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Corrigendum to “Obesity pillars roundtable: Body mass index and body composition in black and female individuals. Race-relevant or racist? Sex-relevant or sexist?” [Obesity Pillars 4C (2022) 100044] 肥胖支柱圆桌会议:黑人和女性的体重指数和身体成分。种族相关还是种族主义?与性别相关还是性别歧视?[肥胖支柱 4C (2022) 100044]
Pub Date : 2024-03-16 DOI: 10.1016/j.obpill.2024.100105
Harold Edward Bays , Sylvia Gonsahn-Bollie , Courtney Younglove , Sean Wharton
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引用次数: 0
Obesity, dyslipidemia, and cardiovascular disease: A joint expert review from the Obesity Medicine Association and the National Lipid Association 2024 肥胖、血脂异常和心血管疾病:肥胖医学协会和国家血脂协会联合专家评论 2024
Pub Date : 2024-03-12 DOI: 10.1016/j.obpill.2024.100108
Harold Edward Bays, Carol Kirkpatrick, Kevin C. Maki, Peter P. Toth, Ryan T. Morgan, Justin Tondt, Sandra Michelle Christensen, Dave Dixon, Terry A. Jacobson

Background

This joint expert review by the Obesity Medicine Association (OMA) and National Lipid Association (NLA) provides clinicians an overview of the pathophysiologic and clinical considerations regarding obesity, dyslipidemia, and cardiovascular disease (CVD) risk.

Methods

This joint expert review is based upon scientific evidence, clinical perspectives of the authors, and peer review by the OMA and NLA leadership.

Results

Among individuals with obesity, adipose tissue may store over 50% of the total body free cholesterol. Triglycerides may represent up to 99% of lipid species in adipose tissue. The potential for adipose tissue expansion accounts for the greatest weight variance among most individuals, with percent body fat ranging from less than 5% to over 60%. While population studies suggest a modest increase in blood low-density lipoprotein cholesterol (LDL-C) levels with excess adiposity, the adiposopathic dyslipidemia pattern most often described with an increase in adiposity includes elevated triglycerides, reduced high density lipoprotein cholesterol (HDL-C), increased non-HDL-C, elevated apolipoprotein B, increased LDL particle concentration, and increased small, dense LDL particles.

Conclusions

Obesity increases CVD risk, at least partially due to promotion of an adiposopathic, atherogenic lipid profile. Obesity also worsens other cardiometabolic risk factors. Among patients with obesity, interventions that reduce body weight and improve CVD outcomes are generally associated with improved lipid levels. Given the modest improvement in blood LDL-C with weight reduction in patients with overweight or obesity, early interventions to treat both excess adiposity and elevated atherogenic cholesterol (LDL-C and/or non-HDL-C) levels represent priorities in reducing the risk of CVD.

背景这篇由肥胖医学协会(OMA)和美国国家血脂协会(NLA)联合撰写的专家综述为临床医生提供了有关肥胖、血脂异常和心血管疾病(CVD)风险的病理生理学和临床注意事项的概述。结果在肥胖症患者中,脂肪组织可储存体内总游离胆固醇的 50%以上。甘油三酯可能占脂肪组织中脂质种类的 99%。脂肪组织膨胀的潜力是大多数人体重差异最大的原因,体脂百分比从不到 5%到超过 60% 不等。人群研究表明,随着脂肪过多,血液中的低密度脂蛋白胆固醇(LDL-C)水平会适度升高,而脂肪过多导致的血脂异常模式通常包括甘油三酯升高、高密度脂蛋白胆固醇(HDL-C)降低、非高密度脂蛋白胆固醇(HDL-C)升高、载脂蛋白 B 升高、低密度脂蛋白颗粒浓度升高以及小而致密的低密度脂蛋白颗粒增加。结论肥胖会增加心血管疾病的风险,至少部分原因是肥胖促进了致动脉粥样硬化脂质的形成。肥胖还会加重其他心脏代谢风险因素。在肥胖症患者中,减轻体重和改善心血管疾病预后的干预措施通常与血脂水平的改善有关。鉴于超重或肥胖患者在减轻体重后血液中的低密度脂蛋白胆固醇(LDL-C)略有改善,因此在降低心血管疾病风险的过程中,应优先采取早期干预措施,治疗过多的脂肪和升高的致动脉粥样硬化胆固醇(LDL-C 和/或非 HDL-C)水平。
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引用次数: 0
Presentation of a weight bias internalization tool for use in pregnancy and a call for future research: A commentary 介绍孕期体重偏差内化工具并呼吁未来开展研究:评论
Pub Date : 2024-03-07 DOI: 10.1016/j.obpill.2024.100107
Taniya S. Nagpal , Nicole Pearce , Kristi B. Adamo

