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EVALUATING TOUR006 IN PARTICIPANTS WITH CHRONIC KIDNEY DISEASE AND ELEVATED HS-CRP: RATIONALE AND DESIGN OF THE TRANQUILITY PHASE 2 STUDY 评估 Tour006 在患有慢性肾脏病和 Hs-CRP 升高的参与者中的应用:Tranquility 2 期研究的原理和设计
IF 4.3 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.ajpc.2024.100778
Emil DeGoma MD

Therapeutic Area

Pharmacologic Therapy

Background

Subgroups of patients with atherosclerotic cardiovascular disease (ASCVD) remain at very high risk of major adverse cardiovascular and limb events despite lifestyle modification and intensive pharmacological management including antiplatelet drugs, antihypertensive therapy, and LDL-lowering medications. Converging evidence from human genetic studies, prospective cohort studies, and mechanistic studies as well as results of canakinumab and colchicine cardiovascular outcome trials support the therapeutic potential of IL-6 pathway inhibition to lower the risk of ASCVD independent of traditional risk factors. TOUR006 is a fully human, high-affinity monoclonal antibody against the IL-6 cytokine. In prior Phase 1/2 studies, TOUR006 administered to patients with high-grade inflammatory autoimmune diseases such as rheumatoid arthritis, Crohn's disease, and systemic lupus erythematosus achieved rapid and durable reductions in C-reactive protein (CRP), the key downstream pharmacodynamic (PD) biomarker of IL-6 activity, as assessed by the high-sensitivity (hs) assay. A pharmacokinetic (PK)/PD model was developed from these data, and simulations in virtual patients showed significant reductions in hs-CRP with both monthly and quarterly dosing of TOUR006. The objective of this Phase 2 study is to characterize the hs-CRP-lowering effect, safety, tolerability, and PK of TOUR006 in patients with chronic kidney disease (CKD) and elevated hs-CRP. The CKD population was selected for this trial because of the high prevalence of elevated hs-CRP as well as evidence supporting a significant role of IL-6 pathway activation in driving ASCVD risk among patients with CKD.

Methods

TRANQUILITY is a Phase 2, randomized, double-blind, placebo-controlled, multicenter, US-based trial enrolling approximately 120 patients with CKD stage 3 or 4 and hs-CRP≥2 and <15 mg/L. Participants will be stratified by CKD stage and randomized to subcutaneous TOUR006 50 mg quarterly, 25 mg quarterly, 15 mg monthly, or placebo (Figure). The primary PD endpoint is change in hs-CRP; additional biomarkers include IL-6, lipoprotein(a), oxidized LDL, and fibrinogen. Treatment and follow-up periods are 180 days and 185 days, respectively.

Conclusions

TRANQUILITY, an ongoing trial with anticipated primary completion in May 2025, will assess the safety, tolerability, PK, and hs-CRP-lowering effect of TOUR006 and inform the dosing regimen and design of future Phase 3 cardiovascular studies in high-risk patients.
治疗领域药物疗法背景尽管改变了生活方式并进行了强化药物治疗(包括抗血小板药物、降压治疗和降低低密度脂蛋白药物),但动脉粥样硬化性心血管疾病(ASCVD)亚群患者发生重大不良心血管和肢体事件的风险仍然很高。来自人类基因研究、前瞻性队列研究、机理研究以及卡纳金单抗和秋水仙碱心血管病结果试验的综合证据都支持抑制 IL-6 通路的治疗潜力,它可以降低 ASCVD 风险,而不受传统风险因素的影响。TOUR006 是一种针对 IL-6 细胞因子的全人源高亲和性单克隆抗体。在之前的1/2期研究中,类风湿性关节炎、克罗恩病和系统性红斑狼疮等高度炎症性自身免疫疾病患者服用TOUR006后,C反应蛋白(CRP)迅速而持久地下降,CRP是IL-6活性的关键下游药效学(PD)生物标志物,由高灵敏度(hs)测定法评估。根据这些数据建立的药代动力学(PK)/药效学(PD)模型,在虚拟患者中进行的模拟显示,每月和每季度服用 TOUR006 均能显著降低 hs-CRP。这项2期研究的目的是鉴定TOUR006对慢性肾病(CKD)和hs-CRP升高患者的降低hs-CRP效果、安全性、耐受性和PK。TRANQUILITY是一项2期、随机、双盲、安慰剂对照、多中心、美国试验,共招募了约120名CKD 3期或4期、hs-CRP≥2和15 mg/L的患者。参与者将按 CKD 分期进行分层,并随机接受皮下注射 TOUR006 50 毫克(每季度一次)、25 毫克(每季度一次)、15 毫克(每月一次)或安慰剂(图)。主要PD终点是hs-CRP的变化;其他生物标志物包括IL-6、脂蛋白(a)、氧化低密度脂蛋白和纤维蛋白原。结论TRANQUILITY是一项正在进行的试验,预计将于2025年5月完成主要试验,它将评估TOUR006的安全性、耐受性、PK和降低hs-CRP的效果,并为未来在高风险患者中开展的心血管3期研究提供剂量方案和设计依据。
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引用次数: 0
ASPCCongress2025_SaveTheDate ASPCCongress2025_SaveTheDate
IF 4.3 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/S2666-6677(24)00232-0
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引用次数: 0
ANGIOGRAPHIC FINDINGS IN SYMPTOMATIC PATIENTS WITH EVIDENCE OF ISCHEMIA BY PET/CT PERFUSION IMAGING BUT WITH ZERO CORONARY ARTERY CALCIUM PET/CT 灌注成像显示缺血但冠状动脉钙化程度为零的无症状患者的血管造影结果
IF 4.3 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.ajpc.2024.100817
Leslie Iverson PA-C

Therapeutic Area

ASCVD/CVD Risk Assessment

Background

Coronary artery calcium (CAC) is a strong, incremental predictor of coronary artery disease (CAD) risk. In contrast, the absence of CAC portends a low but not zero risk, which has been ascribed to non-calcified, “soft” plaques. However, other pathologies in CAC=0 patients (pts) are possible, including spontaneous coronary artery dissection, microvascular disease, coronary anomalies, etc. We sought to determine the spectrum and frequency of angiographic findings in symptomatic pts with ischemia on stress PET/CT who had zero CAC.

