more than half of patients and generally occurs early in onset. After adjustment, female patients and those who received 4-6 chemotherapy cycles were less likely to experience HFS, whereas the absence of concomitant diseases was associated with a greater likelihood of developing HFS. Early monitoring and proactive supportive care remain essential to optimize treatment continuity.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147608410","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}
引用次数: 0
Trends in First-Time Symptomatic Antidementia Drug Dispensations to Home-Dwelling People in Norway: A Nationwide Register-Based Study. 挪威家庭居民首次症状性抗痴呆药物分配趋势:一项基于全国登记的研究。
IF 1.9
Drugs - Real World Outcomes Pub Date : 2026-03-31 DOI: 10.1007/s40801-026-00547-9
Torunn Gudmestad Øvrebø, Anita L Sunde, Arvid Rongve, Svein Reidar Kjosavik, Ingvild Dalen, Ragnhild Oesterhus
{"title":"Trends in First-Time Symptomatic Antidementia Drug Dispensations to Home-Dwelling People in Norway: A Nationwide Register-Based Study.","authors":"Torunn Gudmestad Øvrebø, Anita L Sunde, Arvid Rongve, Svein Reidar Kjosavik, Ingvild Dalen, Ragnhild Oesterhus","doi":"10.1007/s40801-026-00547-9","DOIUrl":"https://doi.org/10.1007/s40801-026-00547-9","url":null,"abstract":"<p><strong>Background: </strong>Symptomatic antidementia drugs can influence cognitive symptoms. According to Norwegian dementia guidelines, general practitioners (GPs) are responsible for assessing, treating, and following up on dementia, with extended assessments provided by specialist healthcare in more complicated cases and for patients under 65 years of age.</p><p><strong>Objective: </strong>The aim of this study was to investigate trends in first-time antidementia drug dispensations to home-dwelling people aged 60 years and older in Norway (2006-2020), and to analyse whether a GP issued the first prescription.</p><p><strong>Methods: </strong>This repeated annual cross-sectional study utilized data from the Norwegian Prescribed Drug Registry (NorPD). Age- and sex-stratified incidence rates of antidementia drugs (ATC N06D) dispensed by Norwegian pharmacies between January 1, 2006, and December 31, 2020, were analysed. The Norwegian GP Registry was linked with NorPD to identify if the prescriber worked as a GP at the time of the first antidementia prescription.</p><p><strong>Results: </strong>In this study, 66,886 individuals received a novel antidementia drug dispensation. The incidence rates of first-time antidementia drug dispensations showed an overall declining trend during the study period. Females accounted for 61.1% of first-time dispensations, with the highest incidence rates observed in the 80-84-years age group across both sexes. Across all age groups, female patients were more likely than male patients to receive their first antidementia prescription from a GP. Patient age had a notable influence on prescriber type, with older people more often receiving their first prescription from a GP compared with younger people.</p><p><strong>Conclusions: </strong>There was a declining trend in the annual incidence rate of antidementia drug dispensations to home-dwelling people. Older age and female sex were associated with an increased likelihood of receiving a first-time symptomatic antidementia drug prescription from a GP.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-03-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147580615","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}
引用次数: 0
Disease Burden in Transfusion-Dependent β-Thalassemia (TDT) Patients and Caregivers in Italy: Results of a Cross-Sectional Descriptive Online Survey. 意大利输血依赖性β-地中海贫血(TDT)患者和护理人员的疾病负担:一项横断面描述性在线调查的结果
IF 1.9
Drugs - Real World Outcomes Pub Date : 2026-03-27 DOI: 10.1007/s40801-026-00545-x
Marcella Contieri, Francesca Gatta, Maria Colonnese, Annamaria Pasanisi, Filomena Longo, Giovanni Battista Ferrero, Antonio Giulio Piga, Roberto Lisi, Domenico Roberti, Chiara Baiano, Gabriella Santangelo, Angelo Perrotta, Gelsomina Simeone, Silverio Perrotta, Immacolata Tartaglione
{"title":"Disease Burden in Transfusion-Dependent β-Thalassemia (TDT) Patients and Caregivers in Italy: Results of a Cross-Sectional Descriptive Online Survey.","authors":"Marcella Contieri, Francesca Gatta, Maria Colonnese, Annamaria Pasanisi, Filomena Longo, Giovanni Battista Ferrero, Antonio Giulio Piga, Roberto Lisi, Domenico Roberti, Chiara Baiano, Gabriella Santangelo, Angelo Perrotta, Gelsomina Simeone, Silverio Perrotta, Immacolata Tartaglione","doi":"10.1007/s40801-026-00545-x","DOIUrl":"https://doi.org/10.1007/s40801-026-00545-x","url":null,"abstract":"<p><strong>Background: </strong>Patients with transfusion-dependent thalassemia (TDT) require lifelong blood transfusions; data on the psychosocial and economic impact on patients and their caregivers remain limited. The study aims to address this gap by describing the burden of TDT on pediatric, young, and adult patients, as well as their caregivers, within real-world settings in Italy.