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Primary End Point1,2

  • Antihypertensive efficacy, as evaluated 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 Points1,2

  • 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

Escape

*Dose of 0.4-8.0 µg/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.

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.

References

  1. Levy JH, Mancao MY, Gitter R, et al. Clevidipine effectively and rapidly controls blood pressure preoperatively in cardiac surgery patients: the results of the randomized, placebo-controlled efficacy study of clevidipine assessing its preoperative antihypertensive effect in cardiac surgery-1. Anesth Analg. 2007;105:918-925.
  2. Singla N, Warltier DC, Gandhi SD, et al, for the ESCAPE-2 Study Group. Treatment of acute postoperative hypertension in cardiac surgery patients: an efficacy study of clevidipine assessing its postoperative antihypertensive effect in cardiac surgery-2 (ESCAPE-2), a randomized, double-blind, placebo-controlled trial. Anesth Analg. 2008;107:59-67.