Clinical Advantage Of Switching To Angiomax From Heparin In Acute Coronary Syndrome Patients Undergoing Early Invasive Treatment

Main Category: Cardiovascular / Cardiology
Also Included In: Clinical Trials / Drug Trials
Article Date: 07 May 2008 - 4:00 PDT

email to a friend   printer friendly   view / write opinions   rate article

The Medicines Company (NASDAQ: MDCO) announced that the Journal of the American College of Cardiology published a new subgroup analysis from the ACUITY (Acute Catheterization and Urgent Intervention Triage strategY) trial demonstrating that switching to Angiomax® (bivalirudin) after pre-treatment with heparin (UFH or enoxaparin) results in comparable ischemic outcomes and approximately 50 percent reduction in major bleeding compared to consistent heparin therapy plus routine glycoprotein IIb/IIIa inhibitor (GPI) for acute coronary syndrome (ACS) patients undergoing early invasive treatment.[1]

"Our new findings from ACUITY challenge previous thinking and provide clinical evidence that switching to Angiomax is as effective and results in reduced bleeding rates compared to the consistent use of heparin," said Roxana Mehran, MD, associate professor of medicine, Columbia University Medical Center. "These data from the ACUITY trial are consistent with overall findings that show Angiomax alone is the preferred antithrombotic strategy in moderate and high risk ACS patients undergoing early invasive treatment."

The ACUITY trial (n=13,819) demonstrated that starting Angiomax prior to angiography results in effective ischemic suppression and 47 percent reduction in major bleeding compared to heparin in combination with a GPI.2 Reduced bleeding has been shown in other trials to be a strong predictor of long-term survival in patients undergoing angioplasty.[2],[3]

"These data clearly illustrate the value of switching from heparin to Angiomax treatment before the patient enters the cath lab," said John Kelley, president and chief operating officer of The Medicines Company. "We anticipate the publication of these ACUITY results in one of the world's preeminent medical journals will further support the use of Angiomax among physicians worldwide."

About the ACUITY Trial

The ACUITY trial is one of the largest ACS clinical trials ever conducted to evaluate anti-clotting therapies administered in the hospital. Enrolling 13,819 patients with unstable angina (UA) or non-segment elevation myocardial infarction (NSTEMI) in 450 centers worldwide, investigators employed an early invasive strategy, starting anticoagulant therapy at arrival to the emergency department and randomly assigning them to treatment with standard therapy of heparin (unfractionated or enoxaparin) plus a drug called a glycoprotein IIb/IIIa inhibitor (GPI), Angiomax plus GPI, or the "Angiomax alone" treatment group. In the Angiomax alone group, selective use of GPIIb/IIIa inhibitor was permitted in limited circumstances, and occurred in less than 10% of patients in the ACUITY trial. Then, based on an evaluation in the cardiac catheterization laboratory, patients were treated for ACS through medical management, bypass surgery, or angioplasty, also known as percutaneous coronary intervention or PCI.[4],[5]

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 Hhttp://www.angiomax.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® (bivalirudin) in the United States 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 http://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.

The Medicines Company References

[1] White, H., et al, Safety and Efficacy of Switching From Either Unfractionated Heparin or Enoxaparin to Bivalirudin in Patients With Non-ST-Segment Elevation Acute Coronary Syndromes Managed With an Invasive Strategy: Results From the ACUITY Trial, The Journal of the American College of Cardiology. May 2008.

[2] Manoukian SV, Feit F, Mehran R, et al. Impact of major bleeding on 30-day mortality and clinical outcomes in patients with acute coronary syndromes: an analysis from the ACUITY trial. Journal of American College of Cardiology. 2007;49(12):1362-1368.

[3] 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.

[4] Stone GW, Ware JH, Bertrand ME, Lincoff AM, Moses JW, Ohman EM, White HD, Feit F, Colombo A, McLaurin BT, Cox DA, Manoukian SV, Fahy M, Clayton TC, Mehran R, Pocock SJ; ACUITY Investigators. Antithrombotic strategies in patients with acute coronary syndromes undergoing early invasive management: One-year results from the ACUITY trial. JAMA 2007 Dec 5; 298(21):2497-2506.

[5] Stone GW, McLaurin BT, Cox DA, Bertrand ME, Lincoff AM, Moses JW, White HD, Pocock SJ, Ware JH, Feit F, Colombo A, Aylward PE, Cequier AR, Darius H, Desmet W, Ebrahimi R, Hamon M, Rasmussen LH, Rupprecht HJ, Hoekstra J, Mehran R, Ohman EM; ACUITY Investigators. Bivalirudin for patients with acute coronary syndromes. N Engl J Med. 2006 Nov 23;355(21):2203-16.

The Medicines Company