Methods

The Intermountain nuclear medicine and hospital electronic medical record databases were searched for CAC=0 pts undergoing stress positron emission tomography (PET/CT) between 2/1/2014 and 7/1/2022. We defined PET abnormality with ischemic burden (IB) >=10% as definite, IB >0<10% as equivocal, and IB=0 as normal. We defined severe and moderate CAD as >=70% and 50-69% stenosis, respectively. Pts were followed for coronary interventions and major adverse cardiovascular events (MACE) over 1.1 +/- 0.9 y.

Results

Of 59,639 total PET/CT studies, 4284 (7.2%) had CAC=0 and no prior history of CAD. Of these, 28 with adequate quality PET (0.65%) had IB >=10% (NPV 99.3%). Table 1 summarizes demographics across IB categories. Coronary angiography (n=21) or coronary CT angiography (n=5) was performed within <90 days in 25 (89%) of IB>=10% pts (Table 2). Severe CAD was present in 11, moderate in 1, mild in 4, and none in 9. Thus, 14 (56%) with positive PET (IB>=10%) of 25 angiographic cases were not explained by severe CAD, suggesting possible microvascular dysfunction. Revascularization was indicated in only 10 (PCI in 6, CABG in 4) of the 28 IB>=10% pts (35.7% of IB>=10%, 0.23% of CAC=0 pts); follow-up MACE occurred in 2 (7%) with IB>=10% (repeat revascularizations) vs 1.6% of others (p=NS).

Conclusions

In this large stress PET/CT experience, IB >=10% in pts with CAC=0 was rare. The majority were not explained by obstructive CAD. However, given the rare possibility of severe CAD or other pathologies, such as microvascular angina, a zero CAC score should be interpreted in the context of clinical judgement in deciding whether to proceed with additional testing such as stress PET.
治疗领域心血管疾病/心血管疾病风险评估背景冠状动脉钙化(CAC)是预测冠状动脉疾病(CAD)风险的强有力的增量指标。相反,没有 CAC 则预示着低风险,但并非零风险,这被归因于未钙化的 "软 "斑块。然而,CAC=0 患者(pts)也可能存在其他病变,包括自发性冠状动脉夹层、微血管疾病、冠状动脉异常等。我们试图确定应激正电子发射断层扫描(PET/CT)发现缺血且 CAC 为零的无症状患者血管造影结果的范围和频率。方法在 Intermountain 核医学和医院电子病历数据库中搜索了 2014 年 1 月 2 日至 2022 年 1 月 7 日期间接受应激正电子发射断层扫描(PET/CT)的 CAC=0 患者。我们将正电子发射断层扫描异常中的缺血负荷(IB)>=10%定义为明确,IB>0<10%定义为等效,IB=0定义为正常。我们将重度和中度 CAD 分别定义为>=70%和 50-69%的狭窄。结果 在总共 59639 例 PET/CT 研究中,有 4284 例(7.2%)CAC=0,既往无 CAD 病史。其中,28 例(0.65%)具有足够质量的 PET,IB >=10%(NPV 99.3%)。表 1 总结了不同 IB 类别的人口统计学特征。25例(89%)IB>=10%的患者在<90天内进行了冠状动脉造影(21例)或冠状动脉CT造影(5例)(表2)。11例存在严重CAD,1例中度,4例轻度,9例无。因此,在 25 例血管造影病例中,有 14 例(56%)PET 阳性(IB>=10%)不能解释为重度 CAD,这表明可能存在微血管功能障碍。在 28 例 IB>=10% 的病例中,只有 10 例(6 例行 PCI,4 例行 CABG)需要进行血管重建(35.7% 的 IB>=10% 病例,0.23% 的 CAC=0 病例);2 例(7%)IB>=10%(重复血管重建)与 1.6% 的其他病例(P=NS)相比,发生了随访 MACE。大多数病例无法用阻塞性 CAD 来解释。然而,考虑到严重的 CAD 或其他病变(如微血管性心绞痛)的罕见可能性,CAC 分数为 0 时应结合临床判断来解释,以决定是否进行压力 PET 等其他检查。
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引用次数: 0
PIECING THE PUZZLE TOGETHER WHEN FAMILY HISTORY IS UNKNOWN: EARLY DIAGNOSIS AND MANAGEMENT OF A PATIENT WITH FAMILIAL HYPERCHOLESTEROLEMIA 家族史不明时的拼图游戏:家族性高胆固醇血症患者的早期诊断和管理
IF 4.3 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.ajpc.2024.100755
Lavanya Garnepudi MD

Therapeutic Area

CVD Prevention – Primary and Secondary

Case Presentation

A 43-year-old male presented to our primary care clinic to establish care. He was in his usual state of health, endorsed a balanced diet and daily exercise. His family history was unknown as he was adopted. Vital signs were normal, and the physical exam was unremarkable. A routine lipid profile revealed a total cholesterol level of 391 mg/dL, LDL-C level of 251 md/dL, HDL-C level of 57 mg/dL, and triglyceride level of 56 mg/dL. Given abnormally elevated LDL-C levels in a patient who otherwise had no known risk factors, an FH screening panel was ordered. The patient was also started on 40 mg atorvastatin daily and referred to the lipid clinic where he was diagnosed with FH using the Dutch Lipid Clinic Diagnostic Criteria (5 points: LDL- C between 250- 325 mg/dL+ 8 points: functional genetic mutation).

Background

Familial Hypercholesterolemia (FH) is a genetic disease that contributes to an increased risk for coronary artery disease, MI, and sudden cardiac death. Although awareness surrounding FH is increasing, this condition remains underdiagnosed and undertreated. In most countries, less than 20% of prevalent cases are diagnosed, and even less patients are aware of their condition, often not until after the first ASCVD event. Literature shows that underdiagnosis is multifactorial, including lack of awareness of the disorder, a lack of international consensus on which diagnostic criteria is superior, and minimal comfort with treating patients with intensive therapy.

