caa a22 4500 606239855 CHVBK 20210128101305.0 cr unu---uuuuu 210128e20150401xx s 000 0 eng 10.1007/s00508-014-0646-x doi (NATIONALLICENCE)springer-10.1007/s00508-014-0646-x Efficacy and tolerability of vildagliptin-based versus comparative dual therapy in type 2 diabetes [Elektronische Daten] Results of the Austrian subpopulation of the EDGE study [Helmut Brath, Christoph Bialek, Ewald Gingl, Michael Resl, Rudolf Prager, Michaela Ratzinger] Effizienz und Verträglichkeit von Vildagliptin basierter versus DPP-4 Hemmer freier oraler Dualtherapie Ergebnisse der österreichischen Subpopulation der EDGE Studie Summary: Background: The aim of this post hoc analysis of data from the Austrian subpopulation of the EDGE study was the evaluation of the effectiveness and tolerability of vildagliptin as an add-on to an existing oral antidiabetic (OAD) monotherapy versus a combination therapy with two OADs without vildagliptin in patients with inadequately controlled type 2 diabetes. Patients and methods: In Austria, 422 patients were included. In the framework of regular visits (at baseline, about once per quarter, and at the study end, after 12 months), adverse events (AEs), courses, and changes of therapy were recorded. In addition to the primary end point defined in the primary study, i.e., a reduction of HbA1c by >0.3% without hypoglycemia, weight gain ≥5%, peripheral edema, or discontinuation due to gastrointestinal events, the most clinically relevant secondary end point, i.e., HbA1c reduction <7% without hypoglycemia or ≥3% increase in body weight after 12 months was used for the analysis of the Austrian data. Results: The initial HbA1c of all enrolled patients was 8.3±1.4%. The mean reduction of HbA1c was −1.1% in the vildagliptin cohort and −1.0% in the comparator cohort. In the vildagliptin cohort, 56.4% of patients, and in the comparator cohort, 45.9% of patients, reached the primary end point (odds ratio: 1.53, p=0.04). In the vildagliptin cohort, 18.7% of patients, and in the comparator cohort, 16.9% of patients, reached the secondary end point (odds ratio: 1.13, p=0.68). The incidence of hypoglycemic events (two in each cohort), AEs (approximately 15% in each cohort), and serious AEs (approximately 2% in each cohort) was comparable between the two groups. Conclusion: In a "real-life” setting, the effectiveness of vildagliptin as second-line treatment is superior to comparator OADs with regard to a reduction in HbA1c of greater than 0.3% from baseline without well-recognized side effects in patients with inadequately controlled type 2 diabetes (mean baseline HbA1c: 8.5% (vildagliptin cohort) vs. 8.1% (comparator cohort)). Springer-Verlag Wien, 2014 Type 2 diabetes nationallicence Dipeptidyl peptidase-IV inhibitor nationallicence Oral antidiabetics nationallicence Noninterventional trial nationallicence Efficacy nationallicence Tolerability nationallicence Typ 2 Diabetes nationallicence Dipeptidyl Peptidase-IV Inhibitor nationallicence Orale Antidiabetika nationallicence Nichtinterventionelle Studie nationallicence Therapieeffizienz nationallicence Therapieverträglichkeit nationallicence Brath Helmut Diabetes Outpatient Clinic, Health Center South, Wienerbergstr. 13, 1100, Vienna, Austria aut Bialek Christoph Medical Practice for Internal Medicine, Friedrich Kheckstrasse 18, 2540, Bad Vöslau, Austria aut Gingl Ewald Novartis Pharma GmbH, 1020, Vienna, Austria aut Resl Michael Department of Endocrinology and Metabolism, University Hospital of Internal Medicine III, Medical University of Vienna, Vienna, Austria aut Prager Rudolf 3rd Medical Department and Karl Landsteiner Institute for Metabolic Diseases and Nephrology, Hietzing Hospital with Rosenhügel Neurological Center, 1130, Vienna, Austria aut Ratzinger Michaela Novartis Pharma GmbH, 1020, Vienna, Austria aut Wiener klinische Wochenschrift Springer Vienna 127/7-8(2015-04-01), 250-255 0043-5325 127:7-8<250 2015 127 508 https://doi.org/10.1007/s00508-014-0646-x text/html Onlinezugriff via DOI BK010053 XK010053 XK010000 Metadata rights reserved Springer special CC-BY-NC licence nationallicence 1 research-article jats NATIONALLICENCE NATIONALLICENCE NL-springer NATIONALLICENCE 856 40 https://doi.org/10.1007/s00508-014-0646-x text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Brath Helmut Diabetes Outpatient Clinic, Health Center South, Wienerbergstr. 13, 1100, Vienna, Austria aut NATIONALLICENCE 700 1- Bialek Christoph Medical Practice for Internal Medicine, Friedrich Kheckstrasse 18, 2540, Bad Vöslau, Austria aut NATIONALLICENCE 700 1- Gingl Ewald Novartis Pharma GmbH, 1020, Vienna, Austria aut NATIONALLICENCE 700 1- Resl Michael Department of Endocrinology and Metabolism, University Hospital of Internal Medicine III, Medical University of Vienna, Vienna, Austria aut NATIONALLICENCE 700 1- Prager Rudolf 3rd Medical Department and Karl Landsteiner Institute for Metabolic Diseases and Nephrology, Hietzing Hospital with Rosenhügel Neurological Center, 1130, Vienna, Austria aut NATIONALLICENCE 700 1- Ratzinger Michaela Novartis Pharma GmbH, 1020, Vienna, Austria aut NATIONALLICENCE 773 0- Wiener klinische Wochenschrift Springer Vienna 127/7-8(2015-04-01), 250-255 0043-5325 127:7-8<250 2015 127 508