Current Medical Research and Opinion最新文献

{"title":"Patient-reported efficacy of adjunctive brexpiprazole in major depressive disorder in a phase 4, open-label, interventional study.","authors":"François Therrien, Pratap Chokka, Jeffrey Habert, Zahinoor Ismail, Roger S McIntyre, Jennifer Dine, T Michelle Brown, Zhen Zhang, Erin M MacKenzie, Caroline L Ward","doi":"10.1080/03007995.2025.2558140","DOIUrl":"10.1080/03007995.2025.2558140","url":null,"abstract":"<p><strong>Objectives: </strong>In ENGAGE, patients with major depressive disorder (MDD) demonstrated improvements in patient-reported depression and life engagement while taking adjunctive brexpiprazole. This analysis aimed to further characterize patient perspectives on the effects of adjunctive brexpiprazole, using patient diary data from ENGAGE, and describe the development of a 'word of the day' activity.</p><p><strong>Methods: </strong>Prior to ENGAGE, word lists describing a 'good,' 'average,' and 'bad' day with depression were generated from semi-structured interviews with patients with MDD. ENGAGE (ClinicalTrials.gov identifier: NCT04830215) was an 8-week, phase 4, single-arm, open-label study of adjunctive brexpiprazole 0.5-2 mg/day in patients with MDD and inadequate response to antidepressant treatment. Patient diaries were completed periodically at home, comprising the Patient Global Impression - Severity of illness (PGI-S), Patient Global Impression - Improvement (PGI-I), and a 'word of the day' activity in which patients selected one word to describe how they felt that day. This analysis evaluated mean change in PGI-S scores (mixed model for repeated measures), mean PGI-I scores (descriptive statistics), PGI-S response and PGI-S sustained response (Kaplan-Meier), PGI-I response (normal approximation), and 'word of the day' (descriptive statistics).</p><p><strong>Results: </strong>In the interviews, 20 patients used 132 words to describe living with depression. Five words of each valence (positive, neutral, negative) were selected for ENGAGE. 122 patients were enrolled in ENGAGE; 120 had evaluable diary data. PGI-S score improved from baseline to week 8 (least squares mean change [standard error]: -1.5 [0.2]; nominal <i>p</i> < 0.001; effect size: 1.04). PGI-I scores at week 8 indicated 'minimal improvement' to 'much improvement' (mean [standard deviation]: 2.6 [1.1]). At week 8, rates of PGI-S response, sustained PGI-S response, and PGI-I response were 86.0% (95% confidence interval: 77.1, 92.8), 67.9% (54.5, 80.6), and 47.1% (38.1, 56.0), respectively. On 'word of the day,' the proportion of positive and neutral words increased from baseline to week 8, and the proportion of negative words decreased.</p><p><strong>Conclusions: </strong>Patient-reported diary data revealed early and sustained improvements in depressive symptom severity during 8 weeks of adjunctive brexpiprazole treatment. 'Word of the day' may be an effective qualitative tool for future trials.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-12"},"PeriodicalIF":2.2,"publicationDate":"2025-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145005941","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of patient-reported depression severity in subpopulation of ESCAPE-TRD study: esketamine nasal spray versus quetiapine extended release for treatment-resistant depression.","authors":"Kristin Clemens, Benoit Rive, Kruti Joshi, Pushpike Thilakarathne, Noam Kirson, Urvi Desai, Jason Doran, Diab Eid, Alice Qu, Yordan Godinov","doi":"10.1080/03007995.2025.2555483","DOIUrl":"https://doi.org/10.1080/03007995.2025.2555483","url":null,"abstract":"<p><strong>Objective: </strong>ESCAPE-TRD, a randomized phase 3b trial, compares the efficacy and safety of esketamine nasal spray (NS) and extended-release (XR) quetiapine, both in combination with ongoing oral antidepressant (OAD) treatment, among individuals with treatment-resistant depression (TRD). Although prior analyses used the clinician-rated MADRS, the comparative efficacy of esketamine NS vs. quetiapine XR using a patient-reported instrument to assess TRD severity among a subgroup treated according to US label is unknown.</p><p><strong>Methods: </strong>ESCAPE-TRD data were evaluated using the patient-rated Patient Health Questionnaire-9 (PHQ-9) instrument for individuals receiving treatment consistent with US prescribing information (NCT04338321). The main outcome was remission at weeks 8 and 32. Additional outcomes included response, time to first remission, time to first response, time to confirmed remission, time to confirmed response, and change in PHQ-9 score from baseline.</p><p><strong>Results: </strong>A significantly higher proportion of individuals in the esketamine NS group than in the quetiapine XR group achieved remission and response at week 8 (remission: 19.3% vs. 12.2%; RD [95% CI]: 7.1% [1.5%, 12.8%]; <i>p</i> = 0.013; response: 49.4% vs. 32.8%, RD [95% CI]:16.6% [9.0%, 24.1%]; <i>p</i> < 0.001). At 32 weeks, a significantly higher proportion of individuals in the esketamine NS group achieved remission and response compared to the quetiapine XR group (remission: 34.8% vs. 18.1%, RD [95% CI]: 16.7% [9.9%, 23.4%]; <i>p</i> < 0.001; response: 58.9% vs. 40.3%, RD [95% CI]:18.5% [10.9%, 26.2%]; <i>p</i> < 0.001).