Abstract
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.
Highlights
Type 2 diabetes mellitus (T2DM) is a chronic, progressive disease
As glycemic control deteriorates over time, treatment intensification with the addition of multiple oral antihyperglycemic agents is often required in patients inadequately controlled with monotherapy [1]
Polypharmacy and complexity of the treatment regimens are associated with poor adherence to treatment, which in turn is associated with inadequate glycemic control [2,3,4]
Summary
Type 2 diabetes mellitus (T2DM) is a chronic, progressive disease. As glycemic control deteriorates over time, treatment intensification with the addition of multiple oral antihyperglycemic agents is often required in patients inadequately controlled with monotherapy [1]. The use of a fixed-dose combination of agents with complementary mechanisms of action is associated with improved patient compliance and adherence to treatment, as well as better glycemic control [5, 6]. Vildagliptin is a potent and selective oral dipeptidyl peptidase-4 inhibitor that improves glycemic control in patients with T2DM by increasing both the α-cell and β-cell responsiveness to glucose [7, 8]. Combination therapy with vildagliptin and metformin has demonstrated a better efficacy and safety profile with good gastrointestinal tolerability than high-dose metformin monotherapy [9, 10]. A single-pill combination of vildagliptin/metformin has been approved in the European Union and across many countries in the world for the treatment of patients with T2DM inadequately controlled with metformin alone [11]. We evaluated the differences in the treatment compliance with vildagliptin/metformin fixed-dose combination and vildagliptin (50 mg bid) added to metformin
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