Efficacy and safety of ertugliflozin: results of the VERTIS CV sub-study in patients receiving a stable dose of insulin
M.S. Novikova, O.M. Koteshkova, M.B. Antsiferov
Endocrinological Dispensary of the Moscow Healthcare Department, Moscow, Russia
Background. The progressive course of type 2 diabetes mellitus (DM2) often necessitates combination therapy with oral antihypergly- cemic agents, and eventually insulin, alone or in combination with other antidiabetic agents, may become necessary to maintain glucose levels.
Objective. Reporting of results of the VERTIS CVsub-study.
Methods. VERTIS CVis a randomized, double-blind, parallel group, placebo-controlled study of ertugliflozin cardiovascular outcomes. Patients were randomly assigned to placebo and ertugliflozin at a dose of 5 or 15 mg/day. A sub-study included patients receiving a stable dose of insulin >20 IU/day. Of8246patients randomized to VERTIS CV, 1065 were included in the sub-study (68.2% male patients, mean age 64.8±7.8 years; DM2 duration: 16.7±9.0 years; glycosylated hemoglobin (HbA1c): 8.4±1.0%). The main end point was the change in HbA1c level from baseline at 18 weeks. Secondary endpoints were changes in fasting plasma glucose (FPG) level, body weight (BW), proportion of patients with HbA1c <7%, systolic blood pressure (SBP), diastolic blood pressure (DBP), and insulin dose. Results. At 18 week, the mean change from baseline in HbA1c level with ertugliflozin 5 and 15 mg versus placebo (95% CI) was -0.58% (-0.71-0.44) and -0.65% (-0.78--0.51), respectively (P<0.001 for both). Ertugliflozin significantly reduced FPG, BW, and SBP. In women, the incidence of genital fungal infections was higher with ertugliflozin (3.5%) compared with placebo (0.0%). The frequency of symptomatic hypoglycemia was similar in the treatment groups.
Conclusion. The addition of ertugliflozin to insulin improved glycemic control, BW, and SBP at 18 weeks in DM2 patients with athero-sclerotic cardiovascular disease compared with placebo.
About the Autors
Corresponding author: Maria S. Novikova, Cand. Sci. (Med.), Nephrologist, Endocrinological Dispensary of the Moscow Healthcare Department, Moscow, Russia; email@example.com; https://orcid.org/0000-0003-1320-0565