Drugs - Real World Outcomes最新文献

{"title":"Persistence of Weekly Injectable Semaglutide Use in Patients with Diabetes Mellitus and Obesity: A Retrospective Follow-Up in Colombia.","authors":"Manuel Enrique Machado-Duque, Andrés Gaviria-Mendoza, Luis Fernando Valladales-Restrepo, Jorge Enrique Machado-Alba","doi":"10.1007/s40801-025-00518-6","DOIUrl":"10.1007/s40801-025-00518-6","url":null,"abstract":"<p><strong>Background: </strong>Semaglutide is an effective antidiabetic agent that is injected weekly to induce weight reduction, and the impact on cardiovascular outcomes is favorable.</p><p><strong>Objective: </strong>The aim was to evaluate the persistence of the use of weekly injectable semaglutide in Colombia for 12 months among new users.</p><p><strong>Methods: </strong>A retrospective longitudinal follow-up study of a cohort of patients with a new prescription of weekly injectable semaglutide between January and December 2022 and persistence for 365 days was evaluated. Kaplan‒Meier survival analyses were performed to evaluate the survival effect of semaglutide.</p><p><strong>Results: </strong>In total, 9356 new users of semaglutide were identified. The average age of the users was 61.6 ± 12.9 years, the main diagnoses were type 2 diabetes mellitus (43.8%) and obesity (41.8%), and 90.8% of them received the 0.25/0.5-mg dose. The mean duration of use was 93.7 ± 76.3 days, but only 13.8% and 0.2% of patients continued the treatment at 6 and 12 months of follow-up, respectively. In total, 35.4% had a prescription for a single month. The other concomitant antidiabetic drugs used were metformin (43.5%), sodium glucose-2 cotransporter inhibitors (38.3%) and insulin (18.2%).</p><p><strong>Conclusions: </strong>Most of the patients started semaglutide at the suggested doses to continue with staging; however, the persistence of use was low, which may be related to difficulties in access, education on application methods, drug tolerability, and lack of follow-up by the clinician.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"615-622"},"PeriodicalIF":1.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12635016/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145211969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patient Experiences with Psoriatic Disease in the USA: Results from the Psoriasis and Beyond Global Study.","authors":"April W Armstrong, Sicily Mburu, George C Gondo, Elena Kornyeyeva, Susan Frade, Alexis Ogdie","doi":"10.1007/s40801-025-00499-6","DOIUrl":"10.1007/s40801-025-00499-6","url":null,"abstract":"<p><strong>Background: </strong>Psoriatic disease (PsD) is a chronic, multisystem, inflammatory disorder encompassing psoriasis, psoriatic arthritis (PsA), and their associated comorbidities.</p><p><strong>Objective: </strong>The aim of this subanalysis of the global \"Psoriasis and Beyond\" study was to evaluate patients' experiences of living with PsD in the USA.</p><p><strong>Methods: </strong>The study included a cross-sectional, quantitative, 25-min online survey of adults with self-reported, healthcare professional-diagnosed, moderate-to-severe psoriasis, with or without PsA. USA-based patients were recruited through online panels by the Institut de Publique Sondage D'Opinion Secteur and The National Psoriasis Foundation.</p><p><strong>Results: </strong>This analysis included 793 US patients with psoriasis; 43% also had PsA. Overall, 75% of patients knew that their disease was systemic, and 65% had heard the term \"psoriatic disease.\" Of patients without diagnosed PsA, 50% screened positive for PsA using the Psoriasis Epidemiology Screening Tool. Psoriasis negatively affected emotional well-being and quality of life (QoL) in the majority of patients (87% and 91%, respectively). Overall, 29% of patients reported that they could not work or study in the week prior to the survey; of these, 98% responded that psoriasis had a very or extremely large impact on their QoL. Mean diagnostic delays of 3.7 and 3.3 years for psoriasis and PsA, respectively, were reported.</p><p><strong>Conclusions: </strong>This analysis of USA-based patients with PsD highlights the profound impact of PsD on emotional well-being and QoL and suggests potential underdiagnosis of PsA. There is a need to ensure early PsD diagnosis and to provide holistic treatment, including mental health support.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"525-539"},"PeriodicalIF":1.