American College of Cardiology Scientific Meeting 2019 Remo H. M. Furtado, et al. On behalf of the DECLARE TIMI-58 Executive & Steering Committees and Investigators Dapagliflozin and CV outcomes in patients with type 2 diabetes and prior myocardial infarction: a sub-analysis from DECLARE TIMI-58 NCT01730534 DECLARE TIMI-58 was funded by a grant from AstraZeneca to Brigham and Women’s Hospital
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Dapagliflozin and CV outcomes in patients with type 2 ......myocardial infarction: a sub-analysis from DECLARE TIMI-58 NCT01730534 DECLARE TIMI-58 was funded by a grant from AstraZeneca
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American College of CardiologyScientific Meeting 2019
Remo H. M. Furtado, et al. On behalf of the DECLARE TIMI-58
Executive & Steering Committees and Investigators
Dapagliflozin and CV outcomes in
patients with type 2 diabetes and prior
myocardial infarction: a sub-analysis
from DECLARE TIMI-58
NCT01730534DECLARE TIMI-58 was funded by a grant from AstraZeneca to Brigham and Women’s Hospital
Background
Wiviott et al. N Eng J Med 2019; 380: 347
~ 60 % with no prior athero CV disease> 90 % eGFR > 60 ml/min/1.73 m2
(CVD/MI/Ischemic Stroke)
Background
Zelniker et al. Lancet 2019; 393: 31
Atherosclerotic Cardiovascular Disease (ASCVD):
Multiple Risk Factors (MRF):
Das et al. J Am Coll Cardiol 2018;72: 3200
Background – ACC guidelines
0
5
10
15
20
25
0 5 10 15 20 25 30 35 40
Background
Cavender et al. Circulation 2015;132:923
MACE in REACH registry (n = 19,699) across the spectrum of atherothrombotic risk Adj K-M
(%)
Months
Diabetes + only risk
factors
Diabetes + ASCVD
without prior ischemic
event
Diabetes + ASCVD
with prior ischemic
event
CV
death
, M
I or
str
oke
To investigate the benefit of
dapagliflozin in the particular
subgroup of patients with
T2DM and prior MI
Objective
▪ DECLARE TIMI-58 trial randomized patients with T2DM and
either established ASCVD or only MRF to dapagliflozin 10 mg
QD versus placebo
▪ Prior MI was pre-specified as a subgroup of interest
▪ The risks of MACE and CVD/HHF (dual primary EPs) in patients
with and without prior MI were compared in the placebo arm,
with adjustment for baseline differences (Cox model)
▪ Efficacy of dapagliflozin regarding both MACE and CVD/HHF
was evaluated stratified by history of MI
▪ Treatment-by-subgroup interactions for the absolute risk
reductions (ARR) were analyzed using Gail−Simon test.