Content area
Full Text
Key Points
Vildagliptin sustained release 100 mg once daily significantly lowers glycated hemoglobin and improves glucose parameters in Indian patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy. |
The addition of vildagliptin sustained release was well tolerated, with observed reductions in blood pressure levels and waist circumference among patients. |
Vildagliptin sustained release 100 mg offers a valuable treatment option for patients with type 2 diabetes not adequately controlled on metformin alone, highlighting its clinical efficacy and tolerability. |
Introduction
Diabetes mellitus is increasingly concerning as a global public health crisis with a significant disease burden [1]. Consistent with global trends, India has also experienced a gradual increase in the burden of diabetes over decades. According to a recent Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) 17 study, India has a huge burden of diabetes, amounting to > 100 million individuals [2].
Dipeptidyl peptidase-4 inhibitors such as vildagliptin selectively and reversibly inhibit dipeptidyl peptidase-4 enzymes, which are known to deactivate incretin hormones such as glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide hormones. These hormones play a crucial role in maintaining glucose homeostasis [3]. Clinical evidence of vildagliptin and its usage in routine clinical practice for the last 15 years offers clinicians an efficacious treatment choice for managing blood glucose levels in patients with type 2 diabetes mellitus (T2DM) [4]. Importantly, the addition of vildagliptin to metformin treatment improved glycated hemoglobin (HbA1c) and plasma glucose levels while not increasing the risk of hypoglycemia as well as weight gain [5, 6].
With the recent approval of vildagliptin sustained release (XR) in India, clinicians have an option of offering a once-daily formulation of vildagliptin 100 mg. Real-world evidence provides important aspects of drug usage and its effectiveness/safety in routine practice that are not always available through clinical trials. Thus, the present study aimed to assess the clinical performance of vildagliptin XR in real-world settings to better understand the effectiveness and safety of vildagliptin XR as an add-on therapy in patients with T2DM who are inadequately controlled on metformin monotherapy.
Materials and Methods
Study Design
This single-arm, observational, prospective, open-label, multicenter, cohort study was conducted across India. Patients with T2DM inadequately controlled on metformin monotherapy received vildagliptin XR once daily for 3 months in addition to current metformin monotherapy. The...