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12634971/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144946577","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Sodium Zirconium Cyclosilicate Duration and Hyperkalemia-Related Healthcare Encounters in Patients with Heart Failure and Cardio/Renal Dysfunction: The GALVANIZE Outcome Study.","authors":"Abiy Agiro, Fan Mu, Erin E Cook, Ali Greatsinger, Jingyi Chen, Manasvi Sundar, Angela Zhao, Ellen Colman, Arun Malhotra","doi":"10.1007/s40801-025-00525-7","DOIUrl":"10.1007/s40801-025-00525-7","url":null,"abstract":"<p><strong>Background and objective: </strong>Patients with heart failure or cardio/renal dysfunction (chronic kidney disease, end-stage kidney disease, or heart failure) are at increased risk of hyperkalemia. Sodium zirconium cyclosilicate (SZC) treats hyperkalemia, but the impact of SZC treatment duration on healthcare resource utilization in these populations is unclear. This study, GALVANIZE Outcome, assessed healthcare resource utilization associated with short-term versus long-term outpatient SZC use in matched cohorts of SZC users with heart failure and, separately, cardio/renal dysfunction.</p><p><strong>Methods: </strong>Data from a large US claims database (7/2018-12/2022) were used to identify adults with heart failure or cardio/renal dysfunction initiating outpatient SZC (index date). Long-term (> 90 days) and short-term SZC users (≤ 30 days) were matched on key baseline characteristics using a two-step approach: exact matching followed by propensity score matching. Rates of hyperkalemia-related hospitalizations or emergency department visits and hyperkalemia-related hospitalizations were compared between long-term and short-term SZC users during the follow-up from index to the earliest of 6 months post-index, end of data availability, new potassium binder use, or reinitiation of SZC post-discontinuation.</p><p><strong>Results: </strong>Among 942 matched heart failure pairs and 2892 matched cardio/renal pairs, long-term SZC users had fewer hyperkalemia-related hospitalizations or emergency department visits compared with short-term users, with reductions of 36% in the heart failure sample and 40% in the cardio/renal dysfunction sample; the respective reductions were 39% and 37% for hyperkalemia-related hospitalizations alone (all p < 0.001).</p><p><strong>Conclusions: </strong>Long-term SZC use is associated with significant reductions in hyperkalemia-related hospitalizations or emergency department visits compared with short-term use among patients with heart failure or cardio/renal dysfunction.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"655-667"},"PeriodicalIF":1.9,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12634977/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145387889","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Understanding Underreporting of Adverse Drug Reactions in the Philippines: A Mixed Methods Study.","authors":"Mark Ryann A Lirasan, Mark Harvey B Adamson, Vieno Gino Cruz, Julie Ann T Capuchino, Leslee Ann Lorna D De Jesus, Roland Amiel C Peñaloza, Jover D Francisco, Maureen Allysandra G Gulmatico, John Eric R Valiente, Maria Glezilda R Soriano, Rizza Ann A Oquendo","doi":"10.1007/s40801-025-00492-z","DOIUrl":"10.1007/s40801-025-00492-z","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Adverse drug reaction (ADR) reporting is a crucial element in ensuring medication safety and effective pharmacovigilance. However, underreporting of ADRs remains a significant challenge in the Philippines despite efforts made by the national pharmacovigilance center (NPVC). This study aims to explore the factors contributing to underreporting of ADRs among healthcare professionals (HCPs) in the Philippines, with a focus on understanding their knowledge, attitudes, and practices (KAP), as well as evaluating the usability of the online ADR reporting system.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;A mixed-methods approach was employed, integrating quantitative and qualitative research methods. The study involved a KAP survey and focus group discussions (FGDs) with HCPs, including pharmacists, nurses, and physicians. The survey gathered quantitative data on KAP related to ADR reporting, while FGDs provided qualitative insights into contextual factors, misconceptions, and barriers. In addition, a system usability survey (SUS) was conducted among participants at the 1st Philippine Pharmacovigilance Summit to assess the usability of the online ADR reporting system. Data collection spanned 4 weeks, followed by thematic analysis of FGD data and descriptive statistical analysis of survey and SUS data.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;The study revealed that HCPs generally recognize the importance of ADR reporting for FDA-approved drugs, vaccines, and antineoplastics, but there is a knowledge gap regarding the reporting of FDA-unapproved drugs. Awareness of the NPVC is limited, with less than half of HCPs (n = 4363) aware of its existence, and even fewer understanding its roles. Reporting practices are inconsistent, with many relying on paper-based methods, and a significant portion of HCPs are unaware of available reporting options. While 71.08% of participants expressed a high likelihood of reporting ADRs if familiar with the process, only 21.54% had actually reported one. Thematic analysis from focus group discussions identified several barriers to effective ADR reporting, including insufficient training, inconsistent practices, fear of legal repercussions, and low adoption of digital tools. The SUS results showed an \"okay\" usability rating for the online ADR reporting system, with a score of 68.81 (grade C). This shows that while many users found the tool acceptable and fairly easy to use, nearly half of the respondents felt it was too complex.