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Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice—EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study
INTRODUCTION: The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice. METHODS: This observational, prospective, multicenter study included 315...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2015
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4604502/ https://www.ncbi.nlm.nih.gov/pubmed/26424330 http://dx.doi.org/10.1007/s12325-015-0245-x |
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author | Gautier, Jean-Francois Martinez, Luc Penfornis, Alfred Eschwège, Eveline Charpentier, Guillaume Huret, Benoît Madani, Suliya Gourdy, Pierre |
author_facet | Gautier, Jean-Francois Martinez, Luc Penfornis, Alfred Eschwège, Eveline Charpentier, Guillaume Huret, Benoît Madani, Suliya Gourdy, Pierre |
author_sort | Gautier, Jean-Francois |
collection | PubMed |
description | INTRODUCTION: The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice. METHODS: This observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA(1c) <7.0% after 2 years of follow-up. RESULTS: At the end of the study, 29.5% of patients maintained liraglutide treatment and reached the HbA(1c) target. Mean (±SD) HbA(1c), fasting plasma glucose concentration, body weight and BMI were significantly reduced from baseline [8.46% (±1.46) to 7.44% (±1.20); 180 (±60) to 146 (±44) mg/dL; 95.2 (±20.0) to 91.1 (±19.6) kg; 34.0 (±7.2) to 32.5 (±6.9) kg/m(2); respectively, all P < 0.0001]. Patient treatment satisfaction increased, with the mean diabetes treatment satisfaction questionnaire status version score increasing from 22.17 (±7.64) to 28.55 (±5.79), P < 0.0001. The main adverse event type was gastrointestinal, with a frequency of 10.9%, and the percentage of patients suffering ≥1 hypoglycemic episode decreased from 6.9% to 4.4%. CONCLUSION: The results of the EVIDENCE study suggest that the effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials. FUNDING: Novo Nordisk A/S. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01226966. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12325-015-0245-x) contains supplementary material, which is available to authorized users. |
format | Online Article Text |
id | pubmed-4604502 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-46045022015-10-19 Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice—EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study Gautier, Jean-Francois Martinez, Luc Penfornis, Alfred Eschwège, Eveline Charpentier, Guillaume Huret, Benoît Madani, Suliya Gourdy, Pierre Adv Ther Original Research INTRODUCTION: The aim of this study was to investigate whether the efficacy of liraglutide observed in randomized controlled trials translates into therapeutic benefits in the French population during routine clinical practice. METHODS: This observational, prospective, multicenter study included 3152 adults with type 2 diabetes who had recently started or were about to start liraglutide treatment. During 2 years of follow-up, an evaluation of the reasons for prescribing liraglutide, maintenance dose of liraglutide, changes in combined antidiabetic treatments, level of glycemic control, change in body weight and body mass index (BMI), patient satisfaction with diabetes treatment and safety of liraglutide were investigated. The primary study endpoint was the proportion of patients still receiving liraglutide and presenting with HbA(1c) <7.0% after 2 years of follow-up. RESULTS: At the end of the study, 29.5% of patients maintained liraglutide treatment and reached the HbA(1c) target. Mean (±SD) HbA(1c), fasting plasma glucose concentration, body weight and BMI were significantly reduced from baseline [8.46% (±1.46) to 7.44% (±1.20); 180 (±60) to 146 (±44) mg/dL; 95.2 (±20.0) to 91.1 (±19.6) kg; 34.0 (±7.2) to 32.5 (±6.9) kg/m(2); respectively, all P < 0.0001]. Patient treatment satisfaction increased, with the mean diabetes treatment satisfaction questionnaire status version score increasing from 22.17 (±7.64) to 28.55 (±5.79), P < 0.0001. The main adverse event type was gastrointestinal, with a frequency of 10.9%, and the percentage of patients suffering ≥1 hypoglycemic episode decreased from 6.9% to 4.4%. CONCLUSION: The results of the EVIDENCE study suggest that the effectiveness of liraglutide in real-world clinical practice is similar to that observed in randomized controlled trials. FUNDING: Novo Nordisk A/S. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01226966. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s12325-015-0245-x) contains supplementary material, which is available to authorized users. Springer Healthcare 2015-09-30 2015 /pmc/articles/PMC4604502/ /pubmed/26424330 http://dx.doi.org/10.1007/s12325-015-0245-x Text en © The Author(s) 2015 https://creativecommons.org/licenses/by-nc/4.0/This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License (http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) ), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. |
spellingShingle | Original Research Gautier, Jean-Francois Martinez, Luc Penfornis, Alfred Eschwège, Eveline Charpentier, Guillaume Huret, Benoît Madani, Suliya Gourdy, Pierre Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice—EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study |
title | Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice—EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study |
title_full | Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice—EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study |
title_fullStr | Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice—EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study |
title_full_unstemmed | Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice—EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study |
title_short | Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice—EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study |
title_sort | effectiveness and persistence with liraglutide among patients with type 2 diabetes in routine clinical practice—evidence: a prospective, 2-year follow-up, observational, post-marketing study |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4604502/ https://www.ncbi.nlm.nih.gov/pubmed/26424330 http://dx.doi.org/10.1007/s12325-015-0245-x |
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