</p><p><strong>Conclusion: </strong>Using patient-reported PHQ-9 scoring to evaluate ESCAPE-TRD results, esketamine NS produced superior short- and long-term efficacy vs. quetiapine XR among individuals with TRD treated according to US label.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-9"},"PeriodicalIF":2.2,"publicationDate":"2025-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145069237","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enhanced guidance on artificial intelligence for medical publication and communication professionals.","authors":"Keith Goldman, Valerie Moss, Stephen Griffiths, Chirag Jay Patel, Gary Dorrell, Amy Foreman-Wykert, Monica Mody, Jason Gardner, Andy Shepherd, Matt Lewis","doi":"10.1080/03007995.2025.2556012","DOIUrl":"https://doi.org/10.1080/03007995.2025.2556012","url":null,"abstract":"<p><p>The International Society for Medical Publication Professionals (ISMPP) position statement and call to action on the use of artificial intelligence (AI), published in 2024, recognized the value of AI while advocating for best practices to guide its use. In this commentary, we offer enhanced guidance on the call to action for ISMPP members and other medical communication professionals on the topics of education and training, implementation and use, and advocacy and community engagement. With AI rapidly revolutionizing scientific communication, members should stay up to date with advancements in the field by completing AI training courses, engaging with ISMPP AI education and training and other external training platforms, developing a practice of lifelong learning, and improving AI literacy. Members can successfully integrate and use AI by complying with organizational policies, ensuring fair access to AI models, complying with authorship guidance, properly disclosing the use of AI models or tools, respecting academic integrity and copyright restrictions, and understanding privacy protections. Members also need to be familiar with the systemic problem of bias with large language models, which can reinforce health inequities, as well as the limits of transparency and explainability with AI models, which can undermine source verification, bias detection, and even scientific integrity. AI models can produce hallucinations, results that are factually incorrect, irrelevant, or nonsensical, which is why all outputs from AI models should be reviewed and verified for accuracy by humans. With respect to advocacy and community engagement, members should advocate for the responsible use of AI, participate in developing AI policy and governance, work with underserved communities to get access to AI tools, and share findings for AI use cases or research results in peer-reviewed journals, conferences, and other professional platforms.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-6"},"PeriodicalIF":2.2,"publicationDate":"2025-09-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145039501","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Brexpiprazole for anxiety symptoms in schizophrenia: a pooled analysis of short- and long-term trials.","authors":"Zahinoor Ismail, Shivani Kapadia, Anton M Palma, Murat Yildirim, Anja Farovik","doi":"10.1080/03007995.2025.2552286","DOIUrl":"10.1080/03007995.2025.2552286","url":null,"abstract":"<p><strong>Objective: </strong>For people with schizophrenia and their caregivers, anxiety is among the top symptoms for which they would like an effective treatment. The aims of this <i>post hoc</i> analysis of clinical trial data were to characterize the efficacy, safety and tolerability of brexpiprazole on anxiety symptoms in adults with schizophrenia, and to investigate the relationships between anxiety symptoms, functioning, and patient life engagement.</p><p><strong>Methods: </strong>Data were pooled for brexpiprazole 2-4 mg/day and placebo from three six-week, randomized, double-blind trials of brexpiprazole in adult inpatients with schizophrenia (ClinicalTrials.gov identifiers: NCT01396421, NCT01393613, NCT01810380) and for brexpiprazole 1-4 mg/day from two 52-week, open-label extension trials (NCT01397786, NCT01810783). People with comorbid anxiety disorders were not enrolled. In this <i>post hoc</i> analysis, anxiety was measured by a single item (G2) of the Positive and Negative Syndrome Scale (PANSS), functioning was measured by the Personal and Social Performance scale, and patient life engagement was measured by a 14-item PANSS subset. Least squares mean changes from baseline were calculated using a mixed model for repeated measures. Anxiety response was defined using two definitions: (1) PANSS G2 improvement of ≥1 point (a clinically interpretable score change) from baseline to Week 6, and (2) PANSS G2 score of <3 points (anxiety symptoms reduced to \"minimal\" or \"absent\") at Week 6 for the subgroup who had anxiety at baseline (G2 score ≥3). This was an exploratory, hypothesis-generating analysis with no correction for multiple comparisons.