t in Cardiac Surgery-2; HTN=hypertension; SBP=systolic blood pressure.
Primary End Point
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Antihypertensive efficacy, as eva luated by comparing the incidence of treatment failure between Cleviprex and placebo over the 30-minute study drug infusion period. Treatment failure was defined as discontinuation of study drug for any reason or failure to decrease systolic blood pressure (SBP) by >=15% before the end of the 30-minute treatment period
Secondary End Points
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Time to target BP (first decrease of SBP by >=15% from baseline); change in mean arterial pressure from baseline; change in heart rate. The incidence of adverse events (AEs) was recorded starting from study drug initiation through hospital discharge or 7 days, whichever came first
Cleviprex Lowered BP to Target in >90% of Patients
*Dose of 0.4-8.0 micrograms/kg/min in preoperative and postoperative coronary and/or valve surgery patients. +Treatment success defined by the absence of treatment failure (discontinuation of Cleviprex or failure to reduce SBP by >=15%).
BP=blood pressure; SBP=systolic blood pressure.
Cleviprex Acts Fast to Reduce BP to Target in More Than 90% of Patients
*P<.0001; +In ESCAPE-2, the decrease in placebo group SBP reflects the number of placebo patients (n=49 at baseline) who bailed out during the 30-minute infusion period (n=10 remaining at 30 minutes); ++P=.0005; $P<.0001; ||P=.0001.
During the 7 days after study drug initiation, the types and rates of the most commonly reported adverse events were similar in the 2 treatment groups in both studies, with none of the differences in adverse event rates being statistically significant
ECLIPSE Trials
In Perioperative Patients Requiring Rapid Reduction of BP, Comparable Safety. Predictable Performance.
The ECLIPSE (eva luation of CLevidipine In the Perioperative Treatment of Hypertension Assessing Safety Events) trial comprised 3 phase 3, prospective, randomized, open-label, parallel, multicenter studies comparing the safety and efficacy of Cleviprex with that of nitroglycerin (NTG), sodium nitroprusside (SNP), and nicardipine (NIC) in the treatment of perioperative and postoperative hypertension in cardiac surgery patients.
Safety eva luated in More Than 1,500 Cardiac Surgery Patients
Primary End Point
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Safety, as assessed by the incidence of death, myocardial infarction, stroke, and renal dysfunction from the start of study drug infusion through postoperative Day 30
Secondary End Point
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Efficacy (BP control) of Cleviprex compared with that of NTG, SNP, and NIC during the first 24 hours or removal of arterial line, whichever came first
Cleviprex Was Similar to Comparators
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There was no difference between the pooled Cleviprex population and the pooled comparator population for any of the 30-day safety outcome measures
NS = not significant.
Excursions Over and Under Target Range Define BP Control
BP control was assessed as a prespecified secondary end point by measuring the magnitude and duration of excursions outside the predefined SBP target ranges of 75-145 mmHg for pre- and postoperative control and 65-135 mmHg for intraoperative control. The following example illustrates a single patient抯 excursions used to assess BP control.
AUC=area under the curve; SBP=systolic blood pressure.
Minimal Excursions Outside of SBP Target Range With Cleviprex
AUC=area und |
