Changes in HbA1c, body weight, and systolic blood pressure in type 2 diabetes patients initiating dapagliflozin therapy: a primary care database study

AIMS To investigate changes in glycated hemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP) in type 2 diabetes (T2D) primary care patients initiating dapagliflozin treatment. METHODS T2D patients who started dapagliflozin in 985 general and 32 diabetologist practices (Disease Analyzer, Germany: December 2012-October 2014) were analyzed (3- and 6-month follow-up). Multivariate linear regression analyses were used to identify clinical characteristics and comorbidity associated with changes in HbA1c, BW, and SBP. RESULTS The study included 1,169 T2D patients (age: 62.5 years; men: 59.3%; diabetologist care: 23%) with newly initiated dapagliflozin therapy. At the 3-month stage, dapagliflozin significantly reduced HbA1c (-0.8%±1.4%) compared to the baseline (8.5%±1.5%) (P<0.001). Changes were maintained after 6 months (-0.8%±1.5%) (P<0.001). Patients with high baseline HbA1c values (>9%) showed greater reductions in HbA1c than the overall sample (3 months -1.8%, 6 months -1.8%; both P<0.05). BW and SBP also showed statistically significant reductions with dapagliflozin over 3 and 6 months (-2.2 kg, P<0.001; -2.2 mmHg, P=0.003 and -2.5 kg, P<0.001; -2.3 mmHg, P=0.011, respectively). After 3 months, 53% of patients achieved a reduction in both HbA1c and BW; the same holds true for 45% of patients at the 6-month mark. Similar results were observed both in general and diabetologist practices. In multivariate analyses, baseline HbA1c (parameter estimate: -0.6479) and diabetologist care (-0.2553) were independent predictors of HbA1c change (6 months) (all P<0.05). CONCLUSION T2D patients treated with dapagliflozin therapy achieved statistically significant reductions in HbA1c, BW, and SBP in a real-world primary and diabetologist care setting. The changes were comparable to the results of the dapagliflozin clinical trial program.