</p><p><strong>Methodology: </strong>This is a cross-sectional, descriptive study conducted between May and December 2021. TDT patients and their caregivers from Italian sites were invited to complete an online survey with the Ratip and Modell questionnaire (1996) and another bespoke questionnaire. All subjects signed an online informed consent before responding to the questionnaires.</p><p><strong>Results: </strong>Seventy-nine subjects completed the survey: 59 patients (43 adults and 16 children) and 20 caregivers (the majority of adult patients were aged 41-50 years). The age at diagnosis differed between adults and pediatric patients, being earlier in the latter (0-2 months in 43.8%). Nearly half of patients received more than one transfusion/month. More than half of the patients experienced blood shortages, particularly during the summer. School absenteeism was reported as a major issue.</p><p><strong>Conclusion: </strong>TDT continues to impose a significant burden, negatively impacting daily life, work, education, and social interactions. The availability of blood resources remains a critical issue, particularly in high-prevalence regions. The study highlights the need for ongoing research, innovative approaches, and enhanced support to ensure improved well-being for TDT patients and their caregivers.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147527762","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}
引用次数: 0
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. 质子泵抑制剂在印度酸性消化性疾病和合并症患者中的药物利用模式:一项基于真实世界电子医疗记录的研究
IF 1.9
Drugs - Real World Outcomes Pub Date : 2026-03-27 DOI: 10.1007/s40801-026-00544-y
Yogesh Garje, Tanish Modi, Mudit Sabharwal, Sunil Gupta, Rajiv Saikia, Ashwini Satpathy, Shruti Dharmadhikari, Neeraj Markandeywar, Chintan Khandhedia, Amey Mane, Suyog Mehta, Sadhna Joglekar
{"title":"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/s40801-026-00544-y","DOIUrl":"https://doi.org/10.1007/s40801-026-00544-y","url":null,"abstract":"<p><strong>Background: </strong>Acid peptic disease (APD) is often associated with comorbidities. Choosing a proton pump inhibitor (PPI) is critical in such patients, given the frequent use of multiple concomitant medications in routine clinical practice. This real-world study was planned in India to understand drug utilization and prescription patterns of PPIs in APD patients with comorbidities.</p><p><strong>Objective: </strong>The aim was to evaluate the real-world drug utilization patterns of PPIs and to explore the adherence, effectiveness, and tolerability of pantoprazole in APD patients with comorbidities in India.</p><p><strong>Methods: </strong>This multicenter, retrospective, electronic medical record-based study analyzed data of adult APD patients with comorbidities treated with PPIs at four Indian outpatient clinics (January 2017-December 2020). Patients aged ≥18 years with at least two follow-up visits were included, and outcomes assessed included utilization patterns, adherence, effectiveness, and tolerability.</p><p><strong>Results: </strong>The study included data from 687 patients with APD, who had a mean age of 47.8 years, and 56.6% of them were male. Patients had various comorbidities, and PPIs were co-prescribed with antidiabetics, antiplatelets, antihypertensives, antibiotics, and antithyroid drugs. Pantoprazole was the most commonly prescribed PPI (51.7%), followed by esomeprazole (20.2%), rabeprazole (13.0%), lansoprazole (9.2%), and omeprazole (6.0%). A greater proportion of patients treated with pantoprazole adhered to treatment when compared to other PPIs at follow-up visits. All APD symptoms significantly reduced at follow-up visit 2 compared to baseline across all PPIs (p < 0.05). All PPIs were well-tolerated, with adverse events consistent with their known profiles.</p><p><strong>Conclusion: </strong>This real-world study highlighted utilization patterns of PPIs and demonstrated that all PPIs are effective and well-tolerated in managing APD symptoms in patients with comorbidities. Pantoprazole was the most co-prescribed and preferred PPI amongst the prescribed PPIs. These findings provide real-world insights into how PPIs are utilized in Indian patients with APD and comorbidities and may help clinicians make informed decisions when selecting an appropriate PPI in routine practice.</p><p><strong>Trial registration: </strong>The study was registered in the Clinical Trial Registry of India (CTRI number: CTRI/2021/06/034237).</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2026-03-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147527702","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}
引用次数: 0
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