Key result
Clevidipine improved management of acute hypertension compared to placebo and other agents, and significantly reduced mortality compared to sodium nitroprusside (1.7% vs 4.7%, P=0.0445).
Why the study?
Does parenteral clevidipine improve acute control of blood pressure in critically ill patients compared to placebo or other antihypertensives?
Does parenteral clevidipine improve acute control of blood pressure in critically ill patients compared to placebo or other antihypertensives?
Absolute Event Rate: 1.7% vs 4.7%
p-value: p=0.0445
Clevidipine is an effective and safe ultra-short-acting calcium channel blocker for the acute management of hypertension in critically ill patients.
May aid acute BP control in critically ill patients; leaves open prospective confirmation of mortality benefit.
Clevidipine is a new calcium channel blocker of the dihydropyridine class that is characterized by its ultra-short onset of action, vascular selectivity, small volume of distribution and extremely high clearance that coupled together result in an extremely short half-life of approximately 1 minute therefore permitting a rapid titration to the desired effect. Structurally similar to other dihydropyridines, clevidipine has an extra ester link that allows its rapid hydrolization to its inactive carboxylic acid metabolite in blood and extravascular tissues. Clevidipine's metabolites are then primarily eliminated through urine and fecal pathways. Clevidipine does not affect cytochrome P450 (CYP) enzymes and no clinically significant drug interactions have been determined. In trials like the ESCAPE trials, ECLIPSE, and VELOCITY, clevidipine demonstrated a significant improvement in the management of acute hypertension when compared to placebo as shown in both ESCAPE trials. The ECLIPSE trial compared clevidipine to other drugs currently used in the management of acute hypertension, such as sodium nitroprusside, nitroglycerine and nicardipine; clevidipine was superior to all three agents; in providing blood pressure support, safety and tolerability clevidipine also showed a significant reduction in mortality rate (4.7% vs 1.7%, P =0.0445) when compared to sodium nitroprusside. In the VELOCITY trial clevidipine demonstrated a reduction in blood pressure of 6% at the 3 minute mark, 15% within 9.5 minutes and 27% at the 18 hour mark.
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Peacock et al. (2009) conducted a review in Acute hypertension in critically ill patients. Clevidipine vs. Placebo, sodium nitroprusside, nitroglycerine, nicardipine was evaluated on Mortality rate (ECLIPSE trial) (p=0.0445). Clevidipine improved management of acute hypertension compared to placebo and other agents, and significantly reduced mortality compared to sodium nitroprusside (1.7% vs 4.7%, P=0.0445).
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