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TRITON-TIMI 38: Greater reductions in thrombotic CV events and stent
thrombosis with Effient + ASA vs clopidogrel + ASA*
Thrombotic CV events (primary composite of CV death, nonfatal
MI, nonfatal stroke) relative risk reduction (RRR) in STEMI-PCI
patients was 21% through 450 days (9.8% Effient + ASA vs
12.2% clopidogrel + ASA, P=0.02)1
— RRR was 30% through 7 days (5.5% Effient + ASA vs
7.8% clopidogrel + ASA, P=0.008) and 32% through 30 days
(6.5% Effient + ASA vs 9.4% clopidogrel + ASA, P=0.002)2,3
Difference in treatments was primarily driven by a significant
reduction in nonfatal MIs, with no significant difference in CV death
or nonfatal stroke1
—In the overall study population, approximately 40% of MIs
occurred periprocedurally and were detected solely by changes
in CK-MB
Stent thrombosis (secondary endpoint) RRR in ACS-PCI patients
was 52% through 450 days (1.1% Effient + ASA vs 2.2% clopidogrel
+ ASA, P<0.0001)4
Stent thrombosis RRR in STEMI-PCI patients was 42% through
450 days ( 1.6% Effient + ASA vs 2.8% clopidogrel + ASA, P=0.02)5
SELECTED SAFETY: Effient increased the risk of TIMI
major or minor bleeding vs clopidogrel
Effient can cause significant, sometimes fatal, bleeding. Overall
rates of non-CABG TIMI major or minor bleeding were significantly
higher with Effient + ASA (4.5%) compared with clopidogrel + ASA
(3.4%). The rates of fatal bleeding were 0.3% with Effient + ASA
and 0.1% with clopidogrel + ASA. In patients who underwent CABG
(N=437), the rates of CABG-related TIMI major or minor bleeding
were 14.1% with Effient + ASA and 4.5% with clopidogrel + ASA
*In TRITON-TIMI 38, the LD of clopidogrel was delayed relative to the placebocontrolled trials that supported its approval for ACS.1
Effient is indicated to reduce the rate of thrombotic cardiovascular (CV) events (including stent thrombosis) in patients with acute coronary
syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI) as follows: [1] patients with unstable angina (UA) or
non–ST-elevation myocardial infarction (NSTEMI); [2] patients with ST-elevation myocardial infarction (STEMI) when managed with primary
or delayed PCI.
The loading dose (LD) of Effient is 60 mg and the maintenance dose (MD) is 10 mg once daily. Effient is available in 5-mg and 10-mg tablets.
IMPORTANT SAFETY INFORMATION
WARNING: BLEEDING RISK
Effient® (prasugrel) can cause significant, sometimes fatal, bleeding.
Do not use Effient in patients with active pathological bleeding or a
history of transient ischemic attack or stroke.
In patients ≥75 years of age, Effient is generally not recommended,
because of the increased risk of fatal and intracranial bleeding
and uncertain benefit, except in high-risk situations (patients with
diabetes or a history of prior myocardial infarction [MI]) where its
effect appears to be greater and its use may be considered.
Do not start Effient in patients likely to undergo urgent coronary
artery bypass graft surgery (CABG). When possible, discontinue
Effient at least 7 days prior to any surgery.
Additional risk factors for bleeding include:
body weight <60 kg
propensity to bleed
concomitant use of medications that increase the risk of
bleeding (eg, warfarin, heparin, fibrinolytic therapy, chronic
use of nonsteroidal anti-inflammatory drugs [NSAIDs])
Suspect bleeding in any patient who is hypotensive and has recently
undergone coronary angiography, percutaneous coronary
intervention (PCI), CABG, or other surgical procedures in the
setting of Effient.
If possible, manage bleeding without discontinuing Effient.
Discontinuing Effient, particularly in the first few weeks after
acute coronary syndrome, increases the risk of subsequent
cardiovascular events.
Please see Brief Summary of Prescribing Information, including
Boxed Warning regarding bleeding risk, on subsequent pages.
References: 1. Effient® (prasugrel) prescribing information. Daiichi Sankyo, Inc. and
Eli Lilly and Company. 2. Data on