Background: Type-2 diabetes mellitus (T2DM) is a growing health concern worldwide and requires effective management to prevent its complications. Bexagliflozin is a novel oral anti-diabetic drug used for the management of T2DM. The safety and efficacy of Bexagliflozin are still debated.
Objectives: To evaluate the efficacy and safety of bexagliflozin in patients with T2DM.
Methods: A thorough literature search was performed in PubMed, Cochrane CENTRAL, and Google Scholar from the inception to the 10th of January 2023 to identify the randomized controlled trials (RCTs) that examined the efficacy (in terms of checking the fasting blood glucose level and hyperglycemia), and safety (in terms of adverse events) of bexagliflozin on severe hyperglycemia in comparison with the placebo or active treatment were included in the study. The Fixed or Random-effects model was used based on the heterogeneity identified by using the I² statistic and Cochran's Q test.
Results: Out of 12 non-duplicate research articles identified through database searching, a total of 5 studies, with 1704 patients were included in this study. The efficacy outcomes like fasting blood glucose (Std. mean difference -0.45, 95% CI: -0.80, -0.10, P= 0.01), systolic blood pressure (Std. mean difference -0.34, 95% CI -0.44,-0.23, P< 0.0001, and the body-mass index (Std. mean difference -2.23, 95% CI -3.79,-0.66, P= 0.005), was significantly reduced with bexagliflozin compared to the control group. On the other hand, HbA1c (Std. mean difference -0.20, 95% CI -0.71-0.30 P= 0.43) and diastolic blood pressure (Std. mean difference 0.68, 95% CI -1.45,2.82 P= 0.53) were non-significant. Considering the safety, there was a significant reduction in hypoglycemia (OR 0.68, 95% CI 0.51,0.90, P= 0.006) and a significantly increased risk of kidney infection (OR 2.17, 95% CI 1.03-4.55, P= 0.01) compared to control.
Conclusions: This systematic review and meta-analysis identified a significant improvement in efficacy outcomes of fasting blood glucose and systolic blood pressure. Non-significant of HbA1c and diastolic blood pressure results may be due to lower population size and a smaller number of outcomes; hence there is a need for large and long-term studies to address these issues further.
