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ANDREW: A Multicenter, Prospective, Observational Study in Patients with Type 2 Diabetes on Persistent Treatment with Dulaglutide
INTRODUCTION: Dulaglutide, a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), became available in Italy in April 2016. The aim of ANDREW (Active Notes on Dulaglutide in the REal World), a multicenter, prospective, observational study, was to evaluate glycemic control and weight (co-pr...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2020
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7547933/ https://www.ncbi.nlm.nih.gov/pubmed/32974879 http://dx.doi.org/10.1007/s13300-020-00929-4 |
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author | Bossi, Antonio C. De Mori, Valentina Scaranna, Cristiana Veronesi, Giovanni Lepore, Giuseppe |
author_facet | Bossi, Antonio C. De Mori, Valentina Scaranna, Cristiana Veronesi, Giovanni Lepore, Giuseppe |
author_sort | Bossi, Antonio C. |
collection | PubMed |
description | INTRODUCTION: Dulaglutide, a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), became available in Italy in April 2016. The aim of ANDREW (Active Notes on Dulaglutide in the REal World), a multicenter, prospective, observational study, was to evaluate glycemic control and weight (co-primary outcomes) for up to 24 months in the real-life setting in consecutive outpatients with type 2 diabetes (T2D) who initiated dulaglutide. Co-secondary outcomes were durability of treatment effects on both glycated hemoglobin (HbA1c) and body weight. METHODS: Overall, 1584 subjects (696 women, 888 men) with T2D (mean age [± standard deviation] 61.7 ± 10.2 years; mean T2D duration 9.9 ± 6.9 years) were treated with dulaglutide (0.75 or 1.5 mg once weekly) between April 2016 and December 2019. RESULTS: A total of 1130 patients completed 12 months of follow-up, while 170 patients interrupted treatment before the 12-month endpoint. At 12 months, average HbA1c and average fasting plasma glucose (FPG) were significantly lower compared to baseline levels (− 10 mmol/mol and − 24.9 mg/dL, respectively), as were body weight (− 3.4 kg) and waist circumference (− 3.3 cm) values (all p < 0.0001). Among subjects that completed 24 months of follow-up (n = 270), the rapid decline in HbA1c and FPG values in the first 12 months was followed by stabilization in the following 12 months (p value for 12–24 months trend: 0.4 and 0.6, respectively). CONCLUSIONS: Dulaglutide is an effective drug for the treatment of T2D that is administered once weekly using a simple auto-injector device. Real-life data confirm the observations in randomized controlled trials that persistent treatment with dulaglutide may help patients with T2D achieve an improvement in some metabolic features and in body weight. It is important that the benefits of therapy with dulaglutide, i.e., the effects of the “glycemic” and the so-called “extra-glycemic” actions of GLP-1RAs, are supported by diabetes care teams emphasizing the need for patients to maintain a healthy lifestyle. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13300-020-00929-4) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-7547933 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-75479332020-10-19 ANDREW: A Multicenter, Prospective, Observational Study in Patients with Type 2 Diabetes on Persistent Treatment with Dulaglutide Bossi, Antonio C. De Mori, Valentina Scaranna, Cristiana Veronesi, Giovanni Lepore, Giuseppe Diabetes Ther Original Research INTRODUCTION: Dulaglutide, a long-acting glucagon-like peptide-1 receptor agonist (GLP-1RA), became available in Italy in April 2016. The aim of ANDREW (Active Notes on Dulaglutide in the REal World), a multicenter, prospective, observational study, was to evaluate glycemic control and weight (co-primary outcomes) for up to 24 months in the real-life setting in consecutive outpatients with type 2 diabetes (T2D) who initiated dulaglutide. Co-secondary outcomes were durability of treatment effects on both glycated hemoglobin (HbA1c) and body weight. METHODS: Overall, 1584 subjects (696 women, 888 men) with T2D (mean age [± standard deviation] 61.7 ± 10.2 years; mean T2D duration 9.9 ± 6.9 years) were treated with dulaglutide (0.75 or 1.5 mg once weekly) between April 2016 and December 2019. RESULTS: A total of 1130 patients completed 12 months of follow-up, while 170 patients interrupted treatment before the 12-month endpoint. At 12 months, average HbA1c and average fasting plasma glucose (FPG) were significantly lower compared to baseline levels (− 10 mmol/mol and − 24.9 mg/dL, respectively), as were body weight (− 3.4 kg) and waist circumference (− 3.3 cm) values (all p < 0.0001). Among subjects that completed 24 months of follow-up (n = 270), the rapid decline in HbA1c and FPG values in the first 12 months was followed by stabilization in the following 12 months (p value for 12–24 months trend: 0.4 and 0.6, respectively). CONCLUSIONS: Dulaglutide is an effective drug for the treatment of T2D that is administered once weekly using a simple auto-injector device. Real-life data confirm the observations in randomized controlled trials that persistent treatment with dulaglutide may help patients with T2D achieve an improvement in some metabolic features and in body weight. It is important that the benefits of therapy with dulaglutide, i.e., the effects of the “glycemic” and the so-called “extra-glycemic” actions of GLP-1RAs, are supported by diabetes care teams emphasizing the need for patients to maintain a healthy lifestyle. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13300-020-00929-4) contains supplementary material, which is available to authorized users. Springer Healthcare 2020-09-24 2020-11 /pmc/articles/PMC7547933/ /pubmed/32974879 http://dx.doi.org/10.1007/s13300-020-00929-4 Text en © The Author(s) 2020 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/. |
spellingShingle | Original Research Bossi, Antonio C. De Mori, Valentina Scaranna, Cristiana Veronesi, Giovanni Lepore, Giuseppe ANDREW: A Multicenter, Prospective, Observational Study in Patients with Type 2 Diabetes on Persistent Treatment with Dulaglutide |
title | ANDREW: A Multicenter, Prospective, Observational Study in Patients with Type 2 Diabetes on Persistent Treatment with Dulaglutide |
title_full | ANDREW: A Multicenter, Prospective, Observational Study in Patients with Type 2 Diabetes on Persistent Treatment with Dulaglutide |
title_fullStr | ANDREW: A Multicenter, Prospective, Observational Study in Patients with Type 2 Diabetes on Persistent Treatment with Dulaglutide |
title_full_unstemmed | ANDREW: A Multicenter, Prospective, Observational Study in Patients with Type 2 Diabetes on Persistent Treatment with Dulaglutide |
title_short | ANDREW: A Multicenter, Prospective, Observational Study in Patients with Type 2 Diabetes on Persistent Treatment with Dulaglutide |
title_sort | andrew: a multicenter, prospective, observational study in patients with type 2 diabetes on persistent treatment with dulaglutide |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7547933/ https://www.ncbi.nlm.nih.gov/pubmed/32974879 http://dx.doi.org/10.1007/s13300-020-00929-4 |
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