Drugs - Real World Outcomes最新文献

{"title":"Estimating Risks of Central Nervous System Disturbance Associated with Medications for Herpes Zoster: Findings from a Regional Population-Based Cohort Study Using the Shizuoka Kokuho Database.","authors":"Ryoya Hagiwara, Eiji Nakatani, Hideaki Kaneda, Hiroshi Okada, Hideo Hashizume, Nagato Kuriyama, Akira Sugawara","doi":"10.1007/s40801-025-00500-2","DOIUrl":"https://doi.org/10.1007/s40801-025-00500-2","url":null,"abstract":"<p><strong>Background: </strong>Herpes zoster commonly occurs in older adults, whose renal function often declines, necessitating careful dosing of antivirals such as acyclovir, valacyclovir, and famciclovir. Insufficient dose adjustment can increase central nervous system (CNS) disturbance risk. Although previous reports show varying neurotoxic risk among these drugs, the safety profiles of these drugs remain underexplored. CNS disturbance significantly impacts quality of life, but it is rare and primarily documented through case reports, with little thorough investigation or comparison across drugs.</p><p><strong>Objective: </strong>This study aims to evaluate the potential risks of CNS disturbance associated with acyclovir and valacyclovir compared with famciclovir in patients with herpes zoster, highlighting the potential influence of renal function and dose adjustments.</p><p><strong>Methods: </strong>We conducted a population-based cohort study using data from the National Health Insurance and the Late-Stage Medical Care System for the Elderly in Japan, including patients diagnosed with herpes zoster and newly prescribed oral or intravenous antiviral drugs between April 2012 and September 2021. The outcome was defined as the occurrence of CNS disturbance within 1 month from the index date. Patients with neurological, infectious or psychiatric disorders during the 1-year baseline period were excluded. The incidence of CNS disturbance with 95% confidence intervals (CIs) was compared between dialysis and nondialysis patients, owing to incomplete renal function data. In addition, we compared the incidence of CNS disturbance among groups using propensity score matching to adjust for confounders, with famciclovir users as the control group. Postmatching, risk differences with 95% CIs, and number needed to harm (NNH) were calculated.</p><p><strong>Results: </strong>The final cohort consisted of 82,646 patients (8646 acyclovir, 46,643 valacyclovir, and 27,357 famciclovir users). Severe renal dysfunction was associated with CNS disturbance. The CNS disturbance incidence was 0.33% in nondialysis and 2.29% (risk difference 1.96%, 95% CI [0.39-3.53]) in dialysis patients using acyclovir/valacyclovir versus 0.18% and 0.60% (risk difference 0.42%, 95% CI [- 0.76 to 1.6]) for famciclovir, respectively. After propensity score matching, CNS disturbances were observed in 0.50% of patients in the acyclovir group versus 0.17% in the famciclovir group and in 0.29% of patients in the valacyclovir group versus 0.17% in the famciclovir group. The risk of CNS disturbance remained higher in both the acyclovir group (risk difference 0.33%, 95% CI [0.16-0.51], NNH 278) and the valacyclovir group (0.12%, [0.04-0.19], 833) compared with the famciclovir group.</p><p><strong>Conclusions: </strong>Acyclovir and valacyclovir, when compared with famciclovir, are associated with an increased risk of CNS disturbance in patients with herpes zoster, particularly among those with","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association Between Vaccination for Human Papillomavirus (HPV) and Autonomic Dysfunction and Menstrual Irregularities: A Self-Controlled Case Series Analysis.","authors":"Linda Wastila, Yu-Hua Fu, Chih Chun Tung, Danya M Qato","doi":"10.1007/s40801-025-00504-y","DOIUrl":"https://doi.org/10.1007/s40801-025-00504-y","url":null,"abstract":"<p><strong>Background: </strong>Limited research has addressed safety concerns related to vaccination against the human papillomavirus (HPV).</p><p><strong>Objective: </strong>To investigate the association between receipt of HPV vaccination and autonomic dysfunction and menstrual irregularities in girls and young women.