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Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add‐on to metformin in patients with type 2 diabetes
AIM: To investigate the association of different categories of baseline cardio‐metabolic risk factors on the treatment effects of empagliflozin 10 and 25 mg when added as second‐line therapy to metformin in patients with type 2 diabetes (T2D). MATERIALS AND METHODS: Patients aged 18 years or older w...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Blackwell Publishing Ltd
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7839733/ https://www.ncbi.nlm.nih.gov/pubmed/33084149 http://dx.doi.org/10.1111/dom.14234 |
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author | Inzucchi, Silvio E. Davies, Melanie J. Khunti, Kamlesh Trivedi, Prabhav George, Jyothis T. Zwiener, Isabella Johansen, Odd Erik Sattar, Naveed |
author_facet | Inzucchi, Silvio E. Davies, Melanie J. Khunti, Kamlesh Trivedi, Prabhav George, Jyothis T. Zwiener, Isabella Johansen, Odd Erik Sattar, Naveed |
author_sort | Inzucchi, Silvio E. |
collection | PubMed |
description | AIM: To investigate the association of different categories of baseline cardio‐metabolic risk factors on the treatment effects of empagliflozin 10 and 25 mg when added as second‐line therapy to metformin in patients with type 2 diabetes (T2D). MATERIALS AND METHODS: Patients aged 18 years or older with HbA1c 7.0%‐10.0% were included. Analysis of covariance compared change from baseline to weeks 24 and 76 in HbA1c, body weight (BW) and systolic blood pressure (SBP) by respective baseline categories (HbA1c <8.5/≥8.5%; BW <80/80‐90/>90 kg, SBP <130/130‐140/>140 mmHg). Analyses were also conducted with a model using continuous covariates of cardio‐metabolic factors. RESULTS: In total, 637 patients (56.7% males; mean [SD] age 55.7 [9.9] years, HbA1c 7.9% [0.9%], BW 81.2 [18.8] kg, SBP 129.4 [14.6] mmHg) received one or more dose of either empagliflozin 10 mg (n = 217) or 25 mg (n = 213), or placebo (n = 207). At both time points, empagliflozin 10/25 mg versus placebo significantly (P < .0001) reduced HbA1c and BW, with greater reductions in HbA1c at higher baseline HbA1c (P interaction week 24/76 categorical and continuous models: .0290/.1431 and .0004/.0042, respectively) and in BW (P interaction .1340/.0012 and .0202/<.0001, respectively). Both empagliflozin doses also significantly lowered SBP versus placebo at both time points, with similar efficacy by subgroups of baseline SBP. Adverse events were consistent with the established empagliflozin safety profile across treatment groups. CONCLUSIONS: Empagliflozin, as add‐on to metformin, decreases HbA1c and BW, particularly in patients with higher HbA1c and BW baseline values, and effectively lowers SBP. |
format | Online Article Text |
id | pubmed-7839733 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | Blackwell Publishing Ltd |
record_format | MEDLINE/PubMed |
spelling | pubmed-78397332021-02-02 Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add‐on to metformin in patients with type 2 diabetes Inzucchi, Silvio E. Davies, Melanie J. Khunti, Kamlesh Trivedi, Prabhav George, Jyothis T. Zwiener, Isabella Johansen, Odd Erik Sattar, Naveed Diabetes Obes Metab Original Articles AIM: To investigate the association of different categories of baseline cardio‐metabolic risk factors on the treatment effects of empagliflozin 10 and 25 mg when added as second‐line therapy to metformin in patients with type 2 diabetes (T2D). MATERIALS AND METHODS: Patients aged 18 years or older with HbA1c 7.0%‐10.0% were included. Analysis of covariance compared change from baseline to weeks 24 and 76 in HbA1c, body weight (BW) and systolic blood pressure (SBP) by respective baseline categories (HbA1c <8.5/≥8.5%; BW <80/80‐90/>90 kg, SBP <130/130‐140/>140 mmHg). Analyses were also conducted with a model using continuous covariates of cardio‐metabolic factors. RESULTS: In total, 637 patients (56.7% males; mean [SD] age 55.7 [9.9] years, HbA1c 7.9% [0.9%], BW 81.2 [18.8] kg, SBP 129.4 [14.6] mmHg) received one or more dose of either empagliflozin 10 mg (n = 217) or 25 mg (n = 213), or placebo (n = 207). At both time points, empagliflozin 10/25 mg versus placebo significantly (P < .0001) reduced HbA1c and BW, with greater reductions in HbA1c at higher baseline HbA1c (P interaction week 24/76 categorical and continuous models: .0290/.1431 and .0004/.0042, respectively) and in BW (P interaction .1340/.0012 and .0202/<.0001, respectively). Both empagliflozin doses also significantly lowered SBP versus placebo at both time points, with similar efficacy by subgroups of baseline SBP. Adverse events were consistent with the established empagliflozin safety profile across treatment groups. CONCLUSIONS: Empagliflozin, as add‐on to metformin, decreases HbA1c and BW, particularly in patients with higher HbA1c and BW baseline values, and effectively lowers SBP. Blackwell Publishing Ltd 2020-11-20 2021-02 /pmc/articles/PMC7839733/ /pubmed/33084149 http://dx.doi.org/10.1111/dom.14234 Text en © 2020 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 Inzucchi, Silvio E. Davies, Melanie J. Khunti, Kamlesh Trivedi, Prabhav George, Jyothis T. Zwiener, Isabella Johansen, Odd Erik Sattar, Naveed Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add‐on to metformin in patients with type 2 diabetes |
title | Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add‐on to metformin in patients with type 2 diabetes |
title_full | Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add‐on to metformin in patients with type 2 diabetes |
title_fullStr | Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add‐on to metformin in patients with type 2 diabetes |
title_full_unstemmed | Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add‐on to metformin in patients with type 2 diabetes |
title_short | Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add‐on to metformin in patients with type 2 diabetes |
title_sort | empagliflozin treatment effects across categories of baseline hba1c, body weight and blood pressure as an add‐on to metformin in patients with type 2 diabetes |
topic | Original Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7839733/ https://www.ncbi.nlm.nih.gov/pubmed/33084149 http://dx.doi.org/10.1111/dom.14234 |
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