Conclusions

Family health history is crucial to disease prevention though physicians often lack time and patients can lack information (as in this case). Genetic testing is the future of preventive medicine but remains underutilized in the primary care setting3. There has historically been uncertainty surrounding insurance coverage of genetic testing and the financial implications for patients. Collaborative efforts among primary care providers, genetics departments, lipid clinics, and insurers are essential to recognize the full potential of genetic testing while ensuring equitable access and affordability to all patients. This case highlights the importance of early identification, treatment, and referral of FH patients who would otherwise be missed given their asymptomatic status and unknown family history.
治疗领域心血管疾病预防--初级和中级病例介绍一名 43 岁的男性来到我们的初级保健诊所寻求治疗。他平时身体健康,饮食均衡,每天坚持锻炼。他的家族史不详,因为他是被领养的。生命体征正常,体格检查无异常。常规血脂检查显示,总胆固醇水平为 391 mg/dL,低密度脂蛋白胆固醇水平为 251 md/dL,高密度脂蛋白胆固醇水平为 57 mg/dL,甘油三酯水平为 56 mg/dL。鉴于患者的低密度脂蛋白胆固醇水平异常升高,而患者又没有已知的风险因素,因此医生要求其接受 FH 筛查。患者开始每天服用 40 毫克阿托伐他汀,并被转诊至血脂诊所,根据荷兰血脂诊所的诊断标准(5 点:背景家族性高胆固醇血症(FH)是一种遗传性疾病,会导致冠心病、心肌梗死和心脏性猝死的风险增加。尽管人们对家族性高胆固醇血症的认识在不断提高,但这种疾病的诊断和治疗仍然不足。在大多数国家,只有不到 20% 的流行病例被确诊,而意识到自己病情的患者则更少,他们往往在首次发生 ASCVD 事件后才意识到自己的病情。文献显示,诊断不足是多因素造成的,包括缺乏对该疾病的认识、对哪种诊断标准更优缺乏国际共识,以及对患者进行强化治疗的舒适度极低。基因检测是预防医学的未来,但在初级医疗机构中仍未得到充分利用3。基因检测的保险范围和对患者的经济影响一直存在不确定性。全科医疗服务提供者、遗传学部门、血脂诊所和保险公司之间的合作对于充分认识基因检测的潜力,同时确保所有患者都能公平地获得并负担得起基因检测费用至关重要。本病例强调了早期识别、治疗和转诊 FH 患者的重要性,否则这些患者会因无症状和家族史不明而被漏诊。
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引用次数: 0
TARGETING CUTANEOUS IMMUNE RESPONSES FOR CARDIOVASCULAR DISEASE PREVENTION AND THERAPY 针对皮肤免疫反应,预防和治疗心血管疾病
IF 4.3 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.ajpc.2024.100742
Kelly Frasier DO, MS
<div><h3>Therapeutic Area</h3><div>Other</div></div><div><h3>Background</h3><div>The intricate interplay between the skin immune system and cardiovascular health has emerged as a compelling area of investigation with profound implications for preventive and therapeutic strategies in cardiovascular diseases (CVDs). While traditional risk factors such as hypertension and dyslipidemia have long been recognized as contributors to CVD development, recent literature underscores the pivotal role of immune-mediated mechanisms, particularly those involving the skin, in cardiovascular pathophysiology. This review aims to analyze the current understanding of how cutaneous immune modulation influences cardiovascular health, exploring potential therapeutic interventions and highlighting avenues for future research. By furthering our understanding of the complex relationship between the skin immune system and CVDs, this review seeks to bridge the gap between dermatology and cardiology, offering insights that could revolutionize approaches to CVD prevention and therapy.</div></div><div><h3>Methods</h3><div>This literature review systematically examined existing research on the interplay between the skin immune system and cardiovascular health to study potential preventive and therapeutic strategies for cardiovascular diseases (CVDs). Relevant articles were identified through comprehensive searches of electronic databases including PubMed and Google Scholar, using keywords such as "skin immune system," "cardiovascular health," "atherosclerosis," "psoriasis," "atopic dermatitis," and "immunomodulatory therapy." Articles published in peer-reviewed journals up to the present date were included, with a focus on original research articles, review papers, and meta-analyses. Additionally, reference lists of retrieved articles were manually searched to identify additional relevant studies. Data extraction involved summarizing key findings related to the role of cutaneous immune modulation in cardiovascular pathophysiology, potential mechanisms linking skin immunity to CVD risk, therapeutic interventions targeting the skin immune system, and areas for future research. The synthesis of findings was organized thematically to provide a comprehensive overview of the current understanding of the topic.</div></div><div><h3>Results</h3><div>The review revealed a substantial body of literature highlighting the intricate relationship between the skin immune system and cardiovascular health. Studies consistently demonstrated the involvement of immune-mediated mechanisms in the pathogenesis of cardiovascular diseases, with particular emphasis on inflammation and immune cell activation. Notably, inflammatory pathways within the vessel wall, driven by cytokines such as interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha), were implicated in endothelial dysfunction and atherosclerosis development. Moreover, the skin immune system was found to play a significant role in mod
治疗领域其他背景皮肤免疫系统与心血管健康之间错综复杂的相互作用已成为一个引人注目的研究领域,对心血管疾病(CVD)的预防和治疗策略具有深远的影响。虽然高血压和血脂异常等传统风险因素早已被认为是心血管疾病的诱因,但最近的文献强调了免疫介导机制,尤其是涉及皮肤的免疫介导机制在心血管病理生理学中的关键作用。本综述旨在分析目前对皮肤免疫调节如何影响心血管健康的理解,探讨潜在的治疗干预措施,并强调未来研究的途径。通过进一步了解皮肤免疫系统与心血管疾病之间的复杂关系,本综述力图在皮肤病学和心脏病学之间架起一座桥梁,提供可能彻底改变心血管疾病预防和治疗方法的见解。方法本文献综述系统地考察了有关皮肤免疫系统与心血管健康之间相互作用的现有研究,以研究心血管疾病(CVDs)的潜在预防和治疗策略。通过对包括 PubMed 和 Google Scholar 在内的电子数据库进行全面检索,并使用 "皮肤免疫系统"、"心血管健康"、"动脉粥样硬化"、"银屑病"、"特应性皮炎 "和 "免疫调节疗法 "等关键词,确定了相关文章。收录了截至目前在同行评审期刊上发表的文章,重点是原创研究文章、综述论文和荟萃分析。此外,还对检索到的文章的参考文献列表进行了人工搜索,以确定更多相关研究。数据提取包括总结以下方面的主要发现:皮肤免疫调节在心血管病理生理学中的作用、皮肤免疫与心血管疾病风险的潜在关联机制、针对皮肤免疫系统的治疗干预措施以及未来研究领域。研究结果的综述按主题进行组织,以全面概述目前对该主题的理解。研究一致表明,免疫介导的机制参与了心血管疾病的发病机制,其中特别强调了炎症和免疫细胞活化。值得注意的是,在白细胞介素-6(IL-6)和肿瘤坏死因子-α(TNF-α)等细胞因子的驱动下,血管壁内的炎症通路与内皮功能障碍和动脉粥样硬化的发展有关。此外,研究还发现皮肤免疫系统在调节全身炎症和心血管风险方面发挥着重要作用,银屑病和特应性皮炎等疾病与心血管疾病发病率增加有关。机理研究表明,皮肤免疫反应可通过释放促炎介质、皮肤微生物群失调以及皮肤驻留免疫细胞和循环免疫细胞之间的相互作用影响心血管健康。在治疗方面,针对皮肤炎症和免疫失调的干预措施,包括生物制剂和微生物靶向方法,在减轻心血管风险方面显示出前景。总之,将皮肤免疫调节与心血管健康联系起来的新证据强调了将皮肤免疫作为心血管疾病预防和治疗干预潜在目标的重要性。虽然初步研究已显示出良好的结果,但还需要进一步的研究来解释其潜在机制,并验证针对皮肤的免疫调节疗法在临床环境中的疗效。通过弥合皮肤病学和心脏病学之间的差距并利用皮肤免疫学的见解,我们可以开发出降低心血管风险和改善患者预后的创新方法。最终,将皮肤免疫调节纳入心血管疾病管理策略有望彻底改变预防心脏病学,并提高心血管疾病高危人群的治疗质量。
{"title":"TARGETING CUTANEOUS IMMUNE RESPONSES FOR CARDIOVASCULAR DISEASE PREVENTION AND THERAPY","authors":"Kelly Frasier DO, MS","doi":"10.1016/j.ajpc.2024.100742","DOIUrl":"10.1016/j.ajpc.2024.100742","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Therapeutic Area&lt;/h3&gt;&lt;div&gt;Other&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;The intricate interplay between the skin immune system and cardiovascular health has emerged as a compelling area of investigation with profound implications for preventive and therapeutic strategies in cardiovascular diseases (CVDs). While traditional risk factors such as hypertension and dyslipidemia have long been recognized as contributors to CVD development, recent literature underscores the pivotal role of immune-mediated mechanisms, particularly those involving the skin, in cardiovascular pathophysiology. This review aims to analyze the current understanding of how cutaneous immune modulation influences cardiovascular health, exploring potential therapeutic interventions and highlighting avenues for future research. By furthering our understanding of the complex relationship between the skin immune system and CVDs, this review seeks to bridge the gap between dermatology and cardiology, offering insights that could revolutionize approaches to CVD prevention and therapy.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Methods&lt;/h3&gt;&lt;div&gt;This literature review systematically examined existing research on the interplay between the skin immune system and cardiovascular health to study potential preventive and therapeutic strategies for cardiovascular diseases (CVDs). Relevant articles were identified through comprehensive searches of electronic databases including PubMed and Google Scholar, using keywords such as \"skin immune system,\" \"cardiovascular health,\" \"atherosclerosis,\" \"psoriasis,\" \"atopic dermatitis,\" and \"immunomodulatory therapy.\" Articles published in peer-reviewed journals up to the present date were included, with a focus on original research articles, review papers, and meta-analyses. Additionally, reference lists of retrieved articles were manually searched to identify additional relevant studies. Data extraction involved summarizing key findings related to the role of cutaneous immune modulation in cardiovascular pathophysiology, potential mechanisms linking skin immunity to CVD risk, therapeutic interventions targeting the skin immune system, and areas for future research. The synthesis of findings was organized thematically to provide a comprehensive overview of the current understanding of the topic.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;The review revealed a substantial body of literature highlighting the intricate relationship between the skin immune system and cardiovascular health. Studies consistently demonstrated the involvement of immune-mediated mechanisms in the pathogenesis of cardiovascular diseases, with particular emphasis on inflammation and immune cell activation. Notably, inflammatory pathways within the vessel wall, driven by cytokines such as interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-alpha), were implicated in endothelial dysfunction and atherosclerosis development. Moreover, the skin immune system was found to play a significant role in mod","PeriodicalId":72173,"journal":{"name":"American journal of preventive cardiology","volume":"19 ","pages":"Article 100742"},"PeriodicalIF":4.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142422747","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}
引用次数: 0
COMPARISON OF AMBULATORY BLOOD PRESSURE MONITORING IN PATIENTS WITH AUTONOMIC DYSFUNCTION VS PATIENTS WITHOUT AUTONOMIC DYSFUNCTION 自律神经功能紊乱患者与无自律神经功能紊乱患者的动态血压监测比较
IF 4.3 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.ajpc.2024.100784
Megan Bach DO

