Effient® (prasugrel) BLEEDING RATES in TRITON-TIMI 38
See clinical data from TRITON-TIMI 38 that show how Effient compared with clopidogrel in ACS-PCI patients.
- TRITON-TIMI 38 was a head-to-head study comparing Effient® (prasugrel) (60-mg LD, followed by a 10-mg once-daily MD) plus ASA with clopidogrel (300-mg LD, followed by a 75-mg once-daily MD) plus ASA in 13,608 patients with ACS managed with PCI (median duration 14.5 months)1,2
- Thienopyridines, including Effient, increase the risk of bleeding. With the dosing regimens used in TRITON-TIMI 38, TIMI major* and TIMI minor1 bleeding events were more common on Effient than on clopidogrel1
*Clinically overt bleeding associated with a fall in hemoglobin of ≥5 g/dL, or intracranial hemorrhage. †Overt bleeding associated with a fall in hemoglobin of ≥3 g/dL but <5 g/dL.
SELECTED SAFETY: BLEEDING RATES IN TRITON-TIMI 38
Effient can cause significant, sometimes fatal, bleeding. Overall rates of non-CABG TIMI major or minor bleeding were significantly higher with Effient plus ASA (4.5%) compared with clopidogrel plus ASA (3.4%). The rates of fatal bleeding were 0.3% with Effient plus ASA and 0.1% with clopidogrel plus ASA. In patients who underwent CABG (N=437), the rates of CABG-related TIMI major or minor bleeding were 14.1% with Effient plus ASA and 4.5% with clopidogrel plus ASA.
References: 1. Effient® (prasugrel) prescribing information. Daiichi Sankyo, Inc. and Eli Lilly and Company. 2. Wiviott SD, Braunwald E, McCabe CH, et al; for the TRITON-TIMI 38 Investigators. N Engl J Med. 2007;357:2001-2015.
Effient® (prasugrel) 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
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.
- Effient is contraindicated in patients with active pathological bleeding, such as from a peptic ulcer or intracranial hemorrhage (ICH), or a history of transient ischemic attack (TIA) or stroke, and in patients with hypersensitivity to prasugrel or any component of the product
WARNINGS AND PRECAUTIONS
- Patients who experience a stroke or TIA while on Effient generally should have therapy discontinued. Effient should also be discontinued for active bleeding and elective surgery
- Premature discontinuation of Effient increases risk of stent thrombosis, MI, and death
- Thrombotic thrombocytopenic purpura (TTP), a rare but serious condition that can be fatal, has been reported with Effient, sometimes after a brief exposure (<2 weeks), and requires urgent treatment, including plasmapheresis
- Hypersensitivity, including angioedema, has been reported in patients receiving Effient, including patients with a history of hypersensitivity reaction to other thienopyridines
- Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction