Liraglutide

利拉鲁肽
  • 文章类型: Journal Article
    目的:本指南(GL)旨在为超重或肥胖与代谢并发症相关且对生活方式改变有抵抗力的成年患者的管理提供临床实践参考。
    方法:外科医生,内分泌学家,胃肠病学家,心理学家,药理学家,全科医生,营养学家,一名护士和一名患者代表充当多学科小组。本总账是根据建议评估等级制定的,开发和评估(等级)方法。由一个方法学组进行系统评价和网络荟萃分析。对于每个问题,小组确定了潜在的相关结果,然后对它们对治疗选择的影响进行评级。在对证据的系统评价中,仅考虑了分类为“关键”和“重要”的结果。那些被归类为“关键”的被认为是临床实践建议。通过多数票达成了关于建议的方向(赞成或反对)和强度(有力或有条件)的共识。
    结果:本GL为BMI>27kg/m2和<40kg/m2与体重相关的代谢合并症相关的成年患者人群的临床管理提供了药物和手术治疗的建议。抵制生活方式的改变。小组:建议及时实施治疗干预措施,除了饮食和体力活动;建议使用semaglutide2.4毫克/周,并建议利拉鲁肽3毫克/天的肥胖或超重患者也受糖尿病或糖尿病前期影响;建议semaglutide2.4毫克/周的肥胖或超重患者也受非酒精性脂肪肝影响;建议semagluttide2.4毫克/周作为超重或超重患者的高甘油三酯降低的患者的一剂情绪化饮食;建议手术干预(袖状胃切除术,Roux-en-Y胃旁路术,对于BMI≥35kg/m2的患者,适合进行代谢手术的患者,或代谢性胃旁路术/单次吻合胃旁路术/胃微型旁路术;并建议尽可能进行胃束带术,虽然效果较差,手术替代方案。
    结论:当前的GL针对所有在医院工作的肥胖患者的医生,领土服务或私人执业-以及全科医生和患者。建议还应考虑患者的偏好以及可用的资源和专业知识。
    OBJECTIVE: This guideline (GL) is aimed at providing a clinical practice reference for the management of adult patients with overweight or obesity associated with metabolic complications who are resistant to lifestyle modification.
    METHODS: Surgeons, endocrinologists, gastroenterologists, psychologists, pharmacologists, a general practitioner, a nutritionist, a nurse and a patients\' representative acted as multi-disciplinary panel. This GL has been developed following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. A systematic review and network meta-analysis was performed by a methodologic group. For each question, the panel identified potentially relevant outcomes, which were then rated for their impact on therapeutic choices. Only outcomes classified as \"critical\" and \"important\" were considered in the systematic review of evidence. Those classified as \"critical\" were considered for clinical practice recommendations. Consensus on the direction (for or against) and strength (strong or conditional) of recommendations was reached through a majority vote.
    RESULTS: The present GL provides recommendations about the role of both pharmacological and surgical treatment for the clinical management of the adult patient population with BMI > 27 kg/m2 and < 40 kg/m2 associated with weight-related metabolic comorbidities, resistant to lifestyle changes. The panel: suggests the timely implementation of therapeutic interventions in addition to diet and physical activity; recommends the use of semaglutide 2.4 mg/week and suggests liraglutide 3 mg/day in patients with obesity or overweight also affected by diabetes or pre-diabetes; recommends semaglutide 2.4 mg/week in patients with obesity or overweight also affected by non-alcoholic fatty liver disease; recommends semaglutide 2.4 mg/week as first-line drug in patients with obesity or overweight that require a larger weight loss to reduce comorbidities; suggests the use of orlistat in patients with obesity or overweight also affected by hypertriglyceridemia that assume high-calorie and high-fat diet; suggests the use of naltrexone/bupropion combination in patients with obesity or overweight, with emotional eating; recommends surgical intervention (sleeve gastrectomy, Roux-en-Y gastric bypass, or metabolic gastric bypass/gastric bypass with single anastomosis/gastric mini bypass in patients with BMI ≥ 35 kg/m2 who are suitable for metabolic surgery; and suggests gastric banding as a possible, though less effective, surgical alternative.
