Aleksandrina Ruseva, Wojciech Michalak, Zhenxiang Zhao, Anthony Fabricatore, Bríain Ó Hartaigh, Devika Umashanker
{"title":"塞马鲁肽 2.4 毫克在实际环境中对肥胖或超重患者的临床疗效:美国一项为期 6 个月的回顾性研究 (SCOPE)。","authors":"Aleksandrina Ruseva, Wojciech Michalak, Zhenxiang Zhao, Anthony Fabricatore, Bríain Ó Hartaigh, Devika Umashanker","doi":"10.1002/osp4.737","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Management guidelines for obesity suggest maintaining a minimum of 5% body weight reduction to help prevent or lower the risk of developing conditions such as hypertension and type 2 diabetes. However, achieving long-term weight control is difficult with lifestyle modification alone, making it essential to combine pharmacotherapy with diet and exercise in individual cases. Semaglutide 2.4 mg has demonstrated significant reductions in body weight and cardiometabolic risk factors in clinical trials, but information on outcomes in a real-world setting is limited.</p><p><strong>Objective: </strong>To assess changes in body weight and other clinical outcomes at 6-month follow-up among adults on semaglutide 2.4 mg in a real-world setting in the United States (US).</p><p><strong>Methods: </strong>Observational and retrospective cohort study of patients initiating treatment between 15 June 2021, and 31 March 2022, using a large US claims-linked electronic health record database.</p><p><strong>Results: </strong>Mean (±SD) body mass index (BMI) of the 343 patients included in the analysis was 37.9 ± 5.5 kg/m<sup>2</sup>. After 6 months, mean body weight change was -10.5 ± 6.8 kg (95% CI: -11.2; -9.8, <i>p</i> < 0.001) and mean percentage body weight change was -10.0% ± 6.6% (95% CI: -10.7; -9.3, <i>p</i> < 0.001). Most (79.0%) patients had ≥5% body weight reduction, 48.1% had ≥10% body weight reduction, and 19.0% had ≥15% body weight reduction. Among patients with available data, the mean change in HbA1c (<i>n</i> = 30) was -0.6% ± 1.2% (95% CI: -1.0; -0.1, <i>p</i> = 0.016) and nearly two-thirds of patients with prediabetes or diabetes at baseline reverted to normoglycemia. Mean reductions of -4.4 ± 12.3 mmHg (95% CI: -5.7; -3.0, <i>p</i> < 0.001) and -1.7 ± 8.4 mmHg (95% CI: -2.6; -0.7, <i>p</i> < 0.001) were observed in systolic and diastolic blood pressure, respectively (<i>n</i> = 307). Statistically significant reductions in mean total cholesterol (-12.2 ± 38.8 mg/dl [95% CI: -24.3 to -0.06, <i>p</i> < 0.049]) and triglycerides (-18.3 ± 43.6 mg/dl [95% CI: -4.7; -31.9, <i>p</i> < 0.009]) were also observed (<i>n</i> = 42).</p><p><strong>Conclusions: </strong>This study demonstrated the effectiveness of semaglutide 2.4 mg in reducing body weight and improving cardiometabolic parameters in adults with overweight or obesity in a real-world clinical practice setting, showing a significant mean body weight reduction and improvements in biomarkers like blood pressure and HbA1c over a 6-month period. These findings, aligning with previous clinical trials at comparable time points, highlight the clinical relevance of semaglutide as an effective therapeutic option for obesity.</p>","PeriodicalId":19448,"journal":{"name":"Obesity Science & Practice","volume":"10 1","pages":"e737"},"PeriodicalIF":1.9000,"publicationDate":"2024-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10851954/pdf/","citationCount":"0","resultStr":"{\"title\":\"Semaglutide 2.4 mg clinical outcomes in patients with obesity or overweight in a real-world setting: A 6-month retrospective study in the United States (SCOPE).