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EFFIENT® (PRASUGREL) BLEEDING RATES IN TRITON‑TIMI 38

  • 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 minor bleeding events were more common on Effient than on clopidogrel1

TIMI bleeding through 15 months in TRITON-TIMI 38

BLEEDING RATES BY PATIENT SUBGROUP

BLEEDING RATES BY WEIGHT AND AGE

TRITON-TIMI 38: TIMI Major/Minor Bleeding Rates in ACS & Patient Subgroup

Non-CABG bleeding in all ACS and by patient subgroup1,3,4

TRITON-TIMI 38: TIMI Major/Minor Bleeding Rates in All ACS by Weight & Age

Non-CABG major* or minor bleeding in all ACS and by weight and age1,5

Clopidogrel (300-mg LD, 75-mg MD) + ASA

Effient (60-mg LD, 10-mg MD) + ASA

*Intracranial hemorrhage or clinically overt bleeding associated with a fall in hemoglobin of ≥5 g/dL. Clinically overt bleeding associated with a fall in hemoglobin of ≥3 g/dL but <5 g/dL.

Clinical Efficacy

See efficacy data from TRITON-TIMI 38 that show how Effient compared with clopidogrel in ACS-PCI patients.

REVIEW THE DATA
  • Patients at highest risk for non-CABG TIMI major or minor bleeding were those ≥75 years of age or <60 kg (132 lb)1
  • The rates of life-threatening bleeding in all-ACS population, including fatal bleeding, were 1.3% with Effient plus ASA and 0.8% with clopidogrel plus ASA1
  • Effient is contraindicated in patients with active pathological bleeding, such as from a peptic ulcer or ICH, or a history of TIA or stroke, and in patients with hypersensitivity to prasugrel or any component of the product1
  • 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 ASA1

Age ≥75 years1

  • The risk of fatal bleeding was highest in patients ≥75 years
  • 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

Body weight <60 kg1

  • Individuals with body weight <60 kg had an increased risk of bleeding and an increased exposure to the active metabolite of Effient. Consider lowering the MD to 5 mg in patients <60 kg. The effectiveness and safety of the 5-mg dose have not been prospectively studied in ACS patients managed with PCI


The TRITON-TIMI 38 trial did not randomize patients based on diabetes status, nor was it designed to independently determine efficacy or safety of Effient in this prespecified subgroup.

Next: Highlights of ACS Guidelines (ACC, ACCF, AHA, SCAI)

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. 3. Data on file: #EFF20100129e: DSI/Lilly. 4. Data on file: #EFF20100129f: DSI/Lilly. 5. Data on file: #EFF20080922c: DSI/Lilly.

INDICATION

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.

CONTRAINDICATIONS

  • 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

ADVERSE REACTIONS

  • Bleeding, including life-threatening and fatal bleeding, is the most commonly reported adverse reaction

Please see Prescribing Information, including Boxed Warning regarding bleeding risk, and Medication Guide.