Therapeutic Area

Preventive Cardiology Best Practices – clinic operations, team approaches, outcomes research

Background

Blood pressure (BP) patterns in patients with autonomic dysfunction (AD), particularly those with postural orthostatic tachycardia syndrome (POTS), remain an area of limited understanding. Utility in ambulatory blood pressure monitoring (ABPM) among patients with various forms of AD compared to patients without a diagnosis of AD remains unknown.

Methods

Patients referred for ABPM between 1/2019 and 7/2023 for a diagnosis AD with POTS, AD / Orthostatic Intolerance (OI) without POTS, or no AD were reviewed. Patient characteristics and ABPM data were analyzed. Statistical analysis was completed through test of trends. The primary outcome was to compare the incidence of uncontrolled 24-hour BP between patients with AD with POTS to those with AD/OI but without POTS and to those without AD. As a secondary outcome, nocturnal dipping status was assessed.

Results

A total of 243 patients were assessed and 62 (25.5%) had a diagnosis of AD, of which 37 (15.2%) had a diagnosis of POTS. Patients with POTS were predominantly female, younger, and of white ethnicity (Table). ABPM data revealed that 81% of patients with POTS and 73% of patients without AD maintained controlled BP over 24 hours, in contrast to just 24% of those with AD/OI but without POTS (p < 0.001). The mean 24-hour SBP for patients with AD with POTS (117.7 mmHg) and patients without AD (131.3 mmHg) were within normal values, in contrast to the 137.1 mmHg observed in those with AD/OI without POTS (p < 0.001). Abnormal dipping status was prevalent in 51% of the AD with POTS cohort, 68% of the AD/OI without POTS cohort, and 56% of the without AD cohort. Nocturnal non-dipping was prevalent in 46% of the AD with POTS cohort, 36% of the AD/OI without POTS cohort, and 37% of the without AD cohort.