Background

Emerging evidence has shown that weight stigma is a concern during pregnancy, with several studies documenting common sources including healthcare, the media and interpersonal networks. Experiencing weight stigma may lead to weight bias internalization (WBI), whereby individuals accept and self-direct negative weight-related stereotypes, and limited research has assessed this in the context of pregnancy. Pregnancy is unique in terms of weight changes as many individuals will experience gestational weight gain (GWG). Accordingly, a WBI tool that accounts for GWG may be a more population-specific resource to use.

Methods

This commentary presents a pregnancy-specific WBI tool that accounts for GWG. The validated Adult WBI scale was modified to include ‘pregnancy weight gain’. This commentary also presents a brief summary of research that has assessed WBI in pregnancy and recommendations for future work.

Results

Recommended future work includes validation of the pregnancy-specific WBI tool and prospective examinations of weight stigma and WBI in pregnancy and implications on maternal and newborn outcomes.

Conclusion

Ultimately this research may inform development of interventions and resources to mitigate weight stigma and WBI in pregnancy and overall may contribute to improving prenatal outcomes and experiences.

背景越来越多的证据表明,体重成见是孕期的一个问题,一些研究记录了常见的成见来源,包括医疗保健、媒体和人际网络。经历体重成见可能会导致体重偏见内化(WBI),即个人接受并自我引导与体重有关的负面刻板印象。就体重变化而言,怀孕是一个独特的现象,因为许多人会经历妊娠体重增加(GWG)。因此,考虑到妊娠期体重增加的 WBI 工具可能是一种更适合特定人群使用的资源。本评论介绍了一种考虑到妊娠体重增加的妊娠体重指数工具。对经过验证的成人妊娠体重指数量表进行了修改,将 "妊娠体重增加 "纳入其中。结果建议今后开展的工作包括验证特定于妊娠期的 WBI 工具,对妊娠期体重羞辱和 WBI 以及对孕产妇和新生儿结局的影响进行前瞻性研究。结论这项研究最终可能会为干预措施和资源的开发提供信息,以减轻妊娠期体重羞辱和 WBI,总体而言,可能有助于改善产前结局和体验。
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引用次数: 0
Weight-centric prevention of cancer 以体重为中心预防癌症
Pub Date : 2024-03-05 DOI: 10.1016/j.obpill.2024.100106
Diego Anazco , Andres Acosta , Elizabeth J. Cathcart-Rake , Stacy D. D'Andre , Maria D. Hurtado

Background

The link between excess adiposity and carcinogenesis has been well established for multiple malignancies, and cancer is one of the main contributors to obesity-related mortality. The potential role of different weight-loss interventions on cancer risk modification has been assessed, however, its clinical implications remain to be determined. In this clinical review, we present the data assessing the effect of weight loss interventions on cancer risk.

Methods

In this clinical review, we conducted a comprehensive search of relevant literature using MEDLINE, Embase, Web of Science, and Google Scholar databases for relevant studies from inception to January 20, 2024. In this clinical review, we present systematic reviews and meta-analysis, randomized clinical trials, and prospective and retrospective observational studies that address the effect of different treatment modalities for obesity in cancer risk. In addition, we incorporate the opinions from experts in the field of obesity medicine and oncology regarding the potential of weight loss as a preventative intervention for cancer.

