Healthcare Industry News: bivalirudin
News Release - March 29, 2008
Angiomax Demonstrated Improved Outcomes in Acute Heart Attack Patients Undergoing Primary Angioplasty Independent of Individual Risk FactorsNew Findings from HORIZONS-AMI Trial Consistent with Overall Results
CHICAGO--(HSMN NewsFeed)--The Medicines Company (Nasdaq: MDCO ) today announced that Angiomax® (bivalirudin) resulted in improved net adverse clinical outcomes and reduced the risk of major bleeding despite the sex, age, diabetes status or renal function of heart attack patients in the HORIZONS-AMI trial compared to a more complex treatment regimen 30 days following primary angioplasty. These data from the landmark global trial were presented today at the SCAI Annual Scientific Session in Partnership with ACCi2. Angiomax is available in Europe as Angiox®.
These new findings are consistent with overall results from the HORIZONS-AMI trial that demonstrate treatment with Angiomax resulted in superior net clinical outcomes and fewer cardiac deaths when compared to unfractionated heparin (UFH) plus a platelet glycoprotein IIb/IIIa inhibitor (GPI) in patients presenting with ST-segment elevation myocardial infarction (STEMI), the most severe form of heart attack. Reduced bleeding has been associated with greater long-term survival in other studies in angioplasty patients1,2.
“These data show that even with individual risk factors that might increase the chance of poor outcomes following percutaneous coronary intervention (PCI), bivalirudin resulted in better net clinical outcomes than a more complex regimen of heparin plus IIb/IIIa inhibitors,” said Gregg W. Stone, MD, professor of medicine, Columbia University Medical Center and chairman of the Cardiovascular Research Foundation, which conducted the trial. “In the entire trial, the reduction in major bleeding with bivalirudin compared to heparin plus IIb/IIIa inhibitors was associated with improved survival at 30 days. We expect HORIZONS-AMI to have an immediate impact on how patients are treated around the world.”
About HORIZONS-AMI Results
In the overall trial of 3,602 patients, Angiomax significantly improved net clinical adverse events by 24 percent, significantly reduced rates of major bleeding by 40 percent, demonstrated comparable rates of major adverse cardiac events, and significantly reduced the incidence of cardiac-related mortality by 38 percent when compared to the more complex regimen of UFH plus GPI 30 days following primary angioplasty. Among Angiomax patients, 7.2 percent received provisional use of a GPI.
Contemporary research confirms that the production and activity of thrombin is critical in coronary thrombosis as it is the most potent physiologic stimulator of platelets known as well as a mediator of coagulation and localized inflammation.3,4
As a direct thrombin inhibitor, Angiomax specifically targets thrombin: effectively deactivating circulating and clot-bound thrombin and thrombin-mediated platelet activation, essentially shutting down a master switch of thrombosis.4,5 Heparin, an indirect thrombin inhibitor, is not effective against clot-bound thrombin, directly activates platelets and is deactivated by substances released at the clot, which may decrease its effectiveness in patients with acute coronary syndrome undergoing PCI.4
“These new data from HORIZONS-AMI add to the wealth of clinical experience that shows Angiomax consistently improves outcomes across the entire spectrum of risk in patients undergoing PCI,” said John Kelley, President and Chief Operating Officer of The Medicines Company. “Given these results, we anticipate greater uptake of Angiomax by physicians worldwide."
About HORIZONS AMI
HORIZONS AMI, co-funded by a grant from The Medicines Company, is the largest study to focus on the appropriate use of anticoagulation medications in patients experiencing STEMI and undergoing primary percutaneous coronary intervention (PCI). The trial is a prospective, single-blind, randomized, multi-center study conducted in 11 countries. Patients undergoing angioplasty were randomly assigned to receive either Angiomax with provisional use of GPI or heparin plus GPI.
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) or major bleeding at 30 days. The secondary endpoint was major adverse cardiovascular events at 30 days.
About Angiomax®/Angiox® (bivalirudin)
Angiomax®/Angiox® (bivalirudin) 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.
For US Media
In the United States, Angiomax with provisional GP IIb/IIIa inhibition 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.
For EU Media
In Europe, Angiox is indicated as an anticoagulant for patients undergoing PCI and for the treatment of adult patients with acute coronary syndromes (unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) planned for urgent or early intervention when used with aspirin and clopidogrel. Please see full prescribing information available at http://www.angiox.com.
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® / Angiox® (bivalirudin) in the United States and other countries 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 TPPT Manoukian, S., et al, Major bleeding is an Independent Predictor of Short-Term Mortality in Moderate and High-Risk Acute Coronary Syndromes: An Analysis from the ACUITY Trial, Innovation in Intervention i2 Summit 2007.
2 TPPT 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.
3 TPPT Lane D, Philippou H and Huntington J. Directing thrombin. Blood. 2005;106:2605-2612.
4 TPPT Weitz, JI and Buller HR. Direct thrombin inhibitors in acute coronary syndromes. Circulation. 2002;105:1004-1011.
5 TPPT Weitz, J, Leslie B and Hudoba M. Thrombin binds to soluble fibrin degradation products where it is protected from inhibition by heparin-antithrombin but susceptible to inactivation by antithrombin-independent inhibitors. Circulation. 1998;97:544-552.
Source: The Medicines Company
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