CLEVIPREX® (clevidipine) Low-volume dosing for rapid BP controlwith CLEVIPREX® (clevidipine)
Excessive fluid intake may lead to adverse outcomes in critically ill patients1,2
ECLIPSE was comprised of three parallel, prospective, randomized, open-label studies that compared the safety and efficacy of CLEVIPREX (n=752) to active comparators: nitroglycerin (n=278) and sodium nitroprusside (n=283) in the perioperative setting, or nicardipine (n=193) in the postoperative setting. Safety was the primary endpoint (defined as the incidence of death, MI, stroke, or renal dysfunction at 30 days). The study was not powered for non-inferiority or superiority.3
CLEVIPREX was not studied or proven to impact fluid overload.
Low-volume dosing with CLEVIPREX4
Watch a video featuring Dr. Solomon Aronson, lead investigator of the ECLIPSE trials, as he discusses the trials and how CLEVIPREX was studied against active comparators. Learn how CLEVIPREX drug administration in the trial compared to nicardipine in the postoperative setting.
Serious adverse events were reported by day 7 or discharge3
- The adverse events observed within 1 hour of the end of infusion were similar between patients who received CLEVIPREX and those who received comparators4
- Incidence of adverse events leading to study drug discontinuation: CLEVIPREX=5.9%; all active comparators=3.2%4
- No adverse reactions were >2% more common with CLEVIPREX compared with the average of all the comparators4
Drug administration in the ECLIPSE trials3
Dosing in the ECLIPSE trials was based on patients’ weight, while the dosing described in the prescribing information is not weight-based. However, the actual doses administered to patients in these trials and recommended by the Prescribing Information are similar. The data to the left only represents 1 of the 3 ECLIPSE trials.
‡Based on the availability of IV nicardipine at the time of ECLIPSE, nicardipine concentration was most likely 0.1 mg/mL.
Median average infusion rate was 4x lower with CLEVIPREX than nicardipine§3
§Adapted based on data from the ECLIPSE trial safety population.
Data presented are observational and should not be overinterpreted.
Low-volume and non–weight-based dosing available in ready-to-use vials4
||Most patients will achieve the desired therapeutic response at approximately 4–6 mg/hr.
Proven efficacy in clinical studies4-8
CLEVIPREX provided blood pressure reduction in a range of patients and various clinical settings.
CLEVIPREX videos for healthcare professionals
Get access to videos about CLEVIPREX presented by renowned anesthesiologist Dr. Horowitz.
References: 1. Child DL, Cao Z, Seiberlich LE, et al. The costs of fluid overload in the adult intensive care unit: is a small-volume infusion model a proactive solution? Clinicoecon Outcomes Res. 2014;7:1-8. 2. O’Connor ME, Prowle JR. Fluid Overload. Crit Care Clin. 2015;31(4):803-821. 3. 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(4):1110-1121. 4. CLEVIPREX® (clevidipine) Prescribing Information. 2021. 5. 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(4):918-925. 6. Singla N, Warltier DC, Gandhi SD, et al; 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(1):59-67. 7. Pollack CV, Varon J, Garrison NA, Ebrahimi R, Dunbar L, Peacock WF. Clevidipine, an intravenous dihydropyridine calcium channel blocker, is safe and effective for the treatment of patients with acute severe hypertension. Ann Emerg Med. 2009;53(3):329-338. 8. Graffagnino C, Bergese S, Love J, et al. Clevidipine rapidly and safely reduces blood pressure in acute intracerebral hemorrhage: the ACCELERATE trial. Cerebrovasc Dis. 2013;36(3):173-180.
The information provided in this website is intended for US healthcare professionals only.
I certify that I am a US healthcare professional.