Abstract
BackgroundType 2 diabetes is a chronic metabolic disorder that is escalating at an alarming rate worldwide. Sodium-glucose cotransporter-2 (SGLT-2) inhibitors are recent oral antihyperglycemic drugs (OADs) with a unique mechanism of action.ObjectivesThis study aimed compared the efficacy and safety profiles of two SGLT-2 inhibitors, empagliflozin and dapagliflozin, in patients with type 2 diabetes as add-on therapy to traditional first-line OADs.MethodsWe conducted a randomized controlled trial comparing empagliflozin and dapagliflozin in patients with type 2 diabetes. Patients were included in the study if they had type 2 diabetes with inadequate glycemic control, defined as glycated hemoglobin (HbA1c) of 7.5% to 11.0%, treated with conventional first-line OADs. Study participants were randomly assigned into two groups. Group A patients received oral empagliflozin, 10 to 25 mg, and Group B patients received oral dapagliflozin, 5 to 10 mg, for 12 weeks. The primary endpoint was the efficacy profile for each SGLT-2 agent in terms of body weight changes, body mass index (BMI), fasting blood glucose (FBG), and HbA1c. The secondary endpoint was to determine the safety and tolerability profiles of each SGLT-2 agent.ResultsAfter 12 weeks of treatment, the mean body weight was reduced significantly in both groups from baseline (empagliflozin: -3.2 kg ± 5.5 kg, p = 0.003; dapagliflozin -2.1 kg ± 4.6 kg, p = 0.008). However, the mean body weight reduction between groups was not statistically significant (p = 0.078). BMI was significantly reduced in both groups (empagliflozin from 28.5 ± 4.9 kg/m2 to 25.8 ± 5.2 kg/m2, p = 0.002; dapagliflozin from 29 ± 5.2 kg/m2 to 27.7 ± 4.8 kg/m2, p = 0.003). However, the patients who received empagliflozin experienced a significantly greater reduction in BMI than patients who received dapagliflozin (p = 0.007).The mean FBG was also reduced in both study groups (empagliflozin: -88.5 mg/dL ± 39.7 mg/dl, p = 0.003; dapagliflozin: -59.8 mg/dL ± 48.5 mg/dL; p = 0.007). However, the patients who received empagliflozin experienced a significantly greater reduction in mean FBG than patients who received dapagliflozin (p = 0.001). HbA1c was also significantly reduced in both groups (empagliflozin: -2.1% ± 1.1%, p = 0.002; dapagliflozin: -1.4% ± 0.9%; p = 0.004). However, patients who received empagliflozin experienced a significantly greater reduction in HbA1c than patients who received dapagliflozin (p = 0.001).The tolerability profiles of both SGLT-2 agents were quite good, and no major adverse effects were reported in the study groups. Urinary infection occurred more often in patients who received dapagliflozin (9.3%) than in patients who received empagliflozin (4.5%; p = 0.002). Patients in the dapagliflozin group also had a higher incidence of genital infections (7.3%) than those in the empagliflozin group (3.8%; p = 0.001).ConclusionBoth empagliflozin and dapagliflozin demonstrated excellent efficacy and safety profiles in our study. These agents should be considered as add-on therapy in patients with type 2 diabetes taking conventional first-line OADs.
Highlights
Type 2 diabetes is a chronic metabolic disorder with an escalating incidence worldwide, found in nearly one in 11 people [1]
body mass index (BMI) was significantly reduced in both groups
The mean fasting blood glucose (FBG) was reduced in both study groups
Summary
Type 2 diabetes is a chronic metabolic disorder with an escalating incidence worldwide, found in nearly one in 11 people [1]. Pakistan has the fourth-most diabetes cases globally, and in 2019, 19.4 million people in Pakistan had diabetes; the number of cases is projected to reach 26.2 million in 2030 and 37.1 million in 2045 [2]. This level of prevalence of diabetes will add significant morbidity and mortality and pose an enormous economic burden on national resources [1,2]. Oral antihyperglycemic drugs (OADs) are usually first-line therapies and lifestyle changes for patients with type 2 diabetes. Sodiumglucose cotransporter-2 (SGLT-2) inhibitors are recent oral antihyperglycemic drugs (OADs) with a unique mechanism of action
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Disclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.