WARNING: BLEEDING RISK
Effient can cause significant, sometimes fatal, bleeding
[see Warnings and Precautions (5.1 and 5.2) and Adverse Reactions ].
Do not use Effient in patients with active pathological bleeding or a history of transient ischemic attack or stroke
[see Contraindications (4.1 and 4.2)].
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 MI) where its effect appears to be greater and its use may be considered
[see Use in Specific Populations ].
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 (
e.g.
, warfarin, heparin, fibrinolytic therapy, chronic use of non-steroidal 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
[see Warnings and Precautions].
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EFFIENT SUMMARY
WARNING: BLEEDING RISK
Effient contains prasugrel, a thienopyridine class inhibitor of platelet activation and aggregation mediated by the P2Y12 ADP receptor.
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:
- Patients with unstable angina (UA) or non-ST-elevation myocardial infarction (NSTEMI).
- Patients with ST-elevation myocardial infarction (STEMI) when managed with primary or delayed PCI.
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NEWS HIGHLIGHTS
Published Studies Related to Effient (Prasugrel)
Effects of prasugrel on platelet inhibition during systemic endotoxaemia: a
randomized controlled trial. [2012]
P2Y(12) receptor antagonists have become a mainstay for the treatment of CVD
(cardiovascular diseases). However, they have rarely been evaluated under
pathophysiological conditions apart from arterial diseases... However, vWF release may reduce prasugrel's
effects under high-shear conditions.
Efficacy and safety of intensive antiplatelet therapy with prasugrel from TRITON-TIMI 38 in a core clinical cohort defined by worldwide regulatory agencies. [2011.10.01]
TRITON-TIMI 38 showed that in patients with acute coronary syndrome undergoing percutaneous coronary intervention prasugrel decreased ischemic events compared to standard clopidogrel, but with more bleeding. The United States Food and Drug Administration and the European Medicines Agency approved prasugrel but provided contraindications in patients with previous stroke or transient ischemic attack and recommended limited use or reduced dose in patients >/=75 years old and weighing <60 kg...
Impact of smoking on antiplatelet effect of clopidogrel and prasugrel after loading dose and on maintenance therapy. [2011.09]
BACKGROUND: Pharmacodynamic studies reported an amplified on-clopidogrel platelet inhibition in smokers potentially caused by an increased metabolic drug activation via induction of cytochrome P450 1A2. The aims of this analysis were to evaluate the impact of smoking on the antiplatelet effect of clopidogrel and prasugrel and to test the potential interaction of smoking with the treatment effect of these drugs... CONCLUSIONS: Smoking does not impact on platelet reactivity in patients after loading or on different maintenance doses of clopidogrel. The clinical treatment effect of clopidogrel versus prasugrel is not affected by smoking status at presentation. Copyright (c) 2011 Mosby, Inc. All rights reserved.
Predictors of bleeding and time dependence of association of bleeding with mortality: insights from the Trial to Assess Improvement in Therapeutic Outcomes by Optimizing Platelet Inhibition With Prasugrel--Thrombolysis in Myocardial Infarction 38 (TRITON-TIMI 38). [2011.06.14]
CONCLUSIONS: The major predictors of serious bleeding were a combination of patient and procedural characteristics and antiplatelet therapies. Although serious bleeding was strongly associated with mortality within the first month of the bleeding event, this association was not significant beyond 40 days. CLINICAL TRIAL REGISTRATION INFORMATION: http://www.clinicaltrial.gov. Unique identifier NCT00097591.
