CLEVIPREX® (clevidipine) provides BP reduction in a range of patients and clinical settings

CLEVIPREX vials with graph

CLEVIPREX efficacy was evaluated across 4 clinical studies1-5

See the results of each clinical study below.

ESCAPE-12

Preoperative hypertension

(N=105):
Efficacy/Safety vs placebo

ESCAPE-23

Postoperative hypertension

(N=110):
Efficacy/Safety vs placebo

VELOCITY4

Severe hypertension

(N=126):
Open-label efficacy/safety in patients with acute severe hypertension

ACCELERATE5

Intracerebral hemorrhage

(N=35):
Open-label pilot study of efficacy/safety in ICH patients with hypertension

ESCAPE-12

Preoperative hypertension

(N=105):
Efficacy/Safety vs placebo

ESCAPE-23

Postoperative hypertension

(N=110):
Efficacy/Safety vs placebo

VELOCITY4

Severe hypertension

(N=126):
Open-label efficacy/safety in patients with acute severe hypertension

ACCELERATE5

Intracerebral hemorrhage

(N=35):
Open-label pilot study of efficacy/safety in patients with ICH and hypertension

ESCAPE-1: Preoperative hypertension

Responsive BP reduction within minutes in the preoperative clinical setting1,2

92.5% of patients on CLEVIPREX achieved treatment success2*

The primary endpoint was the incidence of treatment failure, defined as the inability to decrease systolic blood pressure (SBP) by ≥15% from baseline or the discontinuation of study treatment for any reason within the 30 minutes after study drug initiation.2

*Treatment success was defined as a reduction of SBP of ≥15% from baseline within the 30 minutes after study drug initiation.

Target SBP reduction (≥15% from baseline) achieved within a median time of 6 minutes2

ESCAPE-1 (Preoperative Hypertension) Study Design2

Study type Randomized, double-blind, placebo-controlled, phase 3 study
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Purpose To determine the safety and efficacy of CLEVIPREX in treating preoperative hypertension
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Patient population
  • N=105
  • Cardiac surgery patients
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Key inclusion criteria SBP ≥160 mm Hg and clinically assessed as needing ≥15% reduction in SBP
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Protocol
  • Initiated CLEVIPREX at 1 to 2 mg/h, dose doubled every ~90 seconds up to 16 mg/h until desired SBP was achieved
  • At doses >16 mg/h, dose increments were 7 mg/h
  • Continued treatment for at least 30 minutes, maximum 1 hour, or anesthesia induction

Recommended in Stroke Guidelines

CLEVIPREX has been recommended in the AHA/ASA Acute Ischemic Stroke Guidelines since 2018.6

Review the Guidelines

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ESCAPE-2: Perioperative hypertension

High rate of treatment success in the postoperative clinical setting1,3

91.8% of patients on CLEVIPREX achieved treatment success3*

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 minutes after study drug initiation.3

*Treatment success was defined as a reduction of SBP of ≥15% from baseline within the 30 minutes after study drug initiation.

Target SBP reduction (≥15% from baseline) achieved within a median time of 5.3 minutes3

†The decrease in the placebo group’s SBP reflects the number of placebo patients (N=49 at baseline) who bailed out during the 30-minute infusion period (N=10 remaining at 30 minutes).

ESCAPE-2 (Postoperative Hypertension) Study Design3

Study type Randomized, double-blind, placebo-controlled, phase 3 study
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Purpose To determine the safety and efficacy of CLEVIPREX in treating postoperative hypertension
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Patient population
  • N=110
  • Cardiac surgery patients
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Key inclusion criteria SBP ≥140 mm Hg and clinically assessed as needing ≥15% reduction in SBP
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Protocol
  • Initiated CLEVIPREX at 1 to 2 mg/h, dose doubled every ~90 seconds up to 16 mg/h until desired SBP was achieved
  • At doses >16 mg/h, dose increments were 7 mg/h
  • Continued treatment for at least 30 minutes, maximum 1 hour

CLEVIPREX Flashcard

Download a PDF overview of helpful information about CLEVIPREX.

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VELOCITY: Severe hypertension

Control of acute severe hypertension with low rate of overshoot4

Nearly 89% of patients with acute severe hypertension achieved target BP range4*

  • Target SBP range achieved within a median time of 10.9 minutes4
  • No change in lipid profile was observed4†
  • Mean duration of infusion was 21 hours1,4

*mITT population, n=117.

†Increased blood triglycerides have been observed in the postmarketing experience of CLEVIPREX.

Low rate of overshoot‡ in patients with acute severe hypertension4

  • 1.6% of patients (n=2) experienced overshoot within the first 3 minutes after start of infusion. These 2 patients continued CLEVIPREX infusion beyond 18 hours without experiencing any adverse events (AEs)4
  • In this study, the incidence of AEs leading to study drug discontinuation was 4.8%1

‡Overshoot was defined as SBP below the prespecified initial target range within the first 3 minutes of starting the infusion.

CLEVIPREX safety data in acute severe hypertension

  • Serious AEs from CLEVIPREX initiation to 7 days later were reported in 11 of 126 (8.7%) safety population patients4
  • Headache was the most frequently reported AE, with an overall incidence of 6.3% (8 of 126), followed by nausea 4.8% (6 of 126), chest discomfort 3.2% (4 of 126), and vomiting 3.2% (4 of 126)4
  • The incidence of AEs leading to study drug discontinuation for CLEVIPREX in severe hypertension was 4.8%1

VELOCITY (Acute Severe Hypertension) Study Design4

Study type Open label, single arm
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Purpose To determine the safety and efficacy of CLEVIPREX in treating severe hypertension
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Patient population
  • N=126
  • Patients with severe hypertension
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Key inclusion criteria SBP >180 mm Hg or diastolic blood pressure [DBP] >115 mm Hg
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Protocol7
  • Initiated at 2 mg/h and uptitrated every 3 minutes
  • Doubled up to a maximum dose of 32 mg/h as required to achieve a prespecified target BP range within 30 minutes (primary endpoint)
  • SBP target range was prespecified, patient-specific, and calculated 20 to 40 mm Hg range from the upper to lower limit (selected according to treating physician’s discretion and patient’s presenting condition, baseline BP, and presence of comorbidities)

Dr. Horowitz speaks about CLEVIPREX

Renowned anesthesiologist Dr. Todd Horowitz discusses CLEVIPREX clinical trial results and dosing in a series of informative videos for healthcare professionals.

ACCELERATE: Intracerebral hemorrhage

Median time to achieve target SBP range was 5.5 minutes5

All patients achieved target SBP within 30 minutes5

  • 96.9% achieved target SBP with CLEVIPREX monotherapy5
  • Mild/moderate hypotension was reported in 3 patients and resolved with dose reduction or drug discontinuation5

Mean (±SE) change in SBP with clevidipine (mITT population=33).
Mean baseline SBP=186 mm Hg.

CLEVIPREX is not indicated for the prevention or treatment of stroke.