Drugs & Aging最新文献

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Fall Outcomes in Older Adults Following Benzodiazepine/Z-Drug Discontinuation: A Retrospective Cohort Study in an Academic Health System 停用苯二氮卓/Z-类药物后老年人的跌倒后果:学术医疗系统中的回顾性队列研究
IF 2.8 3区 医学
Drugs & Aging Pub Date : 2024-09-18 DOI: 10.1007/s40266-024-01144-7
Nicole J. Schindler, Lindsay Zepel, Matthew L. Maciejewski, Susan N. Hastings, Amy Clark, Sascha Dublin, Ladia Albertson-Junkans, Juliessa M. Pavon
{"title":"Fall Outcomes in Older Adults Following Benzodiazepine/Z-Drug Discontinuation: A Retrospective Cohort Study in an Academic Health System","authors":"Nicole J. Schindler, Lindsay Zepel, Matthew L. Maciejewski, Susan N. Hastings, Amy Clark, Sascha Dublin, Ladia Albertson-Junkans, Juliessa M. Pavon","doi":"10.1007/s40266-024-01144-7","DOIUrl":"https://doi.org/10.1007/s40266-024-01144-7","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background</h3><p>Benzodiazepines and z-drugs increase the fall risk in older adults. There is a lack of real-world data examining the association between falls and deprescribing medications.</p><h3 data-test=\"abstract-sub-heading\">Objective</h3><p>In a retrospective cohort study of older adults with chronic benzodiazepine or z-drug use receiving care at an academic health system from January 2017 to December 2020, we explored the association between medication discontinuation and falls.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>Chronic use was defined as ≥ 3 medication dispensings and cumulative days’ supply ≥ 45 days within 100 days in 2018. Discontinuation was defined as a dispensing gap of ≥ 180 days within 1 year of chronic use eligibility, with a secondary definition requiring a gap of ≥ 90 days. Non-discontinuers (<i>n</i> = 524) were matched 4:1 to discontinuers (<i>n</i> = 131) if they had a fill in the same month as the matched discontinuation index date. The association between discontinuation and a fall during 2.25-year follow-up was assessed using Cox proportional hazards models. The analysis was repeated using a gap of ≥ 90 days (<i>n</i> = 279 discontinuers; 1116 matched non-discontinuers).</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>The cumulative incidence of falls-related acute visits was 6.9% for discontinuers and 9.7% for non-discontinuers [adjusted hazard ratio (HR) 0.65, 95% confidence interval (CI) 0.31–1.31]. Using the 90-day-gap definition, the cumulative incidence was 9.3% for discontinuers and 8.5% for non-discontinuers (HR 1.12, 95% CI 0.70–1.77).</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>Benzodiazepine/z-drug discontinuation was not associated with reduced risk of falls. However, the relationship between discontinuation and falls varies depending on the definitions used. It is essential to examine different discontinuation definitions in larger studies while considering other relevant clinical outcomes.</p>","PeriodicalId":11489,"journal":{"name":"Drugs & Aging","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142264579","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Co-Designing a Consult Patient Decision Aid for Continuation Versus Deprescribing Cholinesterase Inhibitors in People Living with Dementia 为痴呆症患者共同设计胆碱酯酶抑制剂续用与停用的患者决策咨询辅助工具
IF 2.8 3区 医学
Drugs & Aging Pub Date : 2024-09-18 DOI: 10.1007/s40266-024-01146-5
Nagham J. Ailabouni, Wade Thompson, Sarah N. Hilmer, Lyntara Quirke, Janet McNeece, Alice Bourke, Chloe Furst, Emily Reeve
