HIGHLIGHTS OF EFFIENT® (PRASUGREL) RECOMMENDATIONS IN ACS GUIDELINES
Effient is included in the following clinical guidelines for STEMI and UA/NSTEMI patients undergoing PCI1-8
Duration of DAPT
in CAD patients1,2
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ACC=American College of Cardiology AHA=American Heart Association ACCF=American College of Cardiology Foundation SCAI=Society for Cardiovascular Angiography and Interventions
|In patients with ACS treated with DAPT after BMS or DES, P2Y12 inhibitor prasugrel should be given for at least 12 months COR I, LOE B-R1,2|
|In patients with ACS treated with DAPT after coronary stent implantation who are not at high risk for bleeding complications and who do not have a history of stroke or TIA, it is reasonable to choose prasugrel over clopidogrel for maintenance P2Y12 inhibitor therapy COR IIa, LOE B-R1,2|
|In patients with ACS treated with coronary stent implantation who have tolerated DAPT without a bleeding complication and who are not at high bleeding risk (e.g., prior bleeding on DAPT, coagulopathy, oral anticoagulant use), continuation of DAPT prasugrel for longer than 12 months may be reasonable* COR IIb, LOE A1,2|
|In patients with ACS treated with DAPT after DES who develop a high risk of bleeding (e.g., treatment with oral anticoagulant therapy), are at high risk of severe bleeding complication (e.g., major intracranial surgery), or develop significant overt bleeding, discontinuation of P2Y12 inhibitor therapy after 6 months may be reasonable COR IIb, LOE C-LD1,2|
|Do not use prasugrel in patients with a prior history of TIA or stroke COR III, LOE B-R1,2|
|Prasugrel is recommended in ACS-PCI patients in addition to ASA†‡ COR I, LOE B3-6|
|It is recommended that patients with STEMI receive a loading dose of prasugrel as early as possible, or at time of primary PCI† COR I, LOE B5,6|
|It is recommended that patients with NSTE-ACS receive a loading dose of prasugrel at time of PCI with stenting‡ COR I, LOE A3,4|
*Effient was studied for up to 15 months in the TRITON-TIMI 38 trial.
†From the 2013 ACCF/AHA STEMI Guideline.
‡From the 2014 AHA/ACC NSTE-ACS Guideline.
For more specific and complete recommendations on overall treatment of patients and use of prasugrel, please refer to the appropriate Guideline referenced.
SELECTED SAFETY: SIGNIFICANT BLEEDING RISK
Effient can cause significant, sometimes fatal, bleeding. 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 (diabetes or prior MI) where its effect appears to be greater and its use may be considered.
References: 1. Levine GN, Bates ER, Bittl JA, et al. J Am Coll Cardiol. 2016. [Published online ahead of print.] doi: 10.1016/j.jacc.2016.03.513. 2. Levine GN, Bates ER, Bittl JA, et al. Circulation. 2016. [Published online ahead of print.] doi: 10.1161/CIR.0000000000000404. 3. Amsterdam EA, Wenger NK, Brindis RG, et al. Circulation. 2014;130:e344-e426. doi: 10.1161/IR.0000000000000134. 4. Amsterdam EA, Wenger NK, Brindis RG, et al. J Am Coll Cardiol. 2015;64(24):2645-2687. doi: 10.1016/j.jacc.2014.09.016. 5. O’Gara PT, Kushner FG, Ascheim DD, et al. Circulation. 2013;127:e362-e425. 6. O’Gara PT, Kushner FG, Ascheim DD, et al. J Am Coll Cardiol. 2013;61:e78-e140. 7. Levine GN, Bates ER, Blankenship JC, et al. J Am Coll Cardiol. 2011;58:e44-e122. 8. Levine GN, Bates ER, Blankenship JC, et al. Circulation. 2011;124:e574-e651.
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