Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from SemaglUtide Real-world Evidence (SURE) Germany

被引:15
|
作者
Menzen, Markus [1 ,6 ]
Berentzen, Tina Landsvig [2 ]
Catarig, Andrei-Mircea [2 ]
Pieperhoff, Sebastian [3 ]
Simon, Joerg [4 ]
Jacob, Stephan [5 ]
机构
[1] Gemeinschaftskrankenhaus Bonn, Innere Med Diabetol & Endokrinol, Bonn, Germany
[2] Novo Nordisk A S, Soborg, Denmark
[3] Novo Nordisk Pharm GmbH, Mainz, Germany
[4] MVZ Altstadt Carree Fulda GmbH, Fulda, Germany
[5] Cardiometab Inst, Villingen, Germany
[6] Gemeinschaftskrankenhaus Bonn, Innere Med Diabetol & Endokrinol, Bonner Talweg 4-6, D-53113 Bonn, Germany
关键词
blood pressure; clinical practice; patient-reported outcomes; real-world evidence; glucagon-like peptide-1 receptor agonist; OPEN-LABEL; PHASE; 3A; ADD-ON; EFFICACY; SAFETY; MULTICENTER; METFORMIN; 56-WEEK;
D O I
10.1055/a-2007-2061
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
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 (similar to 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.
引用
收藏
页码:205 / 215
页数:11
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