(047) Efficacy and Safety of Luseogliflozin in Type 2 Diabetes Mellitus: A Systematic Review and Meta-Analysis

Background: Despite the favorable efficacy data available for luseogliflozin, it has not yet received approval from the United States Food and Drug Administration (USFDA). By synthesizing available evidence, the study underscores the potential of luseogliflozin in efficacy and safety outcomes, thus offering valuable insights for clinicians and healthcare providers in optimizing treatment strategies for type 2 diabetes mellitus patients.

Objectives: To conduct a systematic review and meta-analysis to evaluate the efficacy and safety of luseogliflozin in patients with type 2 diabetes mellitus (T2DM).

Methods: A meticulous search of electronic databases such as PubMed, Cochrane CENTRAL, Scopus, and Google Scholar was performed from the inception to December 31st, 2023. Randomized controlled trials (RCTs) evaluating the efficacy (Glycosylated hemoglobin [HbA1c], fasting plasma glucose [FPG], postprandial glucose [PPG]), and body weight and safety of luseogliflozin in comparison with control or other active treatments were included. The Fixed or Random-effect model was used based on the heterogeneity identified using the I2 statistic and Cochran’s Q test.

Results: Out of 50 non-duplicate articles identified through database searching, 11 studies with 1922 patients were included in this study. Luseogliflozin significantly improved glycemic control, as evidenced by decreased HbA1c (MD: -0.59%; 95% CI: -0.90 to -0.29; P< 0.001), fasting plasma glucose (FPG) (MD: -16.01 mg/dL; 95% CI: -19.46, -12.57; P< 0.001), and postprandial glucose (PPG) (MD: -36.63 mg/dL; 95% CI: -43.71, -29.55; P< 0.001). Additionally, luseogliflozin resulted in clinically relevant reductions in body weight (MD: -1.66 kg; 95% CI: -2.23 to -1.12; P< 0.001) and blood pressure (SBP: MD: -4.46 kg; 95% CI: -5.83 to -3.08; P< 0.001; DBP: MD: -2.07 kg; 95% CI: -3.04 to -1.10; P< 0.001). Regarding the safety outcomes, there is no statistically significant difference between the two groups for hypoglycemia (OR: 1.14; 95% CI: 0.70, 1.84; P=0.60). However, Pollakiuria (OR: 4.08; 95% CI: 1.71, 9.69; P< 0.001) and any ADR (OR: 2.04; 95% CI: 1.33, 3.14; P< 0.001) are significantly higher in the luseogliflozin group compared to placebo.

Conclusions: This systematic review and meta-analysis provide robust evidence by supporting the significant improvement in efficacy outcomes of HbA1c, FPG, PPG, and body weight in the luseogliflozin group. Nonsignificant safety results may be due to a smaller population size and fewer studies. Hence, long-term multi-center trials are needed to get drug approvals in countries other than Japan.