    CONCLUSIONS: The present GL is directed to all physicians addressing people with obesity-working in hospitals, territorial services or private practice-and to general practitioners and patients. The recommendations should also consider the patient\'s preferences and the available resources and expertise.
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  • 文章类型: Practice Guideline
    肥胖的药物管理可改善预后并降低肥胖相关并发症的风险。该美国胃肠病学协会指南旨在支持从业人员做出有关超重和肥胖的药物干预措施的决定。
    由内容专家和指南方法学家组成的多学科小组使用了建议评估的分级,开发和评估框架,以优先考虑临床问题,确定以患者为中心的结果,并对以下药物进行证据合成:司马鲁肽2.4毫克,利拉鲁肽3.0mg,苯丁胺-托吡酯缓释(ER),纳曲酮-安非他酮,奥利司他,芬特明,二乙基丙酸,和Gelesis100口服超吸收水凝胶。指南小组使用证据决策框架来制定肥胖的药理学管理建议,并为临床实践提供实施考虑因素。
    指南小组提出了9条建议。专家组强烈建议对超重和肥胖(体重指数≥30kg/m2或体重相关并发症≥27kg/m2)的成年人对生活方式干预反应不足的成年人,除生活方式干预外,还应使用药物治疗。小组建议使用司马鲁肽2.4毫克,利拉鲁肽3.0mg,苯丁胺-托吡酯ER,和纳曲酮-安非他酮ER(基于中等确定性证据),和苯丁胺和二乙基丙酸(基于低确定性证据),用于超重和肥胖的长期管理。指南小组建议不要使用奥利司他。小组确定了使用Gelesis100口服超吸收水凝胶作为知识空白。
    在超重和肥胖的成年人中,仅对生活方式干预反应不足,建议长期药物治疗,具有多种有效和安全的治疗选择。
    Pharmacological management of obesity improves outcomes and decreases the risk of obesity-related complications. This American Gastroenterological Association guideline is intended to support practitioners in decisions about pharmacological interventions for overweight and obesity.
    A multidisciplinary panel of content experts and guideline methodologists used the Grading of Recommendations Assessment, Development and Evaluation framework to prioritize clinical questions, identify patient-centered outcomes, and conduct an evidence synthesis of the following agents: semaglutide 2.4 mg, liraglutide 3.0 mg, phentermine-topiramate extended-release (ER), naltrexone-bupropion ER, orlistat, phentermine, diethylpropion, and Gelesis100 oral superabsorbent hydrogel. The guideline panel used the evidence-to-decision framework to develop recommendations for the pharmacological management of obesity and provided implementation considerations for clinical practice.
    The guideline panel made 9 recommendations. The panel strongly recommended the use of pharmacotherapy in addition to lifestyle intervention in adults with overweight and obesity (body mass index ≥30 kg/m2, or ≥27 kg/m2 with weight-related complications) who have an inadequate response to lifestyle interventions. The panel suggested the use of semaglutide 2.4 mg, liraglutide 3.0 mg, phentermine-topiramate ER, and naltrexone-bupropion ER (based on moderate certainty evidence), and phentermine and diethylpropion (based on low certainty evidence), for long-term management of overweight and obesity. The guideline panel suggested against the use of orlistat. The panel identified the use of Gelesis100 oral superabsorbent hydrogel as a knowledge gap.
    In adults with overweight and obesity who have an inadequate response to lifestyle interventions alone, long-term pharmacological therapy is recommended, with multiple effective and safe treatment options.
