In a landmark global trial of heart attack patients undergoing
angioplasty, the anti-clotting agent Angiomax(R) (bivalirudin)
resulted in superior clinical outcomes and fewer cardiac deaths
compared to a more complex treatment regimen. These findings from the
HORIZONS AMI(1) trial were presented at a late-breaking session of the
19th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific
symposium sponsored by the Cardiovascular Research Foundation.
Angiomax is available in Europe as Angiox(R).
The HORIZONS AMI trial compared Angiomax to heparin plus a
platelet glycoprotein IIb/IIIa inhibitor (GPI) in more than 3,600
patients presenting with a heart attack. Among Angiomax patients, 7.2%
received provisional use of a GPI. Results at 30 days were as follows:
-- Angiomax significantly reduced the incidence of net adverse
clinical events, a composite of major adverse cardiac events
or major bleeding, by 24% (9.2% vs. 12.1%, p = 0.006).
-- Angiomax significantly reduced the incidence of major bleeding
by 40% (4.9% vs. 8.3%, p less than 0.0001).
-- Angiomax demonstrated comparable rates of major adverse
cardiac events (5.4% vs. 5.5%, p = 1.0).
-- Angiomax significantly reduced the incidence of
cardiac-related mortality by 38% (1.8% vs. 2.9%, p= 0.035).
"These data show that the benefits of bivalirudin therapy extend
to patients with heart attacks. We now have compelling evidence
supporting the use of bivalirudin instead of heparin and GPI in
virtually all patients undergoing angioplasty," said Gregg W. Stone,
MD, professor of medicine, Columbia University Medical Center and
chairman of the Cardiovascular Research Foundation, which conducted
the trial. "This landmark trial will help shape best practices and
guidelines for drug therapy during angioplasty in patients with heart
attacks."
Angiomax has previously been shown to result in less bleeding and
similar rates of composite ischemia compared to heparin plus GPI in
patients undergoing angioplasty for stable angina,(2) unstable angina
and non-ST-elevation myocardial infarction (NSTEMI).(3) HORIZONS AMI
demonstrates that these advantages also apply to angioplasty patients
with the most severe form of heart attack, ST-elevation myocardial
infarction, or STEMI. Reduced bleeding in angioplasty patients has
been shown in other studies to be associated with greater long-term
survival.(4,5)
"This study is an important step forward in our efforts to improve
outcomes for heart attack patients," said Harvey D. White, MD,
Director of Coronary Care and Cardiovascular Research at Green Lane
Cardiovascular Service, Auckland City Hospital, Auckland, New Zealand.
He noted the death rate associated with heart attacks 20 years ago was
as high as 13 percent.(6) This rate has fallen with the introduction
of thrombolytics and stents. "Based on data presented today, using
Angiomax instead of combination therapy may further reduce the
incidence of cardiac-related death," Dr. White added.
"The HORIZONS AMI results clearly demonstrate better clinical
outcomes with Angiomax in heart attack patients. Findings from
multiple global studies are remarkably consistent and show Angiomax
improves outcomes across the entire spectrum of patients treated in
the cardiac cath lab," said John Kelley, President and Chief Operating
Officer of The Medicines Company. "Given these results, we anticipate
greater uptake of Angiomax by physicians worldwide."
About HORIZONS AMI
HORIZONS AMI, co-funded by a grant from The Medicines Company, is
the largest study to focus on the appropriate use of anticoagulation
medications in patients experiencing STEMI and undergoing primary
percutaneous coronary intervention (PCI). The trial is a prospective,
single-blind, randomized, multi-center study in more than 3,600
patients presenting with a heart attack to hospitals in 11 countries.
Patients undergoing angioplasty were randomly assigned to receive
either Angiomax with provisional use of GPI or heparin plus GPI.
Patients enrolled in the HORIZONS AMI trial also were assigned
randomly to receive either TAXUS(R) drug-eluting stents or a
bare-metal stent.
The two primary endpoints of the trial were major bleeding and net
adverse clinical events, a composite of major adverse cardiovascular
events (death, reinfarction, stroke or ischemic target vessel
revascularization) and major bleeding at 30 days. The major secondary
endpoint was major adverse cardiovascular events at 30 days.