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;This study reveals significant knowledge gaps among HCPs in the Philippines regarding ADR reporting. While HCPs acknowledge the importance of ADR reporting for patient safety, many perceive the process as complex and burdensome, which discourages consistent participation. The study highlights key barriers, including legal concerns and complexity of online reporting tools. A key policy implication is the need for government agencies, such as the Food and D","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"367-381"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381321/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144186783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacy Dispensing Records to Describe and Evaluate the Use of Acetylcholinesterase Inhibitors Among Swedish Antipsychotic Drug Users with Symptoms of Lewy Body Dementia.","authors":"Jonas Kindstedt, Hugo Lövheim, Maria Gustafsson","doi":"10.1007/s40801-025-00501-1","DOIUrl":"10.1007/s40801-025-00501-1","url":null,"abstract":"<p><strong>Introduction: </strong>People with Lewy body dementia (LBD) experience pronounced psychotic symptoms but are extremely sensitive to side effects from antipsychotic treatment. In comparison, acetylcholinesterase inhibitors (AChEIs) are a safer treatment option for managing cognitive and neuropsychiatric symptoms and should ideally be the first-line treatment according to review literature. This study described the pharmacological treatment of LBD-associated neuropsychiatric symptoms among older people by comparing dispensing records of antipsychotic drugs and AChEIs.</p><p><strong>Methods: </strong>This study included people with records of antipsychotic drugs dispensed in 2019 according to the Swedish Prescribed Drug Register, which functioned as an indicator of neuropsychiatric symptoms, who had been registered with LBD in the Swedish registry for cognitive/dementia disorders according to basal registrations from 2007 to 2020. We then determined the proportions of individuals with and without dispensing records of AChEIs prescribed before their index antipsychotic prescription fill of 2019, by comparing prescribing dates. Age, sex and nursing home residency were included as independent variables in a multiple logistic regression model to analyse associations between demographic factors and first-line treatment with AChEIs.</p><p><strong>Results: </strong>In total, 362 individuals with symptoms of LBD had filled at least one prescription for any antipsychotic drug in 2019. There were 114 people (31.5%) who had been prescribed antipsychotics as first-line treatment instead of AChEIs, and among them, 60 individuals had been diagnosed with LBD after the index antipsychotic prescribing date. First-line treatment with AChEIs was more common among males (odds ratio, OR, 1.65 [95% CI 1.03-2.62]) and nursing home residents (2.51 [1.59-3.96]).</p><p><strong>Conclusions: </strong>Antipsychotics were utilized as first-line treatment instead of AChEIs among almost one-third of antipsychotic users with symptoms of LBD. It is important to consider emerging psychotic symptoms among older people as possible manifestations of LBD to ensure early and appropriate pharmacological treatment.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"383-390"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381332/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144191644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"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":"10.1007/s40801-025-00500-2","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;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.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/strong&gt;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":"399-410"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12380658/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144301352","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluation of Awareness of Photosensitivity Risk and Additional Risk Minimisation Measures for Ketoprofen Gel in Belgium and Luxembourg.","authors":"Veselina Skrinska-Kirilova, Javier Sawchik, Martine Sabbe, Martine Debacker, Guy Weber, Anne-Cécile Vuillemin, Jamila Hamdani","doi":"10.1007/s40801-025-00508-8","DOIUrl":"10.1007/s40801-025-00508-8","url":null,"abstract":"<p><strong>Background: </strong>Topical ketoprofen gel (Fastum gel) is used for the treatment of rheumatic and traumatic musculoskeletal pain. Following reports of photosensitivity reactions, additional risk minimisation measures have been implemented in Europe to inform healthcare professionals (HCPs) and patients about this risk.