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  • 文章类型: Editorial
    非酒精性脂肪性肝病(NAFLD)是一种非常普遍的疾病和未满足的临床需求,我们最近提出将其更名为脂肪肝(FLD),以简化和准确。具有特定的子分类。它通常与代谢合并症有关,包括肥胖,2型糖尿病(T2D),高血压,和高脂血症。由于迄今为止没有联邦和药物管理局(FDA)批准的治疗方法,最近的指南推荐生活方式干预,减肥手术,和药物治疗,即胰高血糖素样肽-1受体激动剂(GLP-1RA),过氧化物酶体增殖物激活受体-γ(PPAR-γ)激动剂,和SGLT-2抑制剂用于其治疗。一种治疗T2D的新药物,泰西帕肽,一个双GIP/GLP-1RA,在指南发布一周后才获得FDA的批准,和正在进行的临床试验表明,不仅对T2D,而且对体重和脂肪变性都有希望的结果。此外,我们意识到在FLD的保护下存在不同的子组,因此,需要更精确的治疗建议,以实现针对这些亚组的个性化医疗和治疗的目标.由于代谢领域进展非常快,并且在可预见的未来,几种分子在发展中很可能在NAFLD治疗中显示出益处,指南需要经常更新。这种快速的变化促使我们提出,准则应作为生活在线文件存在于专业协会的网站上,以便它们继续被更新,并反映出这一医学领域和其他医学领域的快速进展。
    Non-Alcoholic Fatty Liver Disease (NAFLD) is a highly prevalent disease and unmet clinical need that we have recently proposed to be renamed for simplicity and accuracy as Fatty Liver Disease (FLD), with specific subclassifications. It has been commonly associated with metabolic comorbidities, including obesity, type 2 diabetes (T2D), hypertension, and hyperlipidemia. Since no Federal and Drug Administration (FDA) approved treatments exist to date, recent guidelines recommend lifestyle interventions, bariatric surgery, and pharmacotherapy, i.e. glucagon-like peptide-1 receptor agonists (GLP-1RA), peroxisome proliferator-activated receptor-γ (PPAR-γ) agonists, and SGLT-2 inhibitors for its treatment. A new and novel medication for the treatment of T2D, tirzepatide, a dual GIP/GLP-1RA, was approved by the FDA only one week after guidelines were published, and ongoing clinical trials demonstrate promising results not only for T2D but also for body weight and steatosis. Moreover, we realize that distinct subgroups exist under the umbrella of FLD and, thus, more precise therapeutic recommendations would be needed towards the goal of personalized medicine and therapeutics for these subgroups. As the metabolism field is moving forward very fast and as several molecules in development will most likely demonstrate benefits in NAFLD treatment in the foreseeable future, guidelines will need to be frequently updated. This rapid pace of change prompts us to propose that guidelines should exist as living online documents on the websites of professional societies, so that they continue being updated following and reflecting the rapid progress in this and other fields of medicine.
