CLEVIPREX® (clevidipine) provided blood pressure reduction

in a range of patients and various clinical settings

Cleviprex vials with graph

CLEVIPREX was evaluated across 4 clinical studies1-5

PERIOPERATIVE HYPERTENSION

ESCAPE-12

(N=105):
Efficacy/safety vs placebo preoperatively

PERIOPERATIVE HYPERTENSION

ESCAPE-23

(N=110):
Efficacy/safety vs placebo postoperatively

SEVERE
HYPERTENSION

VELOCITY4

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

INTRACEREBRAL HEMORRHAGE

ACCELERATE5

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

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

92.5% of patients on CLEVIPREX achieved treatment success*2

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.2

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Success rate (%) (n=53) (n=52) PLACEBO 0 20 40 60 80 100 92.5 17.3 Treatment success rate*2 P<0.0001 CLEVIPREX

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

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Mean change from baseline in SBP (mmHg) CLEVIPREX PLACEBO –50 –40 –30 –20 –10 0 0 5 10 15 20 25 30 Time (minutes) Mean change in SBP (mmHg)during 30-minute infusion1

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

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

 

Responsive BP reduction within minutes in the postoperative clinical setting1,3

91.8% of patients on CLEVIPREX achieved treatment success*3

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.3

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P<0.0001 Treatment success rate*3 CLEVIPREX (n=61) (n=49) PLACEBO 0 20 40 60 80 100 91.8 20.4 Success rate (%)

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

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Mean change from baseline in SBP (mmHg) –50 –40 –30 –20 –10 0 0 5 10 15 20 25 30 Time (minutes) Mean change in SBP (mmHg)during 30-minute infusion1 PLACEBO CLEVIPREX

The decrease in placebo group 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).

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

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

Control of acute severe hypertension with low rate of overshoot4

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Mean percent change from baseline in SBP (%) CLEVIPREX N=126 –25 –20 –15 –10 –5 0 0 5 10 15 20 25 30 Time (minutes)
  • Nearly 89% of acute severe hypertension patients achieved target BP range4
  • Target SBP range achieved with a median time of 10.9 minutes4
  • No change in lipid profile was observed*4
  • Mean duration of infusion=21 hours1,4

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

VELOCITY safety data

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

Low rate of overshoot in acute severe hypertension patients4

  • 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 events4
  • In this study, the incidence of adverse events 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.

VELOCITY study design4

An open-label, single-arm clinical trial in 126 patients with severe hypertension (SBP >180 mmHg or DBP >115 mmHg). CLEVIPREX infusion was initiated at 2 mg/hr and up-titrated every 3 minutes, doubling up to a maximum dose of 32 mg/hr as required to achieve a prespecified target blood pressure range within 30 minutes (primary endpoint). The SBP target range was prespecified, patient specific, and calculated as 20–40 mmHg range from upper to lower limit. It was selected by the treating physician’s discretion and according to the patient’s presenting condition, baseline blood pressure, and presence of comorbidities.

SBP changes over time with CLEVIPREX5

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
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CLEVIPREX_CHARTS_MASTER_11202019

Mean (+/-SE) change in SBP with clevidipine (mITT population, n=33).
Mean baseline SBP=186 mmHg.

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

Study type Multi-center, prospective, open-label, pilot, phase 3b study
Purpose Evaluate the efficacy and safety of CLEVIPREX in managing hypertension (SBP >160 mmHg) in patients presenting within 6 or 12 hours of symptom onset with intracerebral hemorrhage (ICH)
Patient population N=35
Key inclusion criteria
  • CT evidence of ICH
  • Presentation within 12 hours of ICH symptom onset
  • SBP >160 mmHg
Protocol6
  • CLEVIPREX was initiated at 2 mg/hr and titrated every 90 seconds until SBP <160 mmHg was achieved
  • CLEVIPREX was titrated to maintain SBP within the specified target range (140 mmHg to 160 mmHg) for a minimum of 30 minutes to a maximum of 96 hours
  • BP was monitored continuously via arterial line

Individualized, titratable administration1

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

50 mL and 100 mL CLEVIPREX single-use, ready-to-use vials

CLEVIPREX Flashcard

Download a PDF overview of helpful information about CLEVIPREX.


Demonstrated safety profile

The safety profile of CLEVIPREX was evaluated in multiple randomized studies.1