Ankle Brachial Index (ABI) is an established marker for screening peripheral vascular disease and an independent predictor of amputation, cardiovascular event and mortality risk in patients with diabetes. We conducted a longitudinal cohort study using electronic health record data from the Conquer Diabetes Podiatry Center Registry (CDPCR) evaluating 29 patients for the ABI values, who have been adherent to empagliflozin for more than 24 weeks. Normal ABI was defined as >0.9 and <1.4. The assessment parameters included the risk of regression of high ABI versus progression to high ABI (risk-ratio), proportion (%) of patients with ABI decline of >0.15. Based on assumptions of 5% alpha-error, 25% progression-rate to high ABI, and risk-ratio of 3 with 50% error margin, sample size of 54 was determined. ANOVA was used for the statistical analysis. 58 baseline readings of ABI, from 29 patients of T2DM, were analyzed. Mean age was 57 years, duration of diabetes was 11 years. 45% of patients were females. Mean baseline ABI was 1.3, with 11 abnormal readings (11 high, 0 low). The mean duration of exposure to empagliflozin was 16 months. At follow-up, mean ABI was 1.28. Of the 11 high baseline ABI readings, 5 regressed to normal. Of the 47 normal baseline ABI readings, 7 progressed to high ABI. Relative risk of regression versus progression for high ABI, was 3.66 (95% CI 1.53, 8.75; p = 0.003). Then Number Needed to Treat (NNT) was 3. No patient had ABI decline of >0.15, or developed low ABI, at follow-up. This real-world evidence suggests possible role of empagliflozin in mediating regression of high ABI. We postulate that these clinical benefits may be in part due to the ability of empagliflozin to maintain vascular health especially in a pro-inflammatory environment of endothelium in patients with diabetes. Further, larger long-term randomized trials would be helpful to corroborate our findings.
D. Padhye: None.