Results

Intentional weight loss achieved through different modalities has been associated with a reduced cancer incidence. To date, the effect of weight loss on the postmenopausal women population has been more widely studied, with multiple reports indicating a protective effect of weight loss on hormone-dependent malignancies. The effect of bariatric interventions as a protective intervention for cancer has been studied extensively, showing a significant reduction in cancer incidence and mortality, however, data for the effect of bariatric surgery on certain specific types of cancer is conflicting or limited.

Conclusion

Medical nutrition therapy, exercise, antiobesity medication, and bariatric interventions, might lead to a reduction in cancer risk through weight loss-dependent and independent factors. Further evidence is needed to better determine which population might benefit the most, and the amount of weight loss required to provide a clinically significant preventative effect.

背景对于多种恶性肿瘤而言,过多的脂肪与致癌之间的联系已经得到证实,癌症是导致肥胖相关死亡率的主要因素之一。不同的减肥干预措施对癌症风险的潜在作用已得到评估,但其临床意义仍有待确定。在这篇临床综述中,我们介绍了评估减肥干预对癌症风险影响的数据。方法在这篇临床综述中,我们使用 MEDLINE、Embase、Web of Science 和 Google Scholar 数据库对相关文献进行了全面检索,以查找从开始到 2024 年 1 月 20 日的相关研究。在本临床综述中,我们介绍了针对肥胖症不同治疗方式对癌症风险影响的系统综述和荟萃分析、随机临床试验以及前瞻性和回顾性观察研究。此外,我们还纳入了肥胖医学和肿瘤学领域专家关于减肥作为癌症预防干预措施的潜力的意见。结果通过不同方式实现的有意减肥与癌症发病率的降低有关。迄今为止,减肥对绝经后女性人群的影响研究较多,多份报告显示减肥对激素依赖性恶性肿瘤有保护作用。减肥干预作为一种癌症保护性干预措施,其效果已得到广泛研究,显示可显著降低癌症发病率和死亡率,但减肥手术对某些特定类型癌症的影响数据存在冲突或有限。还需要进一步的证据来更好地确定哪些人群可能受益最大,以及需要减轻多少体重才能产生临床上显著的预防效果。
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引用次数: 0
Evaluating the effectiveness and underlying mechanisms of incretin-based treatments for hypothalamic obesity: A narrative review 评估基于增量素的下丘脑肥胖症治疗方法的有效性和内在机制:叙述性综述
Pub Date : 2024-02-24 DOI: 10.1016/j.obpill.2024.100104
Dionysios V. Chartoumpekis , Evagelia E. Habeos , Aristea Psilopanagioti

Background

Hypothalamic obesity represents a clinical condition within the broader spectrum of obesity that frequently eludes detection and appropriate diagnosis. This subset of obesity is characterized by a dearth of established predictive markers and a paucity of standardized therapeutic protocols. The advent and rising prominence of glucagon-like peptide-1 (GLP-1) receptor agonists in the obesity treatment landscape present novel therapeutic avenues for hypothalamic obesity management. Nonetheless, critical inquiries persist concerning the efficacy of GLP-1 receptor (GLP-1R) agonists in this context, particularly regarding their central mechanisms of action and specific impact on hypothalamic obesity.

Methods

In this narrative review, we concentrate on analyzing research papers that delineate the detection and function of GLP-1 receptors across various hypothalamic and cerebral regions. Additionally, we examine clinical research papers and reports detailing the application of GLP-1 receptor agonists in treating hypothalamic obesity. Furthermore, we include a concise presentation of a clinical case from our unit for contextual understanding.

Results

Currently, the clinical evidence supporting the efficacy of GLP-1 receptor agonists in hypothalamic obesity, as well as the diverse characteristics of this obesity subtype, remains insufficient. Preliminary data suggest that GLP-1R agonists might offer an effective treatment option, albeit with variable outcomes, particularly in younger patient cohorts. From a mechanistic perspective, the presence of GLP-1 receptors in various hypothalamic and broader brain regions potentially underpins the efficacy of GLP-1R agonists, even in instances of hypothalamic damage. Nevertheless, additional research is imperative to establish the functional relevance of these receptors in said brain regions.

Conclusion

GLP-1R agonists represent a potential therapeutic option for patients with hypothalamic obesity. However, further clinical and basic/translational research is essential to validate the efficacy of these drugs across different presentations of hypothalamic obesity and to understand the functionality of GLP-1R in the diverse brain regions where they are expressed.

