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The DIVE/DPV registries: evolution of empagliflozin use in clinical practice in Germany
INTRODUCTION: Empagliflozin reduced morbidity and mortality in patients with type 2 diabetes mellitus (T2DM) in clinical trials. A registry study was undertaken to describe evolution of patient characteristics and assess the real-world effectiveness/safety of empagliflozin. RESEARCH DESIGN AND METHO...
Autores principales: | , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BMJ Publishing Group
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7388887/ https://www.ncbi.nlm.nih.gov/pubmed/32719080 http://dx.doi.org/10.1136/bmjdrc-2020-001486 |
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author | Bramlage, Peter Tittel, Sascha R Wagner, Christian König, Kerstin Raddatz, Dirk Weber-Lauffer, Rosmarie Erath, Diether Hilgenberg, Jost Spies, Carsten Danne, Thomas Gabler, Maximilian Foersch, Johannes Ley, Ludwin Seufert, Jochen |
author_facet | Bramlage, Peter Tittel, Sascha R Wagner, Christian König, Kerstin Raddatz, Dirk Weber-Lauffer, Rosmarie Erath, Diether Hilgenberg, Jost Spies, Carsten Danne, Thomas Gabler, Maximilian Foersch, Johannes Ley, Ludwin Seufert, Jochen |
author_sort | Bramlage, Peter |
collection | PubMed |
description | INTRODUCTION: Empagliflozin reduced morbidity and mortality in patients with type 2 diabetes mellitus (T2DM) in clinical trials. A registry study was undertaken to describe evolution of patient characteristics and assess the real-world effectiveness/safety of empagliflozin. RESEARCH DESIGN AND METHODS: Data from the Diabetes Patienten Verlaufsdokumentation (DPV)/Diabetes Versorgungsevaluation (DIVE) registries on 9571 adults with T2DM (registered in 2014–2019) receiving empagliflozin were used. Patients were grouped according to the following: early users (group 1; n=505) received empagliflozin before the EMPA-REG OUTCOME study publication (mid-September 2015); intermediate users (group 2; n=2961) started empagliflozin after the EMPA-REG OUTCOME publication but before the European Medicines Agency label change (from mid-September 2015 to mid-January 2017); and late users (group 3; n=6105) started empagliflozin after mid-January 2017. Data on clinical and treatment characteristics were collected. RESULTS: Over time, the proportion of recipients aged <65 years decreased (71.1% vs 54.4% among early and late adopters), male patients increased (from 50.9% to 66.5%), body mass index (mean±SD) decreased (from 35.5±6.7 to 32.7±6.6 kg/m(2)), proportion with cardiovascular morbidities increased (from 20.4% to 26.4%), and mean estimated glomerular filtration rate decreased (from 83.2±19.5 to 78.5±21.1 mL/min/1.73 m(2)) (all p<0.001). Patients increasingly received empagliflozin in combination with metformin (60.8% vs 68.6% of early and late adopters; p<0.001), glucagon-like peptide-1 (GLP-1) agonists (11.0 vs 14.1%; p<0.001) or insulin (34.3% vs 49.9%; p<0.001). Empagliflozin was generally added to existing antidiabetic regimens. Six months after empagliflozin initiation, the mean glycated hemoglobin (HbA1c) decreased by 0.4%, the proportion of patients with HbA1c <6.5% increased (19.2% vs 12.8%), and the mean fasting plasma glucose decreased (155.8±49.7 vs 168.0±55.1 mg/dL) (all p<0.001). No significant changes in rates of severe hypoglycemia and no cases of diabetic ketoacidosis were seen. CONCLUSIONS: Over time, empagliflozin is being prescribed to a broader patient range in routine practice, is usually added to existing antidiabetic regimens, and is increasingly used in combination with metformin, GLP-1 agonists and/or insulin. Empagliflozin had a beneficial effect on glycemic control, with no increase in hypoglycemia. |
format | Online Article Text |
id | pubmed-7388887 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2020 |
publisher | BMJ Publishing Group |
record_format | MEDLINE/PubMed |