{"title":"Co-Designing a Consult Patient Decision Aid for Continuation Versus Deprescribing Cholinesterase Inhibitors in People Living with Dementia","authors":"Nagham J. Ailabouni, Wade Thompson, Sarah N. Hilmer, Lyntara Quirke, Janet McNeece, Alice Bourke, Chloe Furst, Emily Reeve","doi":"10.1007/s40266-024-01146-5","DOIUrl":"https://doi.org/10.1007/s40266-024-01146-5","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background and Objective</h3><p>As dementia progresses, people living with dementia may take high-risk, unnecessary, or ineffective medicines. Cholinesterase inhibitors (ChEIs) may have benefit in some people with dementia; however, up to one third are continued when no longer necessary or safe. Our aim was to co-design a consult patient decision aid (CPtDA) to support shared decision making between healthcare professionals and consumers about continuing or deprescribing ChEIs.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>A systematic process was employed to design and test the CPtDA prototype. First, a steering group composed of healthcare professionals and a consumer representative was assembled. Guided by the International Patient Decision Aids Standards, the steering group defined the CPtDA’s purpose, scope, and target audience and drafted the prototype for further testing. Interviews with consumers and healthcare professionals were conducted to gain feedback on the content, format, structure, comprehensibility and usability of the CPtDA prototype.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>After the steering group developed the CPtDA prototype, interviews were conducted with 11 consumers and six healthcare professionals. The content and format of the decision aid were improved iteratively over three rounds after consolidating the feedback at each round. The main changes included rewording the purpose of the decision aid and simplifying its layout and format. Participants reported that the decision aid is comprehensible and may be useful in practice.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>Limited available resources guide shared decision making about deprescribing. This study resulted in a co-designed and alpha-tested CPtDA for people living with dementia and carers to help them review the ongoing need for their ChEIs. Further research is needed to explore using the CPtDA in practice to support people living with dementia and their carers engage in the shared decision-making process about continuing or deprescribing their ChEIs. Our co-designed CPtDA could help people living with dementia and their carers review their goals of care alongside their healthcare professional. This may prompt conversations about appropriately using ChEIs and increase the uptake of deprescribing.</p>","PeriodicalId":11489,"journal":{"name":"Drugs & Aging","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142264679","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Oral Corticosteroids for Skin Disease in the Older Population: Minimizing Potential Adverse Effects 口服皮质类固醇治疗老年人皮肤病:尽量减少潜在的不良影响
IF 2.8 3区 医学
Drugs & Aging Pub Date : 2024-09-16 DOI: 10.1007/s40266-024-01143-8
Kennedy Sparling, Daniel C. Butler
{"title":"Oral Corticosteroids for Skin Disease in the Older Population: Minimizing Potential Adverse Effects","authors":"Kennedy Sparling, Daniel C. Butler","doi":"10.1007/s40266-024-01143-8","DOIUrl":"https://doi.org/10.1007/s40266-024-01143-8","url":null,"abstract":"<p>Corticosteroids play a crucial role as anti-inflammatory and immunomodulatory agents in dermatology and other medical specialties; however, their therapeutic benefits are accompanied by significant risks, especially in older adults. This review examines the broad spectrum of adverse effects (AEs) associated with oral corticosteroid therapy and offers strategies to prevent, monitor, and manage these issues effectively in older adults. AEs associated with systemic corticosteroids include immune suppression, gastrointestinal problems, hyperglycemia, insulin resistance, weight gain, cardiovascular complications, ocular issues, osteoporosis, osteonecrosis, muscle weakness, collagen impairment, psychiatric symptoms, and adrenal suppression. To minimize these AEs, tailored dosing and duration, frequent monitoring, and additional preventative measures can be employed to optimize corticosteroid treatment. By customizing management plans to the specific needs and risk factors associated with each patient, clinicians can promote the safe and effective use of oral corticosteroids, ultimately improving outcomes and quality of life in patients with inflammatory dermatologic disorders.</p>","PeriodicalId":11489,"journal":{"name":"Drugs & Aging","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142264677","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Trends in Drug Duplications in Swedish Older Adults: A Nationwide Register Study from 2006 to 2021 瑞典老年人重复用药的趋势:2006 年至 2021 年全国登记研究
