New Publication Shows Angiomax Significantly Reduces Initial Hospital Costs by $572 Per Patient Compared to Conventional Therapy in Moderateand High-Risk ACS Patients
Prospective Economic Evaluation of Alternative Antithrombotic Strategies Published in the Journal of the American College of Cardiology
Intended for U.S. Audiences Only
PARSIPPANY, N.J, Nov. 18, 2008--(BUSINESS WIRE)--The Medicines Company (NASDAQ: MDCO) announced that a prospective analysis of the ACUITY (Acute Catheterization and Urgent Intervention Triage StrategY) trial showed that total hospital stay costs were lowest with Angiomax monotherapy (mean difference range: $184 to $1,081, p <0.001 for overall comparison) and at 30 days (mean difference range: $123 to $938, p < 0.005). Angiomax monotherapy was associated with an initial hospital cost savings of $572 per patient and a total 30 day cost savings of $422 per patient when compared to heparin and GPI administered prior to catheterization, in patients with moderate and high- risk (UA/NSTEMI) acute coronary syndrome (ACS). 1
“Reducing healthcare costs is critical today, given the current economic situation,” said John Kelley, President, Chief Operating Officer, The Medicines Company. “Hospitals should be evaluating both the clinical and economic benefits of various therapeutic options. There are approximately one million PCI procedures performed every year in the U.S. These procedures significantly contribute to improved clinical outcomes and quality of life, and their overall cost continues to be an area of focus for potential savings.”
This study demonstrated that major and minor bleeding complications contribute significantly to hospital costs, the cost per event being $8,658 and $2,282 for major and minor bleeds, respectively. Angiomax monotherapy was associated with a decrease in frequency of both major and minor bleeding complications with a range of 33% to 50%, and resulted in cost savings that were due to shorter lengths of stay in the hospital as well as the need for fewer ancillary and physician services.
”The cost savings seen in this new analysis provide further support for the use of Angiomax monotherapy as the preferred antithrombotic strategy for patients with ACS undergoing PCI,” said Duane Pinto, MD, first author of the study and an interventional cardiologist at Beth Israel Deaconess Medical Center, Boston, Mass. “The data show Angiomax reduces major and minor bleeding, which leads to improved patient outcomes, as well as shorter length of stay, an increasingly important consideration in clinical cardiovascular care.”
The ACUITY trial, published in the New England Journal of Medicine 2 studied 13,819 patients with moderate and high- risk non-ST elevation acute coronary syndrome (NSTE-ACS) who were randomized to heparin + GPI, Angiomax + GPI, or Angiomax monotherapy. Patients assigned to GPI were also randomized to upstream GPI before catheterization or selective GPI only with PCI. Results from the ACUITY trial showed that patients treated with Angiomax monotherapy experienced significantly less bleeding at 30 days (3.0% vs. 5.7%; P<0.001) and had comparable composite ischemia and mortality at one year compared to patients treated with standard therapies. The ACUITY economic sub-study involved 7,851 U.S. patients and evaluated the economic impact of these antithrombotic strategies in the above patient population.
“These findings are consistent with the cost-savings showed in the REPLACE-2 3 study, which demonstrated a cost savings of $374 per patient at 30 days,” continued Mr. Kelley. “These economic analyses along with the clinical outcomes from the HORIZONS-AMI one year analysis, which show a 43% reduction in cardiac mortality and a 31% reduction in overall mortality in high- risk ACS STEMI patients undergoing primary PCI, demonstrate both the clinical and economic benefit with Angiomax. The Medicines Company is committed to delivering innovative medicines that provide both clinical benefit and value.”
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.
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 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 November 10 2008, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
1 Pinto DS, Stone GW, Shi C, Dunn ES, Reynolds MR, York M, Walczak, Berezin RH, Mehran R, McLaurin BT, Cox DA, Ohman EM, Lincoff AM, Cohen DJ. Economic evaluation of bivalirudin with or without glycoprotein IIB/IIIA inhibition versus heparin with routine glycoprotein IIB/IIIA inhibition for early invasive management of acute coronary syndromes. J Am Coll Cardiol 2008; 52:1758-1768.
2 Stone GW, McLaurin BT, Cox DA, Bertrand ME, Lincoff AM, et al. Bivalirudin for patients with acute coronary syndromes. N Engl J Med 2006; 355:2203-2216.
3 Cohen DJ, Lincoff AM, Lavelle TA, et al. Economic evaluation of bivalirudin with provisional glycoprotein IIB/IIIA inhibition versus heparin with routine glycoprotein IIB/IIIA inhibition for percutaneous coronary intervention: Results from the REPLACE-2 trial. J Am Coll Cardiol 2004; 44: 1792-1800.
Posted: November 2008