RESUMEN
INTRODUCTION: For the recently introduced single-pill combination of empagliflozin and linagliptin, real-world evidence has not been available. This observational study aims to assess real-world effectiveness of this combination, in the Indian outpatient setting of type-2 diabetes. METHODS: This was a prospective cohort study design, involving patients from 4 centres across western India. Patients with type-2 diabetes and uncontrolled HbA1c, were categorized into 4 groups, including: (1) Naïve to DPP-4i or SGLT-2i; (2) Receiving DPP-4i; (3) Receiving SGLT-2i; (4) Receiving SGLT-2i and DPP-4i as individual pills. Patients were initiated on the fixed-dose combination of empagliflozin + linagliptin, and followed-up over 12-week duration. Clinical parameters of changes in glycaemia, body-weight, and blood-pressure were observed. RESULTS: 251 patients were included in the analysis, with just over half of them being males (57%), or having pre-existing cardiovascular disease (54%). The group-wise patient distribution was approximately 47%, 18%,15%, and 20% respectively. The study represented patients across broad range of duration of type-2 diabetes, use of background antidiabetic therapies, and comorbid cardiovascular risk. The use of combination demonstrated significant and clinically meaningful reductions in HbA1c, fasting and postprandial glycaemia levels across all the study groups. Reductions in body-weight and blood-pressure levels were also demonstrated. Interestingly, patients in group 4, who were switched from free drug combination to the fixed-dose combination, also demonstrated significant and meaningful improvements in HbA1c, fasting as well as postprandial glycaemia levels, suggestive of possible improvement in medication-adherence. CONCLUSION: This real-world evidence complements the results observed in randomized controlled trials, for meaningful effectiveness with the use of empagliflozin-linagliptin fixed dose combination in the Indian outpatient setting. More evidence may facilitate further characterization of clinical value of this promising combination.
