Landmark Acute Coronary Syndrome Trial Shows
Integrilin - Eptifibatide - Reduces Combined Rate of
Death or Heart Attack Regardless of Patient
Management Strategy
( BW)(COR-THERAPEUTICS/INTEGRILIN)(CORR)
Landmark Acute Coronary Syndrome Trial Shows Integrilin -
Eptifibatide - Reduces Combined Rate of Death or Heart Attack
Regardless of Patient Management Strategy
Health Editors
SOUTH SAN FRANCISCO, Calif. and MADISON, N.J.--(BW
HealthWire)--August 12, 1998--
- THE "REAL-WORLD," PRACTICE-BASED PURSUIT STUDY PUBLISHED IN THE
NEW ENGLAND JOURNAL OF MEDICINE
Results of PURSUIT, the largest study ever conducted in patients
with serious heart conditions known as unstable angina or
non-Q-wave myocardial infarction, demonstrate that regardless of
how patients were managed in their individual hospitals - with
drug therapy alone or in combination with invasive cardiac
procedures - INTEGRILIN(TM) (eptifibatide) significantly
decreased the combined incidence of death or heart attack within
30 days of treatment. As reported in the August 13 issue of The
New England Journal of Medicine, the combined incidence of
death or heart attack at 30 days was significantly reduced from
15.7 percent with current management strategies alone to 14.2
percent with INTEGRILIN added to current management
strategies in the overall study population of 10,948 patients from
726 hospitals in 27 countries. On average, for every 1,000
patients treated with INTEGRILIN, 15 events of death or heart
attack were prevented.
PURSUIT is unique in that it was the first trial in unstable angina
or non-Q-wave myocardial infarction designed to mirror actual
clinical management of these conditions. "PURSUIT allows
physicians to assess potential outcomes under a wide variety of
management strategies in the typical patient population presenting
with urgent chest pain in the emergency department," noted
Robert A. Harrington, MD, Assistant Professor of Medicine and
Attending Cardiologist in Interventional Cardiology at Duke
University Medical Center, which coordinated the trial in
conjunction with the Cleveland Clinic Foundation and Cardialysis
in Rotterdam, The Netherlands.
As many as 1.3 million Americans are hospitalized each year due
to unstable angina (UA) or non-Q-wave myocardial infarction
(NQMI) - serious heart conditions caused by partial blockage of
blood supply to the heart muscle by a coronary thrombus, an
aggregate of blood cells (platelets). Current treatment strategies
vary widely by country and hospital. Therapy usually begins with
administration of aspirin, intravenous heparin and intravenous
nitroglycerin. Patients are subsequently either stabilized with drug
therapy alone or undergo diagnostic catheterization followed when
appropriate by an invasive cardiac procedure such as percutaneous
coronary intervention (PCI) or coronary artery bypass graft
surgery (CABG). Despite these treatment strategies, up to one in
seven patients dies or experiences a heart attack (acute myocardial
infarction) within the 30-day period following hospitalization for
unstable angina or non-Q-wave myocardial infarction.
PURSUIT was a "real-world" trial designed to evaluate
INTEGRILIN(TM) (eptifibatide) as an adjunct to the broad
spectrum of management strategies used around the world to help
prevent death or heart attack in the 30-day period following an
urgent episode of unstable angina or non-Q-wave myocardial
infarction.
INTEGRILIN is a member of the novel class of drugs called
glycoprotein (GP) IIb-IIIa inhibitors which act to prevent
progression of thrombosis (blood clot formation) responsible for
unstable angina and non-Q-wave myocardial infarction and their
complications.
According to the study in The New England Journal of Medicine,
the combined incidence of death or heart attack at 30 days in
UA/NQMI patients undergoing early percutaneous coronary
intervention (during the first 72 hours of study randomization),
was significantly reduced with INTEGRILIN; 51 events of death
or MI, on average, were prevented per 1,000 patients treated. In
UA/NQMI patients not undergoing early percutaneous coronary
intervention, 11 events were prevented, on average, per 1,000
patients treated with INTEGRILIN.
The full Prescribing Information for INTEGRILIN, which
defines early PCI slightly differently than as defined by the
investigators, reflects an average reduction per 1,000 patients
treated with INTEGRILIN of 50 events for those undergoing
early PCI and 10 events for those not undergoing early PCI.
In terms of the safety profile of INTEGRILIN, the incidence of
stroke, cerebral hemorrhage, or thrombocytopenia (a potentially
serious condition of platelet depletion) with INTEGRILIN was
similar to that for aspirin and heparin alone.
Bleeding is the most common complication encountered during
INTEGRILIN therapy. The majority of excess major bleeding
events were localized at the femoral artery access site.
Oropharyngeal, genitourinary, gastrointestinal, and retroperitoneal
bleeding were seen more commonly with INTEGRILIN
compared with placebo.
According to the study in The New England Journal of Medicine,
the incidence of major bleeding during initial hospitalization was
increased from 9.1 percent in patients randomized to receive
placebo to 10.6 percent in patients randomized to receive
INTEGRILIN. The incidence of minor bleeding during initial
hospitalization in the randomized patient population was increased
from 7.4 percent to 12.9 percent with INTEGRILIN.
The full Prescribing Information for INTEGRILIN, which
includes safety data only for patients who actually were treated
with study drug, indicates an increase in major bleeding from 9.3
percent to 10.8 percent with INTEGRILIN and an increase in
minor bleeding from 7.6 percent to 13.1 percent with
INTEGRILIN.
INTEGRILIN(TM) (eptifibatide) was recently approved for
marketing by the U.S. Food and Drug Administration (FDA).
INTEGRILIN has the broadest range of approved indications
among GP IIb-IIIa inhibitors available in the United States.
INTEGRILIN is indicated for the treatment of patients with acute
coronary syndrome (unstable angina and non-Q-wave myocardial
infarction) including patients who are to be managed medically
and those undergoing percutaneous coronary intervention (PCI).
INTEGRILIN is also indicated for the treatment of patients
undergoing PCI.
INTEGRILIN is contraindicated in the following patient
populations: those with a history of bleeding diathesis, or
evidence of active abnormal bleeding within the previous 30 days;
severe hypertension (systolic blood pressure >200 mm Hg or
diastolic blood pressure >110 mm Hg) not adequately controlled
on antihypertensive therapy; major surgery within the preceding
six weeks; history of stroke within 30 days or any history of
hemorrhagic stroke; current or planned administration of another
parenteral GP IIb-IIIa inhibitor; platelet count <100,000mm(3);
serum creatinine greater than or equal to 2 mg/dL (for the 180
microgram/kg bolus and the 2 microgram/kg/min infusion) or
greater than or equal to 4 mg/dL (for the 135 microgram/kg bolus
and the 0.5 microgram/kg/min infusion); dependency on renal
dialysis; or known hypersensitivity to any component of the
product.
COR Therapeutics, Inc. and Schering-Plough Corporation are
worldwide development partners for INTEGRILIN. In the United
States, both COR and the Key Pharmaceuticals business unit of
Schering-Plough have implemented a comprehensive sales and
marketing campaign intended to educate healthcare professionals
about the high incidence of morbidity and mortality in patients
presenting to U.S. emergency departments with unstable angina
or non-Q-wave myocardial infarction and the need for early
intervention with INTEGRILIN therapy regardless of the ultimate
management plan selected.
COR Therapeutics, Inc. (Nasdaq: CORR) is dedicated to the
discovery, development, and commercialization of novel
pharmaceutical products for the treatment and prevention of severe
cardiovascular diseases. COR has complementary research and
development programs that seek to address critical needs in severe
cardiovascular care, including unstable angina, acute myocardial
infarction, deep vein thrombosis and restenosis.
In addition to the historical information contained herein, this
press release contains forward-looking statements that involve
risks and uncertainties. Actual results of the Company's activities
may differ significantly from the potential results discussed in
such forward-looking statements. These forward-looking
statements are based on current expectations and the Company
assumes no obligation to update this information. A full
discussion of COR Therapeutics, Inc.'s operations and financial
condition, and specific factors that could cause the Company's
actual performance to differ from current expectations, are
discussed in the Company's SEC reports, including, but not
limited to, the Company's Report on Form 10-Q for the quarter
ended March 31, 1998, and Report on Form 10-K for the year
ended December 31, 1997.
Schering-Plough Corporation (NYSE: SGP) is a research-based
company engaged in the discovery, development, manufacturing
and marketing of pharmaceutical and health care products
worldwide. Please consult full Prescribing Information for
INTEGRILIN. INTEGRILIN is a trademark of COR
Therapeutics, Inc.
CONTACT: COR Therapeutics, Inc. or Schering-Plough
Corporation
Laura A. Brege Geraldine Foster (Investors)
Billie Gavin (973) 822-7410
(650) 244-6893 Lisa DeBerardine (Investors)
(973) 822-7437
Janet Barth (Investors)
(973) 822-7417
William O'Donnell (Media)
(973) 822-7476
or
Burns McClellan, Inc.
Lisa Burns (Investors)
Jonathan M. Nugent
Liz Landy (Media)
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