Delving into the Latest Updates on Clevidipine with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Clevelox, Clevidipine, Clevidipine (USAN/INN)

+ [6]

Target

L-type calcium channel

Mechanism

L-type calcium channel blockers(Voltage-gated L-type calcium channel blockers)

Therapeutic Areas

Cardiovascular Diseases

Active Indication

HypertensionPerioperative hypertensionHypotension

Inactive Indication

Acute decompensated heart failureAneurysm, Intracranial Berry, 1Cerebral Hemorrhage+ [3]

Originator Organization

The Medicines Company (Spain) SL

Active Organization

Sichuan Kelun Pharmaceutical Co., Ltd.

Beijing Tide Pharmaceutical Co., Ltd.Shandong Academy of Pharmaceutical Sciences

+ [4]

Inactive Organization

SPH No. 1 Biochemical & Pharmaceutical Co., Ltd.

The Medicines Co.

Chengdu Huide Pharmaceutical Technology Co Ltd

Drug Highest PhaseApproved

First Approval Date

US (01 Aug 2008),

Hypotension

Regulation-

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Structure

Molecular FormulaC21H23Cl2NO6

InChIKeyKPBZROQVTHLCDU-UHFFFAOYSA-N

CAS Registry167221-71-8

The purpose of this study is to determine if treatment of pre-induction hypertension with an intravenous short acting calcium channel antagonist will (1) reduce the magnitude and duration of blood pressure excursions outside of a pre-established normal range and (2) decrease the requirement for vasoactive medications during the period from induction of anesthesia until just prior to surgical incision.

Start Date01 Jan 2024

Sponsor / Collaborator

University of California San Diego

CTR20231630 / CompletedPhase 3

评估丁酸氯维地平注射用乳剂（QLG2071）对比原研丁酸氯维地平注射用乳剂（Cleviprex®）治疗高血压急症和亚急症的有效性和安全性的多中心、随机、双盲、阳性药物对照、平行设计Ⅲ期研究

[Translation] A multicenter, randomized, double-blind, active drug-controlled, parallel-design phase III study to evaluate the efficacy and safety of clevidipine butyrate injection emulsion (QLG2071) versus the original clevidipine butyrate injection emulsion (Cleviprex®) in the treatment of hypertensive emergencies and sub-urgent conditions

主要研究目的:评估丁酸氯维地平注射用乳剂（QLG2071）对比原研丁酸氯维地平注射用乳剂（Cleviprex®）治疗高血压急症和亚急症的疗效相似性。

[Translation]

Main study objective: To evaluate the similarity of the efficacy of clevidipine butyrate injection emulsion (QLG2071) versus the original clevidipine butyrate injection emulsion (Cleviprex®) in the treatment of hypertensive emergencies and sub-emergencies.

Start Date23 Jul 2023

Sponsor / Collaborator

Qilu Pharmaceutica Hainanco Ltd.

100 Clinical Results associated with Clevidipine

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100 Translational Medicine associated with Clevidipine

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100 Patents (Medical) associated with Clevidipine

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169

Literatures (Medical) associated with Clevidipine

01 Dec 2024·Annals of Pharmacotherapy

Incidence of Hypertriglyceridemia in Patients on Propofol, Clevidipine, or Both

Article

Author: Fleming, Travis W. ; Brown, Skyler R. ; Johns, Christopher B. ; Black, Rebekah B. ; Rowe, A. Shaun

Background: Propofol and clevidipine (PC) are commonly used in the treatment of critically ill patients. While both medications are lipid emulsions, there is limited evidence concerning the incidence of hypertriglyceridemia (HTG) when these agents are used individually or concurrently. Objective: The objective of this study is to determine the effects of propofol, clevidipine, or concurrent PC on triglycerides (TGs) and related outcomes in critically ill adults. Methods: This was a retrospective cohort study conducted at an academic medical center. Patients were included if they received ≥24 hours of continuous propofol and/or clevidipine. Excluded were those without TG levels after ≥24 hours of infusion, baseline HTG, acute pancreatitis at admission, or receiving total parenteral nutrition with lipids. The primary outcome was incidence of HTG (defined as a TG level >400 mg/dL). Secondary outcomes included median and peak TG levels, hospital length of stay, intensive care unit length of stay, total lipid infused, time to peak TG level, peak lipase level, and development of pancreatitis. Results: In total, 190 patients were studied: 109 in the propofol group, 50 in the clevidipine group, and 31 in the PC group. Incidence of HTG was similar (19 [17.4%] vs 6 [12%] vs 4 [12.9%] patients, P = 0.6246). Peak and median TG levels were similar for propofol, clevidipine, and PC groups (216 mg/dL vs 189.5 mg/dL vs 205 mg/dL, P = 0.7069; 177 mg/dL vs 185.5 mg/dL vs 177 mg/dL, P = 0.6791). Conclusions and Relevance: There was a similar incidence of HTG in all groups. The results of this study suggest that the concurrent use of PC should not modify the frequency of TG level monitoring.