IF 2.8 3区 医学
Drugs & Aging Pub Date : 2024-09-13 DOI: 10.1007/s40266-024-01145-6
Tatiana Erhan, Jonas W. Wastesson, Johan Fastbom
{"title":"Trends in Drug Duplications in Swedish Older Adults: A Nationwide Register Study from 2006 to 2021","authors":"Tatiana Erhan, Jonas W. Wastesson, Johan Fastbom","doi":"10.1007/s40266-024-01145-6","DOIUrl":"https://doi.org/10.1007/s40266-024-01145-6","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background</h3><p>Drug duplication (DD), the use of two identical drugs simultaneously, is a medication error increasing the risk of adverse drug events. We describe the trends and implicated drugs in potential DD in older adults in Sweden from 2006 to 2021.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>We conducted a register-based, repeated cross-sectional study of all older adults (aged ≥65 years) dispensed drugs at a community pharmacy in 2006–2021. DD was defined as a ≥30-day overlap of two dispensations of drugs with the same 5th level (chemical substance) Anatomical Therapeutic Chemical (ATC) classification, but with different brand names, within a 3-month period each year.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>Among Swedish older adults with ordinary prescriptions (i.e. multidose excluded; <i>n</i> ≈ 1,200,000–1,600,000 per year), the prevalence of potential DD increased from 5.2% to 10.6% in 65- to 79-year-olds and from 7.0% to 11.7% in those aged ≥80 years. The drug groups (ATC level 3; pharmacological subgroup) most frequently implicated in DD in 2006 were β-blocking agents, angiotensin-converting enzyme (ACE) inhibitors, and calcium channel blockers, and in 2021 Vitamin B12 and folic acid, β-blocking agents and angiotensin II receptor blockers.</p><h3 data-test=\"abstract-sub-heading\">Conclusions</h3><p>DD represents a common but unnecessary and potentially hazardous medication error. Our results indicate that during the last two decades, the prevalence has almost doubled in older adults with ordinary prescriptions, reaching 11% in 2021. More national efforts are needed to revert this trend, including a nationally available complete drug list for all patients, and prescriber support to detect DD.</p>","PeriodicalId":11489,"journal":{"name":"Drugs & Aging","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-09-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142178101","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Prospective Monitoring of New Drugs in Older Adults with and without Frailty: Near-Real-Time Assessment of Effectiveness and Safety of Oral Anticoagulants in Medicare Data 前瞻性监测有体弱和无体弱老年人的新药:医疗保险数据中口服抗凝药有效性和安全性的近实时评估
IF 2.8 3区 医学
Drugs & Aging Pub Date : 2024-09-11 DOI: 10.1007/s40266-024-01142-9
Darae Ko, Kueiyu Joshua Lin, Su Been Lee, Zhigang Lu, Susan Cheng, Sachin J. Shah, Robert J. Glynn, Dae Hyun Kim
{"title":"Prospective Monitoring of New Drugs in Older Adults with and without Frailty: Near-Real-Time Assessment of Effectiveness and Safety of Oral Anticoagulants in Medicare Data","authors":"Darae Ko, Kueiyu Joshua Lin, Su Been Lee, Zhigang Lu, Susan Cheng, Sachin J. Shah, Robert J. Glynn, Dae Hyun Kim","doi":"10.1007/s40266-024-01142-9","DOIUrl":"https://doi.org/10.1007/s40266-024-01142-9","url":null,"abstract":"<h3 data-test=\"abstract-sub-heading\">Background and Objective</h3><p>Prospective sequential analyses after a new drug approval allow proactive surveillance of new drugs. In the current study, we demonstrate feasibility of frailty-specific sequential analyses for dabigatran, rivaroxaban, and apixaban versus warfarin.