Prasugrel overcomes high on-clopidogrel platelet reactivity post-stenting more effectively than high-dose (150-mg) clopidogrel: the importance of CYP2C19*2 genotyping. [2011.04]
OBJECTIVES: The primary aim of the study was to determine the antiplatelet effects of prasugrel versus high-dose clopidogrel in patients with high on-treatment platelet reactivity (HTPR) after percutaneous coronary intervention (PCI) and, secondarily, their relation to cytochrome (CYP) 2C19*2 carriage. BACKGROUND: High on-treatment platelet reactivity after clopidogrel administration after PCI is linked to the loss-of-function CYP2C19*2 allele and accompanied by an increased risk of adverse events... CONCLUSIONS: In patients with HTPR after PCI, prasugrel is more effective compared with high clopidogrel in reducing platelet reactivity, particularly in CYP2C19*2 carriers. Genotyping guidance might be helpful only in case an increased clopidogrel maintenance dose is considered. (Prasugrel Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Post Percutaneous Coronary Intervention (PCI); NCT01109784). Copyright (c) 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Clinical Trials Related to Effient (Prasugrel)
An Assessment of Prasugrel on Healthy Adults and Sickle Cell Adults [Recruiting]
The purpose of this study is to measure the exposure to prasugrel's active metabolite and
the pharmacodynamic effects of prasugrel treatment in people with Sickle Cell Disease (SCD).
Clopidogrel to Prasugrel in Acute Coronary Syndrome (ACS) Patients [Recruiting]
This study will evaluate the use of a prasugrel 60 mg loading dose (LD) administered during
percutaneous coronary intervention (PCI) with and without a prior LD of clopidogrel on
platelet inhibition in patients presenting with ACS. Platelet inhibition following a
prasugrel LD in clopidogrel pretreated patients' will be determined in a time-dependent
manner for two different prasugrel loading doses (30 mg and 60 mg). Understanding the
effects of this combination on platelet inhibition will provide guidance to physicians on
the use of prasugrel in patients who have already been pretreated with clopidogrel.
A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease [Not yet recruiting]
The purpose of this study is to determine the correct prasugrel dosage to be given to
children with sickle cell disease (SCD).
Pharmacodynamic Evaluation of Switching From Ticagrelor to Prasugrel in Subjects With Stable Coronary Artery Disease [Recruiting]
This is a Phase 4, multicenter, open-label (blinded Pharmacodynamic PD results), randomized,
3-arm, parallel-design study of subjects with stable Coronary Artery Disease CAD. This study
will compare the PD effect of prasugrel 10 mg QD (once-daily) maintenance dose with
ticagrelor 90 mg BID (twice daily) maintenance dose in subjects with stable CAD who have
previously received ticagrelor loading does (LD) and maintenance dose (MD)..
Therapy With High Clopidogrel Dose or Prasugrel Standard Dose Reduces the Platelet Reactivity in Patients With Genotype Variation RESET Trial [Recruiting]
Dual antiplatelet therapy with aspirin and Clopidogrel for at least one year is essential in
patients following an acute coronary syndrome (ACS) or percutaneous coronary intervention
(PCI) with drug eluting stent(s. Interindividual variability in platelet response to
clopidogrel has been reported, with several mechanisms being implicated for high
post-clopidogrel treatment PR. High on-treatment platelet reactivity (HTPR) is associated
with an increased risk of adverse events after PCI. Studies in patients on chronic
clopidogrel treatment are scarce, mainly in diabetic patients where HTPR is frequently
present and independently predictive of adverse events. Optimization of platelet inhibition
in patients with HTPR by increasing clopidogrel or alternatively, by more potent P2Y12
inhibitors is a controversial issue, mostly studied in post PCI patients, while no data
exist, to the best of the investigators knowledge, in stable patients on chronic clopidogrel
treatment. Therefore all HTPR patients, that will accept to participate, will be enrolled
will randomize (Day 0) in a 1: 1 ratio to either clopidogrel 150 mg a day, or prasugrel 10 mg
a day, until Day 14 post randomization. A 14 ± 2 day visit will be performed for PR
measurement and safety evaluation, with the blood sample being will be obtained 16-18 hours
after the last study-drug dose, will follow by crossover directly to the alternate therapy
for an additional 14 days without an intervening washout period. At Day 28 ± 2 patients will
return for the clinical and laboratory assessment as did on Day 14 visit.
Reports of Suspected Effient (Prasugrel) Side Effects
Thrombosis in Device (77),
Death (52),
Acute Myocardial Infarction (36),
Chest Pain (33),
Haemorrhage (30),
in-Stent Coronary Artery Restenosis (29),
Dyspnoea (29),
Haemorrhage Intracranial (28),
Drug Dose Omission (26),
Myocardial Infarction (26), more >>
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Page last updated: 2013-02-10
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