|NEWSRoom | Source: The Medicines Company|
Improved Perioperative Blood Pressure Control Associated with Reduced Risk of Kidney Dysfunction in Cardiac Surgery Patients
Retrospective Analysis from the ECLIPSE Trial Presented at Annual Meeting of the American Society of Anesthesiologists
A retrospective analysis from ECLIPSE, the largest safety trial of intravenous antihypertensive therapies, showed that improved perioperative blood pressure control in patients undergoing cardiac surgery is strongly associated with a reduced risk of kidney dysfunction within 30 days following the procedure. Perioperative hypertension affects as many as 56 percent of cardiac surgery patients. The findings were presented today at the 2007 Annual Meeting of the American Society of Anesthesiologists (ASA).
"ECLIPSE is the first study to examine the relationship between perioperative blood pressure control and clinical outcomes such as kidney dysfunction," said Solomon Aronson, MD, lead author of the presentation and professor and vice chairman, Department of Anesthesiology, Duke University Medical Center. "The analysis we presented suggests that better blood pressure control may reduce the risk of renal dysfunction, which has a major impact on quality of life and is very costly to treat."
"Data from ECLIPSE underscore the importance of tight blood pressure control in cardiac surgery patients," said John Kelley, President and chief operating officer of The Medicines Company. "There is a clear need for new and better IV antihypertensive agents that provide rapid and predictable blood pressure control, and we are working to address that need."
This ECLIPSE trial included a total of 1,512 cardiac surgery patients enrolled in one of three randomized, open-label studies comparing Cleviprex(tm) (clevidipine butyrate injectable emulsion) to current intravenous antihypertensive agents: nitroglycerin, sodium nitroprusside or nicardipine. Investigators monitored each patient's blood pressure (BP) beginning just before the patient went into cardiac surgery, and administered the assigned antihypertensive agent, at their discretion, if it became too high. The dose of antihypertensive agent was adjusted as necessary to achieve the desired BP response over a 24-hour period. The magnitude and duration of systolic BP excursions above or below predefined perioperative systolic BP ranges (85-145 mm Hg pre- and post-operatively, and 75-135 mm Hg during surgery) were calculated for each patient.
The analysis presented showed a statistically significant association between BP excursions and kidney dysfunction (defined by creatinine being above 2.0 mg/dL, with minimum increase of 0.7mg/dL) at 30 days. Specifically, the risk of kidney dysfunction was more than 75 percent greater in patients with the worst BP control - those in the top 25 percent of BP excursions (odds ratio 1.785, confidence interval 1.132-2.815, p = 0.0126). The findings are consistent with others reported from a separate retrospective analysis of ECLIPSE data showing that poor BP control is associated with greater 30-day mortality risk.
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 IV antihypertensive for the treatment of acute hypertension 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 suitable 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.
The Medicines Company meets the demands of the world's most advanced medical practitioners by developing products that improve acute hospital care. The Company markets Angiomax(r) (bivalirudin) in the United States and recently reacquired rights to the product in Europe, where it is marketed as Angiox(r) (bivalirudin). Angiomax is used in patients undergoing coronary angioplasty, a procedure to clear restricted blood flow in arteries around the heart. In addition to Cleviprex, the Company also has another product in late-stage development, cangrelor. The Company's Web site is http://www.themedicinescompany.com.
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