</p><p><strong>Objective: </strong>The main objectives of our survey were to assess both HCPs' awareness of the risk of photosensitivity associated with Fastum gel and their opinion on the usefulness of an annual direct healthcare professional communication (DHPC) in Belgium and Luxembourg.</p><p><strong>Methods: </strong>A cross-sectional online survey was conducted between June and July 2023, approximately 1 month after the annual distribution of the DHPC. Targeted HCPs were asked about their awareness of the photosensitivity risk associated with Fastum gel, as well as their opinion on the usefulness of the annual DHPC. The study also explored the channels through which the information was received, along with awareness and use of educational materials. Frequencies and percentages were calculated both overall and by HCP category for each country.</p><p><strong>Results: </strong>In Belgium, 569 HCPs responded to the survey. Almost all HCPs reported that they were aware of this risk (99%). More than half of pharmacists (58%) and half of physicians (50%) indicated that an annual DHPC is necessary. Around half of the respondents (49%) recalled receiving information about the risk in 2023, primarily through the DHPC (68%) while outlining other channels such as the logo on the packaging (42%) and the Summary of Product Characteristics (40%). Awareness of the patient card (32%) and the checklist (5%) was overall low, with very limited use in 2023. In Luxembourg, 190 HCPs responded to the survey. Almost all HCPs reported that they were aware of this risk (97%). The majority of pharmacists (70%) and more than half of physicians (52%) supported the annual DHPC distribution. Over two thirds of the respondents (68%) recalled receiving relevant information in 2023, mainly through the DHPC (70%) but also through the SmPC (30%). Awareness of the patient card (22%) and the checklist (13%) was overall low, with very limited use in 2023.</p><p><strong>Conclusions: </strong>The results indicate a high level of awareness of the photosensitivity risk of Fastum gel among participating HCPs. Notably, a majority of HCPs expressed the need for an annual DHPC. This study also underscores the importance of using multiple channels of information to increase the opportunities for reaching HCPs. Nevertheless, the survey revealed limited use of the checklist and the patient card among HCPs.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"425-435"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381325/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144728720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Association Between 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":"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":"467-477"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381344/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144309637","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"CALS and ACB Scales are Associated with Physical and Cognitive Impairment and Predict Mortality in Nursing Home Residents.","authors":"Luca Soraci, Ersilia Paparazzo, Mirella Aurora Aceto, Francesco Bruno, Teresa Serra Cassano, Davide Lagrotteria, Salvatore Claudio Cosimo, Pierluigi Mercatante, Francesco Morelli, Maria Princiotto, Andrea Corsonello, Giuseppe Passarino, Alberto Montesanto","doi":"10.1007/s40801-025-00509-7","DOIUrl":"10.1007/s40801-025-00509-7","url":null,"abstract":"<p><strong>Background and objective: </strong>Anticholinergic medications are known to affect the prognosis of older nursing home residents. Various anticholinergic scales were developed to measure the cumulative anticholinergic burden; among them, the CRIDECO Anticholinergic Load Scale (CALS) has recently emerged as a new tool to identify patients with cognitive impairment due to anticholinergic burden. This study aimed to externally validate the CALS and to evaluate the association of CALS and the anticholinergic cognitive burden (ACB) scales with baseline cognitive and functional impairment, as well as with 3-year mortality rates.</p><p><strong>Methods: </strong>A prospective cohort of 600 nursing home residents (mean age 80.4 ± 8.0 years; 69.8% women) underwent a comprehensive geriatric assessment. Anticholinergic burden was assessed at baseline using both CALS and ACB scales. Cognitive impairment (Mini-Mental State Examination < 24) and physical disability (one or more impaired activities of daily living) were evaluated cross-sectionally using a logistic regression model. Cox proportional hazards models were used to estimate the association between anticholinergic burden and 3-year mortality, adjusting for age, sex, multimorbidity, nutritional status, and cognitive and functional status.