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

ered the assigned antihypertensive agent, at their discretion, if BP became too high. Based on each patient's BP response for 24 hours after initiating the therapy, investigators determined "BP excursions" -- how much and how long systolic BP went above or below predefined, acceptable perioperative BP ranges.

The ECLIPSE analysis evaluated BP excursions from data pooled from all three studies and from the individual studies. In the pooled analysis, for the widest predefined acceptable perioperative BP range of 75-145 mm Hg pre- and post-operatively and 65-135 mm Hg during surgery, Cleviprex resulted in approximately half the BP excursion compared to the other agents (3.8 vs. 7.8 mm Hg x min/h, p = 0.0004). Results for the narrowest BP range of 105-145 mm Hg pre- and post-operatively and 95-135 mm Hg during surgery also favored Cleviprex (87.7 vs. 111.5 mm Hg x min/h, p = 0.0002).

In the individual ECLIPSE-NTG and ECLIPSE-SNP studies, for the widest BP range, Cleviprex resulted in approximately half the BP excursion compared to nitroglycerin (4.14 vs. 8.87 mm Hg x min/h, p = 0.0006) and sodium nitroprusside (4.37 vs. 10.50 mm Hg x min/h, p = 0.0027), respectively. At this BP range, there was no significant difference in BP excursions for Cleviprex vs. nicardipine (1.76 vs. 1.79 mm Hg x min/h, p = 0.8508), however that comparison was restricted to the post-operative period only, since nicardipine is not generally used before or during surgery due to its relatively slow onset and offset of action. Other standard intravenous BP control agents were administered, as deemed appropriate, just before or during surgery in the ECLIPSE-NIC trial.

For the narrowest BP range, Cleviprex also resulted in less BP excursion compared to sodium nitroprusside (100.17 vs. 127.87 mm Hg x min/h, p = 0.0068), nicardipine (76.5 vs. 101.59 mm Hg x min/h, p = 0.0231), and nitroglycerin (83.74 vs. 108.57 mm Hg x min/h, p = 0.0556).

The ECLIPSE-SNP trial also showed t
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