Vildagliptin-Dapagliflozin FDC Effective in High CV Risk Indian T2DM Patients: Findings from Latest DAa-ViNCI Study

The study aimed to assess the early initiation of vildagliptin and dapagliflozin FDC's efficacy, safety, and tolerability in real-world cardiology practice, with ethical approval obtained.

The study was a retrospective, non-randomized, non-comparative investigation conducted across 200 cardiology centers in India. It included 2199 T2DM patients with a mean age of 55 years. The patients were prescribed the FDC of vildagliptin 100 mg SR and dapagliflozin 10 mg. Comprehensive patient information, including demographics, treatment duration, comorbidities, and adverse events, was gathered.

The study included T2D patients with high CV risk with a spectrum of about 10 various cardio-metabolic co-morbidities.

Among the study participants, hypertension was the most prevalent comorbidity (74.81%), followed by dyslipidemia (38.52%), coronary artery disease (14.60%), stroke/transient ischemic attack (5.23%), non-alcoholic fatty liver disease (4.32%), retinopathy (3.50%), nephropathy (3.14%), foot ulcer (1.50%), erectile dysfunction (0.73%), peripheral artery disease (0.64%) and others (1.22%).

The following are the study end points:

- Glycemic endpoints included changes in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial glucose (PPG), and achievement of glycemic goals.

- Blood pressure efficacy was evaluated through changes in mean systolic (SBP) and diastolic (DBP) readings.

Additional efficacy and safety parameters included quality of life (adherence and absence of side effects) and adverse events related to FDC therapy in the past year.

The study also examined FDC usage patterns, including the number and percentage of patients on FDC across age groups, therapy duration, comorbidity duration, and treatment compliance.

Key findings from the study are:

Clinical Efficacy

• Glycemic control improved substantially over three months. HbA1c decreased from 7.7% (SD 3.10) to 5.8% (SD 2.88) leading to a reduction of 1.9%, fasting plasma glucose (FPG) dropped from 142.4 mg/dL (SD 88.4) to 90.2 mg/dL (SD 62.44), resulting in a reduction of 52.2mg/dl and postprandial glucose (PPG) reduced from 205.64 mg/dL (SD 128) to 123.38 mg/dL (SD 89.15), causing a reduction of 82.3mg/dl at 3 months. (Table 1)