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Pivotal Phase III Findings With Investigational Drug Cleviprex,(Clevidipine) Demonstrate Perioperative Blood Pressure Control In,Cardiac Surgery

hat the rate of death was significantly lower with Cleviprex than with sodium nitroprusside (1.7% vs. 4.7%, p = 0.045). Other than this difference, the primary endpoints -- rates of death, stroke, heart attack and kidney dysfunction -- were similar for Cleviprex compared to the other three agents.

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.

About Cleviprex

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.

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