</p><h3 data-test=\"abstract-sub-heading\">Methods</h3><p>We partitioned Medicare data from 2011 to 2020 into datasets based on calendar year following the date of drug approval. Each calendar year of data was added sequentially for analysis. We used a new-user, active comparative design by comparing the initiators of dabigatran versus warfarin, rivaroxaban versus warfarin, and apixaban versus warfarin. Patients aged ≥ 65 years with atrial fibrillation without contraindication to the anticoagulants were included. Claims-based frailty index ≥ 0.25 was used to define frailty. The initiators of each direct oral anticoagulant were propensity-score matched to the initiators of warfarin within each frailty status. The effectiveness outcome was ischemic stroke or systemic thromboembolism, and the safety outcome was major bleeding. For each calendar year, we estimated hazard ratios (HRs) and 95% confidence intervals (CIs) from Cox proportional hazards models using all data available up to that year.</p><h3 data-test=\"abstract-sub-heading\">Results</h3><p>As an example of the results, in the 2020 dataset, compared with warfarin, apixaban was associated with a reduced risk of ischemic stroke or systemic thromboembolism (frail: HR 0.73, 95% CI 0.63–0.85; non-frail: HR 0.65, 95% CI 0.59–0.72) and major bleeding (frail: HR 0.63, 95% CI 0.57–0.69; non-frail: HR 0.59, 95% CI 0.56–0.63) in both frail and non-frail patients. We found evidence for apixaban’s effectiveness and safety within 1–2 years after the drug approval in frail older patients.</p><h3 data-test=\"abstract-sub-heading\">Conclusion</h3><p>Our frailty-specific sequential analyses can be applied to future near-real-time monitoring of newly approved drugs.</p>","PeriodicalId":11489,"journal":{"name":"Drugs & Aging","volume":null,"pages":null},"PeriodicalIF":2.8,"publicationDate":"2024-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142223570","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Direct Oral Anticoagulants in Older and Frail Patients with Atrial Fibrillation: A Decade of Experience. 心房颤动年老体弱患者的直接口服抗凝剂:十年经验
IF 3.4 3区 医学
Drugs & Aging Pub Date : 2024-09-01 Epub Date: 2024-08-14 DOI: 10.1007/s40266-024-01138-5
Jocelyn R Spruit, Tim A C de Vries, Martin E W Hemels, Ron Pisters, Joris R de Groot, René W M M Jansen
{"title":"Direct Oral Anticoagulants in Older and Frail Patients with Atrial Fibrillation: A Decade of Experience.","authors":"Jocelyn R Spruit, Tim A C de Vries, Martin E W Hemels, Ron Pisters, Joris R de Groot, René W M M Jansen","doi":"10.1007/s40266-024-01138-5","DOIUrl":"10.1007/s40266-024-01138-5","url":null,"abstract":"<p><strong>Introduction: </strong>Both the prevalence of atrial fibrillation (AF) and its subsequent use of direct oral anticoagulants (DOACs) are rapidly increasing in patients of older age. In the absence of contra-indications, guidelines advocate anticoagulation based on the CHA2DS2-VASc score for all AF patients aged 75 and above. However, some practitioners are hesitant to prescribe anticoagulants to older and frail patients due to perceived elevated bleeding risks. This review delves into the comparative treatment outcomes of DOACs versus vitamin K antagonists (VKAs) in older patients with AF, particularly focusing on those of advanced age, frailty, increased risk of falling, chronic kidney disease (CKD), or with a history of major bleeding. Additionally, considerations on the use of off-label DOAC doses, the role of left atrial appendage (LAA) closure and future developments in factor XIa-inhibitors will be discussed.</p><p><strong>Results: </strong>While strong evidence supports the use of DOACs in the vital older patients with nonvalvular AF, it remains scant in frail patient groups. There is some evidence from non-randomized studies suggesting that the effect of DOACs compared with VKAs is consistent between frail and nonfrail patients. However, recent findings from a single randomized trial showed increased bleeding risks but comparable thromboembolic outcomes in frail individuals switching from VKAs to DOACs. In patients with an increased risk of falling, data suggest no relevant interaction of increased risk of falling on the effectiveness and safety of DOACs compared with warfarin. Resuming oral anticoagulants in patients with Af after major bleeding seems to be beneficial. Off-label low-dose DOAC is often prescribed to patients who were underrepresented in larger randomized trails because of an elevated risk of bleeding or overexposure to DOACs, but its effect on clinical outcomes remains uncertain.