Healthcare Industry News: ACUITY study
News Release - August 26, 2008
ACUITY 1-Year Sub-Analysis Published in Journal of the American College of Cardiology
New publication shows treatment with Angiomax provides similar protection from ischemic events and death at 1-year, while reducing bleeding at 30 days, compared to standard therapy in moderate- and high- risk ACS patients undergoing PCIPARSIPPANY, N.J.--(HSMN NewsFeed)--The Medicines Company (NASDAQ: MDCO ) announced that a sub-analysis of the ACUITY (Acute Catheterization and Urgent 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 moderate- and high-risk (unstable angina (UA)/non - ST elevation myocardial infarction) acute coronary syndrome (ACS) patients , who 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 measured at one-year post-PCI.
Additionally, as previously reported in The Lancet1 patients in the PCI subset of ACUITY who were treated with Angiomax experienced a 41% reduction in bleeding at 30 days compared to standard treatment.
“These findings are important as the data suggest treatment with Angiomax provides similar protection against ischemia and death over standard therapy at 1-year. Furthermore, at 30 days we saw Angiomax reduced major bleeding. Multiple studies have shown a significant association between bleeding complications in ACS and PCI with mortality,” said Harvey White, MD, Green Lane Hospital, Auckland, New Zealand, Department of Cardiology, one of primary 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 within 30 days and on 1-year outcomes in 7,789 moderate- and high-risk 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 infarction or unplanned 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 plus a GP llb/llla inhibitor
- A 30-day analysis showed major bleeding occurred in 7% of the UFH/enoxaparin plus GP IIb/IIIa inhibitor group compared to 4% in the Angiomax alone group (p < 0.0001).
- Patients who experienced major bleeding significantly longer hospital stays than those who did not experience a major bleed (5.0 days vs. 3.0 days, respectively (p <0.0001).
“These data at 1-year show that Angiomax continues to demonstrate safety and efficacy for a full year following a patient’s angioplasty. This is just the latest analysis from seven major randomized trials in nearly 25,000 patients consistently 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 help reduce hospital costs, particularly because of the reductions we have observed in major bleeding complications. With approximately one million PCI procedures performed in the U.S. per year, incremental cost savings may result in substantial overall savings to the health care system.”
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 http://www.angiomax.com.
MDCO-G
About The Medicines Company
The Medicines Company (NASDAQ: MDCO ) is focused on advancing the treatment of critical care patients through the delivery of innovative, cost-effective medicines to the worldwide hospital marketplace. 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 reduction of blood pressure when oral therapy is not feasible or not desirable. The Company also has an investigational antiplatelet agent, cangrelor, in late-stage development and a serine protease inhibitor, CU-2010, in early-stage development. 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 whether physicians, patients and other key decision-makers will accept clinical trial results,, whether the Company will be able to obtain regulatory approvals 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 11, 2008, which are incorporated herein by reference. The Company specifically disclaims any 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 and Urgent Intervention Triage strategy (ACUITY) trial. The Lancet. 2007;369:907 – 919.
Source: The Medicines Company
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