Healthcare Industry News: bivalirudin
News Release - March 27, 2007
Landmark Findings From ECLIPSE Program Show Improved Control of Perioperative Hypertension Reduces Risk of Death In Cardiac SurgeryLargest Randomized Safety Program of Intravenous Antihypertensives to Date Presented at ACC Scientific Sessions
NEW ORLEANS, March 27 (HSMN NewsFeed) -- Findings from ECLIPSE**, the largest safety program comparing intravenous antihypertensive therapies, show that improved control of perioperative hypertension -- a potentially harmful elevation in blood pressure just before, during and/or after surgery - - in patients undergoing cardiac surgery is strongly associated with a reduced risk of death within 30 days following the procedure. The findings were presented at a late-breaking session here at the 56th Annual Scientific Session of the American College of Cardiology (ACC).
"Perioperative hypertension is a very common problem in cardiac surgery, affecting up to 80 percent of patients," said lead author of the presentation, Solomon Aronson, MD, Duke University Medical Center**. "Findings from ECLIPSE are the first to quantify the relationship between perioperative blood pressure control and clinical outcomes, and demonstrate that better control can dramatically reduce the rate of death in cardiac surgery patients."
"This ECLIPSE analysis contributes to advances in the understanding and treatment of acute hypertension, a condition which affects nearly 3 million people in the U.S. each year," said John Kelley, President and Chief Operating Officer of The Medicines Company. "The Medicines Company is committed to further understanding the importance of better blood pressure control in the acute care setting and we strive to help improve the outcomes of patients who face this life-threatening condition."
Study and Findings
The ECLIPSE program included a total of 1,964 cardiac surgery patients each enrolled in one of three randomized, open-label trials comparing Cleviprex(TM) (clevidipine) to current intravenous antihypertensive agents: nitroglycerin, sodium nitroprusside or nicardipine. Beginning just before patients went into cardiac surgery, investigators monitored each patient's blood pressure (BP) and administered the assigned antihypertensive agent, at their discretion, if it became too high. Based on each patient's BP response for 24 hours after initiating the therapy, investigators determined "BP excursions" -- how much and how long systolic BP went above or below predefined, acceptable perioperative BP ranges (85-145 mm Hg pre- and post- operatively, and 75-135 mm Hg during surgery).
The analysis showed a statistically significant association between BP excursions and 30-day mortality risk. Specifically, the risk of death increased by 20 percent with an average excursion of just 1 mm Hg/min for 60 minutes, and rose rapidly for each additional 1 mm Hg/min. For instance, an excursion of 5 mm Hg/min for 60 minutes was associated with approximately a 150 percent increased risk of death.
About Perioperative Hypertension
Perioperative hypertension affects patients in the operating room, post- anesthesia care unit and intensive care unit. It is thought to be caused by the rapid shifts in blood volume and increased activity of the sympathetic nervous system that accompany surgery, which in turn increase vasoconstriction, vascular resistance, and both systolic and diastolic BP. The increased pressure can damage blood vessels, resulting in inflammation and leaking of fluid or blood into tissues, and complications such as hemorrhagic stroke, ischemic stroke, encephalopathy, myocardial ischemia or infarction, heart arrhythmia, congestive heart failure, and bleeding at the surgical site.
Perioperative hypertension is treated using intravenous antihypertensive agents, but current therapies have various shortcomings. For example, nitroglycerin and sodium nitroprusside dilate both arteries and veins, which can result in less predictable BP control. Nicardipine is selective for arteries, but because it has a slower onset and longer duration of action, and accumulates over time in the body, it is rarely used to control BP during surgery, and is only used occasionally after surgery.
Cleviprex is a novel, investigational drug rationally designed to meet the needs of the acute care practitioner for an intravenous hypertensive agent. It is the first third-generation dihydropyridine calcium channel blocker that acts rapidly and reliably, is vascular- and arterial- selective, and has an ultrashort half-life. Cleviprex recently completed Phase III clinical trials.
About The Medicines Company
The Medicines Company is committed to delivering innovative, cost- effective acute care products in the worldwide hospital marketplace. The Company markets Angiomax® (bivalirudin) in the U.S. 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, Cleviprex(TM) (clevidipine) and cangrelor. The Company's website is http://www.themedicinescompany.com.
Statements contained in this press release about The Medicines Company and Cleviprex 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 March 1, 2007, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
* Evaluation of CLevidipine In the Postoperative Treatment of Hypertension Assessing Safety Events
** Dr. Solomon Aronson is a paid consultant for The Medicines Company
Source: The Medicines Company
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