背景下丘脑性肥胖症是肥胖症中的一种临床症状,常常无法被发现和做出适当诊断。这种肥胖症的特点是缺乏成熟的预测指标和标准化的治疗方案。胰高血糖素样肽-1(GLP-1)受体激动剂的出现和在肥胖症治疗领域的日益突出,为下丘脑肥胖症的治疗提供了新的治疗途径。然而,关于 GLP-1 受体(GLP-1R)激动剂在这方面的疗效,特别是其中枢作用机制和对下丘脑肥胖的具体影响,仍然存在着重要的疑问。方法在这篇叙述性综述中,我们集中分析了描述 GLP-1 受体在不同下丘脑和大脑区域的检测和功能的研究论文。此外,我们还研究了详细介绍应用 GLP-1 受体激动剂治疗下丘脑肥胖症的临床研究论文和报告。结果目前,支持 GLP-1 受体激动剂治疗下丘脑肥胖症疗效的临床证据仍然不足,而且这种肥胖症亚型的特征多种多样。初步数据表明,GLP-1R 激动剂可能是一种有效的治疗选择,尽管疗效不一,尤其是在年轻患者群体中。从机理角度来看,GLP-1 受体存在于下丘脑和更广泛的大脑区域,这可能是 GLP-1R 激动剂疗效的基础,即使在下丘脑受损的情况下也是如此。结论 GLP-1R 激动剂是下丘脑肥胖症患者的一种潜在治疗选择。然而,进一步的临床和基础/翻译研究对于验证这些药物对不同表现的下丘脑肥胖症的疗效以及了解 GLP-1R 在其表达的不同脑区的功能至关重要。
{"title":"Evaluating the effectiveness and underlying mechanisms of incretin-based treatments for hypothalamic obesity: A narrative review","authors":"Dionysios V. Chartoumpekis ,&nbsp;Evagelia E. Habeos ,&nbsp;Aristea Psilopanagioti","doi":"10.1016/j.obpill.2024.100104","DOIUrl":"https://doi.org/10.1016/j.obpill.2024.100104","url":null,"abstract":"<div><h3>Background</h3><p>Hypothalamic obesity represents a clinical condition within the broader spectrum of obesity that frequently eludes detection and appropriate diagnosis. This subset of obesity is characterized by a dearth of established predictive markers and a paucity of standardized therapeutic protocols. The advent and rising prominence of glucagon-like peptide-1 (GLP-1) receptor agonists in the obesity treatment landscape present novel therapeutic avenues for hypothalamic obesity management. Nonetheless, critical inquiries persist concerning the efficacy of GLP-1 receptor (GLP-1R) agonists in this context, particularly regarding their central mechanisms of action and specific impact on hypothalamic obesity.</p></div><div><h3>Methods</h3><p>In this narrative review, we concentrate on analyzing research papers that delineate the detection and function of GLP-1 receptors across various hypothalamic and cerebral regions. Additionally, we examine clinical research papers and reports detailing the application of GLP-1 receptor agonists in treating hypothalamic obesity. Furthermore, we include a concise presentation of a clinical case from our unit for contextual understanding.</p></div><div><h3>Results</h3><p>Currently, the clinical evidence supporting the efficacy of GLP-1 receptor agonists in hypothalamic obesity, as well as the diverse characteristics of this obesity subtype, remains insufficient. Preliminary data suggest that GLP-1R agonists might offer an effective treatment option, albeit with variable outcomes, particularly in younger patient cohorts. From a mechanistic perspective, the presence of GLP-1 receptors in various hypothalamic and broader brain regions potentially underpins the efficacy of GLP-1R agonists, even in instances of hypothalamic damage. Nevertheless, additional research is imperative to establish the functional relevance of these receptors in said brain regions.</p></div><div><h3>Conclusion</h3><p>GLP-1R agonists represent a potential therapeutic option for patients with hypothalamic obesity. However, further clinical and basic/translational research is essential to validate the efficacy of these drugs across different presentations of hypothalamic obesity and to understand the functionality of GLP-1R in the diverse brain regions where they are expressed.</p></div>","PeriodicalId":100977,"journal":{"name":"Obesity Pillars","volume":"10 ","pages":"Article 100104"},"PeriodicalIF":0.0,"publicationDate":"2024-02-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2667368124000068/pdfft?md5=99a0c6546e411fd1fa3fe05da8516265&pid=1-s2.0-S2667368124000068-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140024290","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
Future of Obesity Medicine: Fearless 5-year Predictions for 2029 by Obesity Medicine Association Committee Chairs 肥胖症医学的未来:肥胖医学协会委员会主席对 2029 年的 5 年无畏预测
Pub Date : 2024-02-16 DOI: 10.1016/j.obpill.2024.100102
Harold Bays
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引用次数: 0
Impact Of body Mass Index on Cardiopulmonary Outcomes of COVID-19 Hospitalizations Complicated by Severe Sepsis 体重指数对 COVID-19 严重败血症住院患者心肺功能结果的影响
Pub Date : 2024-02-14 DOI: 10.1016/j.obpill.2024.100101
Sivaram Neppala , Himaja Dutt Chigurupati , Nikhilender Nag Mopuru , Naga Ruthvika Alle , Alpha James , Ami Bhalodia , Sajida Shaik , Revanth Reddy Bandaru , Athmananda Nanjundappa , Praveena Sunkara , Jyotsna Gummadi , Rupak Desai

