Abstract
Objective: To evaluate the efficacy and safety of ertugliflozin in patients with type 2 diabetes. Methods: MEDLINE, EMBASE, and Cochrane Library were searched (July 31, 2021) for phase II/III randomized clinical trials, which reported the efficacy and safety of ertugliflozin. Continuous variables were calculated as weighted mean difference (WMD) and associated 95% confidence intervals (CIs); dichotomous data were expressed as risk ratios (RRs) with 95% CIs. Results: Nine randomized clinical trials including 5638 type 2 diabetes patients were included. For efficacy, ertugliflozin significantly reduced HbA1c (%) (WMD −0.452%; 95% CI −0.774 to −0.129), fasting plasma glucose (FPG) (WMD −0.870 mmol/L; 95% CI −1.418 to −0.322), body weight (WMD −1.774 kg; 95% CI −2.601 to −0.946), and blood pressure levels (systolic blood pressure: WMD −2.572 mmHg; 95% CI −3.573 to −1.571 and diastolic blood pressure: WMD −1.152 mmHg; 95% CI −2.002 to −0.303) compared with placebo and other hypoglycaemic agents. Compared with placebo, ertugliflozin was superior in reducing HbA1c (%) (WMD −0.641%) and FPG (WMD −1.249 mmol/L). And compared with active agents, ertugliflozin also could decrease HbA1c by 0.215% and FPG by 0.266 mmol/L. The interactive effect between different controls was significant (P interaction of 0.039). For safety, similar to other sodium-glucose cotransporter type-2 inhibitors, ertugliflozin mainly increased the risk of genital mycotic infection (RR: 4.004; 95% CI 2.504–6.402). There was no significant difference in the incidence of any adverse events (AEs), AEs related to study drug, serious AEs, deaths, and discontinuations due to AEs. Results were consistent with the most primary outcomes in subgroups analysis and sensitivity analysis. Conclusion: Ertugliflozin was relatively effective and tolerated in patients with type 2 diabetes compared with placebo or other hypoglycaemic agents, except for a high risk of genital mycotic infection. Systematic Review Registration: (ClinicalTrials.gov), identifier (CRD42020206356).
Highlights
Diabetes is a common chronic disease worldwide and is associated with adverse socio-economic outcomes (Bommer et al, 2017)
Continuous variables were calculated as weighted mean difference (WMD) and associated 95% confidence intervals (CIs); dichotomous data were expressed as risk ratios (RRs) with 95% CIs
Similar to other sodium-glucose cotransporter type-2 inhibitors, ertugliflozin mainly increased the risk of genital mycotic infection (RR: 4.004; 95% CI 2.504–6.402)
Summary
Diabetes is a common chronic disease worldwide and is associated with adverse socio-economic outcomes (Bommer et al, 2017). Metformin is recommended as the first-line therapy for patients with type 2 diabetes in the American Diabetes Association guidelines in 2021 (Tse et al, 2020). Sodium-glucose cotransporter type-2 (SGLT2) inhibitors, as a novel class of hypoglycaemic drugs, are recommended for their favourable effects on patients with type 2 diabetes, especially for the established risk of cardiovascular or renal complications (Chen et al, 2020). Ertugliflozin is the fourth SGLT2 inhibitor approved by the US Food and Drug Administration in December 2017 for patients with type 2 diabetes (Markham, 2018). As a potent inhibitor of SGLT2, ertugliflozin reduces plasma glucose and glycated haemoglobin (HbA1c) levels by increasing urinary glucose excretion without inducing excessive insulin secretion in patients with type 2 diabetes (Derosa and Maffioli, 2018)
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