Abstract
It is of interest to evaluate the clinical effectiveness and safety of vildagliptin as monotherapy and combination therapy of vildagliptin and metformin for the management of type 2 diabetes mellitus (T2DM) patients in Indian settings. The study included patients with T2DM (aged >18 years) receiving vildagliptin monotherapy and vildagliptin in combination with metformin therapy of various strengths. Data related to demographics, risk factors, medical history, glycated hemoglobin (HbA1c) levels, and medical therapies were retrieved from medical records. Out of 9678 patients (median age, 52.0 years), 59.1% were men. A combination of vildagliptin and metformin (50/500 mg) was the most commonly used therapy (54.8%), and the median duration of therapy was 24.0 months. The predominant reason for selecting vildagliptin therapy was to improve HbA1c levels (87.8%). A total of 87.5% of patients required dosage up-titration. Vildagliptin therapy was used in patients with T2DM and associated complications (peripheral neuropathy, CAD, nephropathy, retinopathy, autonomous neuropathy, stroke/TIA, and peripheral artery disease). Among 5175 patients who experienced body weight changes, a majority of patients showed a loss of weight (68.6%). The target glycemic control was achieved in 95.3% of patients. The mean HbA1c levels were significantly decreased post-treatment (mean change: 1.34%; p<0.001). Adverse events were reported in 0.4% of patients. Physicians rated the majority of patients as good to excellent on the global evaluation of efficacy and tolerability scale (98.9%, each). Vildagliptin as monotherapy and combination therapy of vildagliptin and metformin was an effective therapy in reducing HbA1c helps in achieving target glycemic control, and was well tolerated in Indian patients with T2DM continuum.
Highlights
The poor glycemic control, long duration of illness, and the ethnicity of the population contribute to the increased susceptibility to diabetes associated complications [1]
The American Diabetes Association (ADA), the European Association for the Study of Diabetes (EASD), and the India-specific diabetes management guidelines recommend the use of metformin along with lifestyle changes as first-line therapy for diabetes management [9,10,11]
There is a need for evidence from India demonstrating the overall clinical benefits of glycemic control and weight reduction with vildagliptin monotherapy [18] or vildagliptin and metformin combination therapy for diabetes [19, 20]
Summary
The poor glycemic control, long duration of illness, and the ethnicity of the population contribute to the increased susceptibility to diabetes associated complications [1]. Targeted glycemic levels may not be achieved by metformin or other oral antidiabetic drugs (OADs) monotherapy. Considering diabetes as a progressive disease, combination therapies of metformin with other oral antidiabetic drugs (OADs) are recommended [9,10,11]. If patients fail to achieve target glycemic levels with monotherapy, the combination therapies of metformin with other OADs and/or insulin are recommended [9,10,11]. There is a need for evidence from India demonstrating the overall clinical benefits of glycemic control and weight reduction with vildagliptin monotherapy [18] or vildagliptin and metformin combination therapy for diabetes [19, 20]. It is of interest to document the treatment patterns, clinical effectiveness, and safety profile of vildagliptin monotherapy, vildagliptin, and metformin combination therapy for the management of the T2DM continuum in India
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