23 Oct 2024·American Journal of Health-System Pharmacy

Comparison of clevidipine vs nicardipine in the treatment of hypertensive urgency and emergency in critically ill patients

Article

Author: Ferreira, Jason ; Erdman, Michael ; Johnson, Logan

AbstractPurposeEvidence has suggested that clevidipine may provide faster blood pressure (BP) reduction with less volume than nicardipine in stroke and cardiothoracic surgery patients, but its use in hypertensive crises has not been well established. The primary objective of this study was to compare the treatment success of clevidipine and nicardipine in hypertensive crisis.MethodsThis was a multicenter, retrospective cohort study including patients who received either clevidipine or nicardipine for treatment of hypertensive crisis. The primary outcome was the time from infusion start to attainment of goal BP, defined as the higher value of the guideline-directed 25% reduction in BP or the physician-ordered goal. Secondary outcomes were the time from infusion start to guideline-directed 25% reduction in BP, drug and total volume intake, the time from order entry to BP goal attainment, the number of BP and heart rate excursions, intensive care unit (ICU) length of stay, and study medication cost.ResultsIn total, 182 patients were included in the study (103 receiving nicardipine and 79 receiving clevidipine). Time to goal BP was similar between the groups (35 vs 33 minutes for clevidipine vs nicardipine, respectively; P = 0.37). Time to guideline-directed 25% reduction was also similar (P = 0.42). Volume from study drug was significantly less with clevidipine (222 vs 518 mL; P = 0.01); however, the total volume received in the ICU was similar (3,370 vs 3,383 mL; P = 0.43). Percent time in the goal BP range was similar (43.1% vs 42.3%). The cost of clevidipine was $199.37 per vial (based on the average wholesale price as of June 2023). This cost was 682% higher than that for a bag of nicardipine.ConclusionTime to goal BP was similar for clevidipine and nicardipine in this population. Any decreases in medication-associated volume with clevidipine were no longer evident when all volume sources were considered. These results show that clevidipine may not provide meaningful benefit in this heterogenous population. The difference in cost does not seem justified given the lack of improvement in clinically relevant outcomes.

01 Oct 2024·Neurocritical Care

Assessment of Blood Pressure and Heart Rate Related Variables in Acute Stroke Patients Receiving Intravenous Antihypertensive Medication Infusions

Article

Author: Gomez, Francisco ; Gomez, Camilo R ; Chandrasekaran, Premkumar N ; Siddiq, Farhan ; Baskett, William I ; Shyu, Chi-Ren ; Lodhi, Abdullah ; Arora, Niraj ; Qureshi, Adnan I

BACKGROUNDWe performed an analysis of a large intensive care unit electronic database to provide preliminary estimates of various blood pressure parameters in patients with acute stroke receiving intravenous (IV) antihypertensive medication and determine the relationship with in-hospital outcomes.METHODSWe identified the relationship between pre-treatment and post-treatment systolic blood pressure (SBP) and heart rate (HR)-related variables and in-hospital mortality and acute kidney injury in patients with acute stroke receiving IV clevidipine, nicardipine, or nitroprusside using data provided in the Medical Information Mart for Intensive Care (MIMIC) IV database.RESULTSA total of 1830 patients were treated with IV clevidipine (n = 64), nicardipine (n = 1623), or nitroprusside (n = 143). The standard deviations [SDs] of pre-treatment SBP (16.3 vs. 13.7, p ≤ 0.001) and post-treatment SBP (15.4 vs. 14.4, p = 0.004) were higher in patients who died compared with those who survived, particularly in patients with intracerebral hemorrhage (ICH). The mean SBP was significantly lower post treatment compared with pre-treatment values for clevidipine (130.7 mm Hg vs. 142.5 mm Hg, p = 0.006), nicardipine (132.8 mm Hg vs. 141.6 mm Hg, p ≤ 0.001), and nitroprusside (126.2 mm Hg vs. 139.6 mm Hg, p ≤ 0.001). There were no differences in mean SDs post treatment compared with pre-treatment values for clevidipine (14.5 vs. 13.5, p = 0.407), nicardipine (14.2 vs. 14.6, p = 0.142), and nitroprusside (14.8 vs. 14.8, p = 0.997). The SDs of pre-treatment and post-treatment SBP were not significantly different in patients with ischemic stroke treated with IV clevidipine, nicardipine, or nitroprusside or for patients with ICH treated with IV clevidipine or nitroprusside. However, patients with ICH treated with IV nicardipine had a significantly higher SD of post-treatment SBP (13.1 vs. 14.2, p = 0.0032).CONCLUSIONSWe found that SBP fluctuations were associated with in-hospital mortality in patients with acute stroke. IV antihypertensive medication reduced SBP but did not reduce SBP fluctuations in this observational study. Our results highlight the need for optimizing therapeutic interventions to reduce SBP fluctuations in patients with acute stroke.

