ACS-PCI Patients With Diabetes

This page includes clinical data from the TRITON-TIMI 38 trial about ACS-PCI patients with diabetes in the following categories:

Reductions in Thrombotic CV Events in UA/NSTEMI, Including High-Risk Patients Such as Those With Diabetes Through 15 Months

In TRITON-TIMI 38, the reduction in the primary composite endpoint of CV death, nonfatal MI, or nonfatal stroke in the prespecified diabetes subgroup was consistent with the overall UA/NSTEMI population through 15 months.

Primary composite endpoint: UA/NSTEMI including diabetes subgroup through 15 months chart

Related content:

Clinical Guidelines for Effient Dosing Patient Identification

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

  • Observed rates of the primary composite endpoint in the UA/NSTEMI population for Effient® (prasugrel) plus ASA and Plavix® (clopidogrel bisulfate) plus ASA were 9.3% vs 11.2%, respectively (1.9% ARR; P=0.002)1
  • Observed rates of the primary composite endpoint in the UA/NSTEMI population with diabetes for Effient plus ASA and Plavix plus ASA were 10.8% vs 15.0%, respectively (4.2% ARR; P=0.002)3
  • 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)1,5
  • The TRITON-TIMI 38 trial was not designed to determine independent efficacy or safety of Effient in prespecified subgroups such as patients with diabetes

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.

References:
  1. Effient® (prasugrel) prescribing information. Daiichi Sankyo, Inc. and Eli Lilly and Company.
  2. Data on file: #EFF20110505a: DSI/Lilly.
  3. Data on file: #EFF20100129h: DSI/Lilly.
  4. Data on file: #EFF20091204a: DSI/Lilly.
  5. Wiviott SD, Braunwald E, McCabe CH, et al; for the TRITON-TIMI 38 Investigators. N Engl J Med. 2007;357:2001-2015.

Reductions in Thrombotic CV Events in UA/NSTEMI, Including High-Risk Patients Such as Those With Diabetes Through Day 30

In TRITON-TIMI 38, the reduction in the primary composite endpoint of CV death, nonfatal MI, or nonfatal stroke in the prespecified diabetes subgroup was consistent with the overall UA/NSTEMI population through day 30.

Primary composite endpoint in UA/NSTEMI patients, including the diabetes subgroup, through day 30 chart

Related content:

Clinical Guidelines for Effient Dosing Patient Identification

*The UA/NSTEMI with diabetes population is a subset of the UA/NSTEMI overall population. †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® (prasugrel) plus ASA compared with Plavix® (clopidogrel bisulfate) plus ASA through day 30 were 5.4% vs 6.7%, respectively (1.3% ARR; P=0.009)1
  • Observed rates of the primary composite endpoint in UA/NSTEMI patients with diabetes for Effient plus ASA and Plavix plus ASA through day 30 were 4.3% vs 7.0%, respectively (2.7% ARR; P=0.004)3
  • Difference in treatments was primarily driven by a significant reduction in nonfatal MIs, with no significant difference in CV death or nonfatal stroke5
    • 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 ACS5
  • 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)5,6
  • The TRITON-TIMI 38 trial was not designed to determine independent efficacy or safety of Effient in prespecified subgroups such as patients with diabetes

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.

References:
  1. Data on file: #EFF20080929c: DSI/Lilly.
  2. Data on file: #EFF20110222a: DSI/Lilly.
  3. Data on file: #EFF20110126a: DSI/Lilly.
  4. Data on file: #EFF20110126b: DSI/Lilly.
  5. Effient® (prasugrel) prescribing information. Daiichi Sankyo, Inc. and Eli Lilly and Company.
  6. Wiviott SD, Braunwald E, McCabe CH, et al; for the TRITON-TIMI 38 Investigators. N Engl J Med. 2007;357:2001-2015.

Reductions in Stent Thrombosis by Patient Subgroup

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.

Reductions in stent thrombosis in ACS-PCI patients with diabetes chart

Related content:

Clinical Guidelines for Effient Dosing Patient Identification

*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.

  • In TRITON-TIMI 38, 94% of the 13,608 patients received stents1,3
    • 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: SIGNIFICANT BLEEDING RISK

Do not start Effient in patients likely to undergo urgent 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, and concomitant use of medications that increase the risk of bleeding (eg, warfarin, heparin, fibrinolytic therapy, chronic use of NSAIDs). Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, PCI, CABG, or other surgical procedures in the setting of Effient. Click here for Safety Information and Boxed Warning.

References:
  1. Data on file: #EFF20091204b: DSI/Lilly.
  2. Data on file: #EFF20100129d: DSI/Lilly.
  3. Wiviott SD, Braunwald E, McCabe CH, et al; for the TRITON-TIMI 38 Investigators. Lancet. 2008;371:1353-1363.
  4. Effient® (prasugrel) prescribing information. Daiichi Sankyo, Inc. and Eli Lilly and Company.

For Healthcare Professionals

The information contained at EffientHCP.com is technical in nature and was specifically created for US Healthcare Professionals. If you are not a US Healthcare Professional, please click the cancel button below.

Yes, I am a US Healthcare Professional and would like to continue.