Synapse
⌘+K
Synapse
PulseExploreClubsResearchersJournals
Instagram
HomeClubsExplore
April 12, 2017Cardiovascular DiabetologyOpen Access

Rationale and design of a multicenter placebo-controlled double-blind randomized trial to evaluate the effect of empagliflozin on endothelial function: the EMBLEM trial

View Full Paper
Ask AI
Bookmark
Share

Key result

Empagliflozin is being evaluated for its effects on endothelial function in patients with type 2 diabetes and established cardiovascular disease in the ongoing EMBLEM trial, with no results currently available.

Why the study?

Does empagliflozin improve endothelial function in patients with T2DM and established CVD?

Population

110 participants with T2DM (HbA1c range 6.0-10.0%) and established cardiovascular disease in Japan.

Comparison

Empagliflozin 10 mg once daily vs Placebo

Design

Other, 1:1, double-blind, placebo-controlled

Follow-up

24 weeks

Authors

ATAtsushi TanakaFriends UnitedMSMichio ShimabukuroPreventive CardiologyYOYosuke OkadaJichi Medical University

Discussion

Loading...

Member takes

Overview

The EMBLEM trial is designed to evaluate whether empagliflozin improves endothelial function in patients with T2DM and established cardiovascular disease.

Study Design

Type

RCT (n=110)

Blinding

Double-blind

Randomization

Web-based minimization dynamic allocation

Multicenter

Yes

Structured PICO

Does empagliflozin improve endothelial function in patients with T2DM and established CVD?

P
Population
110 planned adult participants with type 2 diabetes mellitus and established cardiovascular disease, followed for 24 weeks.
I
Intervention
Empagliflozin 10 mg once daily
C
Comparator
Placebo
O
Outcome
Change in the reactive hyperemia (RH)-peripheral arterial tonometry-derived RH index at 24 weeks from baselinesurrogate

The EMBLEM trial is designed to evaluate whether empagliflozin improves endothelial function in patients with T2DM and established cardiovascular disease.

Limitations

  • Relatively small sample size
  • RH-PAT test measurement is prone to be affected by individual physical conditions, intravascular volume, and the examination room environment
  • Potential for characteristic adverse drug reactions of SGLT2 inhibitors, such as intravascular volume depletion and urinary tract and genital infections

Cite This Study

Tanaka et al. (2017) conducted an RCT in Type 2 diabetes mellitus and established cardiovascular disease (n=110). Empagliflozin vs. Placebo was evaluated on Change in the reactive hyperemia (RH)-peripheral arterial tonometry-derived RH index at 24 weeks from baseline. Empagliflozin is being evaluated for its effects on endothelial function in patients with type 2 diabetes and established cardiovascular disease in the ongoing EMBLEM trial, with no results currently available.

synapsesocial.com/papers/6a8c2b065a23cb8fd8bbb477https://doi.org/10.1186/s12933-017-0532-8
View Full Paper
Ask AI
Bookmark
Share

Also Consider

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

  1. 1Diabetes and Atherosclerosis2002 · 2,729 citations
  2. 2Validity, Reproducibility, and Clinical Significance of Noninvasive Brachial-Ankle Pulse Wave Velocity Measurement.2002 · 1,632 citations
  3. 3Ameliorated pancreatic β cell dysfunction in type 2 diabetic patients treated with a sodium-glucose cotransporter 2 inhibitor ipragliflozin2014 · 56 citations
  4. 4Global Cardiovascular Reserve Dysfunction in Heart Failure With Preserved Ejection Fraction2010 · 729 citations
  5. 5Sodium Glucose Cotransporter 2 Inhibitors in the Treatment of Diabetes Mellitus2016 · 1,379 citations