</p><p><strong>Methods: </strong>Using a 25% random sample of IQVIA PharMetrics^® Plus for Academics claims database from 2016 to 2020, we conducted a self-controlled case series study in commercially insured girls and young women receiving their first HPV vaccine dose (analyses conducted between March 2024 and April 2025). Incidence rate ratios (IRRs) and 95% confidence intervals (CIs) were estimated for two outcomes-autonomic dysfunction and menstrual irregularities. We conducted further analyses stratified by number of HPV vaccine doses received per beneficiary and by age (9-17 years vs. 18-26 years), as well as adjusted for age as a time-varying covariate. The IRRs were estimated over a maximum risk case post-vaccination period of 36 months compared to a 6-month within-person control pre-vaccination period.</p><p><strong>Results: </strong>There were 1654 individuals in the autonomic dysfunction cohort and 3140 individuals in the menstrual irregularities cohort. When adjusted for age, HPV vaccination was associated with elevated IRRs for autonomic dysfunction (IRR 1.23; 95% CI 1.08-1.41) and menstrual irregularities (IRR 1.30; 95% CI 1.18-1.43). IRRs for individual outcomes varied by age group, with the younger cohort showing a significantly higher age-adjusted IRR than the older cohort for menstrual irregularities (IRR 1.51; 95% CI 1.33-1.72 vs. IRR 1.15; 95% CI 0.99-1.33, respectively). Although the risk of experiencing autonomic dysfunction was not significant in the adjusted younger cohort, young women aged 18-26 years had a heightened age-adjusted risk (IRR 1.40; 95% CI 1.12-1.75). Findings from the dose-response analysis were inconclusive.</p><p><strong>Conclusions: </strong>HPV vaccination is associated with elevated risks of autonomic dysfunction and menstrual irregularities, which vary by age. Further research is needed to identify additional risk factors associated with HPV vaccination safety.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":""},"PeriodicalIF":1.9,"publicationDate":"2025-06-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144309637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"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":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662752","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"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":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143968910","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Influenza Vaccination Among Patients with Noncommunicable Diseases: A Survey About Awareness, Usage, and Unmet Needs in the Czech Republic.","authors":"Zdeněk Zadražil, Lenka Cesneková, Jan Kynčl, Zuzana Krištúfková, Laura Colombo, Sanjay Hadigal","doi":"10.1007/s40801-025-00483-0","DOIUrl":"10.1007/s40801-025-00483-0","url":null,"abstract":"<p><strong>Background: </strong>People with noncommunicable diseases (NCDs) are at a higher risk of contracting vaccine-preventable diseases, such as influenza, with a higher likelihood of severity and complications. However, the immunization rates for the influenza vaccine among this population in the Czech Republic are very low.</p><p><strong>Objective: </strong>This survey, among adults with NCDs in the Czech Republic, assessed the knowledge, attitudes, and gaps toward vaccination in general and influenza vaccination in particular.</p><p><strong>Methods: </strong>The survey was conducted between February 2023 and March 2023 among patients with NCDs in the Czech Republic. A structured web-based questionnaire with open-ended questions was administered. This study is a preplanned subgroup ancillary analysis of a previous multicentric study conducted on 1106 patients.</p><p><strong>Results: </strong>In all, 120 patients were enrolled, with 62% (74) aged between 41 and 60 years. Approximately 30% (36) had taken the influenza vaccine in the last 2 years and 70% (84) had not. Of the total sample, only 46% (55) had a positive opinion about influenza vaccines; this increased to 91% (33) among those vaccinated against the influenza virus. The main drivers of influenza vaccination were general physician (GP) recommendation [50% (18)] and patient initiative [47% (17)]. The main barriers to the influenza vaccine were lack of belief regarding its need [52% (44)], experience of mild severity of influenza [30% (25)], and lack of GP recommendation [25% (21)]. Physicians, dedicated websites, and family members are the most common sources of information regarding influenza. Even among those vaccinated for influenza, only 17% (6) had information about the risk of not taking the vaccine. A high level of dissatisfaction with the information was found among patients not vaccinated against influenza. People wanted more information on who should not receive the influenza vaccination. Unvaccinated patients sought information on side effects and efficacy. Only 40% (48) of the respondents said that they are likely/extremely likely to take an influenza vaccination in the future.