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June 14, 2020Journal of Diabetes InvestigationOpen Access

Secondary analyses to assess the profound effects of empagliflozin on endothelial function in patients with type 2 diabetes and established cardiovascular diseases: The placebo‐controlled double‐blind randomized effect of empagliflozin on endothelial function in cardiovascular high risk diabetes mellitus: Multi‐center placebo‐controlled double‐blind randomized trial

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Key result

Empagliflozin treatment for 24 weeks in patients with type 2 diabetes and cardiovascular disease did not affect peripheral endothelial function, with 44.7% of treated patients showing an RHI increase.

Why the study?

Although SGLT2 inhibitors improve outcomes in type 2 diabetes at high cardiovascular risk, their underlying effects on endothelial function remain unclear.

Does empagliflozin improve peripheral endothelial function in patients with type 2 diabetes and established cardiovascular diseases?

Population

Patients with type 2 diabetes and cardiovascular disease

Comparison

Empagliflozin vs placebo

Design

Post-hoc analysis of a multicenter double-blind randomized placebo-controlled trial

Follow-up

24 weeks

Authors

ATAtsushi TanakaMSMichio ShimabukuroNMNoritaka Machii

Discussion

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Overview

Empagliflozin does not improve endothelial function in T2D with CVD; challenges proposed vascular mechanisms of SGLT2 inhibitors.

Key Points

  • To determine whether 24 weeks of empagliflozin treatment improves peripheral endothelial function and to identify clinical characteristics of responders versus non-responders in patients with type 2 diabetes and cardiovascular disease.
  • Conducted a post-hoc analysis of the multicenter, placebo-controlled, double-blind randomized EMBLEM trial.
  • Assessed peripheral endothelial function using reactive hyperemia peripheral arterial tonometry to calculate the reactive hyperemia index (RHI) after 24 weeks of treatment.
  • Among 47 patients randomized to empagliflozin, 21 (44.7%) demonstrated an increase in RHI after 24 weeks, with no clinical differences between patients with or without an RHI increase.
  • No significant difference occurred between treatment groups in the proportion achieving a clinically meaningful change (≥15%) in log-transformed RHI, and changes in RHI did not correlate with vital signs or glycemic laboratory parameters.

Study Design

Type

RCT

Blinding

Double-blind

Randomization

randomized

Multicenter

Yes

Structured PICO

Does empagliflozin improve peripheral endothelial function in patients with type 2 diabetes and established cardiovascular diseases?

P
Population
Patients with type 2 diabetes and cardiovascular disease treated for 24 weeks.
I
Intervention
Empagliflozin for 24 weeks
C
Comparator
Placebo
O
Outcome
Peripheral endothelial function measured by reactive hyperemia peripheral arterial tonometry (reactive hyperemia index, RHI)surrogate

Empagliflozin does not appear to directly improve peripheral endothelial function over 24 weeks in patients with type 2 diabetes and cardiovascular disease, suggesting its cardiovascular benefits are mediated through other mechanisms.

Cite This Study

Tanaka et al. (2020) conducted an RCT in Type 2 diabetes and cardiovascular disease. Empagliflozin vs. Placebo was evaluated on Increase in the reactive hyperemia index (RHI). Empagliflozin treatment for 24 weeks in patients with type 2 diabetes and cardiovascular disease did not affect peripheral endothelial function, with 44.7% of treated patients showing an RHI increase.

synapsesocial.com/papers/6a8fa2c11403187eefcb415chttps://doi.org/10.1111/jdi.13289
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

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  3. 3Effectiveness of dapagliflozin on vascular endothelial function and glycemic control in patients with early-stage type 2 diabetes mellitus: DEFENCE study2017 · 251 citations
  4. 4Vascular failure: a new clinical entity for vascular disease2006 · 81 citations
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