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eicosapentaenoic acid ethyl ester and Fatty Liver

eicosapentaenoic acid ethyl ester has been researched along with Fatty Liver in 3 studies

Fatty Liver: Lipid infiltration of the hepatic parenchymal cells resulting in a yellow-colored liver. The abnormal lipid accumulation is usually in the form of TRIGLYCERIDES, either as a single large droplet or multiple small droplets. Fatty liver is caused by an imbalance in the metabolism of FATTY ACIDS.

Research Excerpts

ExcerptRelevanceReference
"The primary efficacy end point was NAFLD activity score ≤ 3, without worsening of fibrosis; or a decrease in NAFLD activity score by ≥ 2 with contribution from >1 parameter, without worsening of fibrosis, 1 year after the last dose of EPA-E or placebo was given."2.79No significant effects of ethyl-eicosapentanoic acid on histologic features of nonalcoholic steatohepatitis in a phase 2 trial. ( Abdelmalek, MF; Chojkier, M; Cummings, OW; Sanyal, AJ; Suzuki, A, 2014)
"Eicosapentaenoic acid (EPA) is a member of the family of n-3 polyunsaturated fatty acids (PUFAs) that are clinically used to treat hypertriglyceridemia."1.35Highly purified eicosapentaenoic acid prevents the progression of hepatic steatosis by repressing monounsaturated fatty acid synthesis in high-fat/high-sucrose diet-fed mice. ( Harada, T; Imada, K; Kajikawa, S; Kawashima, A; Mizuguchi, K, 2009)

Research

Studies (3)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's1 (33.33)18.2507
2000's1 (33.33)29.6817
2010's1 (33.33)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Sanyal, AJ1
Abdelmalek, MF1
Suzuki, A1
Cummings, OW1
Chojkier, M1
Kajikawa, S1
Harada, T1
Kawashima, A1
Imada, K1
Mizuguchi, K1
Kurihara, T1
Tsuchiya, M1
Akimoto, M1
Hashimoto, H1
Ishiguro, H1
Niimi, A1
Maeda, A1
Shigemoto, M1
Yamashita, K1
Yokoyama, I1
Kikuchi, Y1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase II Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With NASH[NCT01154985]Phase 2243 participants (Actual)Interventional2010-06-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Alanine Transaminase (ALT) Levels

"Mean change from baseline at month 3 analyzed by Analysis of Covariance (ANCOVA) in the efficacy evaluable analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;~EPA-E 2700 mg and Placebo groups~EPA-E 1800 mg and Placebo groups" (NCT01154985)
Timeframe: 3 month endpoint

InterventionU/L (Least Squares Mean)
Placebo-19.3
EPA-E 1800 mg/Day-3.0
EPA-E 2700 mg/Day2.8

Alanine Transaminase (ALT) Levels

"Mean change from baseline at month 6 analyzed by Analysis of Covariance (ANCOVA) in the efficacy analysis set with treatment group as a factor and baseline ALT as a covariate. Principal comparisons were the response between;~EPA-E 2700 mg and Placebo groups~EPA-E 1800 mg and Placebo groups" (NCT01154985)
Timeframe: 6 months

InterventionU/L (Mean)
Placebo-19.1
EPA-E 1800 mg/Day-9.5
EPA-E 2700 mg/Day-3.0

Histological Response Defined by Change From Baseline in Standardized Scoring of Liver Biopsies

"Patient is considered a responder if histological examination shows:~Composite NAS of <=3 AND no worsening in Fibrosis OR Improvement in NAS by >=2 across at least 2 of the NAS components AND no worsening in fibrosis~A priori threshold for statistical significance is p<0.05, 1-sided" (NCT01154985)
Timeframe: 12 months

Interventionparticipants (Number)
Placebo18
EPA-E 1800 mg/Day18
EPA-E 2700 mg/Day20

Trials

1 trial available for eicosapentaenoic acid ethyl ester and Fatty Liver

ArticleYear
No significant effects of ethyl-eicosapentanoic acid on histologic features of nonalcoholic steatohepatitis in a phase 2 trial.
    Gastroenterology, 2014, Volume: 147, Issue:2

    Topics: Biopsy; Disease Progression; Double-Blind Method; Eicosapentaenoic Acid; Fatty Liver; Female; Humans

2014

Other Studies

2 other studies available for eicosapentaenoic acid ethyl ester and Fatty Liver

ArticleYear
Highly purified eicosapentaenoic acid prevents the progression of hepatic steatosis by repressing monounsaturated fatty acid synthesis in high-fat/high-sucrose diet-fed mice.
    Prostaglandins, leukotrienes, and essential fatty acids, 2009, Volume: 80, Issue:4

    Topics: Animals; Dietary Fats; Eicosapentaenoic Acid; Fatty Acids, Monounsaturated; Fatty Liver; Gene Expres

2009
[Blood rheological study in rats with fatty liver--with special reference to effects of ethyl icosapentate].
    Nihon Shokakibyo Gakkai zasshi = The Japanese journal of gastro-enterology, 1997, Volume: 94, Issue:5

    Topics: Animals; Eicosapentaenoic Acid; Fatty Acids; Fatty Liver; Liver; Liver Circulation; Male; Platelet A

1997