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.
This was a prospective cohort study design, involving patients from 4 centers 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.
-- 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.
Conclusively, 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.