Healthcare Industry News: bivalirudin
News Release - November 22, 2006
The New England Journal of Medicine Publishes Angiomax(R) (Bivalirudin) ACUITY Trial ResultsAcute Coronary Syndrome patients treated in Angiomax alone group benefit over standard drug combination comparison
PARSIPPANY, N.J., Nov. 22 (HSMN NewsFeed) -- The New England Journal of Medicine today published results of ACUITY, a landmark clinical trial exploring the potential of the injectable anti-clotting medicine Angiomax® (bivalirudin) in patients experiencing cardiac emergencies known as acute coronary syndromes (ACS). The Medicines Company (Nasdaq: MDCO ) announced the publication written by the ACUITY investigators, who reported that Angiomax, in the "Angiomax alone" treatment group, was effective and reduced the risk of major bleeding, a key risk factor for mortality, by 47% compared to the standard combination of injectable drugs used in ACS patients.
"In ACUITY, we tested several different combinations of drug therapies and found that the simplest regimen was the best," said ACUITY's Principal Investigator, Gregg W. Stone, MD, Professor of Medicine and Director of Cardiovascular Research and Education at Columbia University Medical Center's Center for Interventional Vascular Therapy and Chairman of the Cardiovascular Research Foundation. "Previous ACS trials have added drug on top of drug to achieve better efficacy, sacrificing safety along the way. The ACUITY trial showed that Angiomax alone is as effective as more complicated dual drug regimens, and results in significantly less bleeding, which means improved outcomes for patients."
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 in 17 countries, investigators employed an early invasive strategy, starting anticoagulant therapy at arrival to the emergency department and quickly moving patients to the cardiac catheterization laboratory for evaluation and, in most cases, a percutaneous coronary intervention (PCI), commonly known as angioplasty. Anticoagulant treatments were continued during these procedures.
Each year in the United States, 5 million people go to the emergency department with chest pain, of which about 1.4 million are identified with ACS. Acute coronary syndromes include a range of conditions, such as heart attack, which are caused by insufficient blood supply to the heart due to blockages in the coronary arteries that supply blood to the heart.
Currently, when patients go to the emergency department with ACS symptoms, there is a significant risk for heart attack or death. Most often, there are several different drugs given to ACS patients including the standard injectable combination of heparins (unfractionated or low-molecular weight) plus GP IIb/IIIa inhibitors, sometimes in combination with each other, to prevent heart attack and death. The use of these drugs, especially when given in combination, can lead to bleeding complications in patients undergoing PCI, which further increases the risk of death for patients.
The ACUITY trial results demonstrate that, compared to the heparin combination, Angiomax provided similar protection from heart attacks, death and re-blockage of the diseased coronary artery (revascularization), while significantly reducing bleeding in ACS patients.
"The ACUITY publication adds to a wealth of published data that demonstrate replacing heparin with Angiomax leads to better outcomes," said John Kelley, President and Chief Operating Officer of The Medicines Company. "We anticipate that publication of ACUITY results in one of world's preeminent medical journals will further support the use of Angiomax.
ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) Design
The ACUITY trial was designed to provide answers that will drive improvement in management of ACS patients. ACUITY includes three different treatment groups. The standard comparator group is unfractionated heparin (UFH) or the low-molecular weight heparin enoxaparin combined with GPIIb/IIIa inhibitors (GPI). This treatment group is compared to patients treated with Angiomax used with a GPI, as the combination treatment group, or Angiomax used without GPIIb/IIIa inhibitor, as 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).
Angiomax is currently approved in the U.S. and the European Union, as well as several other territories. Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action. In clinical trials, Angiomax has demonstrated efficacy plus reductions in bleeding complications compared to heparin as the foundation anticoagulant in the contemporary catheterization lab setting. These reductions in ischemic and bleeding complications remain evident even in high-risk patients.
In the U.S., Angiomax is indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA) and with provisional GP IIb/IIIa inhibition in patients undergoing PCI. Angiomax is also indicated in patients with, or at risk of, HIT/HITTS undergoing PCI. 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.
About The Medicines Company
The Medicines Company meets the demands of the world's most advanced medical practitioners by developing products that improve acute hospital care. The Company markets Angiomax® (bivalirudin), an anti-clotting therapy approved in the U.S. and other countries for use in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. The Medicines Company creates value using its range of clinical and commercial skills to develop products acquired from leading life science innovators. The Company's website is http://www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company and Angiomax 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 the extent of the commercial success of Angiomax, physicians' acceptance of Angiomax clinical trial results, whether the Company's products will advance in the clinical trials process, whether clinical trial results will warrant submission of applications for regulatory approval, whether the Company will be able to obtain regulatory approval for additional indications of Angiomax 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 November 8, 2006, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Source: The Medicines Company
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