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Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from the SURE UK Multicentre, Prospective, Observational Study

INTRODUCTION: Once-weekly (OW) semaglutide was associated with clinically relevant improvements in glycaemic control and body weight versus comparators in the SUSTAIN randomised controlled trials (RCTs). SURE UK, which is one of a series of individual studies that comprise the SURE programme, evalua...

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Autores principales: Holmes, Patrick, Bell, Heather Elizabeth, Bozkurt, Karan, Catarig, Andrei-Mircea, Clark, Alice, Machell, Alena, Sathyapalan, Thozhukat
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8475854/
https://www.ncbi.nlm.nih.gov/pubmed/34562237
http://dx.doi.org/10.1007/s13300-021-01141-8
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author Holmes, Patrick
Bell, Heather Elizabeth
Bozkurt, Karan
Catarig, Andrei-Mircea
Clark, Alice
Machell, Alena
Sathyapalan, Thozhukat
author_facet Holmes, Patrick
Bell, Heather Elizabeth
Bozkurt, Karan
Catarig, Andrei-Mircea
Clark, Alice
Machell, Alena
Sathyapalan, Thozhukat
author_sort Holmes, Patrick
collection PubMed
description INTRODUCTION: Once-weekly (OW) semaglutide was associated with clinically relevant improvements in glycaemic control and body weight versus comparators in the SUSTAIN randomised controlled trials (RCTs). SURE UK, which is one of a series of individual studies that comprise the SURE programme, evaluated the use of OW semaglutide in a real-world patient population with type 2 diabetes (T2D) in the UK. METHODS: In this prospective, observational study, adults (≥ 18 years) with ≥ 1 documented glycated haemoglobin (HbA(1c)) value ≤ 12 weeks before semaglutide initiation were enrolled. The primary endpoint was change in HbA(1c) from baseline to end of study (EOS; ~ 30 weeks, although due to the COVID-19 pandemic, visits up to week 52 were permitted). Secondary endpoints included change in body weight, waist circumference and patient-reported outcomes (PROs). Physicians were to report all episodes of documented or severe hypoglycaemia, fatal events, serious adverse drug reactions, pregnancies and adverse events (AEs) in foetuses/newborn infants; other AEs during the study period could be reported on a voluntary basis. RESULT: The estimated mean change in HbA(1c) from baseline to EOS was − 16.3 mmol/mol [95% confidence interval (CI): − 18.22, − 14.37] (− 1.5%-points [95% CI − 1.67, − 1.31]; p < 0.0001) among the 171 enrolled patients who completed the study on treatment. Mean body weight change was − 5.8 kg (95% CI − 6.75, − 4.94; p < 0.0001). Sensitivity analyses showed similar results. Improvements were also observed in other secondary endpoints, including PROs. No new safety concerns were identified with semaglutide treatment. CONCLUSION: Patients receiving OW semaglutide experienced statistically significant and clinically relevant reductions from baseline in HbA(1c) and body weight. These results are in line with those of the SUSTAIN RCTs and support the use of OW semaglutide in routine clinical practice in adults with T2D in the UK. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03876015. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13300-021-01141-8.
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spelling pubmed-84758542021-09-28 Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from the SURE UK Multicentre, Prospective, Observational Study Holmes, Patrick Bell, Heather Elizabeth Bozkurt, Karan Catarig, Andrei-Mircea Clark, Alice Machell, Alena Sathyapalan, Thozhukat Diabetes Ther Original Research INTRODUCTION: Once-weekly (OW) semaglutide was associated with clinically relevant improvements in glycaemic control and body weight versus comparators in the SUSTAIN randomised controlled trials (RCTs). SURE UK, which is one of a series of individual studies that comprise the SURE programme, evaluated the use of OW semaglutide in a real-world patient population with type 2 diabetes (T2D) in the UK. METHODS: In this prospective, observational study, adults (≥ 18 years) with ≥ 1 documented glycated haemoglobin (HbA(1c)) value ≤ 12 weeks before semaglutide initiation were enrolled. The primary endpoint was change in HbA(1c) from baseline to end of study (EOS; ~ 30 weeks, although due to the COVID-19 pandemic, visits up to week 52 were permitted). Secondary endpoints included change in body weight, waist circumference and patient-reported outcomes (PROs). Physicians were to report all episodes of documented or severe hypoglycaemia, fatal events, serious adverse drug reactions, pregnancies and adverse events (AEs) in foetuses/newborn infants; other AEs during the study period could be reported on a voluntary basis. RESULT: The estimated mean change in HbA(1c) from baseline to EOS was − 16.3 mmol/mol [95% confidence interval (CI): − 18.22, − 14.37] (− 1.5%-points [95% CI − 1.67, − 1.31]; p < 0.0001) among the 171 enrolled patients who completed the study on treatment. Mean body weight change was − 5.8 kg (95% CI − 6.75, − 4.94; p < 0.0001). Sensitivity analyses showed similar results. Improvements were also observed in other secondary endpoints, including PROs. No new safety concerns were identified with semaglutide treatment. CONCLUSION: Patients receiving OW semaglutide experienced statistically significant and clinically relevant reductions from baseline in HbA(1c) and body weight. These results are in line with those of the SUSTAIN RCTs and support the use of OW semaglutide in routine clinical practice in adults with T2D in the UK. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03876015. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13300-021-01141-8. Springer Healthcare 2021-09-25 2021-11 /pmc/articles/PMC8475854/ /pubmed/34562237 http://dx.doi.org/10.1007/s13300-021-01141-8 Text en © The Author(s) 2021 https://creativecommons.org/licenses/by-nc/4.0/Open Access This article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Holmes, Patrick
Bell, Heather Elizabeth
Bozkurt, Karan
Catarig, Andrei-Mircea
Clark, Alice
Machell, Alena
Sathyapalan, Thozhukat
Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from the SURE UK Multicentre, Prospective, Observational Study
title Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from the SURE UK Multicentre, Prospective, Observational Study
title_full Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from the SURE UK Multicentre, Prospective, Observational Study
title_fullStr Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from the SURE UK Multicentre, Prospective, Observational Study
title_full_unstemmed Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from the SURE UK Multicentre, Prospective, Observational Study
title_short Real-World Use of Once-Weekly Semaglutide in Type 2 Diabetes: Results from the SURE UK Multicentre, Prospective, Observational Study
title_sort real-world use of once-weekly semaglutide in type 2 diabetes: results from the sure uk multicentre, prospective, observational study
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8475854/
https://www.ncbi.nlm.nih.gov/pubmed/34562237
http://dx.doi.org/10.1007/s13300-021-01141-8
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