</p><p><strong>Conclusions: </strong>DOACs are the recommended oral anticoagulant for vital older patients with AF. The scarcity of data backing DOAC use in frail individuals, those with renal impairments, or significant bleeding history underscores the necessity for further investigation. However, existing evidence suggests at least similar effectiveness and safety and potential benefits for DOACs in these patient subsets. Therefore, there is no reason to suggest these patients should be treated differently than the established guidelines regarding anticoagulation.</p>","PeriodicalId":11489,"journal":{"name":"Drugs & Aging","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11408570/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141975346","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Correction: Treating Lower Urinary Tract Symptoms in Older Adults: Intravesical Options. 更正:治疗老年人的下尿路症状:膀胱内治疗方案
IF 3.4 3区 医学
Drugs & Aging Pub Date : 2024-09-01 DOI: 10.1007/s40266-024-01141-w
Anirban Ganguly, Shachi Tyagi, Christopher Chermansky, Anthony Kanai, Jonathan Beckel, Mamoru Hashimoto, Kang Jun Cho, Michael Chancellor, Jonathan Kaufman, Naoki Yoshimura, Pradeep Tyagi
{"title":"Correction: Treating Lower Urinary Tract Symptoms in Older Adults: Intravesical Options.","authors":"Anirban Ganguly, Shachi Tyagi, Christopher Chermansky, Anthony Kanai, Jonathan Beckel, Mamoru Hashimoto, Kang Jun Cho, Michael Chancellor, Jonathan Kaufman, Naoki Yoshimura, Pradeep Tyagi","doi":"10.1007/s40266-024-01141-w","DOIUrl":"10.1007/s40266-024-01141-w","url":null,"abstract":"","PeriodicalId":11489,"journal":{"name":"Drugs & Aging","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142105464","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Treating Hypercholesterolemia in Older Adults for Primary Prevention of Cardiovascular Events. 治疗老年人高胆固醇血症,实现心血管事件的一级预防。
IF 3.4 3区 医学
Drugs & Aging Pub Date : 2024-09-01 Epub Date: 2024-08-10 DOI: 10.1007/s40266-024-01139-4
Awsse Al-Ani, Yasser Jamil, Ariela R Orkaby
{"title":"Treating Hypercholesterolemia in Older Adults for Primary Prevention of Cardiovascular Events.","authors":"Awsse Al-Ani, Yasser Jamil, Ariela R Orkaby","doi":"10.1007/s40266-024-01139-4","DOIUrl":"10.1007/s40266-024-01139-4","url":null,"abstract":"<p><p>As the population ages, the demographic of adults aged 75 years and older in the U.S. is projected to grow to 45 million by 2050. Hypercholesterolemia is directly linked to atherosclerotic cardiovascular disease (ASCVD), which remains the leading cause of death in older adults. However, primary prevention of ASCVD through lipid-lowering agents remains unclear among older adults owing to limited involvement of older adults in current trials, lack of dedicated trials, and evidence primarily derived from secondary and retrospective analyses. Therefore, this article aims to (1) review key updates from the latest guidelines on treatment of hypercholesterolemia in older adults, (2) highlight limitations of the current ASCVD risk scores in the geriatric population, (3) present outcomes from key studies on the use of lipid-lowering agents and associated side effects, including a brief review of novel agents such as bempedoic acid, although very few adults over age 75 were included in these trial, and (4) finally, highlight upcoming dedicated trials of statins in older adults for the primary prevention of important geriatric outcomes as well as ASCVD.</p>","PeriodicalId":11489,"journal":{"name":"Drugs & Aging","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141912224","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trials. 利眠宁治疗老年人失眠的疗效和安全性:三项临床试验的分析。
IF 3.4 3区 医学
Drugs & Aging Pub Date : 2024-09-01 Epub Date: 2024-08-09 DOI: 10.1007/s40266-024-01135-8