Conclusions

Most patients with AD with POTS, and those without AD, demonstrate normal 24-hour BP readings on ABPM. However, ABPM detected a high incidence of uncontrolled 24-hr BP readings in patients with AD or Orthostatic Intolerance without POTS, prompting discussion of valuable utility of this test in this cohort.
治疗领域预防心脏病学最佳实践--诊所运营、团队方法、结果研究背景自律神经功能障碍(AD)患者,尤其是体位性正位性心动过速综合征(POTS)患者的血压(BP)模式仍然是人们了解有限的领域。方法对2019年1月1日至2023年7月7日期间因诊断为AD伴POTS、AD/Orthostatic Intolerance (OI)不伴POTS或无AD而转诊进行ABPM的患者进行回顾性分析。对患者特征和 ABPM 数据进行了分析。通过趋势检验完成了统计分析。主要结果是比较伴有 POTS 的 AD 患者与伴有 AD/OI 但无 POTS 的患者以及无 AD 患者之间 24 小时血压失控的发生率。结果 共对 243 名患者进行了评估,62 人(25.5%)确诊为 AD,其中 37 人(15.2%)确诊为 POTS。POTS 患者主要为女性、年轻人和白人(见表)。ABPM 数据显示,81% 的 POTS 患者和 73% 的无 AD 患者在 24 小时内保持血压受控,而在有 AD/OI 但无 POTS 的患者中,仅有 24% 的患者保持血压受控(p < 0.001)。伴有POTS的AD患者(117.7 mmHg)和无AD患者(131.3 mmHg)的24小时平均SBP均在正常值范围内,而无POTS的AD/OI患者为137.1 mmHg(p <0.001)。在有 POTS 的注意力缺失症患者队列中,51% 的人存在异常滂沱状况;在无 POTS 的注意力缺失症/注意力缺失症患者队列中,68% 的人存在异常滂沱状况;在无注意力缺失症患者队列中,56% 的人存在异常滂沱状况。46%的 AD POTS 患者、36% 的 AD/OI 无 POTS 患者和 37% 的无 AD 患者夜间不跳血。然而,ABPM在患有AD或无POTS的直立性不耐受患者中检测到的不受控制的24小时血压读数发生率很高,这促使人们讨论该检测在这一人群中的实用价值。
{"title":"COMPARISON OF AMBULATORY BLOOD PRESSURE MONITORING IN PATIENTS WITH AUTONOMIC DYSFUNCTION VS PATIENTS WITHOUT AUTONOMIC DYSFUNCTION","authors":"Megan Bach DO","doi":"10.1016/j.ajpc.2024.100784","DOIUrl":"10.1016/j.ajpc.2024.100784","url":null,"abstract":"<div><h3>Therapeutic Area</h3><div>Preventive Cardiology Best Practices – clinic operations, team approaches, outcomes research</div></div><div><h3>Background</h3><div>Blood pressure (BP) patterns in patients with autonomic dysfunction (AD), particularly those with postural orthostatic tachycardia syndrome (POTS), remain an area of limited understanding. Utility in ambulatory blood pressure monitoring (ABPM) among patients with various forms of AD compared to patients without a diagnosis of AD remains unknown.</div></div><div><h3>Methods</h3><div>Patients referred for ABPM between 1/2019 and 7/2023 for a diagnosis AD with POTS, AD / Orthostatic Intolerance (OI) without POTS, or no AD were reviewed. Patient characteristics and ABPM data were analyzed. Statistical analysis was completed through test of trends. The primary outcome was to compare the incidence of uncontrolled 24-hour BP between patients with AD with POTS to those with AD/OI but without POTS and to those without AD. As a secondary outcome, nocturnal dipping status was assessed.</div></div><div><h3>Results</h3><div>A total of 243 patients were assessed and 62 (25.5%) had a diagnosis of AD, of which 37 (15.2%) had a diagnosis of POTS. Patients with POTS were predominantly female, younger, and of white ethnicity (Table). ABPM data revealed that 81% of patients with POTS and 73% of patients without AD maintained controlled BP over 24 hours, in contrast to just 24% of those with AD/OI but without POTS (p &lt; 0.001). The mean 24-hour SBP for patients with AD with POTS (117.7 mmHg) and patients without AD (131.3 mmHg) were within normal values, in contrast to the 137.1 mmHg observed in those with AD/OI without POTS (p &lt; 0.001). Abnormal dipping status was prevalent in 51% of the AD with POTS cohort, 68% of the AD/OI without POTS cohort, and 56% of the without AD cohort. Nocturnal non-dipping was prevalent in 46% of the AD with POTS cohort, 36% of the AD/OI without POTS cohort, and 37% of the without AD cohort.</div></div><div><h3>Conclusions</h3><div>Most patients with AD with POTS, and those without AD, demonstrate normal 24-hour BP readings on ABPM. However, ABPM detected a high incidence of uncontrolled 24-hr BP readings in patients with AD or Orthostatic Intolerance without POTS, prompting discussion of valuable utility of this test in this cohort.</div></div>","PeriodicalId":72173,"journal":{"name":"American journal of preventive cardiology","volume":"19 ","pages":"Article 100784"},"PeriodicalIF":4.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142422822","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}
引用次数: 0
AWARENESS AND REFERRAL RATES OF CARDIAC REHABILITATION AMONG INTERNAL MEDICINE RESIDENTS IN A COMMUNITY SETTING: A MULTICENTER ANALYSIS 社区环境中内科住院医师对心脏康复的认识和转诊率:多中心分析
IF 4.3 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.ajpc.2024.100774
Harsha Sai Sreemantula MD

Therapeutic Area

Rehabilitation

Background

In the United States, The Centers for Medicare & Medicaid Services and most insurers authorize coverage for Cardiac Rehabilitation (CR) services for patients with stable chronic HF with LVEF ≤35% and NYHA functional class II to IV symptoms despite six weeks of treatment with optimal HF therapy. CR has a Class 1 Recommendation in the current American College of Cardiology/American Heart Association guideline for managing HF. Community hospitals deal with most of the above two indications, and little data exists about the referral processes in such places.

Methods

A questionnaire regarding cardiac rehabilitation, inquiring about internal medicine residents' awareness of indications, components, outcomes, and referral practices, was sent to 5 different community-based institutions. The information was collected anonymously and later analyzed in statistical software.

Results

Out of 136 residents, there was more or less equal distribution among the 3 PGY years, with the majority responding of having a cardiac catheterization lab and acknowledging recurrent heart failure admissions to their institutions. Varied responses were received regarding cardiac rehab availability at respective institutions. Surprisingly, despite somewhat adequate knowledge regarding cardiac rehabilitation's indications, components, and outcomes, only 28.68 % acknowledged routine CR referral. Referral rates increased with increasing training years. Further trends are seen in Table 1, Table 2, and Table 3.