Background

Body Mass Index (BMI) has a significant impact on Coronavirus disease (COVID-19) patient outcomes; however, major adverse cardiac and cerebrovascular outcomes in patients with severe sepsis have been poorly understood. Our study aims to explore and provide insight into its association.

Methods

This is an observational study looking at the impact of BMI on COVID-19-severe sepsis hospitalizations. The primary outcomes are adjusted odds of all-cause in-hospital mortality, respiratory failure, and major adverse cardiac and cerebrovascular events (MACCE), which include acute myocardial infarction, cardiac arrest, and acute ischemic stroke. The secondary outcome was healthcare resource utilization. Coexisting comorbidities and patient features were adjusted with multivariable regression analyses.

Results

Of 51,740 patients with severe COVID-19-sepsis admissions, 11.4% were overweight, 24.8% had Class I obesity (BMI 30–34.9), 19.8% had Class II obesity (BMI 35–39.9), and 43.9% had the categorization of Class III obesity (BMI >40) cohorts with age>18 years. The odds of MACCE in patients with class II obesity and class III obesity (OR 1.09 and 1.54; 95CI 0.93–1.29 and 1.33–1.79) were significantly higher than in overweight (p < 0.001). Class I, Class II, and Class III patients with obesity revealed lower odds of respiratory failure compared to overweight (OR 0.89, 0.82, and 0.82; 95CI 0.75–1.05, 0.69–0.97, and 0.70–0.97), but failed to achieve statistical significance (p = 0.079). On multivariable regression analysis, all-cause in-hospital mortality revealed significantly higher odds in patients with Class III obesity, Class II, and Class I (OR 1.56, 1.17, and 1.06; 95CI 1.34–1.81, 0.99–1.38, and 0.91–1.24) vs. overweight patients (p < 0.001).

Conclusions

Patients with Class II and Class III obesity had significantly higher odds of MACCE and in-hospital mortality in COVID-19-severe sepsis admissions.