\",\"authors\":\"Aleksandrina Ruseva, Wojciech Michalak, Zhenxiang Zhao, Anthony Fabricatore, Bríain Ó Hartaigh, Devika Umashanker\",\"doi\":\"10.1002/osp4.737\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Management guidelines for obesity suggest maintaining a minimum of 5% body weight reduction to help prevent or lower the risk of developing conditions such as hypertension and type 2 diabetes. However, achieving long-term weight control is difficult with lifestyle modification alone, making it essential to combine pharmacotherapy with diet and exercise in individual cases. Semaglutide 2.4 mg has demonstrated significant reductions in body weight and cardiometabolic risk factors in clinical trials, but information on outcomes in a real-world setting is limited.</p><p><strong>Objective: </strong>To assess changes in body weight and other clinical outcomes at 6-month follow-up among adults on semaglutide 2.4 mg in a real-world setting in the United States (US).</p><p><strong>Methods: </strong>Observational and retrospective cohort study of patients initiating treatment between 15 June 2021, and 31 March 2022, using a large US claims-linked electronic health record database.</p><p><strong>Results: </strong>Mean (±SD) body mass index (BMI) of the 343 patients included in the analysis was 37.9 ± 5.5 kg/m<sup>2</sup>. After 6 months, mean body weight change was -10.5 ± 6.8 kg (95% CI: -11.2; -9.8, <i>p</i> < 0.001) and mean percentage body weight change was -10.0% ± 6.6% (95% CI: -10.7; -9.3, <i>p</i> < 0.001). Most (79.0%) patients had ≥5% body weight reduction, 48.1% had ≥10% body weight reduction, and 19.0% had ≥15% body weight reduction. Among patients with available data, the mean change in HbA1c (<i>n</i> = 30) was -0.6% ± 1.2% (95% CI: -1.0; -0.1, <i>p</i> = 0.016) and nearly two-thirds of patients with prediabetes or diabetes at baseline reverted to normoglycemia. Mean reductions of -4.4 ± 12.3 mmHg (95% CI: -5.7; -3.0, <i>p</i> < 0.001) and -1.7 ± 8.4 mmHg (95% CI: -2.6; -0.7, <i>p</i> < 0.001) were observed in systolic and diastolic blood pressure, respectively (<i>n</i> = 307). Statistically significant reductions in mean total cholesterol (-12.2 ± 38.8 mg/dl [95% CI: -24.3 to -0.06, <i>p</i> < 0.049]) and triglycerides (-18.3 ± 43.6 mg/dl [95% CI: -4.7; -31.9, <i>p</i> < 0.009]) were also observed (<i>n</i> = 42).</p><p><strong>Conclusions: </strong>This study demonstrated the effectiveness of semaglutide 2.4 mg in reducing body weight and improving cardiometabolic parameters in adults with overweight or obesity in a real-world clinical practice setting, showing a significant mean body weight reduction and improvements in biomarkers like blood pressure and HbA1c over a 6-month period. These findings, aligning with previous clinical trials at comparable time points, highlight the clinical relevance of semaglutide as an effective therapeutic option for obesity.</p>\",\"PeriodicalId\":19448,\"journal\":{\"name\":\"Obesity Science & Practice\",\"volume\":\"10 1\",\"pages\":\"e737\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2024-02-08\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10851954/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Obesity Science & Practice\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1002/osp4.737\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/2/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q3\",\"JCRName\":\"ENDOCRINOLOGY & METABOLISM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Obesity Science & Practice","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1002/osp4.737","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/2/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"ENDOCRINOLOGY & METABOLISM","Score":null,"Total":0}