</p><p><strong>Results: </strong>Among 600 nursing home residents included in the study, 72.0% had cognitive impairment and 56.3% had at least one activity of daily living limitation. The CALS and ACB scores were significantly correlated ( <math><mi>ρ</mi></math> = 0.76), but CALS identified a higher number of residents with moderate-to-high anticholinergic burden. Multivariate logistic regression showed that CALS ≥ 2 was independently associated with cognitive impairment (odds ratio 1.84, 95% confidence interval 1.02-3.34), whereas ACB ≥ 2 was not. Both scales were associated with activities of daily living disability, with a stronger gradient and better goodness of fit for CALS than ACB. During the 3-year follow-up, 25.3% of residents died. Cox regression analyses showed that residents with CALS or ACB ≥ 2 had significantly lower survival over 3 years. In fully adjusted Cox models, both CALS ≥ 2 (hazard ratio 1.93, 95% confidence interval 1.07-3.46) and ACB ≥ 2 (hazard ratio 1.69, 95% confidence interval 1.02-2.83) remained associated with increased mortality. Prognostic performance was similar (CALS C-index: 0.783; ACB: 0.781), but the model fit favored CALS.</p><p><strong>Conclusions: </strong>In this cohort of nursing home residents, anticholinergic burden as measured by both CALS and ACB was associated with baseline physical impairment and 3-year mortality, but CALS showed a better goodness of fit. Between the two scales, CALS only was independently associated with baseline cognitive impairment. These findings support the clinical utility of CALS in assessing anticholinergic-related risk among frail older adults in institutional settings.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"437-446"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381345/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144717683","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real-World Prescribing Patterns of Long-Acting Injectable Antipsychotics in Australian Psychiatric Inpatients: Trends, Clinical Outcomes, and Substance Use Prevalence.","authors":"Tumilara Akindele, Kanchana De Alwis","doi":"10.1007/s40801-025-00511-z","DOIUrl":"10.1007/s40801-025-00511-z","url":null,"abstract":"<p><strong>Background: </strong>Schizophrenia spectrum disorders (SSD) are chronic psychiatric conditions with high rates of medication nonadherence, relapse, and hospitalization. Long-acting injectable antipsychotics (LAIs) aim to improve adherence; their real-world use in inpatient settings is not yet well understood.</p><p><strong>Objective: </strong>To investigate prescription patterns of LAI antipsychotics in a real-life setting among psychiatric inpatients with SSD in Australia.</p><p><strong>Methods: </strong>This retrospective cross-sectional study was conducted at a major Australian tertiary center. It investigated prescription trends, demographics, hospitalization outcomes, and substance use among inpatients with SSD who received oral, LAI, or combined oral-LAI treatment. Readmission rates were also analyzed in patients with a history of medication nonadherence.</p><p><strong>Results: </strong>Among the total of 510 inpatients with SSD, 26.6% received LAIs, 40% were treated with combined oral-LAI therapy, and 33.3% were prescribed oral antipsychotics alone. Second-generation LAIs were most prevalent (87.5%), with paliperidone being the most frequently used (53.7%). The combined oral-LAI therapy group had the highest rates of nonadherence (83.8%) and substance use (82.8%). Among patients with a history of medication nonadherence, those receiving LAIs had lower 30-day readmission rates compared with the oral antipsychotic treatment group.</p><p><strong>Conclusions: </strong>Findings align with global trends favoring second-generation LAIs and highlight the rising yet understudied use of combined oral-LAI therapy. High nonadherence and substance use in the combined oral-LAI therapy group call for targeted interventions. While LAIs may reduce readmissions in nonadherent patients, further research is needed to assess combined therapy's effectiveness and optimize prescribing. These insights reinforce the role of LAIs in relapse prevention and the need for tailored adherence strategies.</p>","PeriodicalId":11282,"journal":{"name":"Drugs - Real World Outcomes","volume":" ","pages":"489-501"},"PeriodicalIF":1.9,"publicationDate":"2025-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12381317/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144793769","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}