背景体重指数(BMI)对冠状病毒病(COVID-19)患者的预后有重大影响;然而,人们对严重脓毒症患者心脑血管的主要不良预后却知之甚少。方法这是一项观察性研究,探讨 BMI 对 COVID-19 严重脓毒症住院治疗的影响。主要结果是调整后的全因院内死亡率、呼吸衰竭和主要不良心脑血管事件(MACCE)几率,其中包括急性心肌梗死、心脏骤停和急性缺血性中风。次要结果是医疗资源利用率。结果 在 51,740 名入院的严重 COVID-19 败血症患者中,11.4% 超重,24.8% I 级肥胖(BMI 30-34.9),19.8% II 级肥胖(BMI 35-39.9),43.9% III 级肥胖(BMI 40),年龄为 18 岁。II级肥胖和III级肥胖患者发生澳门巴黎人娱乐官网的几率(OR 1.09和1.54;95CI 0.93-1.29和1.33-1.79)明显高于超重患者(p <0.001)。一级、二级和三级肥胖患者发生呼吸衰竭的几率低于超重患者(OR 0.89、0.82 和 0.82;95CI 0.75-1.05、0.69-0.97 和 0.70-0.97),但未达到统计学意义(p = 0.079)。多变量回归分析显示,Ⅲ级肥胖、Ⅱ级肥胖和Ⅰ级肥胖患者的全因院内死亡率明显更高(OR 1.56、1.17 和 1.06;95CI 1.34-1.81、0.99-1.结论在 COVID-19 严重败血症入院患者中,II 级和 III 级肥胖患者发生 MACCE 和院内死亡的几率明显更高。
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引用次数: 0
Impact Of body Mass Index on Cardiopulmonary Outcomes of COVID-19 Hospitalizations Complicated by Severe Sepsis 体重指数对 COVID-19 严重败血症住院患者心肺功能结果的影响
Pub Date : 2024-02-01 DOI: 10.1016/j.obpill.2024.100101
Sivaram Neppala, H. Chigurupati, Nikhilender Nag Mopuru, Naga Ruthvika Alle, Alpha James, Ami Bhalodia, Sajida Shaik, Revanth Reddy Bandaru, Athmananda Nanjundappa, P. Sunkara, Jyotsna Gummadi, Rupak Desai
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引用次数: 0
Patient perceptions of three-dimensional (3D) surface imaging technology and traditional methods used to assess anthropometry 患者对用于评估人体测量的三维(3D)表面成像技术和传统方法的看法
Pub Date : 2024-02-01 DOI: 10.1016/j.obpill.2024.100100
Lucie Nield , Michael Thelwell , Audrey Chan , Simon Choppin , Steven Marshall

Background

Obesity and overweight are commonplace, yet attrition rates in weight management clinics are high. Traditional methods of body measurement may be a deterrent due to invasive and time-consuming measurements and negative experiences of how data are presented back to individuals. Emerging new technologies, such as three-dimensional (3D) surface imaging technology, might provide a suitable alternative. This study aimed to understand acceptability of traditional and 3D surface imaging-based body measures, and whether perceptions differ between population groups.

Methods

This study used a questionnaire to explore body image, body measurement and shape, followed by a qualitative semi-structured interview and first-hand experience of traditional and 3D surface imaging-based body measures.

Results

49 participants responded to the questionnaire and 26 participants attended for the body measurements and interview over a 2-month period. There were 3 main themes from the qualitative data 1) Use of technology, 2) Participant experience, expectations and perceptions and 3) Perceived benefits and uses.

Conclusion

From this study, 3D-surface imaging appeared to be acceptable to patients as a method for anthropometric measurements, which may reduce anxiety and improve attrition rates in some populations. Further work is required to understand the scalability, and the role and implications of these technologies in weight management practice. (University Research Ethics Committee reference number ER41719941).

背景肥胖和超重是普遍现象,但体重管理诊所的减员率却很高。传统的体型测量方法可能会让人望而却步,因为这种方法具有侵入性,测量耗时,而且数据反馈给个人时也会产生负面影响。新兴的新技术,如三维(3D)表面成像技术,可能会提供一种合适的替代方法。本研究旨在了解人们对传统身体测量方法和基于三维表面成像技术的身体测量方法的接受程度,以及不同人群对这些方法的看法是否存在差异。研究方法:本研究采用问卷调查的形式对身体形象、身体测量和体形进行了调查,随后进行了半结构式定性访谈,并对传统身体测量方法和基于三维表面成像技术的身体测量方法进行了亲身体验。定性数据有 3 个主要主题:1)技术的使用;2)参与者的经验、期望和看法;3)感知的益处和用途。要了解这些技术在体重管理实践中的可扩展性、作用和影响,还需要进一步的工作。(大学研究伦理委员会参考编号:ER41719941)。
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引用次数: 0
Effects of phentermine / topiramate extended-release, phentermine, and placebo on ambulatory blood pressure monitoring in adults with overweight or obesity: A randomized, multicenter, double-blind study 芬特明-托吡酯缓释片、芬特明和安慰剂对超重或肥胖成人流动血压监测的影响:随机、多中心、双盲研究
Pub Date : 2024-01-08 DOI: 10.1016/j.obpill.2024.100099
Harold E. Bays , Daniel S. Hsia , Lan T. Nguyen , Craig A. Peterson , Santosh T. Varghese

