Role of novel sodium glucose co-transporter-2 inhibitor enavogliflozin in type-2 diabetes: A systematic review and meta-analysis

Abstract

Background: Enavogliflozin is a novel sodium glucose co-transporter-2 inhibitor (SGLT2i) developed in South Korea. This meta-analysis was done as no meta-analysis has analysed the efficacy and safety of enavogliflozin in type-2 diabetes (T2DM).

Methods: Electronic databases were systematically reviewed for randomized controlled trials having patients with T2DM receiving enavogliflozin in treatment-arm, and placebo/any other medicine in control-arm. Primary outcome was to evaluate changes in glycosylated haemoglobin (HbA1C). Secondary outcomes were to evaluate alterations in fasting glucose (FPG), 2-h post prandial glucose (2-h PPG), blood pressure (BP), weight, lipids, and adverse events.

Results: Data from 4 trials (684 patients) was analysed for clinical outcomes over 12-24 weeks clinical use. Compared to placebo, patients receiving enavogliflozin had significantly lower HbA1c [MD -0.76%(95% CI: 0.93 to -0.60); P < 0.00001; I² = 97%], FPG [MD -2.12 mmol/l(95%CI: 2.47 to -1.77); P < 0.00001; I² = 91%], body-weight [MD-1.37 kgs (95% CI: 1.73-1.00); P < 0.00001; I² = 89%], systolic BP [MD-4.99 mm Hg (95%CI: 7.83 to -2.16); P = 0.0006; I² = 47%], diastolic BP [MD-3.09 mm Hg(95%CI: 3.38 to -2.81); P < 0.00001; I² = 0%]. Treatment emergent adverse-events [OR1.16(95%CI:0.64-2.09); P = 0.63; I² = 0%], serious adverse events [OR1.81(95%CI:0.37-8.83); P = 0.46; I² = 0%], urinary infections [OR1.37(95%CI:0.09-20.61); P = 0.82; I² = 33%] and genital infections [OR 3.07(95%CI:0.31-29.88); P = 0.33; I² = 0%] were comparable. Compared to dapagliflozin, patients receiving enavogliflozin had significantly lower HbA1c [MD-0.06%(95%CI: 0.07-0.05); P < 0.00001; I² = 0%], FPG [MD-0.19 mmol/l(95%CI: 0.21 to -0.17); P < 0.00001; I² = 0%], body-weight [MD-0.20 kgs(95%CI: 0.24 to -0.15); P < 0.00001; I² = 0%], diastolic BP [MD -0.92 mm Hg (95%CI: 1.36 to -0.48); P < 0.0001; I² = 91%] and significantly higher urine glucose creatinine ratio [MD 16.69 g/g (95%CI:16.11-17.26); P < 0.00001; I² = 0%].

Conclusion: Enavogliflozin is a well tolerated and effective SGLT2i for T2DM and may be superior to dapagliflozin with regard to certain clinical aspects over 6 months clinical use.

Keywords: Enavogliflozin; Meta-analysis; Type-2 diabetes; Weight loss.