引用次数: 0
摘要
背景:肥胖症管理指南建议体重至少减轻 5%,以帮助预防或降低罹患高血压和 2 型糖尿病等疾病的风险。然而,仅靠改变生活方式很难达到长期控制体重的目的,因此必须根据具体情况将药物治疗与饮食和运动相结合。在临床试验中,塞马鲁肽 2.4 毫克可显著降低体重和心血管代谢风险因素,但在现实世界中的结果信息却很有限:目的:评估在美国实际环境中服用塞马鲁肽 2.4 毫克的成人在 6 个月随访期间体重和其他临床结果的变化:使用美国大型理赔链接电子健康记录数据库,对2021年6月15日至2022年3月31日期间开始治疗的患者进行观察和回顾性队列研究:纳入分析的 343 名患者的平均(±SD)体重指数(BMI)为 37.9 ± 5.5 kg/m2。6 个月后,平均体重变化为 -10.5 ± 6.8 kg (95% CI: -11.2; -9.8, p p n = 30) -0.6% ± 1.2% (95% CI: -1.0; -0.1, p = 0.016),近三分之二的基线糖尿病前期或糖尿病患者恢复到正常血糖水平。平均降幅为 -4.4 ± 12.3 mmHg (95% CI: -5.7; -3.0, p p n = 307)。总胆固醇平均值明显降低(-12.2 ± 38.8 mg/dl [95% CI: -24.3 to -0.06, p p n = 42):这项研究表明,在真实世界的临床实践中,2.4 毫克的semaglutide 能有效减轻超重或肥胖成人的体重并改善其心脏代谢指标,在 6 个月的时间里,平均体重显著减轻,血压和 HbA1c 等生物标志物也得到改善。这些研究结果与之前在可比时间点进行的临床试验结果一致,凸显了塞马鲁肽作为肥胖症有效治疗方案的临床意义。
Semaglutide 2.4 mg clinical outcomes in patients with obesity or overweight in a real-world setting: A 6-month retrospective study in the United States (SCOPE).
Background: Management guidelines for obesity suggest maintaining a minimum of 5% body weight reduction to help prevent or lower the risk of developing conditions such as hypertension and type 2 diabetes. However, achieving long-term weight control is difficult with lifestyle modification alone, making it essential to combine pharmacotherapy with diet and exercise in individual cases. Semaglutide 2.4 mg has demonstrated significant reductions in body weight and cardiometabolic risk factors in clinical trials, but information on outcomes in a real-world setting is limited.
Objective: To assess changes in body weight and other clinical outcomes at 6-month follow-up among adults on semaglutide 2.4 mg in a real-world setting in the United States (US).
Methods: Observational and retrospective cohort study of patients initiating treatment between 15 June 2021, and 31 March 2022, using a large US claims-linked electronic health record database.
Results: Mean (±SD) body mass index (BMI) of the 343 patients included in the analysis was 37.9 ± 5.5 kg/m2. After 6 months, mean body weight change was -10.5 ± 6.8 kg (95% CI: -11.2; -9.8, p < 0.001) and mean percentage body weight change was -10.0% ± 6.6% (95% CI: -10.7; -9.3, p < 0.001). Most (79.0%) patients had ≥5% body weight reduction, 48.1% had ≥10% body weight reduction, and 19.0% had ≥15% body weight reduction. Among patients with available data, the mean change in HbA1c (n = 30) was -0.6% ± 1.2% (95% CI: -1.0; -0.1, p = 0.016) and nearly two-thirds of patients with prediabetes or diabetes at baseline reverted to normoglycemia. Mean reductions of -4.4 ± 12.3 mmHg (95% CI: -5.7; -3.0, p < 0.001) and -1.7 ± 8.4 mmHg (95% CI: -2.6; -0.7, p < 0.001) were observed in systolic and diastolic blood pressure, respectively (n = 307). Statistically significant reductions in mean total cholesterol (-12.2 ± 38.8 mg/dl [95% CI: -24.3 to -0.06, p < 0.049]) and triglycerides (-18.3 ± 43.6 mg/dl [95% CI: -4.7; -31.9, p < 0.009]) were also observed (n = 42).
Conclusions: This study demonstrated the effectiveness of semaglutide 2.4 mg in reducing body weight and improving cardiometabolic parameters in adults with overweight or obesity in a real-world clinical practice setting, showing a significant mean body weight reduction and improvements in biomarkers like blood pressure and HbA1c over a 6-month period. These findings, aligning with previous clinical trials at comparable time points, highlight the clinical relevance of semaglutide as an effective therapeutic option for obesity.