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EFFIENT® (PRASUGREL) REDUCTIONS IN STENT THROMBOSIS

Greater reductions in stent thrombosis* through 15 months with Effient plus aspirin (ASA) vs clopidogrel plus ASA

REDUCTIONS IN ALL ACS & BY STENT TYPE

REDUCTIONS IN STEMI PATIENTS

TRITON-TIMI 38 Secondary Endpoint: Stent Thrombosis by Stent Type

TRITON-TIMI 38: Secondary endpoint in all ACS and by
stent type through 15 months1,2

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

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

*Stent thrombosis was a prespecified secondary endpoint using the Academic Research Consortium definition of definite or probable stent thrombosis. This analysis represents stent thrombosis in any stent postrandomization. Relative risk reduction. Absolute risk reduction. §Patients who received a combination of DES and BMS were excluded from the analysis (n=640).

TRITON-TIMI 38 secondary endpoint: reductions in stemi patients

TRITON-TIMI 38: Secondary endpoint in STEMI-PCI through 15 months3-5

*Stent thrombosis was a prespecified secondary endpoint using the Academic Research Consortium definition of definite or probable stent thrombosis. This analysis represents stent thrombosis in any stent postrandomization. Relative risk reduction. Absolute risk reduction. §ARR is calculated from observed data, not Kaplan-Meier rates. Percentage is observed data.

In TRITON-TIMI 38, reductions in stent thrombosis were greater with Effient plus ASA in both bare-metal and drug-eluting stents compared with clopidogrel plus ASA

See highlights of Effient recommendations in clinical guidelines.

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  • Results were generally consistent across prespecified subgroups, with the exception of patients with a history of TIA or stroke6
  • 94% of the 13,608 patients in TRITON-TIMI 38 received stents2
    • Of the 12,844 patients who received stents during the index procedure, 45% received only drug-eluting stents (DES) (n=5743), 50% received only bare-metal stents (BMS) (n=6461), and 5% received a combination of DES and BMS (n=640)

In the TRITON-TIMI 38 STEMI-PCI population, 92% of the 3,534 patients received stents5

  • Of the 3,257 STEMI patients who received stents during the index procedure:
    • 36% received only DES (n=1158)
    • 64% received only BMS (n=2099)
  • The TRITON-TIMI 38 trial did not randomize patients based on stent type, nor was it designed to independently determine efficacy or safety of Effient in this prespecified subgroup

Important study design consideration

  • In TRITON-TIMI 38, the LD of clopidogrel was delayed relative to the placebo-controlled trials that supported its approval for ACS6

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 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.

Next: Efficacy in ACS-PCI Patients With Diabetes

References: 1. Data on file: #EFF20091204b: DSI/Lilly. 2. Wiviott SD, Braunwald E, McCabe CH, et al; for the TRITON-TIMI 38 Investigators. Lancet. 2008;371:1353-1363. 3. Montalescot G, Wiviott SD, Braunwald E, et al. Lancet. 2009;373:723-731. 4. Data on file: #EFF20100129c: DSI/Lilly. 5. Data on file: #EFF20150428b: DSI/Lilly. 6. Effient® (prasugrel) prescribing information. Daiichi Sankyo, Inc. and Eli Lilly and Company.

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.