New Publication Shows Cleviprex Provides More Precise Blood Pressure Control in Cardiac Surgery Patients
ECLIPSE Data Published in Anesthesia and Analgesia
FOR U.S. AUDIENCES ONLY
PARSIPPANY, N.J., Oct. 3, 2008--(BUSINESS WIRE)--The Medicines Company (NASDAQ: MDCO) today announced that ECLIPSE, the largest safety program to date comparing intravenous antihypertensive therapies, has been published in the October issue of Anesthesia and Analgesia. Results show Cleviprex™ (clevidipine butyrate) injectable emulsion 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.
“Poorly controlled blood pressure during cardiac surgery can adversely affect patient outcomes,” said lead author Solomon Aronson, MD, Duke University Medical Center. “The ECLIPSE data show that Cleviprex offers reliable and effective perioperative blood pressure control.”
Study and Findings
The ECLIPSE program enrolled 1,964 cardiac surgery patients in one of three randomized, open-label trials comparing Cleviprex to either nitroglycerin or sodium nitroprusside perioperatively, or nicardipine postoperatively. Regarding the primary safety outcome of death, myocardial infarction, stroke, or renal dysfunction at 30 days, there was equivalence among all drugs evaluated with the suggestion that Cleviprex was superior to sodium nitroprusside in mortality (5/286 or 1.7% vs. 13/274 or 4.7%; P=0.04).
In addition, and potentially most importantly, the precision of BP control was also calculated for each patient - how much and for how long systolic BP went above or below predefined, acceptable perioperative BP ranges. Cleviprex was more effective than both nitroglycerin (P =0.0006) and sodium nitroprusside (P =0.003) in maintaining BP within a pre-specified acceptable range. Cleviprex was equivalent to nicardipine in maintaining BP within the initial broad range, however, when the BP range was narrowed, Cleviprex was also significantly better than nicardipine in reducing excursions outside the more narrow range.
“These important data from the ECLIPSE program clearly demonstrate the significant benefits of Cleviprex in cardiac surgery patients, “ said John Kelley, President and Chief Operating Officer of The Medicines Company. “With the recent nationwide launch of Cleviprex, hospitals now have access to therapy that should advance the management of blood pressure in surgical and critical care settings.”
Additional data from the pivotal ECLIPSE program will be presented at the upcoming American Society of Anesthesiologists (ASA) meeting taking place in Orlando, October 18 to October 22.
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 patients 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 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 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.
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Posted: October 2008