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CARDIOVASCULAR ANESTHESIOLOGY

Clevidipine Effectively and Rapidly Controls Blood Pressure Preoperatively in Cardiac Surgery Patients: The Results of the Randomized, Placebo-Controlled Efficacy Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery-1

Jerrold H. Levy, MD^*, Miguel Y. Mancao, MD, Richard Gitter, MD, Dean J. Kereiakes, MD, FACC^||, Alina M. Grigore, MD^¶, Solomon Aronson, MD, FACC, FCCP, FAHA^#, and Mark F. Newman, MD^#

From the *Cardiothoracic Anesthesiology and Critical Care, Emory University Hospital, Atlanta, Georgia; Sacred Heart Health System, Pensacola, Florida; Birmingham Baptist Medical Center Montclair, Birmingham, Alabama; Lindner Research Center and ||Christ Hospital Heart and Vascular Center, The Linder Research Center, Cincinnati, Ohio; ¶Mayo Clinic Hospital, Department of Anesthesiology, Phoenix, Arizona; and #Department of Anesthesiology, Duke University Medical Center, Durham, North Carolina.

Address correspondence and reprint requests to Jerrold H. Levy, MD, Cardiothoracic Anesthesiology and Critical Care, Emory University Hospital, 1364 Clifton Road, NE, Atlanta, GA 30322. Address e-mail to jerrold.levy{at}emoryhealthcare.org.

Abstract

BACKGROUND: Clevidipine is an ultrashort-acting, third-generation IV dihydropyridine calcium channel blocker that exerts rapid and titratable arterial blood pressure reduction, with fast termination of effect due to metabolism by blood and tissue esterases. As an arterial-selective vasodilator, clevidipine reduces peripheral vascular resistance directly, without dilating the venous capacitance bed. In this randomized, double-blind, placebo-controlled multicenter trial we evaluated the efficacy and tolerability of clevidipine in treating preoperative hypertension.

METHODS: One-hundred-fifty-two patients scheduled for cardiac surgery with current or recent hypertension were randomized to receive clevidipine or placebo preoperatively. One-hundred-five patients met postrandomization entrance criteria (systolic blood pressure [SBP] 160 mm Hg after inserting an arterial catheter) for reduction by 15% from baseline in SBP. The patients thus received infusions of clevidipine (0.4–8.0 µg · kg^–1 · min^–1) or 20% lipid emulsion (placebo) for at least 30 min. Treatment failure was defined as failure to reduce SBP by 15% from baseline or discontinuance of drug for any reason.

RESULTS: Patients treated with clevidipine demonstrated a 92.5% rate of treatment success and a significantly lower rate of treatment failure (7.5%, 4 of 53) than patients receiving placebo (82.7%, 43 of 52; P < 0.0001). Clevidipine achieved target blood pressures (SBP reduced by 15%) at a median of 6.0 min (95% confidence interval 6–8 min). A modest increase in heart rate from baseline occurred during clevidipine administration. Adverse events for each treatment group were similar.

CONCLUSIONS: Clevidipine was effective in rapidly decreasing blood pressure preoperatively to targeted blood pressure levels and was well tolerated in patients scheduled for cardiac surgery.

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