Angiomax Reduced Cardiac Mortality by 41%; Reduced Overall Mortality by 25% in Severe Heart Attack Patients Following Angioplasty
HORIZONS-AMI Trial Two-Year Results Presented at TCT
PARSIPPANY, NJ, Sep 25, 2009 (MARKETWIRE via COMTEX) -- The Medicines Company (NASDAQ: MDCO) today announced the presentation of 2-year clinical results from the landmark HORIZONS-AMI Trial. The trial showed that patients who had suffered the most severe form of heart attack were significantly less likely to suffer cardiac death and had better overall survival if treated with Angiomax(R) (bivalirudin) while undergoing angioplasty compared with those treated with heparin plus a platelet glycoprotein IIb/IIIa inhibitor (GPI) during angioplasty. Two-year data of ST-elevation myocardial infarction (STEMI) patients was presented in a late-breaker presentation on September 25, 2009 at the 21st Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference scientific symposium sponsored by the Cardiovascular Research Foundation.
"These data again demonstrate that bivalirudin is a superior treatment option than conventional therapy for STEMI patients undergoing primary percutaneous coronary intervention (PCI). This strategy could save thousands of lives each year if incorporated globally into routine practice," said the study's principal investigator Gregg W. Stone, MD, CRF Chairman, Professor of Medicine and the Director of Research and Education at the Center for Interventional Vascular Therapy at New York-Presbyterian Hospital/Columbia University Medical Center.
HORIZONS-AMI is the first trial of pharmacologic therapy to demonstrate a mortality benefit in STEMI patients undergoing PCI. The trial compared Angiomax vs. unfractionated heparin (UFH) plus glycoprotein IIb/IIIa Inhibitors (GPI) in 3,602 patients presenting with STEMI undergoing a primary PCI strategy. Results at two years showed Angiomax:
-- Significantly reduced the incidence of cardiac-related death by 41 percent (2.5% vs. 4.2%, HR 0.59 [95% CI 0.41-0.88]; p=0.005), -- Significantly reduced all-cause death by 25 percent (4.6% vs. 6.1%, HR 0.75 [95% CI 0.56-1.00]; p=0.049), -- Significantly reduced the incidence of reinfarction by 25 percent (5.1% vs. 6.9%, HR 0.75 [95% CI 0.56-0.98]; p=0.038), -- Significantly reduced rates of major bleeding by 36 percent (6.4% vs. 9.6%, HR 0.64 [95% CI 0.51-0.81]); p < 0.001), -- Demonstrated no difference in rates of major adverse cardiac events (18.8% vs. 18.7%, HR 1.00 [95% CI 0.86-1.17]; p=0.99), -- Demonstrated comparable rates of stent thrombosis (4.3% vs. 4.6%, HR 0.94 [95% CI 0.67-1.32]; p=0.73).
"Once again we see data demonstrating that Angiomax consistently delivers life saving benefits to patients undergoing PCI," said John Kelley, President and Chief Operating Officer of The Medicines Company. "These two-year results are impressive and underscore our commitment to provide drugs that reliably and cost-effectively deliver meaningful clinical advantages for patients in need."
About the HORIZONS-AMI Trial
HORIZONS-AMI, co-funded by a grant from The Medicines Company, is the largest study to focus on the appropriate use of anticoagulation medications and stents in patients experiencing STEMI and undergoing primary percutaneous coronary intervention (PCI), commonly known as angioplasty. This landmark trial was a prospective, single-blind, randomized, multi-center study conducted in 11 countries. Patients undergoing angioplasty were randomly assigned to receive either Angiomax (bivalirudin) with provisional use of GPI or heparin plus GPI. Patients enrolled in the HORIZONS-AMI trial also were assigned randomly to receive either TAXUS 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, 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. 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.
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 5 million people present to the emergency department with chest pain, of which an estimated 1.4 million are identified with ACS.
Angiomax is a direct thrombin inhibitor with a naturally reversible mechanism of action and a 25 minute half-life. In clinical trials, treatment with Angiomax resulted in improved clinical outcomes with significantly reduced rates of major bleeding compared to treatment with heparin plus GPI across the entire spectrum of risk in patients undergoing PCI and numerically lower rates of one-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. Angiomax is not approved for use in ACS patients not undergoing PCI. Please see full prescribing information available at http://www.angiomax.com.
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(R) (bivalirudin) in the United States and other countries for use in patients undergoing coronary angioplasty, and Cleviprex(R) (clevidipine butyrate) injectable emulsion in the United States for the reduction of blood pressure when oral therapy is not feasible or not desirable. The Medicines 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 Quarterly Report on Form 10-Q filed on August 10, 2009, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Contact: Barri Winiarski WeissComm Partners Phone: (212) 301-7209 firstname.lastname@example.org Robyn Brown The Medicines Company Phone: (973) 290-6000 email@example.com
SOURCE: The Medicines Company
Posted: September 2009