Seung-Hwan Lee, Kyung Ah Han, Eun-Gyoung Hong, Jun Goo Kang, Choon Hee Chung, Jong Chul Won, Eon Ju Jeon, Jung-Hwan Cho, Ho Chan Cho, Sin Gon Kim, Eun Seok Kang, So Hun Kim, Hae Jin Kim, In-Kyung Jeong, Sung Wan Chun, Young Min Cho
Aim: This study evaluated the efficacy and safety of empagliflozin 10 and 25 mg compared to placebo as add-on treatment for people with type 2 diabetes mellitus (T2DM) uncontrolled after ≥8 weeks of treatment with metformin and sitagliptin.
Materials and methods: A randomised, double-blind, multicentre, therapeutic confirmatory, phase 3 clinical trial was conducted in 172 patients with T2DM. Participants with glycosylated haemoglobin (HbA1c) levels 7%-10% receiving sitagliptin and metformin were randomised 1:1:1 to empagliflozin 10 mg, empagliflozin 25 mg, or placebo. The primary endpoint was the change in HbA1c from baseline to week 24.
Results: After 24 weeks of treatment, HbA1c levels were significantly decreased in the empagliflozin 10 and 25 mg group versus the placebo group; the adjusted mean differences with empagliflozin 10 and 25 mg versus placebo were -0.7% (95% CI -1.0, -0.4; p <.0001) and -0.8% (95% CI -1.1, -0.5; p <.0001), respectively. Fasting plasma glucose levels were also significantly decreased in both empagliflozin groups compared to the placebo group (both p <.0001). More patients reached HbA1c <7% or <6.5% after 24 weeks in the empagliflozin 10 and 25 mg groups versus the placebo group (both p <.05). Efficacy was maintained in the empagliflozin groups during a 28-week extension period. Empagliflozin add-on was associated with improvements in albuminuria and body weight. The incidence of adverse events was similar across groups; add-on empagliflozin was well tolerated.
Conclusions: These results suggest that coadministration of empagliflozin safely improves glycemic control in Korean patients with T2DM uncontrolled by sitagliptin and metformin.
{"title":"Efficacy and safety of combining empagliflozin in people with type 2 diabetes mellitus uncontrolled with metformin and sitagliptin: A randomised, double-blind, multicentre, therapeutic confirmatory phase 3 clinical trial.","authors":"Seung-Hwan Lee, Kyung Ah Han, Eun-Gyoung Hong, Jun Goo Kang, Choon Hee Chung, Jong Chul Won, Eon Ju Jeon, Jung-Hwan Cho, Ho Chan Cho, Sin Gon Kim, Eun Seok Kang, So Hun Kim, Hae Jin Kim, In-Kyung Jeong, Sung Wan Chun, Young Min Cho","doi":"10.1111/dom.70386","DOIUrl":"https://doi.org/10.1111/dom.70386","url":null,"abstract":"<p><strong>Aim: </strong>This study evaluated the efficacy and safety of empagliflozin 10 and 25 mg compared to placebo as add-on treatment for people with type 2 diabetes mellitus (T2DM) uncontrolled after ≥8 weeks of treatment with metformin and sitagliptin.</p><p><strong>Materials and methods: </strong>A randomised, double-blind, multicentre, therapeutic confirmatory, phase 3 clinical trial was conducted in 172 patients with T2DM. Participants with glycosylated haemoglobin (HbA1c) levels 7%-10% receiving sitagliptin and metformin were randomised 1:1:1 to empagliflozin 10 mg, empagliflozin 25 mg, or placebo. The primary endpoint was the change in HbA1c from baseline to week 24.</p><p><strong>Results: </strong>After 24 weeks of treatment, HbA1c levels were significantly decreased in the empagliflozin 10 and 25 mg group versus the placebo group; the adjusted mean differences with empagliflozin 10 and 25 mg versus placebo were -0.7% (95% CI -1.0, -0.4; p <.0001) and -0.8% (95% CI -1.1, -0.5; p <.0001), respectively. Fasting plasma glucose levels were also significantly decreased in both empagliflozin groups compared to the placebo group (both p <.0001). More patients reached HbA1c <7% or <6.5% after 24 weeks in the empagliflozin 10 and 25 mg groups versus the placebo group (both p <.05). Efficacy was maintained in the empagliflozin groups during a 28-week extension period. Empagliflozin add-on was associated with improvements in albuminuria and body weight. The incidence of adverse events was similar across groups; add-on empagliflozin was well tolerated.</p><p><strong>Conclusions: </strong>These results suggest that coadministration of empagliflozin safely improves glycemic control in Korean patients with T2DM uncontrolled by sitagliptin and metformin.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-12-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145792892","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Aims: To evaluate the prognostic value of serum albumin (ALB), glycated albumin (GA), and the GA-to-ALB ratio (%GA) for survival outcomes in individuals with cardiovascular-kidney-metabolic (CKM) syndrome.
