Target blood pressure control was achieved with Cleviprex, administered by intravenous (IV) infusion, by a median of 6.3 minutes for patients with RD and 11.3 minutes for patients with AHF, with 91 percent of RD patients (N=24) and 94 percent of AHF (N=19) patients reaching their target within 30 minutes. Most patients (88 percent RD, 84 percent AHF) transitioned smoothly to an oral antihypertensive after completing treatment with Cleviprex. In these analyses, there were no hypotensive events and Cleviprex was well tolerated.
"These findings are encouraging, as they show the potential benefits of Cleviprex in high-risk patients that often cannot tolerate currently available therapies," said James Ferguson, M.D., Vice President, Global Medical, Surgical and Critical Care, The Medicines Company. "If approved, Cleviprex is poised to be an important new treatment option, uniquely suited to meet the needs of hospital patients with acute blood pressure."
The Risk of Acutely Elevated Blood Pressure
An acute elevation of blood pressure, or acute hypertension, is a life-threatening condition that can cause permanent damage to the brain, heart, kidneys and blood vessels. It occurs in nearly 50 percent of patients presenting to the hospital with acute heart failure and is a common occurrence for patients with renal dysfunction. It is critical to rapidly manage and maintain optimal blood pressure to minimize risk of death and damage to vital organs.
Blood Pressure Excursions Significantly Linked to Poor Outcomes
Independent research from Duke University Medical Center, also presented at SCCM, of a Duke Heart Center database of 5,000 patients demonstrated that blood pressure (excursions) above or below a target range was significantly linked to 30-day mortality in cardiac surgery patients (P=0.0139). "The impetus for the Duke database analysis were the ECLIPSE results, which showed that improved blood pressure control in cardiac surgery patients significantly reduced the risk of death within 30 days following the procedure," said Solomon Aronson, M.D., Professor of Anesthesiology, Duke University School of Medicine. "These data clearly demonstrate the need to reevaluate the management of acute blood pressure changes during surgery. Furthermore, these data alert us to an important and emerging unmet clinical need for new target therapies that better manage and control severe blood pressure excursions in the hospital."
About the VELOCITY and ECLIPSE trials
VELOCITY was an open-label, single-arm, multi-center study in 126 emergency department patients presenting with acutely elevated blood pressure. The ECLIPSE trial included a total of 1,512 cardiac surgery patients enrolled in one of three randomized, open-label studies comparing Cleviprex to current intravenous antihypertensive agents: nitroglycerin, sodium nitroprusside or nicardipine.
Cleviprex is a novel investigational IV antihypertensive for the treatment of acutely elevated blood pressure, when the use of oral therapy is not feasible or desirable. Cleviprex has a rapid onset and offset of action and can be titrated for predictable blood pressure control. Unlike current antihypertensive treatments which are metabolized by the kidney or liver, Cleviprex is metabolized in the blood and does not accumulate in the body, making it a suitable treatment for patients with end-organ damage.
Cleviprex has been studied in more randomized clinical trials and in more patients than any other intravenous antihypertensive agent. Six Phase III trials of Cleviprex met all of their primary endpoints. The most common adverse reactions seen with Cleviprex use were headache, sinus tachycardia, hypotension, nausea, polyuria, flushing, dizziness and vomiting.
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(R) /Angiox(R) (bivalirudin) in the United States 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 butyrate injectable emulsion) and cangrelor. The Company's website is www.themedicinescompany.com.