STOCKHOLM, August 31, 2010 /PRNewswire/ --
-- New ESC/EACTS Guidelines Recommend Efient(R) (Prasugrel) as First-line Antiplatelet Therapy for Patients with Severe Heart Attacks Managed with Percutaneous Coronary Intervention (PCI)
-- Guidelines also Recommended Prasugrel Should be Used for Patients with Less Severe Heart Attacks Managed with PCI
Prasugrel, an oral antiplatelet medicine, received a Class I recommendation (the highest level of recommendation) for use in patients with severe heart attacks (known as STEMI) undergoing PCI from the Clinical Guidelines Committee of the European Society for Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). The Guidelines Committee also recommended prasugrel for use in patients with less severe heart attacks (NSTEMI).
The ESC/EACTS Guidelines on Myocardial Revascularization were presented at the ESC Congress today and published in the European Heart Journal.(1)
Prasugrel received a Class I recommendation for use in patients with STEMI (ST-elevated myocardial infarction) undergoing PCI. Class I means that a "given treatment" is recommended for use as it "is beneficial, useful and effective". Prasugrel was recommended regardless of a patient's genetic status, with the Guidelines stating that presence of the CYP2C19 allele did not influence the action of prasugrel on platelet function. Prasugrel was also recommended regardless of concomitant proton pump inhibitor (PPI) use.(1)
The Guidelines Committee gave prasugrel a Class IIa recommendation in favor of its "usefulness and efficacy" in patients with NSTEMI (non-ST elevated myocardial infarction). Class IIa recommendations are based on the "weight of evidence and/or opinion".
In diabetic patients presenting with ACS, the guidelines state prasugrel offers "a significant advantage over clopidogrel without increased bleeding".(2) The guidelines state that "prasugrel should be used in patients who present with stent thrombosis whilst taking clopidogrel".
"Based on the latest clinical studies and scientific evidence, these guidelines provide clear recommendations for how prasugrel should be incorporated into medical practice to help reduce the risk of cardiovascular events such as heart attacks and blood clots forming around stents," said Dr. Joerg Rustige, Leader Cardiovascular Medical ACE, Eli Lilly and Company.
"As the ACS-PCI landscape evolves and more evidence comes to the fore, it is important that the cardiology community has updated clinical guidelines that include available treatment options like prasugrel for treating ACS patients managed with angioplasty and stenting," said Dr. Andreas Schirmer, Vice Director, Medical and Scientific Affairs at Daiichi Sankyo Europe. "By recommending prasugrel, these guidelines recognize an important treatment option for ACS-PCI patients who are at increased risk of suffering future cardiovascular events."
Granted marketing authorization by the European Commission in February 2009, prasugrel, co-administered with acetylsalicylic acid dosed between 75-325 mg (ASA - more commonly known as aspirin) once daily, is indicated to lower the chance of having another thrombotic cardiovascular event such as heart attack or stent-related blood clot for patients with ACS who are undergoing primary or delayed PCI.
In the TRITON-TIMI 38 trial, treatment with prasugrel produced a statistically significant 19 percent (P<0.001) reduction in the relative risk of the combined measure of cardiovascular death, nonfatal heart attack or nonfatal stroke compared with clopidogrel. This was driven primarily by a reduction in heart attack. In the TRITON-TIMI 38 clinical trial, the risk of non-coronary artery bypass graft (non-CABG) major bleeding, including fatal bleeding, was higher with prasugrel (2.2 percent incidence) compared with clopidogrel (1.7 percent incidence). Compared with the overall study population, a higher risk of serious bleeding among prasugrel patients was most evident in three distinct patient populations that are readily identifiable: patients who weighed less than 60 kg, patients who were 75 years of age or older and patients who have had a prior transient ischemic attack (TIA) or stroke. A 5 mg maintenance dose is recommended for patients who weigh less than 60 kg. Prasugrel is generally not recommended for use in patients 75 years or older. If treatment is deemed necessary, a 5 mg dose of prasugrel may be used after careful risk-benefit evaluation. Patients with prior TIA or stroke should not be treated with prasugrel.
About prasugrel
Daiichi Sankyo Company, Limited, and Eli Lilly and Company co-developed prasugrel, an oral antiplatelet agent discovered by Daiichi Sankyo and its Japanese research partner, Ube Industries, Ltd. Prasugrel helps keep blood platelets from clumping together and developing a blockage in an artery. The European Commission granted marketing authorization for prasugrel for the prevention of atherothrombotic events in patients with ACS undergoing PCI.
About Acute Coronary Syndromes
Acute coronary syndrome includes heart attacks and unstable angina (chest pain). Coronary heart disease, which can result in ACS, is the single most common cause of death in the European Union, accounting for more than 741,000 deaths in the EU each year.(3) In addition, ACS affects nearly 1.5 million people in the United States annually.(4) Heart attack is a major manifestation of coronary heart disease, which occurs when the arteries become narrowed or clogged by cholesterol and fat deposits. In some cases the plaque can rupture, resulting in a blood clot, which may partially or totally block the blood supply to portions of the heart, resulting in ACS.(5) Many ACS patients undergo PCI to re-open the artery, which usually includes a stent placement.
About Daiichi Sankyo
The Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has created a "Hybrid Business Model," which will respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit: www.daiichisankyo.com.
The company's world headquarters are in Tokyo. Its European base is located in Munich. DAIICHI SANKYO EUROPE has affiliates in 12 European countries in addition to a global manufacturing site located in Pfaffenhofen, Germany.
About Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs. Additional information about Lilly is available at http://www.lilly.com.
(CONTINUA)
