Safety of Ertugliflozin in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Conventional Therapy at Different Periods: A Meta-Analysis of Randomized Controlled Trials.

Aims: To assess the safety of ertugliflozin in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with conventional therapy at different periods.

Methods: We searched PubMed, Embase, and The Cochrane Library from inception to September 23, 2020. A total of six studies involving 4120 patients were included.

Results: Compared with the control group, 15 mg and 5 mg of ertugliflozin were associated with higher risks of genital mycotic infections (GMIs) at 26 weeks ( < 0.0001 and < 0.0001, respectively), 52 weeks ( < 0.00001 and < 0.0001, respectively), and 104 weeks ( < 0.00001 and < 0.0001, respectively). Moreover, females had a higher risk of GMIs than males in the 15 mg group at 26 weeks ( = 0.0008), 52 weeks ( < 0.0001), and 104 weeks ( = 0.02). At 104 weeks, 15 mg and 5 mg of ertugliflozin showed beneficial effects on symptomatic hypoglycemia ( < 0.00001 and = 0.004, respectively) compared with the effects observed in the control group. Compared with the control group, 15 mg and 5 mg of ertugliflozin were associated with higher risks of drug-related adverse events at 26 weeks ( = 0.002 and = 0.002, respectively); 15 mg of ertugliflozin was associated with a higher risk of discontinuation related to adverse events at 104 weeks ( = 0.03). No significant differences were found in the remaining safety outcomes.

Conclusion: This meta-analysis of randomized controlled trials indicates that ertugliflozin is tolerated by T2DM, but the risk of GMIs is noteworthy, especially among females in the high-dose group.