Conclusions

Despite numerous studies highlighting the importance of physician referrals for cardiac rehabilitation enrollment, there is limited data on internal medicine residents' knowledge and referral practices. This is pivotal as they often manage a significant portion of patients with acute coronary syndromes and heart failure exacerbations in a community setting. Further research is needed to uncover disparities and improve cardiac rehabilitation utilization in community-based healthcare settings.
治疗领域康复背景在美国,对于 LVEF≤35% 且 NYHA 功能分级为 II 至 IV 级的稳定型慢性心房颤动患者,尽管已接受六周的最佳心房颤动治疗,但 NYHA 功能分级仍为 II 至 IV 级,美国联邦医疗保险和医疗补助服务中心以及大多数保险公司均授权承保心脏康复 (CR) 服务。CR 在当前的美国心脏病学会/美国心脏协会心房颤动管理指南中被列为一级推荐项目。方法:我们向 5 家不同的社区机构发送了一份有关心脏康复的调查问卷,询问内科住院医师对心脏康复的适应症、组成部分、结果和转诊做法的认识。结果 在 136 名住院医师中,3 个 PGY 年级的住院医师人数分布大致相同,大多数住院医师回答拥有心导管室,并承认其所在机构经常收治心力衰竭患者。关于各医疗机构是否有心脏康复中心,得到的答复各不相同。令人惊讶的是,尽管对心脏康复的适应症、组成部分和结果有了一定程度的了解,但只有 28.68% 的人承认常规的心脏康复转诊。转诊率随着培训年限的增加而增加。表 1、表 2 和表 3 显示了进一步的趋势。结论尽管许多研究强调了医生转诊对心脏康复注册的重要性,但有关内科住院医师的知识和转诊实践的数据却很有限。这一点至关重要,因为在社区环境中,内科住院医师通常负责管理大部分急性冠状动脉综合征和心衰加重的患者。需要进一步开展研究,以发现差异并提高社区医疗机构中心脏康复的利用率。
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引用次数: 0
PEGOZAFERMIN DEMONSTRATED ROBUST HISTOLOGIC IMPROVEMENT AND BENEFIT IN HEPATIC AND METABOLIC BIOMARKERS IN A 48-WEEK MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2B TRIAL (ENLIVEN) 在一项为期 48 周的多中心、随机、双盲、安慰剂对照 2b 期试验(enliven)中,pegozafermin 显示出明显的组织学改善以及肝脏和代谢生物标志物方面的优势
IF 4.3 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.ajpc.2024.100807
Cynthia L. Hartsfield PhD

Therapeutic Area

Pharmacologic Therapy

Background

Metabolic dysfunction-associated steatohepatitis (MASH) is often associated with metabolic disorders such as obesity, metabolic syndrome, and/or diabetes. FGF21 analogs such as pegozafermin (PGZ) have direct effects on liver fibrosis as well as additional hepatic and extrahepatic benefits in patients with MASH. The Phase 2b ENLIVEN trial evaluated the efficacy and safety of PGZ given weekly (QW) or every two-weeks (Q2W) versus placebo in MASH patients with biopsy-proven F2/F3 fibrosis. The primary histology endpoints were assessed at week 24, followed by a 24-week blinded extension for a total of 48 weeks.

Methods

Patients were randomized to PGZ 15mg QW, 30mg QW, or 44mg Q2W or placebo for 24-weeks (histology-based primary endpoints). During the 24-week extension, patients continued their assigned treatment except for a subset of placebo patients who were re-randomized to receive PGZ 30mg QW. The full analysis set includes F2/F3 patients with NAFLD activity score (NAS) ≥4 at baseline (n=192).

Results

Both primary histological endpoints considered as reasonably likely surrogates of clinical outcome benefit - at least one stage of fibrosis improvement without worsening of MASH and MASH resolution without worsening of fibrosis - were achieved by a significantly higher proportion of patients treated with PGZ 30mg QW or 44 mg Q2W than placebo. PGZ treatment also improved liver fat content (MRI-PDFF), biomarkers of fibrosis (VCTE, ELF, PRO-C3) and liver injury (ALT, AST) as well as lipids and HgA1c at both 24 weeks and week 48. PGZ was generally safe and well tolerated with the most common treatment emergent adverse events (TEAEs) being mild/moderate nausea and diarrhea. No deaths occurred; six early terminations for TEAEs including one drug-related serious AE occurred.

