CLEVIPREX® (clevidipine) Low-volume dosing for rapid BP control

with CLEVIPREX® (clevidipine)
Consider CLEVIPREX (clevidipine) for low-volume dosing

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.

(9:59)

BP control was similar across treatments in the ECLIPSE trials3

*P<0.05 vs comparator(s).
†Post-hoc analysis of mITT population.
AUC=area under the curve.

CLEVIPREX was similar to nicardipine in keeping patients within a prespecified BP range

Efficacy was a secondary endpoint and was assessed by measuring the magnitude and duration of blood pressure excursions above or below a predefined SBP range vs. comparators.

Serious adverse events were reported by day 7 or discharge3


CLEVIPREX (n=752) All Comparators (n=754) Patients with ≥1 serious AEAtrial fibrillation Respiratory failure Acute renal failure Ventricular fibrillation Cardiac arrest Cerebrovascular accident Postprocedural hemorrhage 17.7% 20.0% L 2.4% 1.1%2.3% 0.9% 0.5%0.5%0.5% 2.4% 2.5%1.7%1.5%1.1%1.1%1.1%

  • 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
View additional safety results from the ECLIPSE trials

Drug administration in the ECLIPSE trials3

Study drug administration Overall infusion duration (hr) - Median Total infusion volume (mL) - Median Average infusion rate (mL/hr) - Median CLEVIPREX (n=188) 7.1 56.4 7.9 Nicardipine‡ (n=193) 7.9 163.8 33.6 Overall infusion duration starts from the initiation of first infusion to the end of last infusion.

  Show quartiles
Study drug administration Overall infusion duration (hr) - Median Q1, Q3 Total infusion volume (mL) - Median Q1, Q3 Average infusion rate (mL/hr) - Median Q1, Q3 CLEVIPREX (n=188) 7.1 2, 17 56.4 13.7, 142.9 7.9 4.5, 12.9 Nicardipine‡ (n=193) 7.9 3, 18 163.8 42.7, 376.2 33.6 18.9, 48.8 Overall infusion duration starts from the initiation of first infusion to the end of last infusion.

  Hide quartiles

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

Median average infusion rate (mL/hr) 40 35 30 25 20 15 10 5 0 Median average infusion rate (mL/hr) 7.9 33.6 Nicardipine 4x lower infusion rate CLEVIPREX

§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

Consider low-volume dosing for blood pressure reduction with CLEVIPREX when fluid overload may be a concern

||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.

Explore the clinical studies

CLEVIPREX videos for healthcare professionals

Get access to videos about CLEVIPREX presented by renowned anesthesiologist Dr. Horowitz.

Watch videos