</p><p><strong>Results: </strong>Anxiety at baseline (G2 score ≥3) was present in 763/868 (87.9%) participants on brexpiprazole, and 449/517 (86.8%) on placebo. At Week 6, least squares mean change from baseline in G2 score favored brexpiprazole versus placebo: mean difference, -0.19; 95% confidence interval, -0.33 to -0.06; <i>p</i> = .005; Cohen's <i>d</i> effect size, 0.19. Anxiety response for brexpiprazole and placebo, respectively, was shown in 547/863 (63.4%) and 291/515 (56.5%) participants (<i>p</i> = .012; response definition 1), and 283/541 (52.3%) and 135/303 (44.6%) participants (<i>p</i> = .036; response definition 2). Functioning and patient life engagement improved regardless of whether participants' anxiety improved. Long-term data suggested maintenance of treatment effects. Adverse events were consistent with prior analyses.</p><p><strong>Conclusion: </strong>Exploratory analyses suggest that brexpiprazole may help in the management of anxiety symptoms, functioning, and patient life engagement - important outcomes for people with schizophrenia.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-14"},"PeriodicalIF":2.2,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945907","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Retrospective claims analysis of the epidemiology and economic burden of diagnosed congenital cytomegalovirus in Japan.","authors":"Philip O Buck, Debbie Goldschmidt, Annika Anderson, Noam Kirson, Urvi Desai, John Diaz-Decaro","doi":"10.1080/03007995.2025.2554734","DOIUrl":"https://doi.org/10.1080/03007995.2025.2554734","url":null,"abstract":"<p><strong>Objective: </strong>Congenital cytomegalovirus (cCMV) is a leading infectious cause of birth defects; approximately 20%-25% of infants with cCMV develop long-term health complications including hearing loss, microcephaly, and developmental issues. This study assessed the epidemiology and burden of clinically diagnosed cCMV in Japan.</p><p><strong>Methods: </strong>Insurance claims from the Japan Medical Data Center database (2011-2020) were analyzed retrospectively. Infants were included in the cCMV cohort if their first diagnosis (index date) of cCMV or CMV was within the birth/following month and had ≥24 months of continuous health plan enrollment post-index (study period). They were matched 1:1 to non-cCMV controls on sex, birth year, and index year. Birth prevalence was calculated annually through 2019. Healthcare resource utilization (HRU) and costs in 2023 Japanese Yen were summarized for the study period.</p><p><strong>Results: </strong>Birth prevalence of diagnosed cCMV during 2011-2019 ranged from 6.88-22.56 per 100,000 births. 121 matched pairs were included in the burden analysis. The mean number of medical encounters was significantly greater for infants with cCMV than controls in year one post-index (14.6 vs. 11.3, <i>p</i> < 0.0001), driven by outpatient encounters. Infants with cCMV were more likely than controls to have an inpatient admission in the first two years of life. Mean medical costs were significantly greater for infants with cCMV than controls in year one (¥1.6 M vs. ¥378K) and year two (¥483K vs. ¥194K).</p><p><strong>Conclusions: </strong>Infants diagnosed with cCMV in Japan had, on average, substantially higher HRU and healthcare cost burden than non-cCMV controls in the first two years of life.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-11"},"PeriodicalIF":2.2,"publicationDate":"2025-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145039464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Plasma glucose and HbA1c discrepancy may indicate hemoglobinopathy: a case series.","authors":"Gulru Birce Sonmezoz","doi":"10.1080/03007995.2025.2557519","DOIUrl":"https://doi.org/10.1080/03007995.2025.2557519","url":null,"abstract":"<p><strong>Introduction: </strong>Diabetes Mellitus is a chronic disease characterised by elevated plasma glucose (PG) levels. HbA1c has been widely utilized for diabetes diagnosis. However, certain conditions restrict its use. In such cases, plasma glucose (PG) measurements and self-monitoring blood glucose (SMBG) are recommended. This case series highlights the importance of considering both HbA1c and PG or SMBG in the evaluation of patients with diabetes.</p><p><strong>Case report: </strong>This case series presents three cases of patients with diabetes who exhibited a discrepancy between PG and HbA1c levels. Only one patient demonstrated isolated microcytosis, while the remaining two had completely normal hematologic profiles. Due to this discrepancy, hemoglobin electrophoresis was conducted, revealing various hemoglobinopathies in all cases.