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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-we...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Georg Thieme Verlag KG
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10101737/ https://www.ncbi.nlm.nih.gov/pubmed/36599459 http://dx.doi.org/10.1055/a-2007-2061 |
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author | Menzen, Markus Berentzen, Tina Landsvig Catarig, Andrei-Mircea Pieperhoff, Sebastian Simon, Jörg Jacob, Stephan |
author_facet | Menzen, Markus Berentzen, Tina Landsvig Catarig, Andrei-Mircea Pieperhoff, Sebastian Simon, Jörg Jacob, Stephan |
author_sort | Menzen, Markus |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-10101737 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Georg Thieme Verlag KG |
record_format | MEDLINE/PubMed |
spelling | pubmed-101017372023-04-14 Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from SemaglUtide Real-world Evidence (SURE) Germany Menzen, Markus Berentzen, Tina Landsvig Catarig, Andrei-Mircea Pieperhoff, Sebastian Simon, Jörg Jacob, Stephan Exp Clin Endocrinol Diabetes 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. Georg Thieme Verlag KG 2023-03-03 /pmc/articles/PMC10101737/ /pubmed/36599459 http://dx.doi.org/10.1055/a-2007-2061 Text en The Author(s). This is an open access article published by Thieme under the terms of the Creative Commons Attribution-NonDerivative-NonCommercial-License, permitting copying and reproduction so long as the original work is given appropriate credit. Contents may not be used for commercial purposes, or adapted, remixed, transformed or built upon. (https://creativecommons.org/licenses/by-nc-nd/4.0/). https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives License, which permits unrestricted reproduction and distribution, for non-commercial purposes only; and use and reproduction, but not distribution, of adapted material for non-commercial purposes only, provided the original work is properly cited. |
spellingShingle | Menzen, Markus Berentzen, Tina Landsvig Catarig, Andrei-Mircea Pieperhoff, Sebastian Simon, Jörg Jacob, Stephan Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from SemaglUtide Real-world Evidence (SURE) Germany |
title | Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results
from SemaglUtide Real-world Evidence (SURE) Germany |
title_full | Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results
from SemaglUtide Real-world Evidence (SURE) Germany |
title_fullStr | Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results
from SemaglUtide Real-world Evidence (SURE) Germany |
title_full_unstemmed | Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results
from SemaglUtide Real-world Evidence (SURE) Germany |
title_short | Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results
from SemaglUtide Real-world Evidence (SURE) Germany |
title_sort | real-world use of once-weekly semaglutide in type 2 diabetes: results
from semaglutide real-world evidence (sure) germany |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10101737/ https://www.ncbi.nlm.nih.gov/pubmed/36599459 http://dx.doi.org/10.1055/a-2007-2061 |
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