About ST-Segment Elevation Myocardial Infarction (STEMI)
STEMI is the most severe type of heart attack and carries a
substantial risk of death and disability. STEMI involves myocardial
injury, as indicated by significant abnormalities on electrocardiogram
called ST-segment elevations. Guidelines recommend that STEMI patients
be treated with rapid intervention to help prevent further heart
damage.(7,8) According to the American Heart Association, an estimated
865,000 new and recurrent heart attacks occur every year, of which
400,000 are categorized as STEMI.(9)
STEMI is part of a spectrum of acute coronary syndromes (ACS)
caused by acute exacerbation of underlying coronary artery disease.
ACS also includes non-ST elevation myocardial infarction (NSTEMI) and
unstable angina (UA). NSTEMI is typically caused by partial
obstruction of a coronary artery that results in some damage to heart
muscle. UA is chest pain at rest or upon exertion, due to ischemia.
Stable angina is characterized by predictable chest pain during
exertion that resolves at rest, and is not considered a form of ACS.
Each year in the United States, about five million people present to
the emergency department with chest pain, of which an estimated 1.4
million are identified with ACS.(10)
About Angiomax(R) / Angiox(R) (bivalirudin)
Angiomax(R) / Angiox(R) (bivalirudin) is a direct thrombin
inhibitor with a naturally reversible mechanism of action. In clinical
trials, Angiomax has demonstrated comparable efficacy plus reductions
in bleeding complications compared to heparin as the foundation
anticoagulant in the contemporary catheterization lab setting. These
reductions in bleeding complications persist even in high-risk
patients. Regulatory authorities in the United States and Europe are
currently reviewing an application to expand the use of Angiomax /
Angiox to include the emergency use of the drug in ACS patients.
For US Media
In the United States, Angiomax with provisional GP IIb/IIIa
inhibition is indicated in patients undergoing angioplasty, also
called PCI, and in patients with, or at risk of, heparin-induced
thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI.
In addition, Angiomax is indicated for use as an anticoagulant in
patients with UA undergoing percutaneous transluminal coronary
angioplasty (PTCA). Angiomax is intended for use with aspirin. The
most common adverse events for Angiomax in clinical trials comparing
Angiomax and heparin were back pain, pain, nausea, headache, and
hypotension. The incidence of these adverse events was comparable in
both the Angiomax and heparin groups in these trials. An unexplained
fall in blood pressure or hematocrit, or any unexplained symptom,
should lead to serious consideration of a hemorrhagic event and
cessation of Angiomax administration. Angiomax is contraindicated in
patients with active major bleeding or hypersensitivity to Angiomax or
its components. Please see full prescribing information available at
http://www.angiomax.com.
For EU Media
In Europe, Angiox is indicated as an anticoagulant for patients
undergoing PCI. Please see full prescribing information available at
http://www.angiox.com.
MDCO-G
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) is committed to delivering
innovative, cost-effective acute care products in the worldwide
hospital marketplace. The Company markets Angiomax(R) / Angiox(R)
(bivalirudin) in the United States and other countries for use in
patients undergoing coronary angioplasty, a procedure to clear
restricted blood flow in arteries around the heart. The Company also
has two products in late-stage development, Cleviprex(TM) (clevidipine
butyrate injectable emulsion) and cangrelor. The Company's website is
http://www.themedicinescompany.com.
Statements contained in this press release about The Medicines
Company that are not purely historical, and all other statements that
are not purely historical, may be deemed to be forward-looking
statements for purposes of the safe harbor provisions under The
Private Securities Litigation Reform Act of 1995. Without limiting the
foregoing, the words "believes," "anticipates" and "expects" and
similar expressions are intended to identify forward-looking
statements. These forward-looking statements involve known and unknown
risks and uncertainties that may cause the Company's actual results,
levels of activity, performance or achievements to be materially
different from those expressed or implied by these forward-looking
statements. Important factors that may cause or contribute to such
differences include whether the Company's products will advance in the
clinical trials process on a timely basis or at all, whether clinical
trial results will warrant submission of applications for regulatory
approval, whether the Company will be able to obtain regulatory
approvals, whether physicians, patients and other key decision makers
will accept clinical trial results, and such other factors as are set
forth in the risk factors detailed from time to time in the Company's
periodic reports and registration statements filed with the Securities
and Exchange Commission including, without limitation, the risk
factors detailed in the Company's Quarterly Report on Form 10-Q filed
on August 9, 2007, which are incorporated herein by reference. The
Company specifically disclaims any obligation to update these
forward-looking statements
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