Atherosclerotic cardiovascular disease (ASCVD) is a major comorbidity among those with type 2 diabetes mellitus (T2DM) and requires effective management strategies. Few real-world evidence studies have established the safety and efficacy of fixed-dose combinations (FDCs) of dapagliflozin and sitagliptin, specifically in those with T2DM having ASCVD/high cardiovascular risk. The study evaluated the impact of this FDC on glycemic control and the risk of cardiovascular events in those with T2DM and ASCVD or high cardiovascular risk. This retrospective, multicenter, observational study was conducted on those with T2DM and ASCVD/high cardiovascular risk across India. Data were collected before and after 3 months of treatment with an FDC of dapagliflozin/sitagliptin (10 mg/100 mg). Primary outcomes included alterations in glycated hemoglobin (HbA1c), fasting plasma glucose (FPG), postprandial glucose (PPG), systolic blood pressure (SBP), cholesterol levels, and the Framingham risk score (FRS). This study included a total of 1091 people with T2DM. Statistically significant (P < 0.001) reductions in HbA1c (from 8.9 to 7.4%), FPG (from 173.0 to 129.3 mg/dl), PPG (from 257.2 to 185.2 mg/dl), total cholesterol levels (from 234.3 to 192.7 mg/dl), SBP (from 150.5 to 131.5 mmHg), and FRS (from 15.9 to 9.4%) were observed, while high-density lipoprotein levels increased (from 46.0 to 49.4 mg/dl). Common adverse events included urinary tract infections (19.43%), dehydration (19.25%), and hypoglycemia (18.15%). The dapagliflozin/sitagliptin FDC was effective and safe in managing patients with T2DM with cardiovascular risk factors and may offer cardioprotective benefits. Further investigations with longer follow-ups are necessary to confirm these findings.
Bhamri et al. (Thu,) studied this question.