Efficacy and safety of luseogliflozin in improving glycaemic and non-glycaemic outcomes in type-2 diabetes: A meta-analysis

Abstract

Background & aims: No meta-analysis is available analysing the role of luseogliflozin in type-2 diabetes. We undertook this meta-analysis to address this knowledge-gap.

Methods: Electronic databases were searched for RCTs involving diabetes patients receiving luseogliflozin in intervention arm, and placebo/active comparator in control arm. Primary outcome was to evaluate changes in HbA1c. Secondary outcomes were to evaluate alterations in glucose, blood pressure, weight, lipids, and adverse events.

Results: From initially screened 151 articles, data from 10 RCTs involving 1304 patients was analysed. Individuals receiving luseogliflozin 2.5 mg/d had a significantly lower HbA1c [MD -0.76% (95% CI: 1.01 to -0.51); P < 0.01; I² = 83%], fasting glucose [MD -26.69 mg/dl (95% CI: 35.41 to -17.96); P < 0.01; I² = 80%], systolic blood pressure [MD -4.19 mm Hg (95% CI: 6.31 to -2.07); P < 0.01; I² = 0%], body-weight [MD -1.61 kg (95% CI: 3.14 to -0.08); P = 0.04; I² = 0%], triglycerides PCG [MD -12.60 mg/dl (95% CI: 24.25 to -0.95); P = 0.03; I² = 0%], uric acid [MD -0.48 mg/dl (95% CI: 0.73 to -0.23); P < 0.01; I² = 49%] and alanine aminotransferase [MD -4.11 IU/L (95% CI: 6.12 to -2.10); P < 0.01; I² = 0%] compared to placebo. Occurrence of treatment-emergent adverse-events [RR 0.93 (95% CI: 0.72-1.20); P = 0.58; I² = 0%], severe adverse-events [RR 1.19 (95% CI: 0.40-3.55); P = 0.76; I² = 0%], hypoglycaemia [RR 1.56 (95% CI: 0.85-2.85); P = 0.15; I² = 0%] and genital infections [RR 1.42 (95% CI: 0.48-4.18); P = 0.53; I² = 0%] were not increased with luseogliflozin. Cardiovascular outcome trials are lacking and are urgently required.

Conclusion: Luseogliflozin has good glycaemic and non-glycaemic benefits similar to other SGLT2 inhibitors and is well tolerated.

Keywords: Glycaemic variability; Luseogliflozin; Safety; Type-2 diabetes; meta-Analysis.