Abstract

The current study evaluated the effect of SGLT-2 inhibitor, empagliflozin, on blood pressure reduction in Chinese elderly hypertension patients with type 2 diabetes and investigated its possible mechanisms. 124 patients were randomized to receive 25 mg empagliflozin QD, or placebo double blind for 12 weeks. Patients underwent 24-h ABPM. Endothelial function and arterial stiffness were also measured prior to randomization and at week 12. At week 12, adjusted mean difference versus placebo in change from baseline in mean 24-h SBP was − 8.14 mmHg (95% CI − 10.32, − 3.96, P = 0.005). At week 12, adjusted mean difference versus placebo in change from baseline in mean 24-h DBP was − 5.27 mmHg (95% CI − 8.19, − 1.35, P < 0.001). Changes in office BP were consistent with ABPM. Empagliflozin was well tolerated. Empagliflozin was associated with significant and clinically meaningful reductions in BP versus placebo in Chinese elderly patients with type 2 diabetes and hypertension. The underlying mechanisms possiblely at least in part were the improvements of endothelial function and arterial stiffness associated with empagliflozin.Registration number: ChiCTR2100054678, Registration date: December 23, 2021.

Highlights

  • Type 2 diabetes and hypertension are the most common non-communicable diseases in elderly p­ eople[1] and they are the major causes of death in population over 60 years-old[2]

  • The current study evaluated the effect of SGLT-2 inhibitor, empagliflozin, on blood pressure reduction in elderly hypertension patients with type 2 diabetes and investigated its possible mechanisms

  • At week 12, adjusted mean difference versus placebo in change from baseline in mean 24-h SBP was -8.14 mmHg

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Summary

Introduction

Type 2 diabetes and hypertension are the most common non-communicable diseases in elderly p­ eople[1] and they are the major causes of death in population over 60 years-old[2]. Studies have indicated that the adverse effects of hypertension and diabetes may be a­ ddictive[6,7], making the treatments targeted both glycemic and blood pressure control are crucial options for physicians. Traditional antihypertension drugs, such as diuretics and β-adrenoceptor blockers, the effects of which on glycaemic control are negative. ACEI/ARB could improve insulin resistance, high prevalence of persistent cough and angioneurotic edema induced by them urges us to find a new efficient and safe antihypertension drug in patients with diabetes. The current study evaluated the effect of SGLT-2 inhibitor, empagliflozin, on blood pressure reduction in elderly hypertension patients with type 2 diabetes and investigated its possible mechanisms. Key exclusion criteria included uncontrolled hyperglycemia (fast plasma glucose ≥ 13.3 mmol/L), mean seated SBP ≥ 180 mmHg and/ or mean seated DBP ≥ 110 mmHg, known/suspected secondary hypertension, malignant hypertension, history/ evidence of hypertensive retinopathy or hypertensive encephalopathy, renal impairment (estimated glomerular filtration rate [eGFR] ≤ 60 mL/min/1.73 m­ 2,using the MDRD equation), or indication of liver disease (serumalanine aminotransferase, aspartate aminotransferase, or alkaline phosphatase more than three times the upper limit of normal), history of acute coronary syndrome, stroke, or transient ischemic attack

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