Treatment Compliance with Fixed-Dose Combination of VildagliptinMetformin in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Metformin Monotherapy: A 24-Week Observational Study

Abstract EN

Objective.

To evaluate the differences in treatment compliance with vildagliptin/metformin fixed-dose versus free-dose combination therapy in patients with type 2 diabetes mellitus (T2DM) in Greece.

Design.

Adult patients with T2DM, inadequately controlled with metformin monotherapy, (850 mg bid), participated in this 24-week, multicenter, observational study.

Patients were enrolled in two cohorts: vildagliptin/metformin fixed-dose combination (group A) and vildagliptin metformin free-dose combination (group B).

Results.

659 patients were enrolled, 360 were male, with mean BMI 30.1, mean T2DM duration 59.6 months, and mean HbA1c at baseline 8%; 366 patients were assigned to group A and 293 to group B; data for 3 patients was missing.

In group A, 98.9% of patients were compliant with their treatment compared to 84.6% of group B.

The odds ratio for compliance in group A versus B was (OR) 18.9 (95% CI: 6.2, 57.7; P < 0.001 ).

In group A mean HbA1c decreased from 8.1% at baseline to 6.9% ( P < 0.001 ) at the study end and from 7.9% to 6.8% ( P < 0.001 ) in group B.

Conclusions.

Patients in group A were more compliant than patients in group B.

These results are in accordance with international literature suggesting that fixed-dose combination therapies lead to increased compliance to treatment.