</p><p><strong>Conclusions: </strong>Healthcare practitioners are the key influencers for people to get vaccinated. The dissemination of information about the importance of influenza vaccines for people with NCDs needs to be increased in the Czech Republic.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"311-324"},"PeriodicalIF":1.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143763377","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Intravenous Iron Replacement Therapy on Healthcare Costs for Patients with Iron Deficiency Anemia in the USA: A Retrospective Analysis.","authors":"Nicole M Engel-Nitz, Winghan Jacqueline Kwong, Kevin Wang, Summer Tran, Amy Anderson","doi":"10.1007/s40801-025-00496-9","DOIUrl":"10.1007/s40801-025-00496-9","url":null,"abstract":"<p><strong>Background: </strong>Intravenous iron replacement therapy for the treatment of iron deficiency anemia is often required in patients with chronic diseases including cancer, heart failure, or chronic kidney disease.</p><p><strong>Objective: </strong>We aimed to compare healthcare resource utilization and costs for patients treated with intravenous ferric carboxymaltose (FCM) or low-dose iron for iron deficiency anemia.</p><p><strong>Methods: </strong>This analysis of Optum Research Database administrative claims data included patients with iron deficiency anemia who received intravenous iron from 2017 to 2019 and had diagnoses of cancer, heart failure, or chronic kidney disease. Patients were continuously enrolled for 6-month baseline and 12-month follow-up periods. Follow-up all-cause total costs for FCM and low-dose iron cohorts were compared using generalized linear models; inpatient costs were estimated with two-part models to account for patients without hospitalizations. Models were adjusted for age, sex, geographic region, insurance type, index year, baseline comorbidity scores, and healthcare costs. Sensitivity analyses compared FCM with an iron sucrose subgroup.</p><p><strong>Results: </strong>For patients with cancer (n = 10,763), mean adjusted all-cause total costs were numerically lower for FCM than low-dose iron by $2369 (cost ratio [CR] 0.97, P = 0.182) and significantly lower for FCM than iron sucrose by $6712 (CR 0.93, P < 0.001). For heart failure (n = 8337), the mean all-cause total cost was numerically lower for FCM than low-dose iron by $2022 (CR 0.97, P = 0.198) and significantly lower for FCM than iron sucrose by $3892 (CR 0.95, P = 0.024). For chronic kidney disease (n = 10,617), the mean all-cause total cost was statistically significantly lower for FCM than low-dose iron by $3623 (CR 0.94, P = 0.006) and iron sucrose by $4161 (CR 0.93, P = 0.004). For all groups, the FCM and low-dose iron cohorts differed in both the odds of having any inpatient costs and the level of inpatient cost (cancer: odds ratio 0.79, P < 0.001; CR 0.88, P < 0.001; heart failure: odds ratio 0.76, P < 0.001; CR 0.89, P < 0.001; chronic kidney disease: odds ratio 0.75, P < 0.001; CR 0.84, P < 0.001). Inpatient cost results were consistent for iron sucrose.</p><p><strong>Conclusions: </strong>Despite the typically higher drug acquisition cost of FCM versus low-dose intravenous iron, the price differential was offset by the lower inpatient cost incurred in the FCM cohort in each patient population. These findings suggest the potential economic benefit of FCM to reduce inpatient utilization and associated costs to patients and health plans compared with low-dose intravenous iron.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"213-226"},"PeriodicalIF":1.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144186781","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Impact of Modern Systemic Therapies on Survival in Patients with Anaplastic Thyroid Cancer: A Single-Center Retrospective Cohort Review.","authors":"Austin Luong, Darin Poei, Lydia Chow, Ming Li, Qi Nie, Trevor Angell, Liyang Tang, Robert Hsu, Jacob Thomas","doi":"10.1007/s40801-025-00493-y","DOIUrl":"10.1007/s40801-025-00493-y","url":null,"abstract":"<p><strong>Background: </strong>Anaplastic thyroid carcinoma (ATC) is a highly aggressive cancer historically associated with a median survival of about 5 months. Recent advances in tumor genomic testing have identified targetable BRAF mutations in about 35-40% of ATC cases and have shown high levels of programmed death ligand-1 (PD-L1) expression in ATC. These observations have led to clinical trials showing favorable outcomes with targeted therapy and immunotherapy for ATC.