Materials and methods: This study included 4524 adult participants with CKM syndrome stages 0-3 from the National Health and Nutrition Examination Survey (1999-2004), with linked mortality information available through 2019. Multivariable Cox regression models and subgroup analyses were used to evaluate hazard ratios (HRs) and 95% confidence intervals (CIs) for mortality. Restricted cubic spline (RCS) models were used to assess nonlinear associations. Time-dependent ROC curves and random survival forest (RSF) models determined the predictive accuracy of serum ALB, GA, and %GA for survival outcomes.
Results: During the median follow-up of 17.6 years, 1032 deaths occurred, including 281 from cardiovascular-cerebrovascular disease (CCD). Higher %GA was associated with increased risk of all-cause (HR = 1.59; 95% CI: 1.17-2.15) and CCD mortality (HR = 1.94; 95% CI: 1.07-3.53), while higher ALB levels were consistently associated with lower all-cause mortality risk. Absolute GA was not independently associated with either outcome after multivariable adjustment. ROC curve analysis and RSF models revealed that %GA was the most robust marker among the three for long-term mortality risk, with consistent results across 5-, 10-, and 15-year follow-up periods.
Conclusions: This study indicated that higher %GA levels were associated with increased all-cause and CCD mortality risk, supporting the potential predictive value of %GA for the early identification and stratification of mortality risk in CKM stages 0-3.
目的:评估血清白蛋白(ALB)、糖化白蛋白(GA)和GA / ALB比值(%GA)对心血管-肾-代谢(CKM)综合征患者生存结局的预后价值。材料和方法:本研究包括4524名CKM综合征0-3期成人参与者,来自1999-2004年国家健康与营养调查(National Health and Nutrition Examination Survey),相关死亡率信息可获得至2019年。采用多变量Cox回归模型和亚组分析评估死亡率的风险比(hr)和95%置信区间(ci)。限制三次样条(RCS)模型用于评估非线性关联。随时间变化的ROC曲线和随机生存森林(RSF)模型确定了血清ALB、GA和%GA对生存结果的预测准确性。结果:在17.6年的中位随访期间,发生1032例死亡,其中281例死于心脑血管疾病(CCD)。较高的GA %与全因死亡率(HR = 1.59; 95% CI: 1.17-2.15)和CCD死亡率(HR = 1.94; 95% CI: 1.07-3.53)增加相关,而较高的ALB水平始终与较低的全因死亡率相关。经多变量调整后,绝对GA与两种结果均无独立相关性。ROC曲线分析和RSF模型显示,%GA是三种长期死亡风险中最可靠的标志物,在5年、10年和15年的随访期间结果一致。结论:本研究表明,较高的%GA水平与全因死亡风险和CCD死亡风险增加相关,支持%GA对CKM 0-3期早期识别和死亡风险分层的潜在预测价值。
{"title":"Serum glycated albumin-to-albumin ratio and mortality risk in cardiovascular-kidney-metabolic syndrome: Evidence from NHANES over 15 years.","authors":"Zhichao Li, Man Chen","doi":"10.1111/dom.70387","DOIUrl":"https://doi.org/10.1111/dom.70387","url":null,"abstract":"<p><strong>Aims: </strong>To evaluate the prognostic value of serum albumin (ALB), glycated albumin (GA), and the GA-to-ALB ratio (%GA) for survival outcomes in individuals with cardiovascular-kidney-metabolic (CKM) syndrome.</p><p><strong>Materials and methods: </strong>This study included 4524 adult participants with CKM syndrome stages 0-3 from the National Health and Nutrition Examination Survey (1999-2004), with linked mortality information available through 2019. Multivariable Cox regression models and subgroup analyses were used to evaluate hazard ratios (HRs) and 95% confidence intervals (CIs) for mortality. Restricted cubic spline (RCS) models were used to assess nonlinear associations. Time-dependent ROC curves and random survival forest (RSF) models determined the predictive accuracy of serum ALB, GA, and %GA for survival outcomes.</p><p><strong>Results: </strong>During the median follow-up of 17.6 years, 1032 deaths occurred, including 281 from cardiovascular-cerebrovascular disease (CCD). Higher %GA was associated with increased risk of all-cause (HR = 1.59; 95% CI: 1.17-2.15) and CCD mortality (HR = 1.94; 95% CI: 1.07-3.53), while higher ALB levels were consistently associated with lower all-cause mortality risk. Absolute GA was not independently associated with either outcome after multivariable adjustment. ROC curve analysis and RSF models revealed that %GA was the most robust marker among the three for long-term mortality risk, with consistent results across 5-, 10-, and 15-year follow-up periods.</p><p><strong>Conclusions: </strong>This study indicated that higher %GA levels were associated with increased all-cause and CCD mortality risk, supporting the potential predictive value of %GA for the early identification and stratification of mortality risk in CKM stages 0-3.</p>","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145766713","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Kamlesh Khunti, Matt Capehorn, Esther Artime, Lill-Brith von Arx, Alun L Davies, Atif Adam, Anastasia Lampropoulou