Background

A fixed-dose combination of phentermine and extended-release topiramate (PHEN/TPM - approved for weight management) has demonstrated in-clinic reduction of blood pressure (BP). Ambulatory BP monitoring (ABPM) may be a better predictor of cardiovascular disease risk than in-clinic BP.

Methods

This randomized, multicenter, double-blind study enrolled 565 adults with overweight/obesity. Inclusion criteria included participants willing to wear ABPM device for 24 h. Exclusion criteria included screening blood pressure >140/90 mmHg and antihypertensive medications not stable for 3 months prior to randomization. Participants received placebo (n = 184), phentermine 30 mg; (n = 191), or PHEN 15 mg/TPM 92 mg; (n = 190). 24-hour ABPM was performed at baseline and at week 8. The primary endpoint was mean 24-h systolic BP (SBP) as measured by ABPM, in the per protocol population.

Results

Participants were mostly female (73.5 ​%) and White (81.6 ​%), with a mean age of 53.4 years; 32.4 ​% had no hypertension diagnosis or treatment, 62.5 ​% had hypertension using 0 to 2 antihypertensive medications, and 5.1 ​% had hypertension using ≥ 3 antihypertensive medications. Baseline mean SBP/diastolic BP (DBP) was 123.9/77.6 ​mmHg. At week 8, mean SBP change was −0.1 ​mmHg (placebo), +1.4 ​mmHg (phentermine 30 ​mg), and −3.3 ​mmHg (PHEN/TPM). Between-group difference for PHEN/TPM versus placebo was −3.2 ​mmHg (95 ​% CI: -5.48, -0.93 ​mmHg; p ​= ​0.0059). The between-group difference for PHEN/TPM versus phentermine 30 ​mg was −4.7 ​mmHg (95 ​% CI: −6.96, −2.45 ​mmHg; p ​< ​0.0001). Common (>2 ​% in any treatment group) adverse events (i.e., dry mouth, constipation, nausea, dizziness, paresthesia, dysgeusia, headache, COVID-19, urinary tract infection, insomnia, and anxiety) were mostly mild or moderate.

Conclusions

In this randomized, multicenter, double-blind ABPM study, PHEN/ TPM reduced SBP compared to either placebo or phentermine 30 mg (Funding: Vivus LLC; ClinicalTrials.gov: NCT05215418).

