The Medicines Company (NASDAQ: MDCO) today announced that the Journal
of the American College of Cardiology published a new subgroup
analysis from the ACUITY (Acute Catheterization and Urgent
Intervention Triage strategY) trial
demonstrating that switching to Angiomax®
(bivalirudin) after pre-treatment with heparin (UFH or enoxaparin)
results in comparable ischemic outcomes and approximately 50 percent
reduction in major bleeding compared to consistent heparin therapy plus
routine glycoprotein IIb/IIIa inhibitor (GPI) for acute coronary
syndrome (ACS) patients undergoing early invasive treatment.1
“Our new findings from ACUITY challenge
previous thinking and provide clinical evidence that switching to
Angiomax is as effective and results in reduced bleeding rates compared
to the consistent use of heparin,” said Roxana
Mehran, MD, associate professor of medicine, Columbia University Medical
Center. “These data from the ACUITY trial are
consistent with overall findings that show Angiomax alone is the
preferred antithrombotic strategy in moderate and high risk ACS patients
undergoing early invasive treatment.”
The ACUITY trial (n=13,819) demonstrated that starting Angiomax prior to
angiography results in effective ischemic suppression and 47 percent
reduction in major bleeding compared to heparin in combination with a
GPI.2 Reduced bleeding has been shown in other
trials to be a strong predictor of long-term survival in patients
undergoing angioplasty.2,3
“These data clearly illustrate the value of
switching from heparin to Angiomax treatment before the patient enters
the cath lab,” said John Kelley, president and
chief operating officer of The Medicines Company. “We
anticipate the publication of these ACUITY results in one of the world’s
preeminent medical journals will further support the use of Angiomax
among physicians worldwide.”
About the ACUITY Trial
The ACUITY trial is one of the largest ACS clinical trials ever
conducted to evaluate anti-clotting therapies administered in the
hospital. Enrolling 13,819 patients with unstable angina (UA) or non–segment
elevation myocardial infarction (NSTEMI) in 450 centers worldwide,
investigators employed an early invasive strategy, starting
anticoagulant therapy at arrival to the emergency department and
randomly assigning them to treatment with standard therapy of heparin
(unfractionated or enoxaparin) plus a drug called a glycoprotein
IIb/IIIa inhibitor (GPI), Angiomax plus GPI, or the “Angiomax
alone” treatment group. In the Angiomax alone
group, selective use of GPIIb/IIIa inhibitor was permitted in limited
circumstances, and occurred in less than 10% of patients in the ACUITY
trial. Then, based on an evaluation in the cardiac catheterization
laboratory, patients were treated for ACS through medical management,
bypass surgery, or angioplasty, also known as percutaneous coronary
intervention or PCI.4,5
About Angiomax
Angiomax is a direct thrombin inhibitor with a naturally reversible
mechanism of action and 25 minute half-life. In clinical trials,
treatment with Angiomax resulted in improved clinical outcomes with
significantly reduced rates of major bleeding compared to heparin plus
GPI across the entire spectrum of risk in patients undergoing PCI and
numerically lower rates of 1-year mortality in patients undergoing PCI.
In the United States, Angiomax with provisional GPI 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 Hhttp://www.angiomax.comH.
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®
(bivalirudin) in the United States 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, CleviprexTM
(clevidipine butyrate) injectable emulsion and cangrelor. The Company's
website is 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 Annual Report on Form 10-K
filed on February 29, 2008, which are incorporated herein by reference.
The Company specifically disclaims any obligation to update these
forward-looking statements.
1 White, H., et al, Safety and Efficacy of
Switching From Either Unfractionated Heparin or Enoxaparin to
Bivalirudin in Patients With Non-ST-Segment Elevation Acute Coronary
Syndromes Managed With an Invasive Strategy: Results From the ACUITY
Trial, The American Journal of Cardiology. May 2008.
2 Manoukian SV, Feit F, Mehran R, et al. Impact
of major bleeding on 30-day mortality and clinical outcomes in patients
with acute coronary syndromes: an analysis from the ACUITY trial.
Journal of American College of Cardiology. 2007;49(12):1362-1368.
3 Feit, et al, Predictors and Major Impact of
Major Hemorrhage on Mortality Following Percutaneous Coronary
Intervention From the REPLACE-2 Trial, The American Journal of
Cardiology.
4 Stone GW, Ware JH, Bertrand ME, Lincoff AM,
Moses JW, Ohman EM, White HD, Feit F, Colombo A, McLaurin BT, Cox DA,
Manoukian SV, Fahy M, Clayton TC, Mehran R, Pocock SJ; ACUITY
Investigators. Antithrombotic strategies in patients with acute coronary
syndromes undergoing early invasive management: One-year results from
the ACUITY trial. JAMA 2007 Dec 5; 298(21):2497-2506.
5 Stone GW, McLaurin BT, Cox DA, Bertrand ME,
Lincoff AM, Moses JW, White HD, Pocock SJ, Ware JH, Feit F, Colombo A,
Aylward PE, Cequier AR, Darius H, Desmet W, Ebrahimi R, Hamon M,
Rasmussen LH, Rupprecht HJ, Hoekstra J, Mehran R, Ohman EM; ACUITY
Investigators. Bivalirudin for patients with acute coronary syndromes. N
Engl J Med. 2006 Nov 23;355(21):2203-16.
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