<p><strong>Aims: </strong>The multi-country epIdeMiology landscape PAtient Care paThways of Obesity (IMPACT-O) retrospective cohort study utilised existing electronic medical records to gather data on overweight and obesity. We report UK data on obesity-related complications (ORCs) and management strategies.</p><p><strong>Materials and methods: </strong>The UK IQVIA Medical Research Database, The Health Improvement Network database, includes routine data from UK primary care. Outcomes analysed included sociodemographic and clinical characteristics, ORCs and treatments for three cohorts: adults (≥18 years) with a new record of overweight or obesity (body mass index [BMI] ≥25 kg/m<sup>2</sup>; overweight/obesity cohort) or obesity (BMI ≥30 kg/m<sup>2</sup>; obesity cohort) identified by BMI recordings and/or diagnosis codes, and adults with ≥1 recorded interventions with an effect on weight (intervention cohort) between 2018 and 2022.</p><p><strong>Results: </strong>There were 73 279 adults in the overweight/obesity cohort, 62 226 adults in the obesity cohort and 343 755 adults in the intervention cohort. Most adults had ≥1 ORC with a numerically higher proportion of ORCs recorded in the obesity cohort (58.4%) than in the overweight/obesity cohort (48.0%). For the intervention cohort, 77.0% had ≥1 ORC. Lifestyle interventions were recorded for 96.8% of this cohort, followed by pharmacological therapies with an effect on weight (glucagon-like peptide-1 receptor agonists, 3.6%; orlistat, 2.5%), and bariatric surgery (0.3%).</p><p><strong>Conclusions: </strong>Results confirm the high burden of ORCs in adults at first identification of overweight or obesity in primary care and the limited use of pharmacotherapy and bariatric surgery; this suggests a need to evaluate treatment strategies and support for people with overweight and obesity in the UK.</p><p><strong>Plain language summary: </strong>What is the context and purpose of this research study? Health-related information recorded in electronic medical records during visits to your doctor can help increase understanding of the impact of overweight and obesity in healthcare settings. What was done? The epIdeMiology landscape and PAtient Care paThways of Obesity (IMPACT-O) was a study conducted in selected countries in Europe and the Asia-Pacific region that used information from existing healthcare records to report the impact of overweight and obesity. This paper reports the results from the UK part of the study, using information provided by general practitioners. Data on social, demographic and health-related characteristics of people with overweight and obesity were collected for adults (at least 18 years of age) at the time their first record of overweight or obesity was recorded, either with a diagnosis from the doctor or a body mass index (BMI) of ≥25 kg/m<sup>2</sup> (overweight/obesity group) or ≥30 kg/m<sup>2</sup> (obesity group) and for adults with at least one record indicating the use
目的:多国流行病学景观肥胖患者护理路径(IMPACT-O)回顾性队列研究利用现有的电子医疗记录收集超重和肥胖的数据。我们报告了英国关于肥胖相关并发症(ORCs)和管理策略的数据。材料和方法:英国IQVIA医学研究数据库,健康改善网络数据库,包括来自英国初级保健的常规数据。分析的结果包括三个队列的社会人口学和临床特征、orc和治疗方法:通过BMI记录和/或诊断代码确定有超重或肥胖新记录的成年人(≥18岁)(体重指数[BMI]≥25 kg/m2;超重/肥胖队列)或肥胖(BMI≥30 kg/m2;肥胖队列),以及在2018年至2022年期间记录有对体重影响的干预措施≥1项的成年人(干预队列)。结果:超重/肥胖组有73 279人,肥胖组有62 226人,干预组有343 755人。大多数成年人的ORC≥1,肥胖组的ORC比例(58.4%)高于超重/肥胖组(48.0%)。在干预组中,77.0%的患者ORC≥1。96.8%的人记录了生活方式干预,其次是对体重有影响的药物治疗(胰高血糖素样肽-1受体激动剂,3.6%;奥利司他,2.5%)和减肥手术(0.3%)。结论:结果证实了在初级保健中首次发现超重或肥胖的成年人ORCs的高负担以及药物治疗和减肥手术的有限使用;这表明有必要评估英国超重和肥胖人群的治疗策略和支持。摘要:本研究的背景和目的是什么?在看医生期间,电子医疗记录中记录的与健康相关的信息有助于提高对医疗机构中超重和肥胖影响的理解。做了什么?肥胖的流行病学景观和患者护理途径(impact - o)是一项在欧洲和亚太地区选定的国家进行的研究,该研究使用现有医疗记录的信息来报告超重和肥胖的影响。本文报告了英国部分研究的结果,使用了全科医生提供的信息。数据在社会、人口和健康相关的特点,成人超重和肥胖的人收集(至少18岁)他们的第一张唱片时超重或肥胖的记录,医生的诊断或身体质量指数(BMI)≥25 kg / m2(超重/肥胖组)或≥30 kg / m2(肥胖组)和至少一个记录显示为成人使用的减肥方法(干预组)。主要结果是什么?参与研究的大多数成年人至少有一种与肥胖相关的额外疾病,肥胖组的人比超重/肥胖组的人有更多的额外肥胖相关疾病。最常见的与肥胖相关的额外疾病是肥胖组的高血压和超重/肥胖组的抑郁症。在记录减肥方法的小组中,每四个成年人中就有三个至少有一种额外的肥胖相关疾病。该组成人平均BMI为29.0 kg/m2。生活方式的改变,如饮食和运动,被记录在这一组中几乎所有的成年人身上,随后是对体重有影响的药物治疗(如胰高血糖素样肽-1受体激动剂和奥利司他),以及减肥手术。这项研究的原创性和相关性是什么?研究结果证实,当成年人在初级保健中首次正式记录超重或肥胖时,他们已经受到肥胖相关疾病的严重影响。只有少数超重或肥胖的成年人有药物或手术减肥管理的记录。这些结果意味着英国有必要加强对这些成年人的监控。
