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EFFIENT® (PRASUGREL) EFFICACY IN UA/NSTEMI COHORT INCLUDING PATIENTS WITH DIABETES

Greater reductions in thrombotic cardiovascular (CV) events for UA/NSTEMI patients with diabetes through 15 months with Effient plus aspirin (ASA) vs clopidogrel plus ASA

PRIMARY COMPOSITE ENDPOINT

REDUCTIONS THROUGH DAY 30

 TRITON-TIMI 38 Primary Endpoint: Effient® vs Clopidogrel in UA/NSTEMI Patients with Diabetes Through 15 Months

TRITON-TIMI 38: Primary composite endpoint in UA/NSTEMI-PCI and
diabetes subgroup through 15 months*†1-4

*In the UA/NSTEMI population, the curves separated within the first few hours and continued to diverge throughout the 15-month period. The UA/NSTEMI with diabetes population is a subset of the UA/NSTEMI overall population. Relative risk reduction. §Absolute risk reduction. ARR is calculated from observed data, not Kaplan-Meier rates. Percentage is observed data.

TRITON-TIMI 38 Composite Endpoint: Effient® vs Clopidogrel in UA/NSTEMI Patients with Diabetes Through 30 Days

TRITON-TIMI 38: Composite endpoint in UA/NSTEMI-PCI and diabetes
subgroup through day 30*5,6

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

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

*The UA/NSTEMI with diabetes population is a subset of the UA/NSTEMI overall population. Relative risk reduction. Absolute risk reduction.

In TRITON-TIMI 38, the reduction in the primary composite endpoint in the prespecified diabetes subgroup was consistent with the overall UA/NSTEMI population

See highlights of Effient recommendations in clinical guidelines.

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  • Through 15 months, Effient provided a 30% relative risk reduction in the observed rates of the primary composite endpoint of CV death, nonfatal MI, or nonfatal stroke in the prespecified subgroup of UA/NSTEMI patients with diabetes vs clopidogrel (10.8% vs 15.0%; 4.2% ARR; P=0.002)3
  • Through 30 days, Effient provided a 39% relative risk reduction in the composite endpoint of CV death, nonfatal MI,or nonfatal stroke in the prespecified subgroup of UA/NSTEMI patients with diabetes vs clopidogrel (4.3 vs 7.0; 2.7 ARR; P=0.004)6
  • Results were generally consistent across prespecified subgroups, with the exception of patients with a history of TIA or stroke1
  • The TRITON-TIMI 38 trial did not randomize patients based on diabetes status, nor was it designed to independently determine efficacy or safety in this prespecified subgroup

Important efficacy considerations

  • Difference in treatments was primarily driven by a significant reduction in nonfatal MIs, with no significant difference in CV death or nonfatal stroke1
    • In the overall study population, approximately 40% of MIs occurred periprocedurally and were detected solely by changes in CK-MB

Important study design considerations

  • In TRITON-TIMI 38, the loading dose of clopidogrel was delayed relative to the placebo-controlled trials that supported its approval for ACS1

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 UA/NSTEMI-PCI Patients

References: 1. Effient® (prasugrel) prescribing information. Daiichi Sankyo, Inc. and Eli Lilly and Company. 2. Data on file: #EFF20091204a: DSI/Lilly. 3. Data on file: #EFF20100129h: DSI/Lilly. 4. Data on file: #EFF20110505a: DSI/Lilly. 5. Data on file: #EFF20080929c: DSI/Lilly. 6. Data on file: #EFF20110126a: 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.