Markus Menzen, Tina Landsvig Berentzen, Andrei-Mircea Catarig, Sebastian Piperhoff, Jörg Simon, Stephan Jacob
{"title":"实际使用每周一次的西马鲁肽治疗2型糖尿病:来自德国的西马鲁肽实际证据(SURE)的结果。","authors":"Markus Menzen, Tina Landsvig Berentzen, Andrei-Mircea Catarig, Sebastian Piperhoff, Jörg Simon, Stephan Jacob","doi":"10.1055/a-2007-2061","DOIUrl":null,"url":null,"abstract":"<p><strong>Context: </strong>Efficacy and safety of once-weekly semaglutide in type 2 diabetes were established in the phase 3 SUSTAIN trials, which included patients across the continuum of type 2 diabetes care. It is useful to complement these findings with real-world evidence.</p><p><strong>Objective: </strong>SURE Germany evaluated once-weekly semaglutide in a real-world type 2 diabetes patient population.</p><p><strong>Design/setting: </strong>The prospective observational study was conducted at 93 clinical practices in adults with+≥ 1 documented glycated haemoglobin value ≤12 weeks before initiation of semaglutide.</p><p><strong>Intervention: </strong>Once-weekly semaglutide was prescribed at the physicians' discretion.</p><p><strong>Main outcomes: </strong>The primary endpoint was change in glycated haemoglobin from baseline to end-of-study (~30 weeks). Secondary endpoints included changes in body weight and patient-reported outcomes. All adverse events were systematically collected and reported, including patient-reported documented and/or severe hypoglycaemia.</p><p><strong>Results: </strong>Of 779 patients in the full analysis set, 669 (85.9%) completed the study on treatment with semaglutide, comprising the effectiveness analysis set. In this data set, estimated mean changes in glycated haemoglobin and body weight from baseline to end-of-study were -1.0%point (-10.9 mmol/mol; <i>P</i><0.0001) and -4.5 kg (-4.2%; <i>P</i><0.0001). Sensitivity analyses supported the primary analysis. Improvements were observed in other secondary endpoints, including patient-reported outcomes. No new safety concerns were identified.</p><p><strong>Conclusions: </strong>In a real-world population in Germany, patients with type 2 diabetes treated with once-weekly semaglutide experienced clinically significant improvements in glycaemic control and body weight. These results support the use of once-weekly semaglutide in routine clinical practice in adult patients with type 2 diabetes in Germany.</p>","PeriodicalId":12241,"journal":{"name":"Experimental and Clinical Endocrinology & Diabetes","volume":"131 4","pages":"205-215"},"PeriodicalIF":1.6000,"publicationDate":"2023-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/6d/73/10-1055-a-2007-2061.PMC10101737.pdf","citationCount":"6","resultStr":"{\"title\":\"Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from SemaglUtide Real-world Evidence (SURE) Germany.\",\"authors\":\"Markus Menzen, Tina Landsvig Berentzen, Andrei-Mircea Catarig, Sebastian Piperhoff, Jörg Simon, Stephan Jacob\",\"doi\":\"10.1055/a-2007-2061\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Context: </strong>Efficacy and safety of once-weekly semaglutide in type 2 diabetes were established in the phase 3 SUSTAIN trials, which included patients across the continuum of type 2 diabetes care. It is useful to complement these findings with real-world evidence.</p><p><strong>Objective: </strong>SURE Germany evaluated once-weekly semaglutide in a real-world type 2 diabetes patient population.</p><p><strong>Design/setting: </strong>The prospective observational study was conducted at 93 clinical practices in adults with+≥ 1 documented glycated haemoglobin value ≤12 weeks before initiation of semaglutide.</p><p><strong>Intervention: </strong>Once-weekly semaglutide was prescribed at the physicians' discretion.</p><p><strong>Main outcomes: </strong>The primary endpoint was change in glycated haemoglobin from baseline to end-of-study (~30 weeks). Secondary endpoints included changes in body weight and patient-reported outcomes. All adverse events were systematically collected and reported, including patient-reported documented and/or severe hypoglycaemia.</p><p><strong>Results: </strong>Of 779 patients in the full analysis set, 669 (85.9%) completed the study on treatment with semaglutide, comprising the effectiveness analysis set. In this data set, estimated mean changes in glycated haemoglobin and body weight from baseline to end-of-study were -1.0%point (-10.9 mmol/mol; <i>P</i><0.0001) and -4.5 kg (-4.2%; <i>P</i><0.0001). Sensitivity analyses supported the primary analysis. Improvements were observed in other secondary endpoints, including patient-reported outcomes. No new safety concerns were identified.</p><p><strong>Conclusions: </strong>In a real-world population in Germany, patients with type 2 diabetes treated with once-weekly semaglutide experienced clinically significant improvements in glycaemic control and body weight. 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Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from SemaglUtide Real-world Evidence (SURE) Germany.
Context: Efficacy and safety of once-weekly semaglutide in type 2 diabetes were established in the phase 3 SUSTAIN trials, which included patients across the continuum of type 2 diabetes care. It is useful to complement these findings with real-world evidence.
Objective: SURE Germany evaluated once-weekly semaglutide in a real-world type 2 diabetes patient population.
Design/setting: The prospective observational study was conducted at 93 clinical practices in adults with+≥ 1 documented glycated haemoglobin value ≤12 weeks before initiation of semaglutide.
Intervention: Once-weekly semaglutide was prescribed at the physicians' discretion.
Main outcomes: The primary endpoint was change in glycated haemoglobin from baseline to end-of-study (~30 weeks). Secondary endpoints included changes in body weight and patient-reported outcomes. All adverse events were systematically collected and reported, including patient-reported documented and/or severe hypoglycaemia.
Results: Of 779 patients in the full analysis set, 669 (85.9%) completed the study on treatment with semaglutide, comprising the effectiveness analysis set. In this data set, estimated mean changes in glycated haemoglobin and body weight from baseline to end-of-study were -1.0%point (-10.9 mmol/mol; P<0.0001) and -4.5 kg (-4.2%; P<0.0001). Sensitivity analyses supported the primary analysis. Improvements were observed in other secondary endpoints, including patient-reported outcomes. No new safety concerns were identified.
Conclusions: In a real-world population in Germany, patients with type 2 diabetes treated with once-weekly semaglutide experienced clinically significant improvements in glycaemic control and body weight. These results support the use of once-weekly semaglutide in routine clinical practice in adult patients with type 2 diabetes in Germany.
期刊介绍:
Publishing outstanding articles from all fields of endocrinology and diabetology, from molecular biology to clinical research, this journal is a brilliant resource. Since being published in English in 1983, the popularity of this journal has grown steadily, reflecting the importance of this publication within its field.
Original contributions and short communications appear in each issue along with reviews addressing current topics. In addition, supplementary issues are published each year presenting abstracts or proceedings of national and international scientific meetings.
The journal was initially published in German and is still the oldest endocrinological periodical in the German-language market!