Effectiveness of Dapagliflozin as Add-On to Metformin with or without Other Oral Antidiabetic Drugs in Type 2 Diabetes Mellitus: A Multicentre, Retrospective, Real-World Database Study.

Abstract

Real-world Indian studies evaluating effectiveness of dapagliflozin as an add-on to other oral antidiabetic drugs (OAD) in patients with type 2 diabetes mellitus (DM) are scarce. An electronic medical record (EMR)-based, retrospective, multicentre study was conducted to evaluate the effectiveness of dapagliflozin as add-on therapy in adult patients with inadequately controlled DM on metformin with or without other OAD. Baseline characteristics (visit 1: metformin or metformin plus OAD treatment for at least 30 days) and treatment-related outcomes (visit 2: follow-up) considered between 60 and 140 days after adding/switching dapagliflozin [glycated haemoglobin (HbA1c), body mass index (BMI), systolic blood pressure (SBP) and diastolic blood pressure (DBP)] were analysed. A total of 3616 patients were screened from 478 centres. Most patients had received dapagliflozin(D)+metformin(M)+at least one other OAD [D+M+OAD, n=2907 (80.4%), 408 followed-up with HbA1c reported], while 709 patients (19.6%, 138 followed-up with HbA1c reported) received dapagliflozin+metformin (D + M). Treatment with dapagliflozin as an add-on therapy resulted in significant change in HbA1c (-1.1 ± 1.44%; p < 0.05 for HbA1c subgroup ≥7.5%; -1.6±1.41%; p < 0.05 for HbA1c subgroup ≥8%) at visit 2 compared with visit 1. Significant change in body weight (-1.4±3.31 kg; p < 0.05 for HbA1c subgroup ≥7.5%; -1.5±3.22kg; p < 0.05 for HbA1c subgroup ≥8%) was observed at visit 2. Similarly, a significant change in BMI was noted for the HbA1c subgroup ≥7.5% (-1.0±8.38 kg/m2). However, the change in BMI in the HbA1c subgroup ≥8% was noted to be -1.4±10.4 kg/m2, which was not statistically significant (p=0.08). In the overall study population, significant change in the SBP (-4.5±14.9mmHg; p < 0.05 for HbA1c subgroup ≥7.5%; -4.5±15.1 mmHg; p < 0.0001 for HbA1c subgroup ≥8%) was observed at visit 2 compared with visit 1. On identical lines, significant change in DBP (-1.5±8.94 mmHg; p < 0.05 for HbA1c subgroup ≥7.5%; -1.4±8.91mmHg; p < 0.05 for HbA1c subgroup ≥8%) was noted. Dapagliflozin showed significant improvement in glycemic parameter, BMI and BP when added to metformin, with or without other OADs in a real-world scenario.