背景芬特明和缓释托吡酯的固定剂量组合(PHEN/TPM--获准用于体重管理)已证明可降低门诊血压(BP)。这项随机、多中心、双盲研究共招募了 565 名超重/肥胖成人。纳入标准包括愿意佩戴 ABPM 设备 24 小时的参与者。排除标准包括筛查血压为 140/90 mmHg,以及随机分组前 3 个月内服用的降压药物不稳定。参与者分别接受安慰剂(184 人)、芬特明 30 毫克(191 人)或 PHEN 15 毫克/TPM 92 毫克(190 人)治疗。在基线和第 8 周时进行 24 小时 ABPM。主要终点是通过 ABPM 测得的按方案人群的 24 小时平均收缩压 (SBP)。结果参加者大多为女性(73.5%)和白人(81.6%),平均年龄为 53.4 岁;32.4% 未确诊或接受过高血压治疗,62.5% 患有高血压,使用 0 至 2 种降压药物,5.1% 患有高血压,使用≥ 3 种降压药物。基线平均 SBP/ 舒张压 (DBP) 为 123.9/77.6 mmHg。第 8 周时,平均 SBP 变化为-0.1 mmHg(安慰剂)、+1.4 mmHg(芬特明 30 毫克)和-3.3 mmHg(PHEN/TPM)。PHEN/TPM 与安慰剂的组间差异为 -3.2 mmHg(95 % CI:-5.48, -0.93 mmHg;p = 0.0059)。PHEN/TPM 与芬特明 30 毫克的组间差异为-4.7 毫米汞柱(95 % CI:-6.96,-2.45 毫米汞柱;p = 0.0001)。常见的不良事件(占任何治疗组的 2%)(即结论在这项随机、多中心、双盲 ABPM 研究中,与安慰剂或芬特明 30 毫克(资助方:Vivus LLC;ClinicalTrials.gov:NCT05215418)相比,PHEN/ TPM 可降低 SBP。)
{"title":"Effects of phentermine / topiramate extended-release, phentermine, and placebo on ambulatory blood pressure monitoring in adults with overweight or obesity: A randomized, multicenter, double-blind study","authors":"Harold E. Bays ,&nbsp;Daniel S. Hsia ,&nbsp;Lan T. Nguyen ,&nbsp;Craig A. Peterson ,&nbsp;Santosh T. Varghese","doi":"10.1016/j.obpill.2024.100099","DOIUrl":"10.1016/j.obpill.2024.100099","url":null,"abstract":"<div><h3>Background</h3><p>A fixed-dose combination of phentermine and extended-release topiramate (PHEN/TPM - approved for weight management) has demonstrated in-clinic reduction of blood pressure (BP). Ambulatory BP monitoring (ABPM) may be a better predictor of cardiovascular disease risk than in-clinic BP.</p></div><div><h3>Methods</h3><p>This randomized, multicenter, double-blind study enrolled 565 adults with overweight/obesity. Inclusion criteria included participants willing to wear ABPM device for 24 h. Exclusion criteria included screening blood pressure &gt;140/90 mmHg and antihypertensive medications not stable for 3 months prior to randomization. Participants received placebo (n = 184), phentermine 30 mg; (n = 191), or PHEN 15 mg/TPM 92 mg; (n = 190). 24-hour ABPM was performed at baseline and at week 8. The primary endpoint was mean 24-h systolic BP (SBP) as measured by ABPM, in the per protocol population.</p></div><div><h3>Results</h3><p>Participants were mostly female (73.5 ​%) and White (81.6 ​%), with a mean age of 53.4 years; 32.4 ​% had no hypertension diagnosis or treatment, 62.5 ​% had hypertension using 0 to 2 antihypertensive medications, and 5.1 ​% had hypertension using ≥ 3 antihypertensive medications. Baseline mean SBP/diastolic BP (DBP) was 123.9/77.6 ​mmHg. At week 8, mean SBP change was −0.1 ​mmHg (placebo), +1.4 ​mmHg (phentermine 30 ​mg), and −3.3 ​mmHg (PHEN/TPM). Between-group difference for PHEN/TPM versus placebo was −3.2 ​mmHg (95 ​% CI: -5.48, -0.93 ​mmHg; p ​= ​0.0059). The between-group difference for PHEN/TPM versus phentermine 30 ​mg was −4.7 ​mmHg (95 ​% CI: −6.96, −2.45 ​mmHg; p ​&lt; ​0.0001). Common (&gt;2 ​% in any treatment group) adverse events (i.e., dry mouth, constipation, nausea, dizziness, paresthesia, dysgeusia, headache, COVID-19, urinary tract infection, insomnia, and anxiety) were mostly mild or moderate.</p></div><div><h3>Conclusions</h3><p>In this randomized, multicenter, double-blind ABPM study, PHEN/ TPM reduced SBP compared to either placebo or phentermine 30 mg (Funding: Vivus LLC; ClinicalTrials.gov: <span>NCT05215418</span><svg><path></path></svg>).</p></div>","PeriodicalId":100977,"journal":{"name":"Obesity Pillars","volume":"9 ","pages":"Article 100099"},"PeriodicalIF":0.0,"publicationDate":"2024-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S2667368124000019/pdfft?md5=af3a54e4dff0c78a5b9dd3deedb8b337&pid=1-s2.0-S2667368124000019-main.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139455543","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}
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Obesity Pillars
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