100 Deals associated with Clevidipine

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External Link

KEGG	Wiki	ATC	Drug Bank
D08892	Clevidipine	C08CA16	DB04920

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hypertension	NZ	-	22 Feb 2012
Perioperative hypertension	CH	CHIESI Farmaceutici SpA	11 Jun 2010
Hypotension	US	Chiesi USA, Inc	01 Aug 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute decompensated heart failure	Preclinical	DE	The Medicines Co.	01 Dec 2008
Acute decompensated heart failure	Preclinical	FR	The Medicines Co.	01 Dec 2008
Hypertension	Preclinical	US	The Medicines Co.	01 Dec 2003
Acute decompensated heart failure	Discovery	FR	The Medicines Co.	01 Dec 2008
Acute decompensated heart failure	Discovery	DE	The Medicines Co.	01 Dec 2008

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01369147 (CTgov)	Phase 2	Critical Illness	12	Enteral feeding+Propofol+Clevidipine+Dextrose-containing IV Fluids (Parenteral Nutrition Energy Dose at 0.6 x Measured REE)	lhnsidqdsh(pkujbqrtnv) = ujrorwpyyp jriposykos (rlmekepbxb, xgmqemqcxt - xnrqvosygc) View more	-	10 Jun 2022
				Enteral feeding+Propofol+Clevidipine+Dextrose-containing IV Fluids (Parenteral Nutrition Energy Dose at 1.0 x Measured REE)	lhnsidqdsh(pkujbqrtnv) = zlmoscjixz jriposykos (rlmekepbxb, bjkipykmlu - lzrhuucuku) View more
ASN2016	Not Applicable	Hypertriglyceridemia \| Fasting \| Ketosis	-	Clevidipine	rxwfnozyvj(zhulmcnipg) = To our knowledge this is the first reported case of severe hypertriglyceridemia and fasting ketoacidosis associated with intravenous CLV. For fasting patients receiving CLV, close monitoring of triglycerides and administration of glucose with insulin should be considered. gncwozzupm (upsvkxdzgr )	-	15 Nov 2016
				Nicardipine
NCT01645111 (CTgov)	Phase 2/3	Scoliosis \| Hypotension	50	Clevidipine	pzisxqbexn(ucjrnysead) = ikqteutkzv qzgzagwqcm (umcmwehptm, vkutkhvsfu - noctzaohos) View more	-	18 Feb 2015
ISC2015	Not Applicable	Ischemic stroke \| Hypertension	-	Nicardipine	(rtffwwdmix) = fvndlqxjcl ehlnvadkyv (cgycjxonqw ) View more	-	01 Feb 2015
				Labetalol	(rtffwwdmix) = ecrqkpfbxi ehlnvadkyv (cgycjxonqw ) View more
NCT00799604 (SPRINT, CTgov)	Phase 2	Hypertension	30	Clevidipine (Cohort 1: Clevidipine 250 μg (0.5 mL))	qgicxluhga(ocdqyfbzox) = rkmwygjxvw xopsavizvy (kfhaqumgab, fufmugwphz - vhndpdtqyj) View more	-	04 Jun 2014
				Clevidipine (Cohort 2: Clevidipine 500 μg (1.0 mL))	qgicxluhga(ocdqyfbzox) = orysfqzbak xopsavizvy (kfhaqumgab, wyotzdvsgm - vhiptdkmmp) View more
NCT00952081 (CTgov)	Phase 4	Epilepsy \| Hypertension \| Brain Cancer	22	Clevidipine	sirgjygcgt(aprdtifomp) = sbjeparuxb uvrpkeqykd (fsbgkvjvkj, xntcpxqyhf - wmhqpntlbn) View more	-	30 Oct 2013
NCT00666328 (ACCELERATE, CTgov)	Phase 3	Cerebral Hemorrhage \| Hemorrhage \| Hypertension	37	clevidipine	cgvqpqrvfb(fadkltavkm) = nllxhfheuk eygxalpeiy (xpiiwhvhsk, unvzjtnfit - afyzemwbwb) View more	-	08 Apr 2013
NCT00369837 (Pubmed \| Ann Emerg Med)	Phase 3	Hypertension, severe	126	Clevidipine	pbubdrlcld(mbysaznnol) = nqbexjjmhm wopzljfkil (tbkihzhemv )	-	01 Mar 2009
NCT00093262 (ESCAPE-2, Pubmed \| Anesth Analg)	Phase 3	Hypertension	206	Clevidipine	(hkdnvukqvc) = gwnllrwlwy szhqvvpkgf (avbxpyzpdx ) View more	Positive	01 Jul 2008
				Placebo	(hkdnvukqvc) = hckiqmyilm szhqvvpkgf (avbxpyzpdx )