CLEVIPREX® (clevidipine) demonstrated safety in multiple clinical trials


Learn about CLEVIPREX® (clevidipine)

The ECLIPSE study design1

3 parallel, prospective, randomized, open-label studies in patients undergoing cardiac surgery at 61 medical centers (N=1506)

POSTOPERATIVE PERIOPERATIVE CLEVIPREX CLEVIPREX CLEVIPREX CLEVIPREX (n=268 * ) Nitroglycerin (n=278 * ) CLEVIPREX (n=296 * ) Sodium Nitroprusside (n=283 * ) CLEVIPREX (n=188 * ) Nicardipine (n=193 * ) vs vs vs Nicardipine Sodium Nitroprusside Nitroglycerin 1:1 1:1 1:1

Primary Endpoint: Safety, defined as incidence of death, MI, stroke, or renal dysfunction at 30 days vs comparators. Study was not powered for non-inferiority or superiority.

Secondary Endpoint: Efficacy by measuring the magnitude and duration of blood pressure excursions above or below a pre-defined SBP range vs comparators.

*Numbers for safety population. MI=myocardial infarction; SBP=systolic blood pressure.

Incidence of serious adverse events in ECLIPSE trials1,2

The adverse events observed within 1 hour of the end of infusion were similar in patients who received CLEVIPREX and those who received comparator agents.2

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Serious Adverse Event (%) 1 Patients with ≥1 serious adverse event Atrial fibrillationRespiratory failureAcute renal failureVentricular fibrillationCardiac arrestCerebrovascular accidentPostprocedural hemorrhage 17.7%2.4%1.1%2.3%0.9%0.5%0.5%0.5% Incidence of AEs leading to study drug discontinuation: CLEVIPREX=5.9%; all active comparators=3.2%. CLEVIPREX (n=752)

The ability to differentiate the AE profile between treatments was limited2

  • Many adverse events were associated with the operative procedure
  • Relatively few were plausibly related to CLEVIPREX and the comparators
  • AEs observed within 1 hour of the end of infusion were similar between patients who received CLEVIPREX and those who received comparators
  • No adverse reactions were >2% more common with CLEVIPREX compared with the average of all the comparators

Common adverse events (AEs) by day 7 or discharge vs placebo in the perioperative setting

AE Pyrexia Atrial fibrillation Acute renal insufficiency/failure Nausea CLEVIPREX (n=53)18.9%13.2%9.4%5.7% Placebo (n=51)13.7%11.8%2.0%9.8% D05 Table 1 (mobile) ESCAPE-1 3 AE Nausea Atrial fibrillation Insomnia CLEVIPREX (n=61)21.3%21.3%11.5% Placebo (n=49)12.2%12.2%6.1% ESCAPE-2 4

†In ESCAPE-1 (preoperative), AEs reported by >5.7% of CLEVIPREX-treated patients from study drug initiation until hospital discharge or 7 days.

‡In ESCAPE-2 (postoperative), AEs reported by ≥10% of CLEVIPREX-treated patients from study drug initiation until hospital discharge or 7 days.

ESCAPE-13 and ESCAPE-24 Study Design

These results are from two double-blind, randomized, parallel, placebo-controlled, multicenter trials of cardiac surgery patients—preoperative use (n=105) and postoperative use (n=110). Patients were undergoing coronary artery bypass grafting with or without valve replacement. The primary endpoint was the incidence of treatment failure, defined as the inability to decrease SBP by ≥15% from baseline, or the discontinuation of study treatment for any reason within the 30-minute period after study drug initiation.

Individualized, titratable administration1

CLEVIPREX has a low-volume, non–weight-based dosing regimen that is independent of renal or hepatic function.1

50 mL and 100 mL CLEVIPREX single-use vials