Empagliflozin treatment effects across categories of baseline HbA1c, body weight and blood pressure as an add‐on to metformin in patients with type 2 diabetes

AIMS:In EMPA-REG MET, in patients with type 2 diabetes mellitus (T2DM) on stable background metformin (≥1500 mg/day), empagliflozin versus placebo significantly improved glycated haemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP) over 24 and ≤76 weeks. This analysis investigated empagliflozin treatment effects by baseline cardio-metabolic factors. MATERIALS AND METHODS:Patients aged ≥18 years with HbA1c ≥7.0 to ≤10.0% were included. Analysis of covariance compared change from baseline to weeks 24 and 76 in HbA1c, BW, and SBP by respective baseline categories (HbA1c <8.5/≥8.5%; BW <80/80-90/>90 kg, SBP <130/130-140/>140 mmHg). Analyses were also conducted with a model using continuous covariates of cardio-metabolic factors. RESULTS:In total, 637 patients (56.7% males; mean [SD] age 55.7 [9.9] years, HbA1c 7.9 [0.9] %, BW 81.2 [18.8] kg, SBP 129.4 [14.6] mmHg) received ≥1 dose of either empagliflozin 10 mg (n=217), or 25 mg (n=213), or placebo (n=207). At both time points, empagliflozin 10/25 mg versus placebo significantly (P<0.0001) reduced HbA1c and BW, with greater reductions in HbA1c at higher baseline HbA1c (P interaction week 24/76 categorical and continuous models: 0.0290/0.1431 and 0.0004/0.0042, respectively) and in BW (P interaction 0.1340/0.0012 and 0.0202/<0.0001, respectively). Both empagliflozin doses also significantly lowered SBP versus placebo at both time points, with similar efficacy by subgroups of baseline SBP. Adverse events were consistent with established empagliflozin safety profile across treatment groups. CONCLUSIONS:Empagliflozin, as add-on to metformin, decreases HbA1c and BW, particularly in patients with higher HbA1c and BW baseline values, and effectively lowers SBP. This article is protected by copyright. All rights reserved.