This study will evaluate the pharmacokinetic linearity of a single 35 mg fenofibric acid dose and demonstrate the bioequivalence of three 35 mg fenofibric acid tablets (105 mg total single dose) to a single 105 mg fenofibric acid tablet in healthy adult volunteers when each dose is administered under fasted conditions. Fifty-four healthy, non-smoking, non-obese, 18-45 year old, male and female volunteers will be randomly assigned in a crossover fashion to receive each of three fenofibric acid dosing regimens in sequence with a 7 day washout period between dosing periods. On the morning of the first day of each dosing period, after an overnight fast of at least 10 hours, subjects will receive single doses of fenofibric acid (1 x 35 mg tablet), fenofibric acid (3 x 35 mg tablets - 105 mg total dose), or fenofibric acid (1 x 105 mg tablet). Fasting will continue for 4 hours after dose administration. Blood samples will be drawn from all participants prior to dosing and for 72 hours post-dose, at ...
Fenofibrate is rapidly and completely hydrolyzed to fenofibric acid, the active moiety. The primary objective of this study is to evaluate the bioequivalence of fenofibric acid and fenofibrate under fasting conditions. Additionally, the safety and tolerability of the study treatments will be evaluated. Fifty-four healthy, non-smoking, non-obese, 18-45 year old, male and female volunteers will be randomly assigned in a crossover fashion to receive each of two dosing regimens, fenofibric acid (Fibricor™) and fenofibrate (Tricor®) in sequence with a 7 day washout period between dosing periods. On the morning of Day 1, after an overnight fast of at least 10 hours, subjects will receive either a single oral dose of the test formulation, fenofibric acid (1 x 105 mg tablet) or a single oral dose of the reference formulation, fenofibrate (1 x 145 mg tablet). After a 7 day washout period, on the morning of Day 8 after an overnight fast, subjects will receive the alternate regimen. Fasting will ...
Introduction: Fenofibrate is a peroxisome proliferator-activated receptor (PPAR)-alpha agonist which showed beneficial effects on lipid profile and total cardiovascular risk in patients with type 2 diabetes in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study. This study aimed to investigate the long-term effect of fenofibrate therapy on three novel biomarkers of cardiovascular risk, namely adipocyte-fatty acid binding protein (A-FABP), fibroblast growth factor 21 (FGF21), and retinol-binding protein 4 (RBP4), which are all downstream targets of PPAR-alpha or PPAR-gamma, in patients with type 2 diabetes.. Methods: A total of 216 patients (108 in the fenofibrate group and 108 in the placebo group) were randomly selected from the FIELD study cohort. A-FABP, FGF21, and RBP4 levels were measured in serum samples at both baseline and the fifth year of the study.. Results: Relative to the placebo group, the changes of serum FGF21 and RBP4 levels were 85% (P,0.001) and 10% ...
Composition: Micronized Fenofibrate 200 mg. Form: Capsule. Description:. What is fenofibrate in FenoFit used for? Fenofibrate is the generic form of the brand name drug Tricor, used to treat high levels of cholesterol and triglyceride in your blood. Fenofibrate belongs to a class of medications known as antilipemics and fibric acid. It works by breaking down fats and helping the body eliminate triglycerides.. What are the uses of FenoFit?. Fenofibrate is used along with a proper diet to help lower "bad" cholesterol and fats (such as LDL, triglycerides) and raise "good" cholesterol (HDL) in the blood. It works by increasing the natural substance (enzyme) that breaks down fats in the blood. Fenofibrate belongs to a group of drugs known as "FenoFit" Lowering triglycerides in people with very high triglyceride blood levels may decrease the risk of pancreas disease (pancreatitis). However, fenofibrate might not lower your risk of a heart attack or stroke.. What are the side effects of FenoFit?. This ...
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Despite improving standards of care, people with diabetes remain at risk of development and progression of diabetic retinopathy (DR) and visual impairment. Identifying novel therapeutic approaches, preferably targeting more than one pathogenic pathway in DR, and at an earlier stage of disease, is attractive. There is now consistent evidence from two major trials, the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study and the Action to Control Cardiovascular Risk in Diabetes Eye (ACCORD-Eye) study, totalling 11,388 people with type 2 diabetes (5,701 treated with fenofibrate) that fenofibrate reduces the risk of development and progression of DR. Therefore, fenofibrate may be considered a preventive strategy for patients without DR or early intervention strategy for those with mild DR. A number of putative therapeutic mechanisms for fenofibrate, both dependent and independent of lipids, have been proposed. A deeper understanding of the mode of action of fenofibrate will further ...
