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31 August 2011

New ESC Guidelines Recommend Efient® (Prasugrel) as First-line Antiplatelet Therapy for Patients with Non-ST Segment Myo

In new guidelines from the European Society of Cardiology (ESC), prasugrel - a once daily oral antiplatelet medicine - received a Class I recommendation for use in patients undergoing percutaneous coronary intervention (PCI) after experiencing a non-ST-segment elevation acute coronary syndrome (which comprises non-ST segment elevation myocardial infarction or NSTEMI - a type of heart attack - and unstable angina or UA). The highest available recommendation, Class I recognizes that prasugrel is considered a "beneficial, useful and effective" treatment option for first line use in these patients.
The Guidelines Committee endorsed the use of prasugrel in UA/NSTEMI patients (especially those with diabetes) who are clopidogrel naive in whom coronary anatomy is known and who are proceeding to PCI. The guidelineswere presented at the ESC Congress 2011 in Paris and are published in the European Heart Journal.
"UA and NSTEMI patients are at high risk of cardiovascular events, and they often represent a challenge in clinical practice. There is a significant body of evidence which showed that prasugrel can form part of an appropriate management strategy to minimize risk for these patients," said Professor Gilles Montalescot, Head of the Cardiac Care Unit at Pitie-Salpetriere Hospital, Paris, France. "The guidelines, based on the latest clinical evidence, set out clear recommendations that offer alternative treatment options, such as prasugrel, for treating some of these high risk patients."
In the updated guidelines - titled Management of acute coronary syndromes in patients presenting without persistent ST-segment elevation - prasugrel was recommended regardless of a patient's genetic status, and the guidelines state prasugrel does not appear to be affected by CYP inhibitors, including proton pump inhibitors.
NSTEMI and UA accounts for about 2.5 million hospital admissions worldwide each year. In developed countries NSTEMI is the most frequent type of ACS and represents the largest group of patients undergoing PCI. Despite advances in medical and interventional treatments, the mortality and morbidity remain high and equivalent to that of patients with severe heart attacks (known as STEMI) after the initial month. However, patients with NSTEMI constitute a heterogeneous group of patients with a highly variable prognosis. Therefore, early risk stratification is essential for selection of medical as well as interventional treatment strategies.
This new recommendation is based on the clinical evidence for prasugrel in UA/NSTEMI patient population in the TRITON-TIMI 38 study, which led to a level of evidence 'B' ('data derived from a single randomized clinical trial'). In the TRITON-TIMI 38 study, which included 10,074 patients withchest pain at rest (UA) or experiencing NSTEMI (74 percent of the study population), treatment with prasugrel produced a statistically significant 18 percent reduction in the relative risk of the combined endpoint of cardiovascular death, nonfatal heart attack or nonfatal stroke compared with clopidogrel. In this patient population, the incidence of non-CABG-related TIMI major (2.2 percent with prasugrel vs. 1.6 percent with clopidogrel) and minor (2.3 percent with prasugrel and 1.6 percent with clopidogrel) bleeding was statistically significantly higher in patients treated with prasugrel compared to clopidogrel.(5)
The publication of the guidelines comes just a few months after the addition of prasugrel to the joint American Heart Association (AHA), American College of Cardiology (ACC) and the Society for Cardiovascular Angiography and Interventions (SCAI) clinical practice guidelines in the United States, in which it was granted a Class I recommendation in UA/NSTEMI patients.
Granted marketing authorization by the European Commission in February 2009, prasugrel, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with ACS undergoing primary or delayed PCI.

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