Conclusions

Treatment with PGZ in MASH patients with F2/F3 fibrosis led to highly significant fibrosis regression and MASH resolution and to robust and sustained improvements in non-invasive biomarkers of liver fat and inflammation, fibrosis, and metabolic markers, with a favorable safety and tolerability profile. PGZ is the first therapy to achieve fibrosis regression and MASH resolution with a Q2W dosing regimen. The confirmatory Phase 3 program in MASH was recently initiated.
Please note that ENLIVEN 28-week data were presented at EASL 2023 and ENLIVEN 48-week data are accepted as an oral presentation for EASL 2024. This is the first abstract to include both data sets.
治疗领域药物疗法背景代谢功能障碍相关性脂肪性肝炎(MASH)通常与肥胖、代谢综合征和/或糖尿病等代谢紊乱有关。FGF21 类似物(如培戈非明 (PGZ))对肝纤维化有直接作用,对 MASH 患者的肝脏和肝脏外也有益处。ENLIVEN 2b 期试验评估了每周(QW)或每两周(Q2W)给予 PGZ 与安慰剂对活检证实 F2/F3 肝纤维化的 MASH 患者的疗效和安全性。主要组织学终点在第24周进行评估,随后进行为期24周的盲法延长期,共48周。方法患者被随机分配到PGZ 15mg QW、30mg QW或44mg Q2W或安慰剂中,为期24周(基于组织学的主要终点)。在24周的延长期内,除了一部分安慰剂患者被重新随机分配到接受PGZ 30mg QW治疗外,其他患者继续接受指定的治疗。结果接受PGZ 30mg QW或44mg Q2W治疗的患者中,达到这两项组织学主要终点(至少一个阶段的纤维化改善而MASH不恶化,以及MASH缓解而纤维化不恶化)的比例明显高于接受安慰剂治疗的患者。PGZ 治疗还改善了肝脏脂肪含量(MRI-PDFF)、肝纤维化生物标志物(VCTE、ELF、PRO-C3)、肝损伤(ALT、AST)以及血脂和 HgA1c(24 周和 48 周)。PGZ总体上安全且耐受性良好,最常见的治疗突发不良事件(TEAEs)为轻度/中度恶心和腹泻。结论对F2/F3纤维化的MASH患者使用PGZ治疗后,纤维化显著消退,MASH得到缓解,肝脏脂肪和炎症的非侵入性生物标志物、纤维化和代谢标志物都得到了有力和持续的改善,而且安全性和耐受性良好。PGZ 是第一种通过 Q2W 给药方案实现纤维化消退和 MASH 消除的疗法。请注意,ENLIVEN 28 周数据已在 EASL 2023 上公布,ENLIVEN 48 周数据已被接受作为 EASL 2024 的口头报告。这是第一份包含这两组数据的摘要。
{"title":"PEGOZAFERMIN DEMONSTRATED ROBUST HISTOLOGIC IMPROVEMENT AND BENEFIT IN HEPATIC AND METABOLIC BIOMARKERS IN A 48-WEEK MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 2B TRIAL (ENLIVEN)","authors":"Cynthia L. Hartsfield PhD","doi":"10.1016/j.ajpc.2024.100807","DOIUrl":"10.1016/j.ajpc.2024.100807","url":null,"abstract":"<div><h3>Therapeutic Area</h3><div>Pharmacologic Therapy</div></div><div><h3>Background</h3><div>Metabolic dysfunction-associated steatohepatitis (MASH) is often associated with metabolic disorders such as obesity, metabolic syndrome, and/or diabetes. FGF21 analogs such as pegozafermin (PGZ) have direct effects on liver fibrosis as well as additional hepatic and extrahepatic benefits in patients with MASH. The Phase 2b ENLIVEN trial evaluated the efficacy and safety of PGZ given weekly (QW) or every two-weeks (Q2W) versus placebo in MASH patients with biopsy-proven F2/F3 fibrosis. The primary histology endpoints were assessed at week 24, followed by a 24-week blinded extension for a total of 48 weeks.</div></div><div><h3>Methods</h3><div>Patients were randomized to PGZ 15mg QW, 30mg QW, or 44mg Q2W or placebo for 24-weeks (histology-based primary endpoints). During the 24-week extension, patients continued their assigned treatment except for a subset of placebo patients who were re-randomized to receive PGZ 30mg QW. The full analysis set includes F2/F3 patients with NAFLD activity score (NAS) ≥4 at baseline (n=192).</div></div><div><h3>Results</h3><div>Both primary histological endpoints considered as reasonably likely surrogates of clinical outcome benefit - at least one stage of fibrosis improvement without worsening of MASH and MASH resolution without worsening of fibrosis - were achieved by a significantly higher proportion of patients treated with PGZ 30mg QW or 44 mg Q2W than placebo. PGZ treatment also improved liver fat content (MRI-PDFF), biomarkers of fibrosis (VCTE, ELF, PRO-C3) and liver injury (ALT, AST) as well as lipids and HgA1c at both 24 weeks and week 48. PGZ was generally safe and well tolerated with the most common treatment emergent adverse events (TEAEs) being mild/moderate nausea and diarrhea. No deaths occurred; six early terminations for TEAEs including one drug-related serious AE occurred.</div></div><div><h3>Conclusions</h3><div>Treatment with PGZ in MASH patients with F2/F3 fibrosis led to highly significant fibrosis regression and MASH resolution and to robust and sustained improvements in non-invasive biomarkers of liver fat and inflammation, fibrosis, and metabolic markers, with a favorable safety and tolerability profile. PGZ is the first therapy to achieve fibrosis regression and MASH resolution with a Q2W dosing regimen. The confirmatory Phase 3 program in MASH was recently initiated.</div><div>Please note that ENLIVEN 28-week data were presented at EASL 2023 and ENLIVEN 48-week data are accepted as an oral presentation for EASL 2024. This is the first abstract to include both data sets.</div></div>","PeriodicalId":72173,"journal":{"name":"American journal of preventive cardiology","volume":"19 ","pages":"Article 100807"},"PeriodicalIF":4.3,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142422912","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}
引用次数: 0
LIPID OPTIMIZATION AMONG PATIENTS WITH PERIPHERAL ARTERY DISEASE FOLLOWING REVASCULARIZATION IN A SINGLE-CENTER COHORT 单中心队列中外周动脉疾病患者血管再通术后的血脂优化
IF 4.3 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.ajpc.2024.100761
Franck H. Azobou Tonleu MD

Therapeutic Area

Peripheral Artery Disease

Background

Lipid management is a cornerstone of peripheral artery disease (PAD) treatment to reduce major adverse cardiac events. The 2018 ACC/AHA cholesterol guidelines recommended statins, ezetimibe, and/or PCSK9 inhibitors in selected patients to reach a low density lipoprotein cholesterol (LDL-c) < 70 mg/dL.

Methods

The cohort included all patients who underwent their index limb revascularization for PAD between 01/01/2021 and 12/31/2022 at a large urban safety net hospital. The cohort was created using ICD-10 and CPT codes. Lipid lowering medications and LDL-c were abstracted at baseline (prior to index revascularization) and at one year post index discharge. For baseline labs, we used values either prior or during (if no prior value) index revascularization.

Results

The final cohort included 311 patients with 36% female, 49% Hispanic, 36% Black, and was 63 ± 10 years old. History of hypertension, hyperlipidemia, and type 2 diabetes were seen in 98%, 93%, and 79% of patients, respectively. Prior to revascularization, 78% of patients were on statins (53% high intensity, 22% moderate intensity), 7% on ezetimibe and no patients on PCSK-9i. By one year following revascularization, 94% were on statins (75% high intensity, 18% moderate intensity), 8% on ezetimibe, and no patients on PCSK-9i. Among 233 patients with baseline LDL-c, median was 81 mg/dL with 37% (86/233) with LDL-c < 70 mg/dL. Following revascularization, 132 patients had repeat lipid panel with median LDL-c 65 mg/dL and 55% (73/132) of them with LDL-c < 70 mg/dL.

