Reduction in Thrombotic CV Events in UA/NSTEMI Patients

In TRITON-TIMI 38, Effient^® (prasugrel) plus ASA provided greater protection against the primary composite endpoint of CV death, nonfatal MI, or nonfatal stroke in the UA/NSTEMI population compared with Plavix^® (clopidogrel bisulfate) plus ASA.

*In the UA/NSTEMI population, the curves separated within the first few hours and continued to diverge throughout the 15-month period. ^†Absolute risk reduction is calculated from observed data, not KM rates.

• Observed rates of the primary composite endpoint in the UA/NSTEMI population for Effient plus ASA and Plavix plus ASA were 9.3% vs 11.2%, respectively (1.9% ARR; P=0.002)¹
• 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
• In TRITON-TIMI 38, the LD of Plavix was delayed relative to the placebo-controlled trials that supported its approval for ACS¹
• TRITON-TIMI 38 was a head-to-head study comparing Effient (60-mg LD, followed by a 10-mg once-daily maintenance dose) plus ASA with Plavix (300-mg LD, followed by a 75-mg once-daily maintenance dose) plus ASA in 13,608 patients with ACS managed with PCI (median duration 14.5 months)^1,3

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 Plavix plus ASA (3.4%). The rates of fatal bleeding were 0.3% with Effient plus ASA and 0.1% with Plavix 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 Plavix plus ASA. Click here for Safety Information and Boxed Warning.

Reduction in Thrombotic CV Events in UA/NSTEMI Patients Through Day 30

In TRITON-TIMI 38, Effient^® (prasugrel) plus ASA provided greater protection against the primary composite endpoint of CV death, nonfatal MI, or nonfatal stroke in the UA/NSTEMI population compared with Plavix^® (clopidogrel bisulfate) plus ASA through day 30.

*Absolute risk reduction is calculated from observed data, not KM rates.

• Observed rates of the primary composite endpoint in the UA/NSTEMI population for Effient plus ASA and Plavix plus ASA were 5.4% vs 6.7%, respectively (1.3% ARR; P=0.009)¹
• 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
• In TRITON-TIMI 38, the loading dose of Plavix was delayed relative to the placebo-controlled trials that supported its approval for ACS¹
• TRITON-TIMI 38 was a head-to-head study comparing Effient (60-mg LD, followed by a 10-mg once-daily maintenance dose) plus ASA with Plavix (300-mg LD, followed by a 75-mg once-daily maintenance dose) plus ASA in 13,608 patients with ACS managed with PCI (median duration 14.5 months)^1,3

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 Plavix plus ASA (3.4%). The rates of fatal bleeding were 0.3% with Effient plus ASA and 0.1% with Plavix 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 Plavix plus ASA. Click here for Safety Information and Boxed Warning.

Reductions in Thrombotic CV Events Across UA/NSTEMI Subgroups

In TRITON-TIMI 38, the reduction in the primary composite endpoint of CV death, nonfatal MI, or nonfatal stroke was consistent with the overall UA/NSTEMI population for most subgroups.

• Effient^® (prasugrel) 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 product
• TRITON-TIMI 38 was a head-to-head study comparing Effient (60-mg LD, followed by a 10-mg once-daily maintenance dose) plus ASA with Plavix^® (clopidogrel bisulfate) (300-mg LD, followed by a 75-mg once-daily maintenance dose) plus ASA in 13,608 patients with ACS managed with PCI (median duration 14.5 months)^1,2
• The TRITON-TIMI 38 trial was not designed to determine independent efficacy or safety of Effient in prespecified subgroups
• In the TRITON-TIMI 38 clinical study, the incidence of stroke in patients with a history of TIA or stroke in the entire study population was higher with Effient plus ASA (6.5% total: 4.2% thrombotic, 2.3% ICH) compared with Plavix plus ASA (1.2% total, all thrombotic)¹
• In TRITON-TIMI 38, the LD of Plavix was delayed relative to the placebo-controlled trials that supported its approval for ACS¹

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 Plavix plus ASA (3.4%). The rates of fatal bleeding were 0.3% with Effient plus ASA and 0.1% with Plavix 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 Plavix plus ASA. Click here for Safety Information and Boxed Warning.

Reductions in Stent Thrombosis in UA/NSTEMI Patients

In TRITON-TIMI 38, Effient^® (prasugrel) plus ASA provided greater protection against stent thrombosis compared with Plavix^® (clopidogrel bisulfate) plus ASA in patients with ACS managed with PCI.

*Stent thrombosis was a prespecified secondary endpoint using the Academic Research Consortium (ARC) definition of definite or probable stent thrombosis. This analysis represents stent thrombosis in any stent postrandomization.

• 42% RRR in the STEMI population (1.6% with Effient plus ASA [N=1624] vs 2.8% with Plavix plus ASA [N=1633]; 1.2% ARR; P=0.02)²
• In TRITON-TIMI 38, 94% of the 13,608 patients received stents^1,3
  • 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 TRITON-TIMI 38, the LD of Plavix was delayed relative to the placebo-controlled trials that supported its approval for ACS⁴

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 Plavix plus ASA (3.4%). The rates of fatal bleeding were 0.3% with Effient plus ASA and 0.1% with Plavix 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 Plavix plus ASA. Click here for Safety Information and Boxed Warning.