The efficiency and tolerability of vildagliptin as the second-line drug as compared with other oral antidiabetics for diabetes mellitus type 2:
Worldwide Observation Study in the conditions of clinical practice (EDGE – results of the subanalysis of included patients in Slovakia)

Authors: Katarína Rašlová 1;  Dagmar Bucková 2
Authors‘ workplace: Metabolické centrum MUDr. Kataríny Rašlovej, s. r. o., Bratislava 1;  Novartis Slovakia s. r. o., Bratislava 2
Published in: Forum Diab 2014; 3(3): 155-162
Category: Pharmacotherapy news


The care of patients with type 2 diabetes mellitus (DM2T) is made more complicated by an increasing number of drugs now available for the treatment of this illness. While metformin is an established first-line drug within the monotherapy for DM2T, later on it is usually needed to intensify the treatment through a combination of multiple antidiabetics. The most recent guidelines for the treatment of diabetes recommend, when the second-line oral antidia­betics are being chosen, that not only their efficiency but also tolerability, price and patients’ preferences should be considered. There is only few literary data available from the large drug studies within the actual clinical practice that would make it possible to complete and compare the data on efficiency and safety of the new drugs, obtained from the randomized controlled clinical trials.

Target of the study:
The study aimed to evaluate the efficiency and tolerability of vildagliptin as compared with other oral antidiabetics (PAD) as an add-on to PAD monotherapy in the conditions of clinical practice and review the benefits and limitations of the extensive “pragmatic“ studies. In this paper we present the results of the subanalysis in the patients included in the EDGE study in the Slovak Republic.

Materials and methods:
EDGE was a prospective one-year observation study conducted in various countries of the world, which in the conditions of clinical practice focused on the efficiency and tolerability of vildagliptin (dipeptidyl peptidase 4 inhibitor), added on to the monotherapy with an (per)oral antidiabetic drugs (PAD), as compared with any combinations of two PADs without vildagliptin (the combined group). In our subanalysis, 45 physicians engaged in the trial in Slovakia provided data on the effects of PAD added on to metformin in 1 121 patients with DM2T, who did not reach a satisfactory glycaemic compensation through a PAD monotherapy. The primary target indicator of efficiency and safety (PEP) was defined as the proportion of patients who reached a decrease in HbA1c > 0.3%, without hypoglycaemia, weight gain, peripheral oedema or gastrointestinal undesirable effects. The clinically most significant secondary target indicator (SEP) evaluated the proportion of patients with the initial HbA1c ≥7%, who reached a target HbA1c < 7% without hypoglycaemia, or ≥ 3% weight gain.

In accordance with the general data from the study, the treatment of DM2T within EDGE was intensified using the other PAD at an average HbA1c 8 % (± 1,33), with no difference identified between the cohorts in Slovakia as regards the initial value HbA1c. After adding of the second drug, more than half of the patients successfully reached the primary target indicator (57.1 % of the patients treated with vildagliptin and 60.04 % patients treated with a comparator), which means OR 0.89 (95% CI: 0.70 -1.13; p = 0.32) without any significant difference between the cohorts. The trend in favour of the vildagliptin based treatment was observed in relation to the secondary target indicator (SEP) being reached in patients with the initial HbA1c ≥7%, (38.5% of the patients treated with vildagliptin as compared to 33 % of those treated by the comparator), OR 1,27 (95% CI: 0,97-1,66; p = 0,082), although without attaining statistical significance. The occurrence of undesirable effects was generally low and the safety profile of vildagliptin and the other PADs matched the previous data obtained in the studies.

The EDGE study has proved that vildagliptin as the second-line PAD can, in the conditions of clinical practice, effectively reduce HbA1c to a ≤ 7% target value with a satisfactory safety profile, which was also confirmed in the Slovak cohort of the study.

Key words:
diabetes mellitus 2. type – metformin – oral antidiabetic drugs – vildagliptin


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