spelling | pubmed-73888872020-08-11 The DIVE/DPV registries: evolution of empagliflozin use in clinical practice in Germany Bramlage, Peter Tittel, Sascha R Wagner, Christian König, Kerstin Raddatz, Dirk Weber-Lauffer, Rosmarie Erath, Diether Hilgenberg, Jost Spies, Carsten Danne, Thomas Gabler, Maximilian Foersch, Johannes Ley, Ludwin Seufert, Jochen BMJ Open Diabetes Res Care Cardiovascular and Metabolic Risk INTRODUCTION: Empagliflozin reduced morbidity and mortality in patients with type 2 diabetes mellitus (T2DM) in clinical trials. A registry study was undertaken to describe evolution of patient characteristics and assess the real-world effectiveness/safety of empagliflozin. RESEARCH DESIGN AND METHODS: Data from the Diabetes Patienten Verlaufsdokumentation (DPV)/Diabetes Versorgungsevaluation (DIVE) registries on 9571 adults with T2DM (registered in 2014–2019) receiving empagliflozin were used. Patients were grouped according to the following: early users (group 1; n=505) received empagliflozin before the EMPA-REG OUTCOME study publication (mid-September 2015); intermediate users (group 2; n=2961) started empagliflozin after the EMPA-REG OUTCOME publication but before the European Medicines Agency label change (from mid-September 2015 to mid-January 2017); and late users (group 3; n=6105) started empagliflozin after mid-January 2017. Data on clinical and treatment characteristics were collected. RESULTS: Over time, the proportion of recipients aged <65 years decreased (71.1% vs 54.4% among early and late adopters), male patients increased (from 50.9% to 66.5%), body mass index (mean±SD) decreased (from 35.5±6.7 to 32.7±6.6 kg/m(2)), proportion with cardiovascular morbidities increased (from 20.4% to 26.4%), and mean estimated glomerular filtration rate decreased (from 83.2±19.5 to 78.5±21.1 mL/min/1.73 m(2)) (all p<0.001). Patients increasingly received empagliflozin in combination with metformin (60.8% vs 68.6% of early and late adopters; p<0.001), glucagon-like peptide-1 (GLP-1) agonists (11.0 vs 14.1%; p<0.001) or insulin (34.3% vs 49.9%; p<0.001). Empagliflozin was generally added to existing antidiabetic regimens. Six months after empagliflozin initiation, the mean glycated hemoglobin (HbA1c) decreased by 0.4%, the proportion of patients with HbA1c <6.5% increased (19.2% vs 12.8%), and the mean fasting plasma glucose decreased (155.8±49.7 vs 168.0±55.1 mg/dL) (all p<0.001). No significant changes in rates of severe hypoglycemia and no cases of diabetic ketoacidosis were seen. CONCLUSIONS: Over time, empagliflozin is being prescribed to a broader patient range in routine practice, is usually added to existing antidiabetic regimens, and is increasingly used in combination with metformin, GLP-1 agonists and/or insulin. Empagliflozin had a beneficial effect on glycemic control, with no increase in hypoglycemia. BMJ Publishing Group 2020-07-27 /pmc/articles/PMC7388887/ /pubmed/32719080 http://dx.doi.org/10.1136/bmjdrc-2020-001486 Text en © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. |
spellingShingle | Cardiovascular and Metabolic Risk Bramlage, Peter Tittel, Sascha R Wagner, Christian König, Kerstin Raddatz, Dirk Weber-Lauffer, Rosmarie Erath, Diether Hilgenberg, Jost Spies, Carsten Danne, Thomas Gabler, Maximilian Foersch, Johannes Ley, Ludwin Seufert, Jochen The DIVE/DPV registries: evolution of empagliflozin use in clinical practice in Germany |
title | The DIVE/DPV registries: evolution of empagliflozin use in clinical practice in Germany |
title_full | The DIVE/DPV registries: evolution of empagliflozin use in clinical practice in Germany |
title_fullStr | The DIVE/DPV registries: evolution of empagliflozin use in clinical practice in Germany |
title_full_unstemmed | The DIVE/DPV registries: evolution of empagliflozin use in clinical practice in Germany |
title_short | The DIVE/DPV registries: evolution of empagliflozin use in clinical practice in Germany |
title_sort | dive/dpv registries: evolution of empagliflozin use in clinical practice in germany |
topic | Cardiovascular and Metabolic Risk |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7388887/ https://www.ncbi.nlm.nih.gov/pubmed/32719080 http://dx.doi.org/10.1136/bmjdrc-2020-001486 |
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