Investigational Drug Controls BP

JUNE 01, 2007
Susan Farley

A phase 3 trial of clevidipine (Cleviprex) found the drug to provide favorable outcomes for controlling perioperative hypertension. The trial, known as Evaluation of Clevidipine in the Postoperative Treatment of Hypertension Assessing Safety Events (ECLIPSE), included 1964 cardiac patients randomly assigned to 1 of 3 open-label trials that compared clevidip-ine with antihypertensive drugs such as nitroglycerin, sodium nitroprusside, or nicardipine. Prior to surgery, researchers took the patients? blood pressure (BP), and if the BP rose too high, they would administer one of the antihypertensive agents. By monitoring BP response for the following 24 hours, researchers were able to determine "how much and how long systolic BP went above or below predefined, acceptable perioperative BP ranges"?what researchers termed a "BP excursion." The widest predefined perio-perative range was 75 to 144 mm Hg before and after surgery and 65 to 135 mm Hg during surgery. The "BP excursion" of clevidipine was half that of the other anti-hypertensive agents (3.8 mm Hg vs 7.8 mm Hg). In 1 of the 3 trials, clevidipine was shown to result in a significantly lower rate of death when compared with sodium nitroprusside (1.7% vs 4.7%). Clevidipine is a novel, investigational drug to be used as an intravenous antihy-pertensive agent; it is a third-generation dihydropyridine calcium channel blocker.

Ms. Farley is a freelance medical writer based in Wakefield, RI.



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