New Treatment Guidelines Cite ReoPro(R) Favorably for PCI in Acute Heart Attack Patients
July 16 2004 - 10:48AM
PR Newswire (US)
New Treatment Guidelines Cite ReoPro(R) Favorably for PCI in Acute
Heart Attack Patients INDIANAPOLIS, July 16 /PRNewswire-FirstCall/
-- New guidelines issued by the American College of Cardiology and
the American Heart Association are in favor of using ReoPro(R)
(abciximab) in acute heart attack patients (ST- Elevation
Myocardial Infarction or STEMI) who are having a balloon or
stenting procedure (PCI). ReoPro, a glycoprotein IIb/IIIa
inhibitor, is indicated for adjunctive use with PCI for the
prevention of cardiac ischemic complications in patients undergoing
this procedure. "ACC/AHA Guidelines for the Management of Patients
with ST-Elevation Myocardial Infarction - Executive Summary" was
published July 13 in Circulation. In addition, the guidelines will
be featured in the July 21 issue of the Journal of the American
College of Cardiology. The last revision of the guidelines related
to the treatment of patients with acute heart attacks was in 1999.
Cardiologists use these guidelines to help manage more severe heart
attack patients. ReoPro received the "Class IIa, level of evidence
B" recommendation in the new guidelines, meaning that the treatment
is useful/effective but may have some conflicting evidence from a
clinical trial. The guidelines are in favor of starting treatment
with ReoPro as early as possible before primary PCI (with or
without stenting) in patients with STEMI. Dosing and administration
instructions for ReoPro indicate that ReoPro should be administered
10-60 minutes before the start of PCI. "We are very pleased to get
this recommendation. We believe ReoPro in conjunction with PCI is
an excellent choice to help manage acute heart attack patients as
well as many other patients who are having a balloon or stenting
procedure," said Dr. Mark Effron, medical director, U.S. Acute
Care, Eli Lilly and Company. "ReoPro has been studied extensively,
including more than five randomized clinical trials in ST-elevation
MI, as well as many other trials in a variety of patient types."
Nationwide, an estimated 500,000 people have an acute heart attack
annually, according to the ACC. Aggressive recognition and
treatment of acute heart attacks, as outlined in these guidelines,
including the use of ReoPro with PCI, may contribute to a reduction
in death and complications from this disease. About ReoPro ReoPro
is a member of a class of drugs known as glycoprotein (GP) IIb/IIIa
inhibitors that target the platelet component of blood clots and
reduce the complications associated with blood flow restrictions
during coronary intervention, including angioplasty and stenting.
In these settings, ReoPro prevents complications associated with
thrombi (blood clots), and has shown this in clinical trials by
reducing the incidence of a composite of mortality, repeat heart
attacks, or repeat PCI. ReoPro has the potential to increase the
risk of bleeding, particularly in the presence of anti-coagulation
agents, e.g., from heparin or other anticoagulants. The risk of a
major bleed due to ReoPro therapy is increased in patients
receiving thrombolytics and should be weighed against the
anticipated benefits. Because ReoPro may increase the risk of
bleeding, its use is contraindicated in the following clinical
situations: active internal bleeding, recent (within 6 weeks)
gastrointestinal (GI) or genitourinary (GU) bleeding of clinical
significance, history of cerebrovascular accident (CVA) within 2
years, or CVA with a significant residual neurological deficit,
bleeding diathesis, administration of oral anticoagulants within 7
days unless prothrombin time <
/= 1.2 times control, thrombocytopenia (< 100,000 cells/ micro
L), recent (within 6 weeks) major surgery or trauma, intracranial
neoplasm, arteriovenous malformation, or aneurysm, severe
uncontrolled hypertension, presumed or documented history of
vasculitis, use of intravenous dextran before percutaneous coronary
intervention, or intent to use it during intervention, known
hypersensitivity to any component of this product or to murine
proteins. In clinical trials, patients treated with ReoPro were
more likely than patients who received placebo to experience
decreases in platelet counts, including severe thrombocytopenia.
Administration of ReoPro may result in the formation of human anti
chimeric antibodies (HACA) that could potentially cause allergic or
hypersensitivity reactions (including anaphylaxis),
thrombocytopenia, or diminished benefit upon readministration.
ReoPro readministration may be associated with an increased
incidence and severity of thrombocytopenia. This increased risk was
associated with a history of thrombocytopenia on prior ReoPro
exposure, a positive HACA assay at baseline, and readministration
within 30-days. Full prescribing information for ReoPro is
available by calling 1-800-545-5979. ReoPro was developed by
Centocor of Malvern, Pa., USA, and is manufactured by Centocor,
B.V., in Leiden, the Netherlands. Eli Lilly and Company markets and
distributes the product worldwide except in Japan. About Eli Lilly
and Company Lilly, a leading innovation-driven corporation, is
developing a growing portfolio of first-in-class and best-in-class
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/ .
About Centocor Centocor is a leading biopharmaceutical company that
creates, acquires and markets cost-effective therapies that yield
long-term benefits for patients and the health care community. Its
products, developed primarily through monoclonal antibody
technology, help physicians deliver innovative treatments to
improve human health and restore patients' quality of life.
Centocor is a wholly owned subsidiary of Johnson & Johnson, a
worldwide leader of health care products. ReoPro(R) (abciximab,
Centocor), Lilly (Logo:
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://www.newscom.com/cgi-bin/prnh/20040716/CENTOCORLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
http://www.newscom.com/cgi-bin/prnh/20040716/CENTOCORLOGO
DATASOURCE: Eli Lilly and Company CONTACT: Janice Chavers of Eli
Lilly and Company, +1-317-651-6253
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