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ECLIPSE Trials

In Perioperative Patients Requiring Rapid Reduction of BP,
Comparable Safety. Predictable Performance.

The ECLIPSE (Evaluation 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 Evaluated in More Than 1,500 Cardiac Surgery Patients


Primary End Point

  • 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

  • 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

  • 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.

 

IMPORTANT SAFETY INFORMATION

Cleviprex is intended for intravenous use. Titrate drug depending on the response of the individual patient to achieve the desired blood pressure reduction. Monitor blood pressure and heart rate continually during infusion, and then until vital signs are stable. Patients who receive prolonged Cleviprex infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped.

Cleviprex is contraindicated in patients with allergies to soybeans, soy products, eggs, or egg products; defective lipid metabolism such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and in patients with severe aortic stenosis.

Hypotension and reflex tachycardia are potential consequences of rapid upward titration of Cleviprex. Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully. Cleviprex gives no protection against the effects of abrupt beta-blocker withdrawal.

Most common adverse reactions (> 2%) are headache, nausea, and vomiting.

Cleviprex should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Maintain aseptic technique while handling Cleviprex. Cleviprex contains phospholipids and can support microbial growth. Do not use if contamination is suspected. Once the stopper is punctured, use and discard within 4 hours.

Please see full Prescribing Information.

Reference

Aronson S, Dyke CM, Stierer KA, et al. The ECLIPSE trials: comparative studies of clevidipine to nitroglycerin, sodium nitroprusside, and nicardipine for acute hypertension treatment in cardiac surgery patients. Anesth Analg. 2008;107:1111-1122.