</p><p><strong>Objective: </strong>We aimed to evaluate treatments and outcomes of patients diagnosed with anaplastic thyroid cancer treated at our institution in order to determine the impact of targeted therapy and immunotherapy.</p><p><strong>Methods: </strong>A retrospective review of ATC patients at a single institution was performed. Data were collected from institutional electronic medical records, including demographic information, treatments administered, and outcomes including survival.</p><p><strong>Results: </strong>A total of 28 patients were identified within the period under study. Systemic therapy was initiated in 61% of patients. The median overall survival for all patients was 7.3 months. There was a statistically significant improvement in overall survival for patients who received targeted therapy or immunotherapy compared to those who did not.</p><p><strong>Conclusions: </strong>In this single-institution cohort of 28 patients with ATC, patients who received either targeted therapies or immunotherapy demonstrated markedly improved outcomes. Further clinical trials are required to determine the optimal systemic therapy for this patient population.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"295-300"},"PeriodicalIF":1.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144085800","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Safety and Effectiveness of Brigatinib in Anaplastic Lymphoma Kinase (ALK) Positive Metastatic Non-Small Cell Lung Cancer (NSCLC) in Argentina: A Post-Marketing Surveillance Study.","authors":"Claudio Martin, Gabriela Ileana Malcervelli, Gastón Lucas Martinengo, Patricio Levit, Patricio Servienti, Elisa Malaver, Laura Brion, Vanesa Patronella, Andrea Zumárraga, Jose Zarba","doi":"10.1007/s40801-025-00484-z","DOIUrl":"10.1007/s40801-025-00484-z","url":null,"abstract":"<p><strong>Background: </strong>Brigatinib, a next-generation anaplastic lymphoma kinase (ALK) inhibitor was licensed for the treatment of ALK-positive metastatic non-small cell lung cancer in 2016. However, real-world evidence on the safety and effectiveness of brigatinib in Latin America remains limited.</p><p><strong>Objective: </strong>The aim of this study was to assess the safety and effectiveness of brigatinib in the real world in Argentina.</p><p><strong>Methods: </strong>We conducted a non-interventional cohort study of adult patients (aged ≥  18 years) with a diagnosis of ALK-positive metastatic non-small cell lung cancer not previously treated (first line) or previously treated (second line) with an ALK inhibitor and who received at least one dose of brigatinib between November 2020 and March 2023. The primary outcome was the incidence of treatment-emergent adverse events. Secondary outcomes at the 24-week follow-up were the percentage of patients with an overall best objective response rate of complete or partial response; intracranial objective response rate; progression-free survival; and overall survival.</p><p><strong>Results: </strong>Of the 39 patients included in the study (n = 22 [first line]; n = 17 [second line]), 12 patients (30.7%) experienced treatment-emergent adverse events, with the most frequent being increased levels of transaminases (7.6%), increased level of blood creatine phosphokinase (5%) and hypokalaemia (5%). Most adverse events (85.7%) were mild to moderate. Effectiveness outcomes at 24 weeks in patients treated with brigatinib first line or second line, respectively, were as follows: overall objective response rate: 81.8% and 70.5%; intracranial objective response rate (in patients with brain metastases at baseline): 66.6% and 88.8%; progression-free survival: 93.8% and 82.4%; overall survival: 100% and 87.5%.</p><p><strong>Conclusions: </strong>Brigatinib was demonstrated to be a safe and effective treatment option for ALK-positive metastatic non-small cell lung cancer in routine clinical practice in Argentina.</p><p><strong>Clinical trial registration: </strong>NCT04887519.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"227-235"},"PeriodicalIF":1.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143514965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Treatment Pattern of Heart Failure Patients in Sweden During 2021-2023 in Relation to Updated Treatment Recommendations.","authors":"Michaela Eklund, Magnus Husberg, Therese Eriksson, Mattias Enoksson, Staffan Gustavsson, Lars-Åke Levin, Lars Bernfort","doi":"10.1007/s40801-025-00494-x","DOIUrl":"10.1007/s40801-025-00494-x","url":null,"abstract":"<p><strong>Background: </strong>In early 2022, new treatment recommendations for heart failure (HF) were introduced in Sweden.