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Erschienen in: Wiener klinische Wochenschrift 7-8/2015

01.04.2015 | original article

Efficacy and tolerability of vildagliptin-based versus comparative dual therapy in type 2 diabetes

Results of the Austrian subpopulation of the EDGE study

verfasst von: MD Dr. Helmut Brath, MD Dr. Christoph Bialek, MD Ewald Gingl, MD Michael Resl, MD Univ. Prof. Dr. Rudolf Prager, MD Michaela Ratzinger

Erschienen in: Wiener klinische Wochenschrift | Ausgabe 7-8/2015

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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)).
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Metadaten
Titel
Efficacy and tolerability of vildagliptin-based versus comparative dual therapy in type 2 diabetes
Results of the Austrian subpopulation of the EDGE study
verfasst von
MD Dr. Helmut Brath
MD Dr. Christoph Bialek
MD Ewald Gingl
MD Michael Resl
MD Univ. Prof. Dr. Rudolf Prager
MD Michaela Ratzinger
Publikationsdatum
01.04.2015
Verlag
Springer Vienna
Erschienen in
Wiener klinische Wochenschrift / Ausgabe 7-8/2015
Print ISSN: 0043-5325
Elektronische ISSN: 1613-7671
DOI
https://doi.org/10.1007/s00508-014-0646-x

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