Delving into the Latest Updates on Long Chain Fat Emulsion (OO) with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

脂肪/磷脂, ClinOleic, 克凌诺

Target-

Mechanism-

Therapeutic Areas-

Active Indication-

Inactive Indication-

Originator Organization

Baxter SA

Active Organization

Baxter SA

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

CN (01 Apr 2011)

Regulation-

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Small studies suggest differences in efficacy and safety exist between olive oil-based and soybean oil-based parenteral nutrition regimens in hospitalized adult patients. A study in China suggested that olive oil-based parenteral nutrition provided effective nutrition, was well tolerated, was associated with fewer infections and conferred greater ease-of-use than soybean oil-based parenteral nutrition. The objectives of this study were to assess safety and efficacy of an ClinOleic-based lipid parenteral nutrition regimen compared with Structolipid-based lipid parenteral nutrition regimen in Chinese adults after pancreatectomy for whom oral or enteral nutrition was not possible, insufficient or contraindicated.

Start Date01 Jul 2017

Sponsor / Collaborator

Third Affiliated Hospital of Nanjing Medical University

[+1]

NCT01943409 / CompletedPhase 4IIT

Parenteral Nutrition in Hospitalized Patients: Comparison of Two Commercially Available Lipid Emulsions

Intravenous nutrition is an important therapy for the recovery of many patients. It is indicated when the patients cannot take food by mouth or use their intestines for feeding. It is important to indicate it in the appropriate setting because it's not free of complications and is a costly treatment. Some of the complications are: elevated blood sugar or lipids, elevated liver function tests, infection of the catheter or device used to administer intravenous nutrition. Intravenous nutrition is composed by proteins, lipids, carbohydrates (sugar in the form of glucose) and vitamins. Until recently, Intralipid, a soybean oil-based lipid emulsion was the only lipid available in Canada for this kind of nutrition. Since 2010, a new lipid emulsion (ClinOleic) based on olive-oil has been approved by Health Canada for use in intravenous nutrition. There is an increasing need for hospitals to evaluate the quality of intravenous nutrition administered to hospitalized patients in terms of: assessing indications, prescription, complications, clinical results and costs. The objective of this study is to determine if intravenous nutrition prescribed in hospitalized patients is indicated following existing guidelines in terms of timing of nutrition support, prescription, monitoring and whether it is associated with complications. In addition, length of stay and mortality will be assessed. Also, we will evaluate nutritional, infectious and inflammatory parameters in patients receiving soybean oil-based lipid emulsion (Intralipid) compared to those of patients receiving olive oil-based lipid emulsion (ClinOleic).

Start Date01 Jul 2013

Sponsor / Collaborator

University Health Network

NCT01786759 / Unknown statusPhase 4IIT

Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion

The etiology of parenteral nutrition-associated cholestasis(PNAC)although elusive is thought to be multifactorial, and proposed theories also include problems arising from lipid emulsions, leading us to explore alternative products available elsewhere.So we compare the different fat emulsion, and want to see if the olive oil lipid emulsions can improve hepatic tolerance in preterm infant.

Start Date01 Oct 2012

Sponsor / Collaborator

Shanghai Jiao Tong University

100 Clinical Results associated with Long Chain Fat Emulsion (OO)

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100 Translational Medicine associated with Long Chain Fat Emulsion (OO)

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100 Patents (Medical) associated with Long Chain Fat Emulsion (OO)

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76

Literatures (Medical) associated with Long Chain Fat Emulsion (OO)

01 Sep 2024·Cell Biochemistry and Biophysics

ClinOleic Impairs ROS Production and Phagocytosis in M1 Macrophages Without Affecting M1 Differentiation

Article

Author: Sheu, Shew-Meei ; Yeh, Hsuan-Te ; Lin, Wen-Chun ; Chang, Hui-Ju ; Chen, Ming-Shan ; Tsai, Yi-Sheng

Lipid emulsions are the primary source of calories and fatty acids that are used to provide essential energy and nutrients to patients suffering from severe intestinal failure and critical illness. However, their use has been linked to adverse effects on patient outcomes, notably affecting immune defenses and inflammatory responses. ClinOleic is a lipid emulsion containing a mixture of olive oil and soybean oil (80:20). The effect of ClinOleic on the differentiation of M1 macrophages remains unclear. In this study, we isolated human monocytes and added ClinOleic to differentiation culture media to investigate whether it affects monocyte polarization into M1 macrophages and macrophage functions, such as reactive oxygen species (ROS) production and phagocytosis. ROS production was stimulated by live S. aureus and detected with L-012, a chemiluminescence emission agent. Phagocytic capacity was assayed using pHrodo™ Green S. aureus Bioparticles^® Conjugate. We found that M1 cell morphology, surface markers (CD80 and CD86), and M1-associated cytokines (TNF-α and IL-6) did not significantly change upon incubation with ClinOleic during M1 polarization. However, S. aureus-triggered ROS production was significantly lower in M1 macrophages differentiated with ClinOleic than in those not treated with ClinOleic. The inhibitory effect of ClinOleic on macrophage function also appeared in the phagocytosis assay. Taken together, these findings reveal that ClinOleic has a limited impact on the M1 differentiation phenotype but obviously reduces ROS production and phagocytosis.