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  • 文章类型: Journal Article
    2008年,美国食品和药物管理局要求新的2型糖尿病(T2D)药物必须符合心血管结局安全要求。因此,全球LEADER试验调查了利拉鲁肽治疗T2D的心血管结局,胰高血糖素样肽-1受体激动剂。LEADER(NCT01179048)是一项从2010年至2016年进行的多区域临床试验(MRCT),在2017年国际协调理事会(ICH)关于MRCT的E17指南发布之前完成。诺和诺德预先指定的LEADER参与者区域心血管结局分析。本文根据ICHE17一致性评价指南对预先指定的区域结果进行评估。区域LEADER参与者人数与ICHE17指南大致一致,在整个欧洲同样平衡,亚洲,北美,和世界其他地方。试验的总体主要不良心血管事件(MACE)复合结局:风险比(HR)(95%CI)0.87(0.78;0.97);区域结果各不相同,范围从HR(95%CI)0.62(0.37;1.04)(亚洲)到1.01(0.84;1.22)(北美)。然而,预先指定的Cox比例风险回归分析未显示区域与主要结局之间相互作用的明确证据(p=0.20).此外,对北美地区美国人口的事后分析发现,调整外在或内在因素并不能解释这一差异[HR(95%CI)1.03(0.84;1.25)].LEADER数据评估表明,不同地区的心血管安全总体上是一致的,除了美国的参与者。北美地区的差异可能与药物暴露或机会有关,但是,因为这些是事后调查结果,总体主要结果是有效的,符合ICHE17指南。
    The US Food and Drug Administration in 2008 required new type 2 diabetes (T2D) medications to be subject to cardiovascular outcomes safety requirements. Accordingly, the global LEADER trial investigated cardiovascular outcomes of T2D treatment with liraglutide, a glucagon-like peptide-1 receptor agonist. LEADER (NCT01179048) was a multiregional clinical trial (MRCT) conducted from 2010 to 2016, thus completed before publication of the International Council for Harmonization (ICH) E17 guideline on MRCTs in 2017. Novo Nordisk pre-specified analysis of regional cardiovascular outcomes of LEADER participants. This paper assesses the pre-specified regional outcomes based on the ICH E17 guidelines on consistency evaluation. Regional LEADER participant numbers were broadly aligned with ICH E17 guidance and equally balanced across Europe, Asia, North America, and rest of the world. Overall primary major adverse cardiovascular events (MACE) composite outcome for the trial: hazard ratio (HR) (95% CI) 0.87 (0.78; 0.97); regional results varied, ranging from HR (95% CI) 0.62 (0.37; 1.04) (Asia) to 1.01 (0.84; 1.22) (North America). However, pre-specified Cox proportional-hazard regression analyses did not show clear evidence of interaction between regions and primary outcome (p = 0.20). Furthermore, post hoc analysis of the US population in the North American region found that adjusting for extrinsic or intrinsic factors did not account for this difference [HR (95% CI) 1.03 (0.84; 1.25)]. LEADER data evaluation demonstrated general consistency in cardiovascular safety across regions, except for US participants. Discrepancies in the North American region may relate to drug exposure or chance, but, as these were post hoc findings, the overall primary result is valid, aligned with ICH E17 guidelines.
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  • 文章类型: Journal Article
    The American Diabetes Association and the European Association for the Study of Diabetes convened a panel to update the prior position statements, published in 2012 and 2015, on the management of type 2 diabetes in adults. A systematic evaluation of the literature since 2014 informed new recommendations. These include additional focus on lifestyle management and diabetes self-management education and support. For those with obesity, efforts targeting weight loss, including lifestyle, medication and surgical interventions, are recommended. With regards to medication management, for patients with clinical cardiovascular disease, a sodium-glucose cotransporter-2 (SGLT2) inhibitor or a glucagon-like peptide-1 (GLP-1) receptor agonist with proven cardiovascular benefit is recommended. For patients with chronic kidney disease or clinical heart failure and atherosclerotic cardiovascular disease, an SGLT2 inhibitor with proven benefit is recommended. GLP-1 receptor agonists are generally recommended as the first injectable medication.
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    文章类型: Journal Article
    In an effort to facilitate the widest possible application of recent findings in diabetology and the related medical fields, with regard to characteristics of medicines and current possibilities of using modern procedures, but also to their limitations due to the financial capacities of health insurance companies, SDS innovates its therapeutic recommendations for the treatment of diabetes mellitus on a regular basis. The most recent recommendations were issued by SDS in August 2016. The review discusses and describes several factors which the authors considered during their preparation: (1) Compliance with the findings of evidence-based medicine, compliance with reference recommendations (therapeutic recommendations ADA/EASD), compliance with summary characteristics of active substances in the treatment of diabetes mellitus and approved possibilities of their use, and compliance with indica-tive restrictions (IO) which define medical and economic conditions for health insurance covered treatment. (2) Certain departure from the \"glucocentric\" approach to therapy, in favour of the approach preferring the selection of drugs based on clinical characteristics of the patient and proven benefits/risks of individual drugs (3) Preference of groups as well as individual active substances within groups based on evidence medicine regarding the individual active substances for specific patient groups. (4) Emphasis on individualization of goals for glycemic control (5) Emphasis on the right classification of diabetes mellitus as the basic condition for the selection of an optimum thera-peutic procedure, and (6) Emphasis on education and overcoming of clinical inertia, and patient medication adherence and medication \"literacy\" as the basic condition for successful therapy. The discussion also considers the outcomes of the most recent studies including of the studies focusing on empagliflozin and liraglutide, as well as recent modifications of the therapeutic recommendations of the American and Canadian Diabetes Association.Key words: type 2 diabetes mellitus - therapeutic recommendations - algorithm - empagliflozin - liraglutide.
