.
Figure adapted from Kieler-Jensen N et al. Acta Anaesthesiol Scand. 2000;44:186-193.
Efficacy of Cleviprex
Rapid On, Rapid Off: A Predictable Performance
Cleviprex has a rapid onset and offset of BP-lowering effects for a predictable pharmacologic response, and an ultrashort half-life of approximately 1 minute provides rapid-acting control. Cleviprex demonstrates a dose-dependent BP-lowering response. The onset of effect is seen within 2 to 4 minutes after infusion, and full recovery of BP is achieved 5 to 15 minutes after the infusion is stopped in most patients.
Safety Profile
Demonstrated Safety in Clinical Trials in More Than 1,800 Patients
Drug-drug interactions
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The potential of Cleviprex to interact with other drugs is low
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Cleviprex does not have the potential for blocking or inducing any CYP enzyme
Adverse reactions
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The most common adverse reactions (>2%) with Cleviprex are headache, nausea, and vomiting
Special populations
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No adjustment of initial dosage necessary in patients with renal or hepatic dysfunction
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In geriatric patients, doses should be titrated cautiously, starting at the low end of the dosing range. In clinical tirals, no overall differences in safety or effectiveness were observed between these and younger patients with Cleviprex
Additional considerations
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Cleviprex is photosensitive and storage in cartons protects against photodegradation. Protection from light during administration is not required
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Store vials refrigerated at 2 to 8癈 (36-46癋). Do not freeze
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Cleviprex should not be administered in the same line as other medications
CLINICAL TRIALS
Cleviprex has been eva luated in 19 clinical studies, including more than 1,400 Cleviprex-treated patients in a variety of clinical settings, including the emergency department, operating room, and critical care unit.
Cleviprex Phase 3 Clinical Trial Program
BP=blood pressure; ECLIPSE=eva luation of CLevidipine In the Perioperative Treatment of Hypertension Assessing Safety Events; ESCAPE= Efficacy Study of Clevidipine Assessing Its Preoperative/Postoperative Antihypertensive Effect in Cardiac Surgery; NIC=nicardipine; NTG=nitroglycerin; SNP=sodium nitroprusside; VELOCITY=eva luation of the Effect of ULtra-ShOrt-Acting Clevidipine In the Treatment of Patients With Severe HYpertension.
ESCAPE Trials
In Perioperative Patients Requiring Rapid Reduction of Blood Pressure, Rapid Control That抯 on Target
Cleviprex rapidly reduced blood pressure (BP) to target levels in cardiac surgery patients requiring preoperative or postoperative BP control in the ESCAPE-1 (Efficacy Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery-1) and ESCAPE-2 (Efficacy Study of Clevidipine Assessing Its Postoperative Antihypertensive Effect in Cardiac Surgery-2) trials.1,2
The ESCAPE trials were phase 3, randomized, double-blind, placebo-controlled, multicenter trials eva luating the efficacy and tolerability of Cleviprex in a total of 215 cardiac surgery patients requiring preoperative (ESCAPE-1) or postoperative (ESCAPE-2) BP control.1,2
ESCAPE-1=Efficacy Study of Clevidipine Assessing Its Preoperative Antihypertensive Effect in Cardiac Surgery-1; ESCAPE-2=Efficacy Study of Clevidipine Assessing Its Postoperative Antihypertensive Effec
