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Long‐term efficacy and safety of combined insulin and glucagon‐like peptide‐1 therapy: Evidence from the LEADER trial
AIM: Glucagon‐like peptide‐1 receptor agonist (GLP‐1RA) and insulin combination therapy is an effective treatment option for type 2 diabetes, but long‐term data are lacking. The aim was to assess the long‐term efficacy of the GLP‐1RA liraglutide in subgroups by insulin use in the LEADER trial. MATER...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Blackwell Publishing Ltd
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6852575/ https://www.ncbi.nlm.nih.gov/pubmed/31282028 http://dx.doi.org/10.1111/dom.13826 |
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author | Tack, Cees J. Jacob, Stephan Desouza, Cyrus Bain, Stephen C. Buse, John B. Nauck, Michael A. Petrie, John R. Poulter, Neil R. Pratley, Richard E. Stegmann, Helen Vanya B. K. Bosch‐Traberg, Heidrun Startseva, Elena Zinman, Bernard |
author_facet | Tack, Cees J. Jacob, Stephan Desouza, Cyrus Bain, Stephen C. Buse, John B. Nauck, Michael A. Petrie, John R. Poulter, Neil R. Pratley, Richard E. Stegmann, Helen Vanya B. K. Bosch‐Traberg, Heidrun Startseva, Elena Zinman, Bernard |
author_sort | Tack, Cees J. |
collection | PubMed |
description | AIM: Glucagon‐like peptide‐1 receptor agonist (GLP‐1RA) and insulin combination therapy is an effective treatment option for type 2 diabetes, but long‐term data are lacking. The aim was to assess the long‐term efficacy of the GLP‐1RA liraglutide in subgroups by insulin use in the LEADER trial. MATERIALS AND METHODS: LEADER assessed cardiovascular (CV) safety and efficacy of liraglutide (1.8 mg) versus placebo (plus standard of care therapy) in 9340 patients with type 2 diabetes and high risk of CV disease, for up to 5 years. We analyzed CV events, metabolic parameters and hypoglycaemia post hoc in three subgroups by baseline insulin use (basal‐only insulin, other insulin or no insulin). Insulin was a non‐random treatment allocation as part of standard of care therapy. RESULTS: At baseline, 5171 (55%) patients were not receiving insulin, 3159 (34%) were receiving basal‐only insulin and 1010 (11%) other insulins. Insulin users had a longer diabetes duration and slightly worse glycaemic control (HbA1c) than the no‐insulin subgroup. Liraglutide reduced HbA1c and weight versus placebo in all three subgroups (P < .001), and severe hypoglycaemia rate in the basal‐only insulin subgroup. The need for insulin was less with liraglutide. CV risk reduction with liraglutide was similar to the main trial results in the basal‐only and no‐insulin subgroups. CONCLUSIONS: In patients on insulin, liraglutide improved glycaemic control, weight and need for insulin versus placebo, for at least 36 months with no increased risk of severe hypoglycaemia, while maintaining CV safety/efficacy, supporting the combination of liraglutide and insulin for management of type 2 diabetes. |
format | Online Article Text |
id | pubmed-6852575 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Blackwell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-68525752019-11-21 Long‐term efficacy and safety of combined insulin and glucagon‐like peptide‐1 therapy: Evidence from the LEADER trial Tack, Cees J. Jacob, Stephan Desouza, Cyrus Bain, Stephen C. Buse, John B. Nauck, Michael A. Petrie, John R. Poulter, Neil R. Pratley, Richard E. Stegmann, Helen Vanya B. K. Bosch‐Traberg, Heidrun Startseva, Elena Zinman, Bernard Diabetes Obes Metab Original Articles AIM: Glucagon‐like peptide‐1 receptor agonist (GLP‐1RA) and insulin combination therapy is an effective treatment option for type 2 diabetes, but long‐term data are lacking. The aim was to assess the long‐term efficacy of the GLP‐1RA liraglutide in subgroups by insulin use in the LEADER trial. MATERIALS AND METHODS: LEADER assessed cardiovascular (CV) safety and efficacy of liraglutide (1.8 mg) versus placebo (plus standard of care therapy) in 9340 patients with type 2 diabetes and high risk of CV disease, for up to 5 years. We analyzed CV events, metabolic parameters and hypoglycaemia post hoc in three subgroups by baseline insulin use (basal‐only insulin, other insulin or no insulin). Insulin was a non‐random treatment allocation as part of standard of care therapy. RESULTS: At baseline, 5171 (55%) patients were not receiving insulin, 3159 (34%) were receiving basal‐only insulin and 1010 (11%) other insulins. Insulin users had a longer diabetes duration and slightly worse glycaemic control (HbA1c) than the no‐insulin subgroup. Liraglutide reduced HbA1c and weight versus placebo in all three subgroups (P < .001), and severe hypoglycaemia rate in the basal‐only insulin subgroup. The need for insulin was less with liraglutide. CV risk reduction with liraglutide was similar to the main trial results in the basal‐only and no‐insulin subgroups. CONCLUSIONS: In patients on insulin, liraglutide improved glycaemic control, weight and need for insulin versus placebo, for at least 36 months with no increased risk of severe hypoglycaemia, while maintaining CV safety/efficacy, supporting the combination of liraglutide and insulin for management of type 2 diabetes. Blackwell Publishing Ltd 2019-07-07 2019-11 /pmc/articles/PMC6852575/ /pubmed/31282028 http://dx.doi.org/10.1111/dom.13826 Text en © 2019 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd. This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Original Articles Tack, Cees J. Jacob, Stephan Desouza, Cyrus Bain, Stephen C. Buse, John B. Nauck, Michael A. Petrie, John R. Poulter, Neil R. Pratley, Richard E. Stegmann, Helen Vanya B. K. Bosch‐Traberg, Heidrun Startseva, Elena Zinman, Bernard Long‐term efficacy and safety of combined insulin and glucagon‐like peptide‐1 therapy: Evidence from the LEADER trial |
title | Long‐term efficacy and safety of combined insulin and glucagon‐like peptide‐1 therapy: Evidence from the LEADER trial |
title_full | Long‐term efficacy and safety of combined insulin and glucagon‐like peptide‐1 therapy: Evidence from the LEADER trial |
title_fullStr | Long‐term efficacy and safety of combined insulin and glucagon‐like peptide‐1 therapy: Evidence from the LEADER trial |
title_full_unstemmed | Long‐term efficacy and safety of combined insulin and glucagon‐like peptide‐1 therapy: Evidence from the LEADER trial |
title_short | Long‐term efficacy and safety of combined insulin and glucagon‐like peptide‐1 therapy: Evidence from the LEADER trial |
title_sort | long‐term efficacy and safety of combined insulin and glucagon‐like peptide‐1 therapy: evidence from the leader trial |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6852575/ https://www.ncbi.nlm.nih.gov/pubmed/31282028 http://dx.doi.org/10.1111/dom.13826 |
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