01 Jul 2024·Farmacia Hospitalaria

[Artículo traducido] Efectividad comparativa de 2 emulsiones lipídicas en la prevención de la retinopatía del prematuro en neonatos pretérmino que requieren nutrición parenteral

Article

Author: Montoro Ronsano, José Bruno ; Clemente Bautista, Susana ; Gorgas Torner, M Queralt ; Martín-Begué, Nieves ; Castillo Salinas, Félix ; Cabañas Poy, M José

OBJECTIVESThe main aim was to compare the effects of two parenteral lipid emulsions on retinopathy of prematurity (ROP) incidence, severity, and need for treatment. Secondary aim was to compare the effect on weight gain in the first 6 weeks of life.METHODSSingle-center, observational, retrospective study analyzing preterm infants with a gestational age < 31 weeks and a birth weight < 1,251 g, born between April 2015 and December 2018. The infants' medical records were reviewed to collect clinical data. Parenteral nutrition details were obtained from the hospital pharmacy database.RESULTSIn total, 180 patients were included: 90 received ClinOleic® and 90 received SMOFlipid®. No significant differences were observed for the incidence of ROP (40% in ClinOleic® group and 41% in SMOFlipid® group, p=0.88) or ROP requiring treatment (4% and 10% respectively, p=0.152). Weekly weight gain was similar in the two groups.CONCLUSIONSThis study showed no difference between the two groups regarding ROP, ROP requiring treatment or weekly weight gain in the first 6 weeks of life.

01 Jul 2024·Farmacia Hospitalaria

Comparative effectiveness of two lipid emulsions in preventing retinopathy of prematurity in preterm infants requiring parenteral nutrition

Article

Author: Montoro Ronsano, José Bruno ; Cabañas Poy, Mª José ; Clemente Bautista, Susana ; Martín-Begué, Nieves ; Castillo Salinas, Félix ; Gorgas Torner, Mª Queralt

OBJECTIVESThe main aim was to compare the effects of 2 parenteral lipid emulsions on retinopathy of prematurity (ROP) incidence, severity, and need for treatment. Secondary aim was to compare the effect on weight gain in the first 6 weeks of life.METHODSSingle-center, observational, retrospective study analyzing preterm infants with a gestational age (GA) <31 weeks and a birth weight <1251 g born between April 2015 and December 2018. The infants' medical records were reviewed to collect clinical data. Parenteral nutrition (PN) details were obtained from the hospital pharmacy database.RESULTSIn total, 180 patients were included: 90 received ClinOleic® and 90 received SMOFlipid®. No significant differences were observed for the incidence of ROP (40% in ClinOleic® group and 41% in SMOFlipid® group, p=.88) or ROP requiring treatment (4% and 10%, respectively, p=.152). Weekly weight gain was similar in the 2 groups.CONCLUSIONSThis study showed no difference between the 2 groups regarding ROP, ROP requiring treatment, or weekly weight gain in the first 6 weeks of life.

100 Deals associated with Long Chain Fat Emulsion (OO)

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R&D Status

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00672854 (TPN2, CTgov)	Phase 2/3	Dietary Supplement \| stress oxidative	100	Intralipid (Total Parenteral Nutrition (TPN) Given Intralipid 20%)	imlatjocpl(nfzqojkjic) = ffodisslld mrkbfnthkn (vbvulstcmm, ctyimtruqr - qhwesbvuqw) View more	-	01 Aug 2014
				ClinOleic (Total Parenteral Nutrition (TPN) Given ClinOleic 20%)	imlatjocpl(nfzqojkjic) = qzfaaefvlo mrkbfnthkn (vbvulstcmm, tkpqvkggpp - theszrkere) View more
NCT01096771 (CTgov)	Phase 2	Respiratory Distress Syndrome, Adult	14	ClinOleic (Experimental ClinOleic 20%)	uvhgnszmrx(leiwxqffrz) = uafeqdqwxu ytuklnmxhn (ernuinmtpb, mrwcawvwgs - shwbcajeca) View more	-	26 May 2014
				Intralipid (Control: Intralipid 20%)	uvhgnszmrx(leiwxqffrz) = hfujjgfddl ytuklnmxhn (ernuinmtpb, izwkulvjup - msbzqcenwf) View more