TY - JOUR
T1 - Treatment of acute postoperative hypertension in cardiac surgery patients
T2 - An efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (escape-2), a randomized, double-blind, placebo-controlled trial
AU - Singla, Neil
AU - Warltier, David C.
AU - Gandhi, Sweeta D.
AU - Lumb, Philip D.
AU - Sladen, Robert N.
AU - Aronson, Solomon
AU - Newman, Mark F.
AU - Corwin, Howard L.
PY - 2008/7
Y1 - 2008/7
N2 - BACKGROUND: Acute postoperative hypertension is a well-known complication of cardiac surgery and is associated with postoperative morbidity. Clevidipine, an ultrashort-acting, third-generation dihydropyridine calcium channel blocker, exerts vascular-selective, arterial-specific vasodilation to decrease arterial blood pressure without negatively impacting cardiac function. In this double-blind, placebo-controlled trial, we examined the efficacy and safety of clevidipine in treating postoperative hypertension in cardiac surgery patients. METHODS: Two hundred six patients undergoing cardiac surgery were randomized preoperatively. Of these, 110 met postrandomization inclusion criteria for the study [systolic blood pressure (SBP) ≥140 mm Hg within 4 h of admission to a postoperative setting, and clinically assessed as needing SBP reduction by ≥15% from baseline]. Patients received an infusion of either clevidipine (0.4-8.0 μg kg min) or 20% lipid emulsion (placebo) for 30 min to a maximum of 1 h unless treatment failure occurred sooner. The primary end point was the incidence of treatment failure, defined as the inability to decrease SBP by ≥15% from baseline, or the discontinuation of study treatment for any reason within the 30-min period after study drug initiation. RESULTS: Clevidipine-treated patients had a significantly lower incidence of treatment failure than placebo patients [8.2% (5 of 61) vs 79.6% (39 of 49), P < 0.0001]. Treatment success was achieved in 91.8% of clevidipine-treated patients. Median time to target SBP with clevidipine was 5.3 min (95% confidence interval, 4-7 min). No clinically significant increase in heart rate from baseline was observed. Adverse event rates were similar for both treatment groups. CONCLUSIONS: Clevidipine is effective and safe in the rapid treatment of acute postoperative hypertension after cardiac surgery.
AB - BACKGROUND: Acute postoperative hypertension is a well-known complication of cardiac surgery and is associated with postoperative morbidity. Clevidipine, an ultrashort-acting, third-generation dihydropyridine calcium channel blocker, exerts vascular-selective, arterial-specific vasodilation to decrease arterial blood pressure without negatively impacting cardiac function. In this double-blind, placebo-controlled trial, we examined the efficacy and safety of clevidipine in treating postoperative hypertension in cardiac surgery patients. METHODS: Two hundred six patients undergoing cardiac surgery were randomized preoperatively. Of these, 110 met postrandomization inclusion criteria for the study [systolic blood pressure (SBP) ≥140 mm Hg within 4 h of admission to a postoperative setting, and clinically assessed as needing SBP reduction by ≥15% from baseline]. Patients received an infusion of either clevidipine (0.4-8.0 μg kg min) or 20% lipid emulsion (placebo) for 30 min to a maximum of 1 h unless treatment failure occurred sooner. The primary end point was the incidence of treatment failure, defined as the inability to decrease SBP by ≥15% from baseline, or the discontinuation of study treatment for any reason within the 30-min period after study drug initiation. RESULTS: Clevidipine-treated patients had a significantly lower incidence of treatment failure than placebo patients [8.2% (5 of 61) vs 79.6% (39 of 49), P < 0.0001]. Treatment success was achieved in 91.8% of clevidipine-treated patients. Median time to target SBP with clevidipine was 5.3 min (95% confidence interval, 4-7 min). No clinically significant increase in heart rate from baseline was observed. Adverse event rates were similar for both treatment groups. CONCLUSIONS: Clevidipine is effective and safe in the rapid treatment of acute postoperative hypertension after cardiac surgery.
UR - http://www.scopus.com/inward/record.url?scp=49849098985&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=49849098985&partnerID=8YFLogxK
U2 - 10.1213/ane.0b013e3181732e53
DO - 10.1213/ane.0b013e3181732e53
M3 - Article
C2 - 18635468
AN - SCOPUS:49849098985
VL - 107
SP - 59
EP - 67
IS - 1
ER -