Cardiology Magazine November - December 2011 : Page 2
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. FOR HIGH-RISK ACS-PCI PATIENTS, DEMAND… PREDICTABLE ANTIPLATELET EFFECT No relevant effect of genetic variation or concomitant medications involving cytochrome P450 enzymes on the active metabolite of Effient 1 Approximately 90% of patients had at least 50% inhibition of platelet aggregation (IPA) by 1 hour 1 – The relationship between IPA and clinical activity has not been established GREATER PROTECTION IN UA/NSTEMI AND STEMI In TRITON-TIMI 38, Effient plus aspirin (ASA) provided greater protection against thrombotic CV events, including stent thrombosis, compared with Plavix ® (clopidogrel bisulfate) plus ASA 1-3 – Difference in treatments was primarily driven by a significant reduction in nonfatal MIs, with no significant difference in CV death or stroke 1 – In the overall study population, approximately 40% of MIs occurred periprocedurally and were detected solely by changes in CK-MB – Of all periprocedural MIs, approximately 80% had at least 1 CK-MB measurement > 5x the upper limit of normal 4 – The LD of Plavix was delayed relative to the placebo-controlled trials that supported its approval for ACS 1 Effient plus ASA produced higher rates of clinically significant bleeding than Plavix plus ASA in TRITON-TIMI 38 1 CONVENIENT ONCE-DAILY MAINTENANCE DOSING 1 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. References: 1. Effient ® (prasugrel) prescribing information. Daiichi Sankyo, Inc. and Eli Lilly and Company. 2. Data on file: #EFF20091204b: DSI/Lilly. 3. Data on file: #EFF20100129c: DSI/Lilly. 4. Data on file: #EFF20091207a: DSI/Lilly. 5. Data on file: #EFF20110809a: DSI/Lilly. ® Effient and the Effient logo are registered trademarks of Eli Lilly and Company. Plavix ® is a registered trademark of sanofi-aventis Corp. Copyright © 2011 Daiichi Sankyo, Inc. and Lilly USA, LLC. All Rights Reserved. PG69947. PGHCPISI10Dec2010. Printed in USA. November 2011.