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Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study

INTRODUCTION: The aim of the study was to evaluate whether the reduction in glycated hemoglobin (HbA1c) observed in clinical trials with liraglutide in type 2 diabetes (T2D) could be attained in routine clinical practice. METHODS: ReaL was a multicenter, non-interventional, observational, retrospect...

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Autores principales: Lapolla, Annunziata, Berra, Cesare, Boemi, Massimo, Bossi, Antonio Carlo, Candido, Riccardo, Di Cianni, Graziano, Frontoni, Simona, Genovese, Stefano, Ponzani, Paola, Provenzano, Vincenzo, Russo, Giuseppina T., Sciangula, Luigi, Simioni, Natalino, Bette, Cristiano, Nicolucci, Antonio
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5818560/
https://www.ncbi.nlm.nih.gov/pubmed/29270781
http://dx.doi.org/10.1007/s12325-017-0652-2
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author Lapolla, Annunziata
Berra, Cesare
Boemi, Massimo
Bossi, Antonio Carlo
Candido, Riccardo
Di Cianni, Graziano
Frontoni, Simona
Genovese, Stefano
Ponzani, Paola
Provenzano, Vincenzo
Russo, Giuseppina T.
Sciangula, Luigi
Simioni, Natalino
Bette, Cristiano
Nicolucci, Antonio
author_facet Lapolla, Annunziata
Berra, Cesare
Boemi, Massimo
Bossi, Antonio Carlo
Candido, Riccardo
Di Cianni, Graziano
Frontoni, Simona
Genovese, Stefano
Ponzani, Paola
Provenzano, Vincenzo
Russo, Giuseppina T.
Sciangula, Luigi
Simioni, Natalino
Bette, Cristiano
Nicolucci, Antonio
author_sort Lapolla, Annunziata
collection PubMed
description INTRODUCTION: The aim of the study was to evaluate whether the reduction in glycated hemoglobin (HbA1c) observed in clinical trials with liraglutide in type 2 diabetes (T2D) could be attained in routine clinical practice. METHODS: ReaL was a multicenter, non-interventional, observational, retrospective, longitudinal study on the effectiveness of liraglutide, a human glucagon-like peptide-1 analog, in individuals with T2D treated in daily practice in Italy. Between 26 March and 16 November 2015, data were taken from clinical records of patients aged ≥ 18 years with treatment follow-up data of up to 24 months and who received their first prescription of liraglutide in 2011. RESULTS: A total of 1723 patients were included in the analysis. At baseline, mean age was 58.9 years, duration of diabetes was 9.6 years, and HbA1c was 8.3%. At 12 months, 36.1% of patients were prescribed the maximum 1.8 mg dose; 43.5% [95% confidence interval (CI): 40.9; 46.2] of patients attained the primary outcome of a reduction in HbA1c of ≥ 1% point at 12 months. At 24 months, 40.9% (95% CI 38.1; 43.7) of patients had attained the HbA1c target of ≤ 7%. Additionally, body weight significantly decreased by 3.4 kg (95% CI − 3.6; − 3.1, p < 0.0001). CONCLUSION: In this observational study conducted in routine clinical practice for up to 2 years, treatment with liraglutide improved HbA1c and reduced body weight in a similar fashion to that observed under randomized clinical trial conditions. The data support the use of liraglutide as an effective treatment for T2D in clinical practice. FUNDING: Novo Nordisk S.p.A. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02255266. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s12325-017-0652-2) contains supplementary material, which is available to authorized users.
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spelling pubmed-58185602018-02-27 Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study Lapolla, Annunziata Berra, Cesare Boemi, Massimo Bossi, Antonio Carlo Candido, Riccardo Di Cianni, Graziano Frontoni, Simona Genovese, Stefano Ponzani, Paola Provenzano, Vincenzo Russo, Giuseppina T. Sciangula, Luigi Simioni, Natalino Bette, Cristiano Nicolucci, Antonio Adv Ther Original Research INTRODUCTION: The aim of the study was to evaluate whether the reduction in glycated hemoglobin (HbA1c) observed in clinical trials with liraglutide in type 2 diabetes (T2D) could be attained in routine clinical practice. METHODS: ReaL was a multicenter, non-interventional, observational, retrospective, longitudinal study on the effectiveness of liraglutide, a human glucagon-like peptide-1 analog, in individuals with T2D treated in daily practice in Italy. Between 26 March and 16 November 2015, data were taken from clinical records of patients aged ≥ 18 years with treatment follow-up data of up to 24 months and who received their first prescription of liraglutide in 2011. RESULTS: A total of 1723 patients were included in the analysis. At baseline, mean age was 58.9 years, duration of diabetes was 9.6 years, and HbA1c was 8.3%. At 12 months, 36.1% of patients were prescribed the maximum 1.8 mg dose; 43.5% [95% confidence interval (CI): 40.9; 46.2] of patients attained the primary outcome of a reduction in HbA1c of ≥ 1% point at 12 months. At 24 months, 40.9% (95% CI 38.1; 43.7) of patients had attained the HbA1c target of ≤ 7%. Additionally, body weight significantly decreased by 3.4 kg (95% CI − 3.6; − 3.1, p < 0.0001). CONCLUSION: In this observational study conducted in routine clinical practice for up to 2 years, treatment with liraglutide improved HbA1c and reduced body weight in a similar fashion to that observed under randomized clinical trial conditions. The data support the use of liraglutide as an effective treatment for T2D in clinical practice. FUNDING: Novo Nordisk S.p.A. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02255266. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s12325-017-0652-2) contains supplementary material, which is available to authorized users. Springer Healthcare 2017-12-21 2018 /pmc/articles/PMC5818560/ /pubmed/29270781 http://dx.doi.org/10.1007/s12325-017-0652-2 Text en © The Author(s) 2017 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
Lapolla, Annunziata
Berra, Cesare
Boemi, Massimo
Bossi, Antonio Carlo
Candido, Riccardo
Di Cianni, Graziano
Frontoni, Simona
Genovese, Stefano
Ponzani, Paola
Provenzano, Vincenzo
Russo, Giuseppina T.
Sciangula, Luigi
Simioni, Natalino
Bette, Cristiano
Nicolucci, Antonio
Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study
title Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study
title_full Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study
title_fullStr Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study
title_full_unstemmed Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study
title_short Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study
title_sort long-term effectiveness of liraglutide for treatment of type 2 diabetes in a real-life setting: a 24-month, multicenter, non-interventional, retrospective study
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5818560/
https://www.ncbi.nlm.nih.gov/pubmed/29270781
http://dx.doi.org/10.1007/s12325-017-0652-2
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