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Effectiveness and Tolerability of Vildagliptin and the Single Pill Combination of Vildagliptin and Metformin in “Real-World” Management of Type 2 Diabetes Mellitus: The G-FORCE Study
INTRODUCTION: Randomized clinical trials showed that vildagliptin is well tolerated and leads to clinically meaningful decreases in glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) both in monotherapy and as add-on therapy in inadequately controlled type 2 diabetes mellitus (T2DM) patien...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer Healthcare
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6531546/ https://www.ncbi.nlm.nih.gov/pubmed/30919316 http://dx.doi.org/10.1007/s13300-019-0601-y |
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author | Van Gaal, Luc Hermans, Michel P. Daci, Evis Denhaerynck, Kris De Meester, Lut MacDonald, Karen Abraham, Ivo Vancayzeele, Stefaan Maris, Michael |
author_facet | Van Gaal, Luc Hermans, Michel P. Daci, Evis Denhaerynck, Kris De Meester, Lut MacDonald, Karen Abraham, Ivo Vancayzeele, Stefaan Maris, Michael |
author_sort | Van Gaal, Luc |
collection | PubMed |
description | INTRODUCTION: Randomized clinical trials showed that vildagliptin is well tolerated and leads to clinically meaningful decreases in glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) both in monotherapy and as add-on therapy in inadequately controlled type 2 diabetes mellitus (T2DM) patients. Nevertheless, there is an increased interest for real-life studies to confirm the clinical trial findings in the setting of a daily clinical practice. The aim of this study was to evaluate the effectiveness and tolerability of vildagliptin in a real-life clinical setting and to explore factors determining drug adherence and T2DM management. METHODS: G-FORCE was a prospective, observational, open-label, multi-center study in which T2DM patients were prescribed de novo vildagliptin. Clinical effectiveness was determined by changes in HbA1c and FPG and by the proportion of patients reaching glycemic goal. Data were collected at baseline, after 105 ± 15 days and after 180 ± 15 days. RESULTS: A total of 1230 patients were included in this analysis. Mean age was 63.9 ± 10.8 years, and mean HbA1c and FPG levels were 8.2 ± 1.3% and 171.0 ± 53.3 mg/dL, respectively. At 180 days of treatment, HbA1c and FPG levels decreased to 7.2 ± 1.0% and 141.1 ± 44.0 mg/dL, respectively, while the proportion of patients reaching HbA1c and FPG goals rose from 8.6 to 44.6% and from 14.2 to 42.8%, respectively. CONCLUSION: In this real-world study, vildagliptin was an effective and safe treatment for T2DM patients already treated with metformin, while the single pill combination of vildagliptin and metformin provides a convenient alternative while ensuring comparable effectiveness and tolerability. FUNDING: Novartis Pharma. |
format | Online Article Text |
id | pubmed-6531546 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-65315462019-06-07 Effectiveness and Tolerability of Vildagliptin and the Single Pill Combination of Vildagliptin and Metformin in “Real-World” Management of Type 2 Diabetes Mellitus: The G-FORCE Study Van Gaal, Luc Hermans, Michel P. Daci, Evis Denhaerynck, Kris De Meester, Lut MacDonald, Karen Abraham, Ivo Vancayzeele, Stefaan Maris, Michael Diabetes Ther Original Research INTRODUCTION: Randomized clinical trials showed that vildagliptin is well tolerated and leads to clinically meaningful decreases in glycated hemoglobin (HbA1c) and fasting plasma glucose (FPG) both in monotherapy and as add-on therapy in inadequately controlled type 2 diabetes mellitus (T2DM) patients. Nevertheless, there is an increased interest for real-life studies to confirm the clinical trial findings in the setting of a daily clinical practice. The aim of this study was to evaluate the effectiveness and tolerability of vildagliptin in a real-life clinical setting and to explore factors determining drug adherence and T2DM management. METHODS: G-FORCE was a prospective, observational, open-label, multi-center study in which T2DM patients were prescribed de novo vildagliptin. Clinical effectiveness was determined by changes in HbA1c and FPG and by the proportion of patients reaching glycemic goal. Data were collected at baseline, after 105 ± 15 days and after 180 ± 15 days. RESULTS: A total of 1230 patients were included in this analysis. Mean age was 63.9 ± 10.8 years, and mean HbA1c and FPG levels were 8.2 ± 1.3% and 171.0 ± 53.3 mg/dL, respectively. At 180 days of treatment, HbA1c and FPG levels decreased to 7.2 ± 1.0% and 141.1 ± 44.0 mg/dL, respectively, while the proportion of patients reaching HbA1c and FPG goals rose from 8.6 to 44.6% and from 14.2 to 42.8%, respectively. CONCLUSION: In this real-world study, vildagliptin was an effective and safe treatment for T2DM patients already treated with metformin, while the single pill combination of vildagliptin and metformin provides a convenient alternative while ensuring comparable effectiveness and tolerability. FUNDING: Novartis Pharma. Springer Healthcare 2019-03-27 2019-06 /pmc/articles/PMC6531546/ /pubmed/30919316 http://dx.doi.org/10.1007/s13300-019-0601-y Text en © The Author(s) 2019 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 Van Gaal, Luc Hermans, Michel P. Daci, Evis Denhaerynck, Kris De Meester, Lut MacDonald, Karen Abraham, Ivo Vancayzeele, Stefaan Maris, Michael Effectiveness and Tolerability of Vildagliptin and the Single Pill Combination of Vildagliptin and Metformin in “Real-World” Management of Type 2 Diabetes Mellitus: The G-FORCE Study |
title | Effectiveness and Tolerability of Vildagliptin and the Single Pill Combination of Vildagliptin and Metformin in “Real-World” Management of Type 2 Diabetes Mellitus: The G-FORCE Study |
title_full | Effectiveness and Tolerability of Vildagliptin and the Single Pill Combination of Vildagliptin and Metformin in “Real-World” Management of Type 2 Diabetes Mellitus: The G-FORCE Study |
title_fullStr | Effectiveness and Tolerability of Vildagliptin and the Single Pill Combination of Vildagliptin and Metformin in “Real-World” Management of Type 2 Diabetes Mellitus: The G-FORCE Study |
title_full_unstemmed | Effectiveness and Tolerability of Vildagliptin and the Single Pill Combination of Vildagliptin and Metformin in “Real-World” Management of Type 2 Diabetes Mellitus: The G-FORCE Study |
title_short | Effectiveness and Tolerability of Vildagliptin and the Single Pill Combination of Vildagliptin and Metformin in “Real-World” Management of Type 2 Diabetes Mellitus: The G-FORCE Study |
title_sort | effectiveness and tolerability of vildagliptin and the single pill combination of vildagliptin and metformin in “real-world” management of type 2 diabetes mellitus: the g-force study |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6531546/ https://www.ncbi.nlm.nih.gov/pubmed/30919316 http://dx.doi.org/10.1007/s13300-019-0601-y |
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