Anti-anginal and Antiischemic Effects of Empagliflozin in Diabetic Patients With Refractory Angina:A Phase III, Multicentre, Randomised, Parallel Group, Double Blind Cardiovascular Safety Study of BI 10773 (10 mg Administered Orally Once Daily) Compared to Placebo in Type 2 Diabetes Mellitus Patients With Refractory Angina(EMPT-ANGIN TRIAL)

This was a prospective, double-blind, randomized pilot trial in which a total of 75 subjects were enrolled with T2DM and refractory angina, despite using conventional anti-anginal agents; and were randomly assigned to group A(Empagliflozin group) or B(placebo group) by blinded envelopes method. the study was conducted in two tertiary centers in Isfahan, Iran. The protocol of the study was revised and approved by the institutional ethics committee of Isfahan University of Medical Sciences; and each patient provided an informed consent before participating in the study. The primary aim of the trial was to examine the efficacy of Empagliflozin versus placebo on angina frequency in subjects with T2DM, CAD, and chronic stable angina who remain symptomatic, despite treatment with either one or two anti-anginal agents.The secondary outcome of this study was the evaluation of Physical limitations, angina stability, treatment satisfaction, quality of life, and overall SAQ andeffects o Empaglofolzine vs placebo on treadmill exercise duration, times to angina onset and to 1mm ST segment depression and mean of heart rate recovery(HRR) prior to randomization and after 6 weeks of treatment at peak drug level.