{"title":"Burden of long-term conditions and management of people with overweight and obesity: Data from the United Kingdom primary care cohort of the IMPACT-O study.","authors":"Kamlesh Khunti, Matt Capehorn, Esther Artime, Lill-Brith von Arx, Alun L Davies, Atif Adam, Anastasia Lampropoulou","doi":"10.1111/dom.70345","DOIUrl":"10.1111/dom.70345","url":null,"abstract":"<p><strong>Aims: </strong>The multi-country epIdeMiology landscape PAtient Care paThways of Obesity (IMPACT-O) retrospective cohort study utilised existing electronic medical records to gather data on overweight and obesity. We report UK data on obesity-related complications (ORCs) and management strategies.</p><p><strong>Materials and methods: </strong>The UK IQVIA Medical Research Database, The Health Improvement Network database, includes routine data from UK primary care. Outcomes analysed included sociodemographic and clinical characteristics, ORCs and treatments for three cohorts: adults (≥18 years) with a new record of overweight or obesity (body mass index [BMI] ≥25 kg/m<sup>2</sup>; overweight/obesity cohort) or obesity (BMI ≥30 kg/m<sup>2</sup>; obesity cohort) identified by BMI recordings and/or diagnosis codes, and adults with ≥1 recorded interventions with an effect on weight (intervention cohort) between 2018 and 2022.</p><p><strong>Results: </strong>There were 73 279 adults in the overweight/obesity cohort, 62 226 adults in the obesity cohort and 343 755 adults in the intervention cohort. Most adults had ≥1 ORC with a numerically higher proportion of ORCs recorded in the obesity cohort (58.4%) than in the overweight/obesity cohort (48.0%). For the intervention cohort, 77.0% had ≥1 ORC. Lifestyle interventions were recorded for 96.8% of this cohort, followed by pharmacological therapies with an effect on weight (glucagon-like peptide-1 receptor agonists, 3.6%; orlistat, 2.5%), and bariatric surgery (0.3%).</p><p><strong>Conclusions: </strong>Results confirm the high burden of ORCs in adults at first identification of overweight or obesity in primary care and the limited use of pharmacotherapy and bariatric surgery; this suggests a need to evaluate treatment strategies and support for people with overweight and obesity in the UK.</p><p><strong>Plain language summary: </strong>What is the context and purpose of this research study? Health-related information recorded in electronic medical records during visits to your doctor can help increase understanding of the impact of overweight and obesity in healthcare settings. What was done? The epIdeMiology landscape and PAtient Care paThways of Obesity (IMPACT-O) was a study conducted in selected countries in Europe and the Asia-Pacific region that used information from existing healthcare records to report the impact of overweight and obesity. This paper reports the results from the UK part of the study, using information provided by general practitioners. Data on social, demographic and health-related characteristics of people with overweight and obesity were collected for adults (at least 18 years of age) at the time their first record of overweight or obesity was recorded, either with a diagnosis from the doctor or a body mass index (BMI) of ≥25 kg/m<sup>2</sup> (overweight/obesity group) or ≥30 kg/m<sup>2</sup> (obesity group) and for adults with at least one record indicating the use ","PeriodicalId":158,"journal":{"name":"Diabetes, Obesity & Metabolism","volume":" ","pages":""},"PeriodicalIF":5.7,"publicationDate":"2025-12-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145773001","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}