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Comparative Efficacy of Lobeglitazone Versus Pioglitazone on Albuminuria in Patients with Type 2 Diabetes Mellitus

INTRODUCTION: The aim of this analysis was to evaluate the efficacy of lobeglitazone on albuminuria at 24 weeks of follow-up in patients with type 2 diabetes mellitus (T2DM) compared with pioglitazone using data from a randomized, double-blinded phase III trial. METHODS: In the phase III trial, pati...

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Autores principales: Kim, Kyung-Soo, Hong, Sangmo, Ahn, Hong-Yup, Park, Cheol-Young
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7843821/
https://www.ncbi.nlm.nih.gov/pubmed/33099742
http://dx.doi.org/10.1007/s13300-020-00948-1
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author Kim, Kyung-Soo
Hong, Sangmo
Ahn, Hong-Yup
Park, Cheol-Young
author_facet Kim, Kyung-Soo
Hong, Sangmo
Ahn, Hong-Yup
Park, Cheol-Young
author_sort Kim, Kyung-Soo
collection PubMed
description INTRODUCTION: The aim of this analysis was to evaluate the efficacy of lobeglitazone on albuminuria at 24 weeks of follow-up in patients with type 2 diabetes mellitus (T2DM) compared with pioglitazone using data from a randomized, double-blinded phase III trial. METHODS: In the phase III trial, patients who were inadequately controlled with metformin received 0.5 mg of lobeglitazone or 15 mg of pioglitazone for 24 weeks. Post hoc, exploratory analysis was used to investigate mean changes from baseline in the urine albumin–creatinine ratio (UACR) between the lobeglitazone (N = 104) and pioglitazone (N = 101) treatment groups. RESULTS: After 24 weeks of treatment, UACR was slightly decreased in the lobeglitazone group (− 4.3 mg/g creatinine [Cr]) compared to baseline and slightly increased in the pioglitazone group (5.2 mg/g Cr), with no change in the estimated glomerular filtration rate in either group; this difference was not statistically significant (P = 0.476). The incidence of new-onset microalbuminuria (2.4%) and the progression of albuminuria by > 1 stage (2.9%) in the lobeglitazone group were lower than the respective values in the pioglitazone group (6.8 and 6.1%, respectively). Of the patients in the lobeglitazone group, 50% exhibited regression to normoalbuminuria, compared to 39.3% of the patients in the pioglitazone. In subjects in the lobeglitazone group with micro- and macroalbuminuria, UACR tended to be more decreased and HbA1c was more reduced compared to those with normoalbuminuria (P = 0.014). CONCLUSION: Lobeglitazone had a tendency to improve albuminuria in patients with T2DM and had comparable effects on albuminuria as pioglitazone which has demonstrated beneficial effects. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01106131. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13300-020-00948-1) contains supplementary material, which is available to authorized users.
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spelling pubmed-78438212021-02-04 Comparative Efficacy of Lobeglitazone Versus Pioglitazone on Albuminuria in Patients with Type 2 Diabetes Mellitus Kim, Kyung-Soo Hong, Sangmo Ahn, Hong-Yup Park, Cheol-Young Diabetes Ther Original Research INTRODUCTION: The aim of this analysis was to evaluate the efficacy of lobeglitazone on albuminuria at 24 weeks of follow-up in patients with type 2 diabetes mellitus (T2DM) compared with pioglitazone using data from a randomized, double-blinded phase III trial. METHODS: In the phase III trial, patients who were inadequately controlled with metformin received 0.5 mg of lobeglitazone or 15 mg of pioglitazone for 24 weeks. Post hoc, exploratory analysis was used to investigate mean changes from baseline in the urine albumin–creatinine ratio (UACR) between the lobeglitazone (N = 104) and pioglitazone (N = 101) treatment groups. RESULTS: After 24 weeks of treatment, UACR was slightly decreased in the lobeglitazone group (− 4.3 mg/g creatinine [Cr]) compared to baseline and slightly increased in the pioglitazone group (5.2 mg/g Cr), with no change in the estimated glomerular filtration rate in either group; this difference was not statistically significant (P = 0.476). The incidence of new-onset microalbuminuria (2.4%) and the progression of albuminuria by > 1 stage (2.9%) in the lobeglitazone group were lower than the respective values in the pioglitazone group (6.8 and 6.1%, respectively). Of the patients in the lobeglitazone group, 50% exhibited regression to normoalbuminuria, compared to 39.3% of the patients in the pioglitazone. In subjects in the lobeglitazone group with micro- and macroalbuminuria, UACR tended to be more decreased and HbA1c was more reduced compared to those with normoalbuminuria (P = 0.014). CONCLUSION: Lobeglitazone had a tendency to improve albuminuria in patients with T2DM and had comparable effects on albuminuria as pioglitazone which has demonstrated beneficial effects. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT01106131. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13300-020-00948-1) contains supplementary material, which is available to authorized users. Springer Healthcare 2020-10-24 2021-01 /pmc/articles/PMC7843821/ /pubmed/33099742 http://dx.doi.org/10.1007/s13300-020-00948-1 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
Kim, Kyung-Soo
Hong, Sangmo
Ahn, Hong-Yup
Park, Cheol-Young
Comparative Efficacy of Lobeglitazone Versus Pioglitazone on Albuminuria in Patients with Type 2 Diabetes Mellitus
title Comparative Efficacy of Lobeglitazone Versus Pioglitazone on Albuminuria in Patients with Type 2 Diabetes Mellitus
title_full Comparative Efficacy of Lobeglitazone Versus Pioglitazone on Albuminuria in Patients with Type 2 Diabetes Mellitus
title_fullStr Comparative Efficacy of Lobeglitazone Versus Pioglitazone on Albuminuria in Patients with Type 2 Diabetes Mellitus
title_full_unstemmed Comparative Efficacy of Lobeglitazone Versus Pioglitazone on Albuminuria in Patients with Type 2 Diabetes Mellitus
title_short Comparative Efficacy of Lobeglitazone Versus Pioglitazone on Albuminuria in Patients with Type 2 Diabetes Mellitus
title_sort comparative efficacy of lobeglitazone versus pioglitazone on albuminuria in patients with type 2 diabetes mellitus
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7843821/
https://www.ncbi.nlm.nih.gov/pubmed/33099742
http://dx.doi.org/10.1007/s13300-020-00948-1
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