Abstract
Background: A selective inhibitor of sodium-glucose cotransporter 2 (SGLT2), empagliflozin, has demonstrated its effects in reducing cardiovascular mortality and hospitalization rates for heart failure in type 2 diabetes patients. However, the cardiac-intrinsic mechanism for this cardiovascular benefit has not been sufficiently studied. We therefore aimed to investigate the effect of empagliflozin on left ventricular function in a group of patients with grade I hypertension. Methods: We carried out a single-arm non-randomized clinical trial at the National Obesity Centre in Yaounde over a period of 8 months (October 2016 to May 2017), where patients were assigned to receive 25 mg of empagliflozin once daily. Cardiac ultrasound, 24-hour ambulatory blood pressure measurement, resting electrocardiography and biological assessment were carried out at baseline and at the end of a 6-week treatment period with empagliflozin. The primary outcome was the improvement of the left ventricular relaxation evaluation criteria. Ethical approval was obtained from the Centre Regional Ethics Committee in Yaounde, Cameroon. Results: A total of 11 patients were treated (median observation time, 6 weeks). We noted a non-significant improvement in the early lateral annular velocity from 9.7 [9.2 - 11.4] cm/s to 9.1 [8.8 - 10.2] cm/s, p =0.21. We also noted a non-significant improvement of the mitral profile (E/A) from 0.71 [0.63 - 0.78] cm/s to 0.81 [0.58 - 0.88] cm/s, p = 0.08. There were no differences in E/E’ ratio, 5.0 [4.1 - 6.3] vs 5.6 [4.9 - 7.4], p = 0.07. There was a non-significant drop in both systolic (p = 0.06) and diastolic (p = 0.09) blood pressure. We also observed on ECG a drop of the PR interval from 200 [157 - 200] ms to 160 [143 - 186] ms, p = 0.04. Conclusion: Short-term treatment with empagliflozin does not show an improvement of the left ventricular function in grade I hypertensive patients with diastolic dysfunction. Trial registration: This study was retrospectively registered on Clinical Trial Registry with ClinicalTrials.gov Identifier: NCT04203914.
Highlights
The cardiovascular safety of novel anti-diabetic agents has increasingly become center-stage in clinical diabetes management [1]
The sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin when compared with placebo in the Empagliflozin, Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) study demonstrated significant cardiovascular benefits including significant reduction in cardiovascular death and hospitalization for heart failure by 38% and 35% respectively [2]
Calcium channel blockers were the most common drugs used in 8 participants, followed by diuretics and beta blockers in 6 participants, angiotensin converting enzyme inhibitors (ACEIs) in 3 participants and Angiotensin II receptor antagonists (ARA II) in 2 participants
Summary
The cardiovascular safety of novel anti-diabetic agents has increasingly become center-stage in clinical diabetes management [1]. The sodium-glucose cotransporter 2 (SGLT2) inhibitor empagliflozin when compared with placebo in the Empagliflozin, Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME) study demonstrated significant cardiovascular benefits including significant reduction in cardiovascular death and hospitalization for heart failure by 38% and 35% respectively [2]. This significant benefit on heart failure on SGLT2 inhibition was confirmed in the Canagliflozin Cardiovascular Assessment Study (CANVAS) program [3]. We aimed to investigate the effects of empagliflozin on left ventricular function in non-diabetic hypertensive (grade I) patients with initial diastolic dysfunction
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