</p><p><strong>Conclusion: </strong>For patients with discrepancies between PG levels and HbA1c, we suggest a thorough evaluation that includes consideration of potential hemoglobinopathies. These hemoglobin variants can present with isolated microcytosis or entirely normal hematologic parameters and may lead to falsely low HbA1c values. In cases of discordance between PG and HbA1c, hemoglobin electrophoresis can serve as a valuable diagnostic tool. Identifying hemoglobinopathies before determining treatment regimens can help mitigate the risk of complications from inadequate treatment, and awareness of HbA1c limitations allows clinicians to use both HbA1c and PG/SMBG to optimize diabetes management and minimize the risk of diabetic complications.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-5"},"PeriodicalIF":2.2,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145029289","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Serum albumin demonstrates comparable or superior prognostic value compared to albumin-based ratios in sepsis.","authors":"Gianni Turcato, Arian Zaboli, Alessandro Cipriano, Gloria Brigiari, Paolo Ferretto, Fabrizio Lucente, Lucia Filippi, Michael Maggi, Massimo Marchetti, Lorenzo Ghiadoni, Christian J Wiedermann","doi":"10.1080/03007995.2025.2558128","DOIUrl":"10.1080/03007995.2025.2558128","url":null,"abstract":"<p><strong>Background: </strong>Serum albumin is a well-known biomarker in sepsis, and several albumin-based ratios have been proposed to enhance its prognostic performance. However, it remains unclear whether these composite indices outperform serum albumin alone in predicting outcomes in septic patients.</p><p><strong>Methods: </strong>We conducted a prospective observational study including 413 adult patients with sepsis admitted to the Intermediate Care Unit of Santorso Hospital, Italy, between January 2023 and June 2024. Clinical data, laboratory parameters, and six albumin-based ratios were collected at admission. The primary outcome was 30-day mortality. Prognostic performance was assessed using ROC curves, Brier Scores, and Decision Curve Analysis (DCA). Correlation with clinical severity was evaluated using Spearman's correlation with SOFA and APACHE II scores.</p><p><strong>Results: </strong>Among the 413 patients enrolled, 30-day mortality was 16.9%. Serum albumin demonstrated the highest predictive value compared to all albumin-based ratios. DCA confirmed the superior net clinical benefit of serum albumin across a wide range of threshold probabilities, especially in early risk stratification. LAR showed comparable performance in AUC but lower clinical utility in DCA. Albumin also showed the strongest inverse correlation with SOFA (ρ = -0.276, <i>p</i> < 0.001) and APACHE II (ρ = -0.391, <i>p</i> < 0.001) scores.</p><p><strong>Conclusions: </strong>Serum albumin is a strong, independent predictor of 30-day mortality in patients with sepsis and outperforms multiple albumin-based ratios in both statistical and clinical utility. Its use in early risk stratification should be encouraged in clinical practice. Further multicenter studies are warranted to confirm these findings and explore their generalizability.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-9"},"PeriodicalIF":2.2,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144999870","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Patients as partners in medical publications: the ISMPP journey of engagement.","authors":"Simon R Stones, Dawn Lobban, Catherine Skobe, Nichola Gokool, Trishna Bharadia, Anna Geraci, Robert J Matheis","doi":"10.1080/03007995.2025.2556317","DOIUrl":"https://doi.org/10.1080/03007995.2025.2556317","url":null,"abstract":"<p><p>Patient engagement (PE) has evolved from an emerging concept to a fundamental ethos underpinning healthcare research and communication. In this commentary, we explore the historical evolution in medical research from patients being participants in clinical trials to becoming integral partners in communicating medical research findings. The progression from \"why\" to \"how\" PE should occur represents a fundamental shift in the medical publication landscape. We also highlight the International Society for Medical Publication Professionals' (ISMPP) journey in embracing and advancing PE within medical publications through ISMPP's initiatives and activities, including the establishment of its PE Task Force, patient membership, and support programs, while examining the cultural transformations occurring within the profession. Looking ahead, we discuss opportunities for expanding patient roles, improving accessibility to tools and frameworks, and integrating patient perspectives into leadership positions. This commentary serves as both a reflective narrative and a call to action for medical publication professionals to champion authentic and meaningful PE, ensuring publications truly engage and serve the patients at the heart of the research they describe, as exemplified by ISMPP.