- Nesti L, Pugliese NR, Sciuto P, et al. Mechanisms of reduced peak oxygen consumption in subjects with uncomplicated type 2 diabetes. Cardiovasc Diabetol. 2021;20(1):124.
- Nesti L, Pugliese NR, Sciuto P, Natali A. Type 2 diabetes and reduced exercise tolerance: a review of the literature through an integrated physiology approach. Cardiovasc Diabetol. 2020;19(1):134.
- Natali A, Nesti L, Fabiani I, Calogero E, Di Bello V. Impact of empagliflozin on subclinical left ventricular dysfunctions and on the mechanisms involved in myocardial disease progression in type 2 diabetes: rationale and design of the EMPA-HEART trial. Cardiovasc Diabetol. 2017;16(1):130.
Background
What do we already know about this topic?
- Therapy with sodium-glucose co-transporter-2 (SGLT2) inhibitors reduce hospitalisation for heart failure (HF) by 30–40% irrespective of established HF at baseline, however, the underlying mechanisms facilitating this benefit are still under investigation.1
- Exercise tolerance is a key and strong predictor of overall health and survival, predicting incidence of cardiovascular disease (CVD) and HF.2
- 40–50% of asymptomatic patients with type 2 diabetes (T2D) without heart disease display effort intolerance and asymptomatic systo-diastolic dysfunctions.2
- This prevalence increases using more sensitive evaluation, such as global longitudinal strain (GLS) and the cardiopulmonary exercise test (CPET), especially if their use is combined.3
How was this study conducted?
- This Phase 3, randomised, active-controlled, parallel group, single centre, exploratory study primarily sought to identify whether empagliflozin increased contractility (measured using GLS) and increased aerobic capacity (respiratory oxygen uptake [VO2], measured using iCPET), accounting for the known effect of empagliflozin as a diuretic and improved glycaemic control.
- Enrolled patients had T2D and sub-optimal glycaemic control, on stable cardioactive and antidiabetic therapy (either metformin alone or alongside basal insulin), no history of heart disease, preserved kidney function, and preserved left ventricular ejection function (LVEF).
- After baseline evaluations patients were randomised to either 10 mg daily empagliflozin doses or 100 mg daily sitagliptin doses, with measurements taken for analysis after 1 and 6 months.
- Exploratory outcomes explored changes in plasma biomarkers and differences in the subgroup with subclinical systolic dysfunction.
