�Intervention Triage strategY study, published in the September 2, 2008 issue of the Journal of American College of Cardiology, shows that Angiomax� (bivalirudin) monotherapy provides hold in and high-risk (unstable angina (UA)/non - ST elevation myocardial infarct) acute coronary thrombosis syndrome (ACS) patients , world Health Organization are undergoing percutaneous coronary intervention (PCI), with similar results from ischemic events and death versus standard therapy (unfractionated heparin [UFH] or enoxaparin plus a glycoprotein [GP] IIb/IIIa inhibitor) as metric at one-year post-PCI.
Additionally, as antecedently reported in The Lancet1 patients in the PCI subset of ACUITY wHO were toughened with Angiomax experienced a 41% simplification in hemorrhage at 30 days compared to criterion treatment.
"These findings ar important as the information suggest treatment with Angiomax provides similar protection against ischemia and death over standard therapy at 1-year. Furthermore, at 30 days we saw Angiomax decreased major bleeding. Multiple studies have shown a significant association between bleeding complications in ACS and PCI with mortality rate," said Harvey White, MD, Green Lane Hospital, Auckland, New Zealand, Department of Cardiology, one of master investigators and author of the study. "The data from the ACUITY sub-analysis suggest treatment with Angiomax is an attractive antithrombotic therapeutic option for patients undergoing PCI."
The analysis of the ACUITY-PCI subset assessed the impact of treatment with Angiomax inside 30 years and on 1-year outcomes in 7,789 tone down and speculative ACS patients undergoing PCI compared to standard therapy. In the study, patients were randomized to UFH or enoxaparin plus a GP IIb/IIIa inhibitor, Angiomax plus a GP IIb/IIIa inhibitor, or Angiomax alone. Endpoints included assessment of composite ischemia, defined as death, myocardial infarction, or unplanned revascularization, mortality at 1-year and highlighted the impact of bleeding.
Specifically, the results of the ACUITY trial in patients undergoing PCI showed that:
- Patients treated with Angiomax experienced comparable composite ischemia (death, myocardial infarct or unwitting revascularization) and mortality at 1-year compared to patients treated with standard therapy.
-- Composite ischemia results were 19.2% bivalirudin alone,
19.4% bivalirudin plus a GP llb/llla inhibitor vs. 17.8%
UFH/ enoxaparin plus a GP llb/llla inhibitor
-- Mortality results were 3.1% bivalirudin alone, 3.3%
bivalirudin plus a GP llb/llla inhibitor vs. 3.2%
UFH/enoxaparin asset a GP llb/llla inhibitor
- A 30-day analysis showed major bleeding occurred in 7% of the UFH/enoxaparin addition GP IIb/IIIa inhibitor grouping compared to 4% in the Angiomax alone group (p
- Patients who experient major bleeding significantly yearner hospital stays than those who did not experience a major bleed (5.0 days vs. 3.0 years, respectively (p
"These information at 1-year show that Angiomax continues to certify safety and efficacy for a full year following a patient's angioplasty. This is simply the latest analysis from seven major randomized trials in intimately 25,000 patients systematically demonstrating Angiomax offers improved outcomes for angioplasty patients compared to standard therapy," said John Kelley, President, Chief Operating Officer, The Medicines Company. "Additionally, Angiomax may assist reduce hospital costs, in particular because of the reductions we bear observed in major haemorrhage complications. With approximately i million PCI procedures performed in the U.S. per year, incremental cost nest egg may outcome in significant overall nest egg to the health care system."
About Angiomax
Angiomax is a direct thrombin inhibitor with a by nature reversible mechanism of action and 25 minute half life. In clinical trials, treatment with Angiomax resulted in improved clinical outcomes with significantly rock-bottom rates of major bleeding compared to heparin addition GPI across the total spectrum of risk in patients undergoing PCI and numerically turn down 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 danger of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is indicated for purpose as an anticoagulant in patients with UA undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for utilization with st. Joseph. The most common adverse events for Angiomax in clinical trials comparing Angiomax and liquaemin were indorse pain, pain, nausea, cephalalgia, and hypotension. The incidence of these adverse events was comparable in both the Angiomax and lipo-Hepin groups in these trials. An unexplained fall in blood pressure or hematocrit, or whatever unexplained symptom, should lead to grave consideration of a haemorrhagic event and cessation of Angiomax giving medication. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components. Please see full prescribing information available at hypertext transfer protocol://www.angiomax.com.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) is focused on advancing the handling of critical care patients through the delivery of innovative, cost-efficient medicines to the worldwide hospital market. The Company markets Angiomax� (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty and Cleviprex� (clevidipine butyrate) injectable emulsion in the United States for the diminution of rip pressure when oral therapy is non feasible or not desirable. The Company also has an investigational antiplatelet agent, cangrelor, in late-stage evolution and a serine peptidase inhibitor, CU-2010, in early-stage development. The Company's internet site is hTTP://www.themedicinescompany.com.
Statements contained in this weigh release most The Medicines Company that are not purely diachronic, and all other statements that are not purely historical, whitethorn be deemed to be forward-looking statements for purposes of the safe harbour provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes," "anticipates" and "expects" and alike expressions ar intended to identify advanced statements. These forward-looking statements involve known and unknown risks and uncertainties that may grounds 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 grounds or put up to such differences include whether whether physicians, patients and other key decision-makers will accept clinical visitation results,, whether the Company will be able to obtain regulative approvals and such other factors as are fructify forth in the risk factors elaborated from time to time in the Company's occasional reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the danger factors detailed in the Company's Quarterly Report on Form 10-Q filed on August 11, 2008, which are incorporated herein by reference. The Company specifically disclaims whatsoever obligation to update these forward-looking statements.
1 G . Stone , H . White , E . Ohman , et al. Bivalirudin in patients with acute coronary syndromes undergoing percutaneous coronary intervention: a subgroup analysis from the Acute Catheterization nd Urgent Intervention Triage strategy (ACUITY) trial. The Lancet. 2007;369:907 - 919.
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Saturday, 6 September 2008
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