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

الملخص EN

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.