Conclusions

LDL-c optimization is a cornerstone of PAD management, especially in a post-revascularization population. In this cohort, there was increase in both overall statin use and use of high intensity by 1 year following revascularization. However, only 42% of patients had repeat lipid panel following revascularization and the use of non-statin therapies remained low despite only half achieving targeted LDL-C. These findings highlight an important care gap, and revascularization as an important opportunity for lipid optimization. Clinician education and EHR (Electronic Health Record) interventions could be leveraged to improve outcomes in this population.
治疗领域外周动脉疾病背景血脂管理是治疗外周动脉疾病(PAD)以减少主要不良心脏事件的基石。2018年ACC/AHA胆固醇指南推荐对特定患者使用他汀类药物、依折麦布和/或PCSK9抑制剂,以达到低密度脂蛋白胆固醇(LDL-c)< 70 mg/dL.方法队列包括2021年1月1日至2022年12月31日期间在一家大型城市安全网医院因PAD接受指数肢体血管重建术的所有患者。队列使用 ICD-10 和 CPT 编码创建。降脂药物和低密度脂蛋白胆固醇在基线(指数血管再通术前)和指数出院后一年进行抽样。对于基线实验室检查,我们使用了指数血管再通术之前或期间的数值(如果之前没有数值)。结果最终队列包括 311 名患者,其中女性占 36%,西班牙裔占 49%,黑人占 36%,年龄为 63 ± 10 岁。分别有98%、93%和79%的患者有高血压、高脂血症和2型糖尿病史。血管重建前,78%的患者服用他汀类药物(53%为高强度,22%为中等强度),7%服用依折麦布,没有患者服用PCSK-9i。血管再通术后一年,94%的患者服用他汀类药物(75%为高强度,18%为中等强度),8%服用依折麦布,没有患者服用 PCSK-9i。在基线 LDL-c 为 81 mg/dL 的 233 名患者中,37%(86/233)的 LDL-c 为 70 mg/dL。结论 LDL-c 优化是 PAD 管理的基石,尤其是在血管重建后人群中。在该队列中,他汀类药物的总体使用率和高强度使用率在血管再通术后一年都有所上升。然而,只有42%的患者在血管再通后再次进行了血脂检查,尽管只有一半的患者达到了低密度脂蛋白胆固醇的目标值,但非他汀类药物的使用率仍然很低。这些发现凸显了一个重要的护理缺口,而血管再通术则是优化血脂的一个重要机会。临床医生教育和电子病历(EHR)干预措施可用于改善这一人群的治疗效果。
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引用次数: 0
CHARACTERISTICS AND RISK FACTORS OF YOUNG ATHEROSCLEROTIC CARDIOVASCULAR DISEASE IN AN UNDERREPRESENTED COHORT: INSIGHTS FROM THE ALL OF US RESEARCH PROGRAM 代表性不足人群中年轻动脉粥样硬化性心血管疾病的特征和风险因素:"我们大家 "研究计划的启示
IF 4.3 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Pub Date : 2024-09-01 DOI: 10.1016/j.ajpc.2024.100779
Sara J. King MD

Therapeutic Area

ASCVD/CVD in Special Populations

Background

Recent research has found an increasing prevalence of atherosclerotic cardiovascular disease (ASCVD) in young adults (ages less than 50), however most studies were performed in predominantly White populations. We sought to evaluate the demographics, traditional medical risk factors, and social determinants of health of young ASCVD in the All of Us Research Program, an emerging national cohort study that seeks to investigate underrepresented populations.

Methods

We queried the All of Us database for individuals ages 20 to 49 years from 2017 to March, 2024 with completed data on demographics, income, education, and insurance. ASCVD was defined using ICD-10 codes for coronary artery disease (I20–I25) and stroke (I63, I65). Traditional medical risk factors were defined using ICD-10 codes and included type 2 diabetes mellitus (T2DM), hypertension, and hyperlipidemia. Tobacco use and obesity were defined using survey responses and body mass index, respectively. Unadjusted univariate and adjusted multivariate logistic regression models were performed with ASCVD as outcome and reported as odds ratios (OR) with 95% confidence intervals (CI).

Results

There were 90,313 individuals included, with 64.3% female, 50.2% non-white race, 24.5% Hispanic or Latino or other ethnicity, and 58.4% with annual income under $50,000. ASCVD was present in 2,219 (2.5%). In unadjusted univariate models, age (OR 1.10, CI 1.09-1.11), male gender (OR 1.16, CI 1.06-1.27), Black race (OR 1.46, CI 1.32-1.62), other race (OR 1.17, CI 1.04-1.30), annual incomes less than $25,000 (ORs 1.26-1.77, CIs 1.04-2.22), and traditional medical risk factors were associated with ASCVD. In adjusted multivariate logistic regression models, age, male gender, Black race, annual incomes less than $25,000, most education levels lower than college graduate, and traditional medical risk factors except obesity were associated with ASCVD, with hypertension showing the strongest association (Figure 1). Having medical insurance was associated with higher odds of ASCVD.

Conclusions

Several traditionally underrepresented groups including Black race, low annual income (less than $25,000), and education levels lower than college graduate were associated with ASCVD at a young age.
治疗领域特殊人群中的动脉粥样硬化性心血管疾病/心血管疾病背景最近的研究发现,动脉粥样硬化性心血管疾病(ASCVD)在年轻人(50 岁以下)中的发病率越来越高,但大多数研究都是在以白人为主的人群中进行的。我们试图评估 "我们所有人研究计划"(All of Us Research Program)中年轻人 ASCVD 的人口统计学特征、传统医疗风险因素和健康的社会决定因素,这是一项新兴的全国队列研究,旨在调查代表性不足的人群。ASCVD的定义采用ICD-10冠状动脉疾病(I20-I25)和中风(I63、I65)代码。传统的医疗风险因素使用 ICD-10 代码定义,包括 2 型糖尿病 (T2DM)、高血压和高脂血症。烟草使用和肥胖分别根据调查回答和体重指数来定义。结果共纳入 90,313 人,其中女性占 64.3%,非白人种族占 50.2%,西班牙裔或拉丁裔或其他种族占 24.5%,年收入低于 50,000 美元的占 58.4%。2219人(2.5%)患有ASCVD。在未经调整的单变量模型中,年龄(OR 1.10,CI 1.09-1.11)、男性(OR 1.16,CI 1.06-1.27)、黑人(OR 1.46,CI 1.32-1.62)、其他种族(OR 1.17,CI 1.04-1.30)、年收入低于 25,000 美元(OR 1.26-1.77,CI 1.04-2.22)和传统的医疗风险因素与 ASCVD 相关。在调整后的多变量逻辑回归模型中,年龄、男性性别、黑人种族、年收入低于 25,000 美元、大多数教育水平低于大学毕业以及除肥胖以外的传统医疗风险因素都与 ASCVD 相关,其中高血压的相关性最强(图 1)。结论一些传统上代表性不足的群体,包括黑人、年收入低(低于 25,000 美元)和教育水平低于大学毕业的群体,在年轻时就与心血管疾病相关。
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引用次数: 0
期刊
American journal of preventive cardiology
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