Efficacy and safety of ertugliflozin in older patients with type 2 diabetes mellitus: A pooled analysis of phase III studies.

AIMS To assess the efficacy and safety of ertugliflozin in older patients with type 2 diabetes (T2DM). MATERIALS AND METHODS This is a post hoc analysis of patients with T2DM aged <65 and ≥65 years who participated in randomized, double-blind phase III studies of ertugliflozin. Efficacy was evaluated in a pooled analysis of three placebo-controlled studies (ertugliflozin monotherapy and add-on therapy). Safety was evaluated in a pooled analysis of seven placebo- and active-controlled studies (including those used for efficacy). Least-squares (LS) mean change from baseline was calculated for glycated haemoglobin (HbA1c), fasting plasma glucose (FPG), body weight (BW) and systolic blood pressure (SBP). Safety evaluation included overall and prespecified adverse events (AEs). RESULTS In participants aged <65 years, the placebo-adjusted mean changes from baseline in HbA1c, BW and SBP with ertugliflozin 5 mg and 15 mg at Week 26 were: -0.9% and -1.0%; -1.9 kg and -1.8 kg; and -3.7 mmHg and -3.6 mmHg, respectively; in participants aged ≥65 years they were: -0.6% and -0.8%; -1.9 kg and -2.2 kg; and -2.7 mmHg and -3.4 mmHg, respectively. The incidences of AEs, serious AEs, discontinuations and deaths in participants aged <65 years and ≥65 years were generally similar across the treatment groups. In patients aged ≥65 years, the incidences of volume depletion AEs and genital mycotic infection were higher with ertugliflozin than with non-ertugliflozin. CONCLUSIONS Ertugliflozin improved glycaemic control, BW and SBP in younger and older individuals with T2DM and was generally well tolerated in both groups. This article is protected by copyright. All rights reserved.