Mark H Gotfried, Sanford H Auerbach, Thien Thanh Dang-Vu, Kazuo Mishima, Dinesh Kumar, Margaret Moline, Manoj Malhotra
{"title":"Efficacy and safety of insomnia treatment with lemborexant in older adults: analyses from three clinical trials.","authors":"Mark H Gotfried, Sanford H Auerbach, Thien Thanh Dang-Vu, Kazuo Mishima, Dinesh Kumar, Margaret Moline, Manoj Malhotra","doi":"10.1007/s40266-024-01135-8","DOIUrl":"10.1007/s40266-024-01135-8","url":null,"abstract":"<p><strong>Background: </strong>Insomnia is more common as people age. Several common hypnotics used to treat insomnia often do not adequately alleviate sleep issues in older adults and may be associated with negative residual effects such as an increased risk of falls, cognitive impairment, automobile accidents, and lack of response to auditory stimuli. The objective of these analyses of three clinical studies was to investigate the efficacy and safety of the dual orexin-receptor antagonist lemborexant (LEM) in older adults.</p><p><strong>Methods: </strong>Study E2006-G000-304 (Study 304; NCT02783729) was a randomized, double-blind, placebo (PBO)-controlled, active-comparator trial where subjects with insomnia disorder received LEM 5 mg (LEM5), LEM 10 mg (LEM10), zolpidem tartrate extended-release 6.25 mg (ZOL), or PBO for 30 days. In crossover Study E2006-E044-106 (Study 106; NCT02583451), healthy subjects (good sleepers) received LEM 2.5 mg, LEM5, LEM10, or PBO for eight nights or zopiclone on days 1 and 8 (and PBO on days 2-7). In crossover Study E2006-A001-108 (Study 108; NCT03008447), healthy subjects received a single dose of LEM5, LEM10, PBO, or ZOL. Sleep assessments included polysomnography-based latency to persistent sleep (LPS), wake after sleep onset (WASO), WASO in the second half of the night (WASO2H), sleep efficiency, postural stability, middle-of-the-night and next-day cognitive performance, middle-of-the-night auditory awakening threshold and return-to-sleep latency, and driving performance.</p><p><strong>Results: </strong>Overall, 453 of 1006 (45%; Study 304), 24 of 48 (50%; Study 106), and 28 of 56 (50%; Study 108) subjects were aged ≥ 65 years. In Study 304, LEM decreased (improved) LPS, WASO, and WASO2H from baseline more than ZOL and PBO; subjects treated with LEM had greater increases in sleep efficiency (improved) than with ZOL or PBO. In both Studies 304 and 108, postural stability was not impaired at waketime in subjects who received LEM compared with PBO. At waketime, LEM did not impair memory compared with PBO. In Study 108, following middle-of-the-night awakening, LEM and ZOL did not affect subjects' ability to awaken to auditory stimuli; LEM did not affect tests of memory and attention. In Study 106, LEM did not impair next-day driving performance in healthy elderly compared with PBO. LEM was well tolerated in subjects aged ≥ 65 years.</p><p><strong>Conclusions: </strong>LEM provided benefits on sleep variables without next-morning residual effects in subjects aged ≥ 65 years, supporting LEM as a treatment option for older adults with insomnia.</p><p><strong>Trial registration numbers and dates of registration: </strong>Study 304: ClinicalTrials.gov identifier, NCT02783729, date of registration, 26 May 2016. Study 106: ClinicalTrials.gov identifier, NCT02583451, date of registration, 22 October 2015. Study 108: ClinicalTrials.gov identifier, NCT03008447, date of registration, 2 January 2017.</p>","PeriodicalId":11489,"journal":{"name":"Drugs & Aging","volume":null,"pages":null},"PeriodicalIF":3.4,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11408585/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141906197","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Still's Disease Onset in Older Adults: Clinical Features, Diagnosis, and Management. 老年斯蒂尔病的发病:临床特征、诊断和处理。
IF 3.4 3区 医学
Drugs & Aging Pub Date : 2024-09-01 Epub Date: 2024-08-03 DOI: 10.1007/s40266-024-01137-6
Yoshifumi Tada, Akihito Maruyama, Yuri Shirahama
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