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-8"},"PeriodicalIF":2.2,"publicationDate":"2025-09-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145029297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Real world treatment patterns and unmet needs of migraine preventive treatments in Japan: JMDC claims analysis.","authors":"Takao Takeshima, Gina Ahmadyar, Molly Duan, Toru Yamazaki, Shoko Inoue, Chiori Nishimura","doi":"10.1080/03007995.2025.2552277","DOIUrl":"https://doi.org/10.1080/03007995.2025.2552277","url":null,"abstract":"<p><strong>Objective: </strong>We evaluated real-world treatment patterns and unmet needs associated with migraine preventive medications in Japan following the introduction of calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs), focusing on persistence, switching, and adherence rates.</p><p><strong>Methods: </strong>This retrospective cohort study analyzed JMDC (previously Japan Medical Data Center) claims data (index date: April 2021 to January 2024) for treatment-naïve patients who initiated oral migraine preventive medications (OMPMs; <i>n</i> = 12,750) and patients initiating CGRP mAbs (<i>n</i> = 3,280). Persistence was defined as continuous therapy without a 60-day or longer gap. Treatment patterns were evaluated at 3, 6, and 12 months post-initiation.</p><p><strong>Results: </strong>Most patients were female (74.1% OMPMs, 78.1% CGRP mAbs), over half of childbearing age. For OMPM initiators, persistence rates declined from 49.7% at 3 months to 21.7% at 12 months, with antiepileptics showing highest persistence (27.0%). CGRP mAb initiators demonstrated higher initial persistence (85.6% at 3 months), declining to 36.5% at 12 months. 22.9% of OMPM and 19.7% of CGRP mAb patients switched by 12 months. Among OMPM switchers, only 20% switched to CGRP mAbs. Both cohorts had a high prevalence of comorbidities, including non-migraine headaches (approx. 50%), mental health disorders (26-31%), and sleep disorders (approx. 29%).</p><p><strong>Conclusion: </strong>Substantial unmet needs exist in migraine preventive treatment in Japan, as demonstrated by low 12-month persistence across all medication classes. Despite higher initial persistence, CGRP mAbs showed similar declining patterns over time, indicating most migraine patients do not remain on their index treatment and suggesting the need for additional options.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-13"},"PeriodicalIF":2.2,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145005913","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Brexpiprazole for agitation in clinically relevant patient subgroups: a <i>post hoc</i> analysis of efficacy and safety in patients with agitation associated with dementia due to Alzheimer's disease.","authors":"Jared Stroud, Jeffrey L Cummings, Sanjeda R Chumki, Pedro Such, David Wang, Anton M Palma, Zhen Zhang, Malaak Brubaker, George T Grossberg","doi":"10.1080/03007995.2025.2552278","DOIUrl":"10.1080/03007995.2025.2552278","url":null,"abstract":"<p><strong>Objective: </strong>To explore the efficacy and safety of brexpiprazole for the treatment of agitation symptoms in clinically relevant subgroups of patients with dementia due to Alzheimer's disease.</p><p><strong>Methods: </strong>Data were pooled for brexpiprazole (2 or 3 mg/day) and placebo from two international, randomized, double-blind trials in adults with a clinical diagnosis of Alzheimer's dementia with mild-to-severe cognitive dysfunction and with agitation (ClinicalTrials.gov identifiers: NCT01862640, NCT03548584). Change in agitation frequency over 12 weeks was measured using the Cohen-Mansfield Agitation Inventory (CMAI). Safety measures included treatment-emergent adverse events (TEAEs). In this <i>post hoc</i> analysis, thirteen clinically relevant subgroups were investigated based on care setting (institutionalized, non-institutionalized), severity of cognitive dysfunction (mild/moderate, severe), co-occurring behavioral symptoms (psychosis, depression, anxiety, irritability, sleep disturbance), and use of concomitant medications for dementia (acetylcholinesterase inhibitor, memantine) and psychiatric conditions (antidepressant, benzodiazepine).</p><p><strong>Results: </strong>In the randomized sample (<i>N</i> = 621), mean age was 74 years (range 55-90 years), 344 (55.4%) participants were female, and 277 (44.6%) were male. Over 12 weeks, brexpiprazole showed numerically greater reduction in agitation frequency than placebo in 12 of 13 subgroups. The only exception was \"concomitant benzodiazepines\", which was a small subgroup (<i>n</i> = 71), but showed efficacy for brexpiprazole in secondary analyses. The largest differences in favor of brexpiprazole versus placebo were for the concomitant antidepressant, co-occurring sleep disorder, and co-occurring psychosis subgroups. The overall incidence of TEAEs was generally consistent across subgroups.</p><p><strong>Conclusion: </strong>In these exploratory analyses, brexpiprazole reduced symptoms of agitation across a wide range of patients with agitation associated with dementia due to Alzheimer's disease.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1-12"},"PeriodicalIF":2.2,"publicationDate":"2025-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144945933","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}