</p><p><strong>Objective: </strong>This study aims to evaluate and analyze the pharmaceutical treatment patterns of HF patients over time in Sweden, in relation to the updated treatment recommendations.</p><p><strong>Methods: </strong>This observational study is based on registry data. The study population consisted of patients ≥18 years old who, at any time between 2017 and 2023, had an HF diagnosis, defined using ICD-10 code I50 (n = 212,757). Descriptive statistics were presented for the study population. Based on data from the national drug prescription registry, the treatment patterns between 2021 and 2023 were analyzed using biannual datasets before and after the introduction of treatment recommendations.</p><p><strong>Results: </strong>The mean age of the study population was 79 years and 56% were men. The utilization of quadruple therapy and SGLT2 inhibitors, both as monotherapy and in combination, increased over time, with a rising trend already apparent prior to the introduction of the updated treatment recommendations. At the end of 2023, about 30% of the incident HF population had at least tried quadruple therapy. Furthermore, a growing number of diverse treatment pathways among HF patients was observed over time, which may indicate an increased consideration for individualized treatment.</p><p><strong>Conclusions: </strong>Even though the implementation of the treatment recommendations for HF is not yet optimal, this study found a notable adoption of quadruple therapy in Sweden. There was an increased use of SGLT2 inhibitors and quadruple therapy, beginning even before the introduction of the updated Swedish treatment recommendations.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"281-293"},"PeriodicalIF":1.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144076503","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Treatment Outcomes in Black, Hispanic, Asian, and White Patients with Multiple Sclerosis Treated with Natalizumab.","authors":"Karen Blitz-Shabbir, Aimee M Banks, Hina Garg, Flavia Nelson, Suma Shah, Nicholas Belviso, Jason P Mendoza, Robin L Avila, Boyang Bian, Kinyee Fong","doi":"10.1007/s40801-025-00495-w","DOIUrl":"10.1007/s40801-025-00495-w","url":null,"abstract":"<p><strong>Background: </strong>Multiple sclerosis (MS) is a heterogeneous disease that may manifest differently among racial/ethnic groups, influencing response to disease-modifying therapy (DMT). Data on natalizumab (NTZ) effectiveness in people with MS (PwMS) based on race/ethnicity are limited.</p><p><strong>Objective: </strong>The aim of this study was to evaluate the effectiveness of NTZ on relapse onset and rate, and to assess MS-related healthcare encounters and costs in Black, Hispanic, Asian, and White PwMS.</p><p><strong>Methods: </strong>This was a retrospective analysis of the Komodo Health Claims Database, including adult patients in the US with one or more MS claim at index date (January 1, 2016-August 31, 2022). Patients were followed from first NTZ exposure through end of study, end of insurance eligibility, gap in index DMT > 45 days, or DMT switch. Annualized relapse rate (ARR), time to first relapse, and MS-related healthcare encounters and costs were compared in the 12 months pre/post NTZ initiation and while on treatment across racial strata.</p><p><strong>Results: </strong>The study included 3244 PwMS (Black, n = 632; Hispanic, n = 382; Asian, n = 49; White, n = 2181). Mean post-index NTZ exposure was 15.5-19.2 months. Post-index ARRs were significantly reduced across racial/ethnic groups (p < 0.001). The adjusted Kaplan-Meier estimated proportion of relapse-free patients at 2 years for all racial/ethnic groups was not significantly different from the White group. Significant differences were observed in annualized MS-related healthcare cost rates but not in annualized MS-related encounter rates before and after NTZ initiation across the racial/ethnic groups.</p><p><strong>Conclusion: </strong>NTZ was effective across racial/ethnic groups although not significantly different between groups.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"301-310"},"PeriodicalIF":1.9,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144180477","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}