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  • 文章类型: Journal Article
    BACKGROUND: Type 2 diabetes mellitus (DM2) is a disease of epidemic proportions. In the adult Spanish population, prevalence of DM2 is nearly 14%, which makes its monitoring and treatment imperative. Liraglutide has achieved relevance due to its efficacy and safety in DM treatment. The aim of this study is to gather expert opinion on diabetes to assess the current role of liraglutide in DM2.
    METHODS: The survey was performed by 57 internal medicine specialists using the Delphi method. The questionnaire had 56 items regarding liraglutide in DM treatment.
    RESULTS: Consensus was reached in 71.4% of items. Panelists stated agreement regarding liraglutide suitability in the treatment of patients with DM2, high cardiovascular risk, and with pathologies related to obesity, highlighting its role in weight loss, low risk of hypoglycemia, and improvement of vascular risks. Moreover, consensus was not reached regarding the suitability of liraglutide in patients with special situations, mainly due to minimal experience caused by the small number of patients.
    CONCLUSIONS: Due to its safety and hypoglycemic efficacy, liraglutide is an excellent choice for DM treatment in combination with other drugs. Its effects on the reduction of weight and other cardiovascular risk factors, make it an optimal treatment, especially in overweight or obese patients.
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  • DOI:
    文章类型: Journal Article
    This guidance is an update to the South Asian Consensus Guideline: Use of GLP1RA in Diabetes during Ramadan, published in the Indian Journal of Endocrinology and Metabolism in 2012. A five country working group has collated evidence and experience to suggest guidelines for the safe and rational use of glucagon-like peptide1 receptor agonists during Ramadan. The suggestions contained herewith are based upon recently published evidence as well as available basic pharmacological data.
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  • 文章类型: Journal Article
    暂无摘要。
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  • 文章类型: Journal Article
    斋月是阴历月,在此期间,世界各地的穆斯林迅速观察仪式。这不仅对希望观察禁食的糖尿病患者而且对管理他的糖尿病的医疗保健专业人员提供了挑战。挑战是使用有效维持良好的血糖控制并且同时在没有卡路里摄入的几个小时期间具有低的引起低血糖的倾向的疗法。GLP-1类似物是独特的药剂,其在低血糖风险非常低的情况下有效地提供血糖降低,并且因此在斋月期间的糖尿病管理中找到重要的位置。这份共识声明描述了斋月前的评估,规划,对服用GLP-1类似物的患者进行处方、管理和监测,有或没有其他抗糖尿病疗法。
    Ramadan is a lunar based month, during which Muslims across the world observe the ritual fast. This provides a challenge not only to the diabetic patient who wishes to observe the fast but also to the health care professional managing his diabetes. The challenge is to use therapies which are effective in maintaining good glycemic control and at the same time have a low propensity to cause hypoglycemia during the several hours of no calorie intake. The GLP-1 analogues are unique agents which are effective in providing glycemic reduction with a very low risk of hypoglycemia and hence find an important place in the management of diabetes during Ramadan. This Consensus Statement describes the pre-Ramadan assessment, planning, prescription and management and monitoring of patients who are on GLP-1 analogues, with or without other antidiabetic therapies.
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