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Cardiovascular and Metabolic Risk
The DIVE/DPV registries: evolution of empagliflozin use in clinical practice in Germany
  1. Peter Bramlage1,
  2. Sascha R Tittel2,3,
  3. Christian Wagner4,
  4. Kerstin König5,
  5. Dirk Raddatz6,
  6. Rosmarie Weber-Lauffer7,
  7. Diether Erath8,
  8. Jost Hilgenberg9,
  9. Carsten Spies10,
  10. Thomas Danne11,
  11. Maximilian Gabler12,
  12. Johannes Foersch12,
  13. Ludwin Ley12,
  14. Jochen Seufert13
  1. 1Institute for Pharmacology and Preventive Medicine, Cloppenburg, Germany
  2. 2Institut für Epidemiologie und medizinische Biometrie, University of Ulm, Ulm, Germany
  3. 3Deutsches Zentrum für Diabetesforschung eV, München-Neuherberg, Germany
  4. 4Praxis Wagner, Saaldorf-Surheim, Germany
  5. 5Medizinische Kompetenzkollegium, Kamen, Germany
  6. 6Department of Gastroenterology and Endocrinology, University of Göttingen, Gottingen, Germany
  7. 7Schwerpunktpraxis Diabetologie, Karlsruhe, Germany
  8. 8Praxis für Innere Medizin, Rottweil, Germany
  9. 9Gemeinschaftspraxis, Nienburg - Locum - Landsbergen, Germany
  10. 10St Vincenz Krankenhaus, Limburg, Germany
  11. 11Diabeteszentrum für Kinder und Jugendliche, Kinderkrankenhaus auf der Bult, Hannover, Germany
  12. 12Boehringer Ingelheim Pharma GmbH und Co KG, Ingelheim, Germany
  13. 13Freiburg University Hospital, Freiburg, Germany
  1. Correspondence to Professor Peter Bramlage; peter.bramlage{at}ippmed.de

Abstract

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/m2), 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 m2) (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.

  • empagliflozin
  • sodium-glucose cotransporter-2 inhibitor
  • type 2 diabetes mellitus
  • registry
  • routine clinical practice
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/.

https://doi.org/10.1136/bmjdrc-2020-001486

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    Footnotes

    • Contributors CW, KK, DR, RW-L, DE, JH and TD contributed to data collection. PB, SRT, MG, JF and LL defined the scope and the relevant parameters to be assessed in this work. PB and SRT designed the analysis, drafted the manuscript and created the figure. SRT was responsible for the statistical analyses. CW, KK, DR, RW-L, DE, JH, TD, MG, JF, LL, and JS contributed to the discussion and reviewed/edited the manuscript. SRT had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. All authors approved the final manuscript to be submitted.

    • Funding The DPV registry was supported by the European Foundation for the Study of Diabetes (EFSD). Further financial support was provided by the German Diabetes Society (DDG) and the German Center for Diabetes Research (DZD). The DIVE registry received funding from Abbott, AstraZeneca, Bayer and Sanofi. These organizations were not involved in the analysis and interpretation of data, writing of the report or the decision to submit the article for publication. The present work was funded by Boehringer Ingelheim. MG, JF and LL, as employees of Boehringer Ingelheim, were involved in developing the concept, interpretation of data, writing of the report and the decision to submit for publication.

    • Competing interests JS and TD report grants and personal fees from Abbott, AstraZeneca, and Sanofi, outside the submitted work. PB reports to have received research support from the funders of DIVE. MG, JF and LL are employees of Boehringer Ingelheim. SRT, CW, KK, DR, RW-L, DE, and JH have no competing interests to disclose.

    • Patient consent for publication Not required.

    • Ethics approval The DPV initiative, which was established in 1995, was approved by the ethics committee of the University of Ulm, and data collection was approved by the local review boards. The DIVE registry was established in Germany in 2011. The protocol was approved by the ethics committee of the Medical School of Hannover.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement The data sets generated and analyzed during the current study are not publicly available due to data privacy, but aggregated data may be available from the corresponding author on reasonable request.