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 (p < 0.0001 and p < 0.0001, respectively), 52 weeks (p < 0.00001 and p < 0.0001, respectively), and 104 weeks (p < 0.00001 and p < 0.0001, respectively). Moreover, females had a higher risk of GMIs than males in the 15 mg group at 26 weeks (p = 0.0008), 52 weeks (p < 0.0001), and 104 weeks (p = 0.02). At 104 weeks, 15 mg and 5 mg of ertugliflozin showed beneficial effects on symptomatic hypoglycemia (p < 0.00001 and p = 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 (p = 0.002 and p = 0.002, respectively); 15 mg of ertugliflozin was associated with a higher risk of discontinuation related to adverse events at 104 weeks (p = 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.