Safety and efficacy of dapagliflozin versus empagliflozin as add-on therapy in type 2 diabetes mellitus management
Authors: Velusamy Sivakumar , Kumar S. Ram 
Published: January 2025

Objectives:
Sodium-glucose cotransporter 2 (SGLT-2) inhibitors are drugs used as the oral hypoglycaemic that have a significant effect in lowering blood glucose, glycated haemoglobin (HbA1c), weight and blood pressure in patients of type 2 diabetes mellitus (T2DM). SGLT-2 inhibitors, such as empagliflozin and dapagliflozin, are used in addition to diet and exercise to help persons with T2DM improve their glucose control. The drugs are combined with other antidiabetic medications or used as monotherapy.

Materials and Methods:
The aim of this study was to evaluate the efficacy and the safety of the drug dapagliflozin against empagliflozin in individuals with T2DM as an add-on treatment. The study is carried out in a Tertiary Care Hospital in Coimbatore using a prospective observational research design. T2DM patients with a HbA1c level of >7% are included in the study. Patient information was collected by patient interviews and from the patient file. Participants in the study are categorised into two groups: one group consists of patients taking oral dapagliflozin in doses of 5 mg or 10 mg alongside other oral hypoglycemic agents (OHAs), while the other group comprises patients taking oral empagliflozin in doses of 10 mg or 20 mg alongside other OHAs. The endpoints were to assess the safety and effectiveness of each SGLT-2 inhibitor by monitoring changes in the diabetic profile, body weight, body mass index (BMI), blood pressure and cardiovascular risk.

Results:
The study included 100 patients, with 56 males and 44 females. Most participants were aged 51–60 years. In both treatment groups, A and B, significant reductions in body weight Group A: 3.14 kg and Group B: 2.29 kg and BMI Group A: 0.65 kg/m2 and Group B: 0.84 kg/m2 were observed after 6 months of treatment follow-up. Both groups experienced decreases in HbA1c levels from baseline to 6 months of treatment. The mean differences in HbA1c were 0.36% in Group A and 0.55% in Group B; empagliflozin led to a more significant reduction in HbA1c (0.19%) compared to dapagliflozin. Significant reductions were noted in fasting blood sugar (FBS) and postprandial blood sugar (PPBS) levels in both groups. Both dapagliflozin and empagliflozin were associated with reductions in systolic blood pressure (SBP) after 6 months of therapy. Dapagliflozin showed a greater reduction in SBP of 10.26 mmHg compared to 4.2 mmHg with empagliflozin. In addition, dapagliflozin increases diastolic blood pressure (DBP) by 2.25 mmHg, while empagliflozin reduces DBP by 3.61 mmHg. While both groups experienced reductions in SBP, only the group using empagliflozin showed a significant reduction in DBP. The Framingham risk score showed significant reductions in mean differences observed in both groups after 6 months of treatment, with a mean difference of 1.08% in Group A and 2.17% in Group B. However, the score is not statistically different between the groups. Both drugs exhibited equal effects on the prevention of cardiovascular risk. Both drugs exhibited a similar safety profile, with mild-to-moderate adverse events reported, including urinary tract infections (Group A: 18% and Group B: 12%) and hypoglycaemia (Group A: 24% and Group B: 20%) during the study period.

Conclusion:
SGLT-2 inhibitors dapagliflozin and empagliflozin have favourable efficacy and safety in the management of T2DM; both drugs show equal effects on HbA1c, FBS, PPBS, body weight and BMI. Empagliflozin led to a more significant reduction in HbA1c compared to dapagliflozin. In both hypertensive and non-hypertensive patients, dapagliflozin exhibited greater systolic blood pressure reduction compared to empagliflozin, whereas empagliflozin exhibited greater reduction in diastolic blood pressure compared to dapagliflozin; in contrast, dapagliflozin has shown to increase DBP. Further investigation is required to explore the blood pressure effects of SGLT-2 inhibitors in a large population. In addition, these drugs decreased cardiovascular risk. Both medications exhibited fewer instances of hypoglycaemic episodes and urinary tract infections.