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| Key Cardiology Research Presented In Stockholm: New ER-TIMI 19 Study Reports That Pre-Hospital Administration of RETAVASE(R) May Save Time to Treatment For Heart-Attack Patients |
STOCKHOLM, Sweden, Sept. 2 /PRNewswire/ -- A study presented today at the
European Society of Cardiology (ESC) Congress appears to demonstrate the
benefits of the clot-dissolving agent RETAVASE(R) (reteplase) in the treatment
of heart-attack patients. The study, known as ER-TIMI 19, reported that
doctors could accelerate the treatment of heart attack patients by 33 minutes
by administering RETAVASE in the ambulance rather than waiting until the
patient reached the hospital.
According to the National Institutes of Health, half of the 500,000 deaths
from heart attacks each year occur within the first hour of experiencing
symptoms such as chest pain and shortness of breath. Typically, patients
receive a clot-busting therapy only after they have arrived at the emergency
department.*
"RETAVASE, a fibrinolytic agent that is administered in two fixed doses
and does not require a patient to be weighed before it is administered,
facilitates treatment in the pre-hospital setting," said Donald Rosenberg,
M.D., professor of clinical medicine at the University of Miami School of
Medicine and medical director of Miami-Dade Fire Rescue. "Time is of the
essence when treating heart-attack patients, and giving RETAVASE in the
ambulance has been shown to be safe and feasible, and to save time to
treatment."
According to the National Heart, Lung, and Blood Institute, the
government's leading health agency for cardiovascular disease, patients wait
an average of 2.3 hours from the onset of symptoms until the start of
treatment with a cardiovascular medication. Yet, the rate of lives saved is
highest among patients who are treated with fibrinolytics within the first
hour of symptoms.
Michael Waller, M.D., Centocor's senior director, clinical trials
management, North America, added, "RETAVASE was tested in the ER TIMI 19 trial
because the double-bolus administration without weight adjustment facilitates
its use in the ambulance. The preliminary results of ER-TIMI 19 reported that
pre-hospital administration of RETAVASE enables earlier treatment of heart
attacks." He noted that the most important first step in treating heart
attacks is to open the artery, and RETAVASE has been proven to restore blood
flow in significantly more patients, compared with t-PA, at 60 and 90 minutes
after administration.
About the ER-TIMI 19 Study
The ER-TIMI 19 trial is a multicenter, open-label study involving
20 geographically diverse emergency medical systems in North America. The
primary endpoint is time saved with pre-hospital initiation of RETAVASE in
fibrinolytic-eligible patients with ST elevation on a 12-lead ECG, transmitted
to hospital-based medical control physicians.
The study found that for patients receiving pre-hospital treatment with
RETAVASE, the median time from EMS arrival to the first RETAVASE bolus was
31 minutes, compared with 64 minutes for those given RETAVASE at the hospital.
The rapid pre-hospital administration of RETAVASE worked to stabilize heart-
attack patients, with 29% already showing a greater than 50% resolution of
their elevated ST segments, an electrocardiogram indicator of heart health, by
the time they arrived at the emergency room. Complete ST-segment resolution
(>70%) was achieved in 15 percent of pre-hospital-treated patients by
emergency department arrival and 54 percent by 90 minutes after the first
bolus of RETAVASE. To date, twelve (5.4%) deaths and two (0.9%) intracranial
hemorrhages have occurred, rates that are consistent with other fibrinolytic
trials.
About Heart Attack
According to the American Heart Association, an estimated 1.1 million
Americans suffer heart attacks each year. Approximately 450,000 of these
heart attacks are recurrent heart attacks. Nearly all heart attacks are
caused by a thrombus-a blood clot that obstructs the flow of blood to the
heart, thereby depriving it of oxygen and nutrients.
Blood clots are composed of a protein called fibrin and disk-shaped blood
elements known as platelets. While clot-busting, or thrombolytic, agents such
as RETAVASE target only the fibrin component of clots, drugs known as
glycoprotein IIb/IIIa inhibitors (e.g., ReoPro) target the platelet component
of blood clots.
About RETAVASE
RETAVASE is a recombinant biologic cardiology care product administered
for the treatment of acute myocardial infarction, or heart attack, to improve
blood flow in the heart. When compared with older thrombolytic agents,
RETAVASE distinguishes itself by its ease of administration - a simple two-
bolus injection given 30 minutes apart. RETAVASE also restored blood flow in
significantly more patients, compared with t-PA, at 60 and 90 minutes after
administration. However, the relationship between coronary artery patency and
clinical efficacy has not been established.
As with all fibrinolytic agents, RETAVASE therapy increases the risk of
bleeding, including intracranial bleeding, and should be used only in
appropriate patients. In addition, fibrinolytic therapy increases the absolute
risk of strokes, including hemorrhagic stroke, in patients of advanced age.
Please see http://www.RETAVASE.com for full prescribing information.
About Centocor, Inc.
Centocor is a leading biopharmaceutical company that creates, acquires and
markets cost-effective therapies that yield long-term benefits for patients
and the healthcare 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 healthcare
products. For more information, visit Centocor's web site at
http://www.centocor.com.
Certain of the matters discussed herein with respect to clinical studies
and Centocor's products may constitute forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements are based on current expectations, estimates and
projections about the industry, management beliefs and certain assumptions
made by management. Investors are cautioned that matters subject to forward-
looking statements involve risks and uncertainties, including economic,
competitive, governmental, technological and other factors discussed in the
company's respective filings with the Securities and Exchange Commission,
which may affect its business and prospects. More specifically, there can be
no assurance that this product will achieve commercial success or that
competing products will not preempt any market opportunity that might exist
for the product.
* The TIMI 19 trial was conducted in the following states:
Arkansas, Connecticut, Florida, Georgia, Indiana, Kentucky, Massachusetts,
Minnesota, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, and
Washington.
RETAVASE(R) is a registered trademark of Centocor, Inc.
SOURCE Centocor, Inc.
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CONTACT:
Bill Newbould of Centocor, +1-610-651-6122,
or newbouldw@centocor.com, or Jade Cantor of Edelman PR
Worldwide, +1-212-704-4578, or jade.cantor@edelman.com, for
Centocor
