Cardiovascular Benefit of Empagliflozin.pdf (296.55 kB)
Download file

Cardiovascular Benefit of Empagliflozin Across the Spectrum of Cardiovascular Risk Factor Control in the EMPA-REG OUTCOME Trial

Download (296.55 kB)
journal contribution
posted on 18.03.2021, 12:45 by SE Inzucchi, K Khunti, DH Fitchett, C Wanner, M Mattheus, JT George, AP Ofstad, B Zinman
Context
Control of multiple cardiovascular (CV) risk factors reduces CV events in individuals with type 2 diabetes.

Objective
To investigate this association in a contemporary clinical trial population, including how CV risk factor control affects the CV benefits of empagliflozin, a sodium-glucose cotransporter-2 inhibitor.

Design
Post hoc analysis.

Setting
Randomized CV outcome trial (EMPA-REG OUTCOME).

Participants
Type 2 diabetes patients with established CV disease.

Intervention
Empagliflozin or placebo.

Main Outcome Measures
Risk of CV outcomes—including the treatment effect of empagliflozin—by achieving 7 goals for CV risk factor control at baseline: (1) glycated hemoglobin <7.5%, (2) low-density lipoprotein cholesterol <100 mg/dL or statin use, (3) systolic blood pressure <140 mmHg and diastolic blood pressure <90 mmHg, (4) pharmacological renin-angiotensin-aldosterone system blockade, (5) normoalbuminuria, (6) aspirin use, (7) nonsmoking.

Results
In the placebo group, the hazard ratio (HR) for CV death was 4.00 (95% CI, 2.26–7.11) and 2.48 (95% CI, 1.52–4.06) for patients achieving only 0–3 or 4–5 risk factor goals at baseline, respectively, compared with those achieving 6–7 goals. Participants achieving 0–3 or 4–5 goals also had increased risk for the composite outcome of hospitalization for heart failure or CV death (excluding fatal stroke) (HR 2.89 [1.82–4.57] and 1.90 [1.31–2.78], respectively) and 3-point major adverse CV events (HR 2.21 [1.53–3.19] and 1.42 [1.06–1.89]). Empagliflozin significantly reduced these outcomes across all risk factor control categories (P > 0.05 for treatment-by-subgroup interactions).

Conclusions
Cardiovascular risk in EMPA-REG OUTCOME was inversely associated with baseline CV risk factor control. Empagliflozin’s cardioprotective effect was consistent regardless of multiple baseline risk factor control.

History

Citation

The Journal of Clinical Endocrinology & Metabolism, Volume 105, Issue 9, September 2020, Pages 3025–3035, https://doi.org/10.1210/clinem/dgaa321

Author affiliation

Diabetes Research Centre, College of Life Sciences

Version

VoR (Version of Record)

Published in

The Journal of clinical endocrinology and metabolism

Volume

105

Issue

9

Pagination

3025-3035

Publisher

Oxford University Press (OUP) for Endocrine Society

issn

0021-972X

eissn

1945-7197

Acceptance date

30/05/2020

Copyright date

2020

Available date

18/03/2021

Spatial coverage

United States

Language

English

Usage metrics

Categories

Licence

Exports