Poor Perioperative Blood Pressure Control Linked To 30-Day Morbidity And Mortality In Cardiac Surgery Patients - New Analysis From The ECLIPSE Trial

Main Category: Cardiovascular / Cardiology
Also Included In: Hypertension
Article Date: 22 Oct 2008 - 1:00 PDT

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The Medicines Company (NASDAQ: MDCO) announced that poor blood pressure control during cardiac surgery is associated with a higher risk of 30-day death, stroke, myocardial infarction and renal dysfunction, compared to patients with tight blood pressure control, according to a post-hoc analysis of the ECLIPSE trial. The data were presented at the American Society of Anesthesiologists (ASA) 2008 Annual Meeting.

"In this analysis, what we found was clear: the worse the blood pressure control, the poorer the outcome in these cardiac surgery patients," said Solomon Aronson, M.D., Professor of Anesthesiology, Duke University School of Medicine. "These data support the need to more effectively manage blood pressure in the surgical and critical care settings."

The ECLIPSE trial enrolled 1,964 cardiac surgery patients in one of three randomized, open-label trials comparing Cleviprex™ (clevidipine butyrate) injectable emulsion to nitroglycerin, sodium nitroprusside or nicardipine. In this post-hoc analysis, 1507 ECLIPSE patients were stratified by precision of blood pressure control measured as excursions and time out of a pre-specified range. Adverse outcomes, assessed as death, myocardial infarction, stroke and renal dysfunction at 30 days post-discharge, were significantly higher in patients with poor blood pressure control (14.4%) than in patients with tight blood pressure control (8.8%).

"These critical new findings underscore the risk posed by uncontrolled blood pressure during cardiac surgery and emphasize the need for tight blood pressure control in these patients," said James Ferguson, M.D., Vice President, Global Medical, Surgical and Critical Care, The Medicines Company. "Cleviprex, recently approved by the FDA, provides physicians with an important, new clinical tool for achieving rapid and predictable blood pressure control."

Additional post-hoc data from the pivotal ECLIPSE program, involving patients undergoing cardiac valve surgery, will be presented at the American College of Chest Physicians (ACCP) annual meeting in Philadelphia on Tuesday, October 28, 2008.

ECLIPSE Program

ECLIPSE, the largest safety program to date comparing intravenous antihypertensive therapies, found that Cleviprex is safe and effective for managing blood pressure in patients undergoing cardiac surgery and provides more precise blood pressure control than three commonly used IV antihypertensives.

About Cleviprex

Cleviprex is the latest-generation IV dihydropyridine calcium channel blocker. The first-cycle U.S. approval of Cleviprex was based on six Phase III trials, including the three ECLIPSE studies, and involved 1,406 medical and surgical patients treated with Cleviprex. All Phase III trials met all of their primary endpoints. Cleviprex may produce systemic hypotension and reflex tachycardia. The most common adverse reactions (>2%) seen with Cleviprex are headache, nausea and vomiting. Cleviprex is contraindicated in patients with allergy to soy or eggs, defective lipid metabolism or severe aortic stenosis. Please see full prescribing information available at http://www.cleviprex.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 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 physicians, patients and other key decision-makers will accept clinical trial results, 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, 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.

Source
Julie Normart
WeissComm Partners

The Medicines Company