We have previously shown that the administration of fenofibrate to high-drinker UChB rats markedly reduces voluntary ethanol intake. Fenofibrate is a PPAR agonist, which induces the proliferation of peroxisomes in the liver, leading to increases in catalase levels that result in acetaldehyde accumulation at aversive levels in the blood when animals consume ethanol. In these new studies, we aimed at investigate if the effect of fenofibrate on ethanol intake is produced exclusively in the liver (increasing catalase and systemic levels of acetaldehyde) or there might be additional effects at central level. High drinker rats (UChB) were allowed to voluntary drink 10% ethanol for 2 months. Afterward, a daily dose of fenofibrate (25, 50 or 100 mg/kg/day) or vehicle (as control) was administered orally for 14 days. Voluntary ethanol intake was recorded daily. After that time, animals were deprived of ethanol access for 24 hours and administered with an oral dose of ethanol (1 g/kg) for acetaldehyde
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Fibrates, such as fenofibrate, are peroxisome proliferator-activated receptor-α (PPARα) agonists and have been used for several decades as hypolipidemic agents in the clinic. However, contradictory observations exist on the role of fibrates in host response to acute inflammation, with unclear mechanisms. The role of PPARα in colitis was assessed using fenofibrate and Ppara-null mice. Wild-type or Ppara-null mice were subjected to acute colitis under three distinct protocols, dextran sulfate sodium, trinitrobenzenesulfonic acid, and Salmonella Typhi. Serum and colon lipidomics were analyzed to characterize the metabolic profiles by ultra-performance liquid chromatography-coupled with electrospray ionization quadrupole time-of-flight mass spectrometry. Messenger RNAs of PPARα target genes and genes involved in inflammation were determined by qunatitative PCR analysis. Fenofibrate treatment exacerbated inflammation and tissue injury in acute colitis, and this was dependent on PPARα activation.
Walker et al1 demonstrated that short-term treatment with fenofibrate improves vascular endothelial function in healthy normolipidemic middle-aged and older adults by reducing oxidative stress and induces an increase in endothelial NO synthase without lowering systolic and diastolic blood pressure (SBP and DBP) significantly, providing potential support for the non-lipid-lowering effects of fenofibrate in mediating its vascular health-promoting influence in humans.. With regard to arterial blood pressure (BP), the effect of fenofibrate is inconsistent because baseline BP may affect the effect of fenofibrate. Indeed, we first reported that fenofibrate significantly reduced SBP by 3 mm Hg (P=0.007) and DBP by 3 mm Hg (P=0.033) after 2 months administration in hypertriglyceridemic, hypertensive patients when compared with baseline SBP 142 and DBP 90 mm Hg.2 In a different study of ours in patients with primary hypertriglyceridemia,3 fenofibrate did not significantly reduce SBP and DBP. Ten among ...
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ABSTRACT. A rapid and sensitive liquid chromatography-tandem mass spectrometric (LC-MS/MS) assay method has been developed and fully validated for simultaneous quantification of two lipid lowering agents rosuvastatin and fenofibric acid in human plasma. Lovastatin was used as an internal standard. Analytes and the internal standard were extracted from human plasma by liquid-liquid extraction technique using a 50:50, v/v mixture of ethyl acetate and diethyl ether. The reconstituted samples were chromatographed on a C18 column by using a 80:20, v/v mixture of acetonitrile and 0.1% formic acid as the mobile phase at a flow rate of 1.0 mL/min. The calibration curve obtained was linear (r2 ³ 0.99) over the concentration range of 0.10-80.00 ng/mL for rosuvastatin and 50-9003 ng/mL for fenofibric acid. The multiple reaction monitoring mode was used for quantification of ion transitions at m/z 482/258, 319/233 and 405/199 for the rosuvastatin, fenofibric acid and the internal standard, respectively. ...
Purpose: Inflammation plays a substantial role in the development of diabetic retinopathy (DR). Fenofibrate, a lipid reducing drug is known to decrease inflammation and improve insulin sensitivity, and reduce the risk of DR. We aim to determine the effectiveness of fenofibrate in the treatment of diabetes by detecting the levels of downstream inflammatory mediators (IM) in hyperglycemic mice retina.. Methods: Wild type mice were fed with high fat diet (HFD), HFD with fenofibrate (30mg/kg) and normal diet for 10 weeks. Akita (Ins2Akita) mice received a dose of 50mg/kg fenofibrate and saline weekly via oral medication for 10 weeks (n=20 mice per group). Pre and post-treatment blood glucose level (BGL) measurements and retinal assessments were conducted weekly. To determine the effectiveness of fenofibrate, 11 IM levels, namely atrial natriuretic peptide (ANP), Fractalkine (CX3CR1), ICAM-1, interleukin-1 beta (IL-1β), interleukin-6 (IL-6), MCP-1, NADPH oxidase 2 (NOX2), NADPH oxidase 4 (NOX4), ...
Mellies, M.J.; Stein, E.A.; Khoury, P.; Lamkin, G.; Glueck, C.J., 1987: Effects of fenofibrate on lipids lipoproteins and apolipoproteins in 33 subjects with primary hypercholesterolemia
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Essentialis, Inc., today announced Phase 2b trial results for its investigational compound DCCR demonstrating a reduction in triglyceride (TG) levels by 30 to 40 percent in patients whose TG levels exceeded 500 mg/dL (Very High Triglycerides VHTG). The study included an arm combining DCCR with fenofibrate treatment (Abbott Laboratories [email protected] (fenofibric acid)); in the combination arm, DCCR was shown to be additive to fenofibrate for all lipid fractions except LDL-C. In contrast, a 2009 study of VHTG patients using prescription omega-3 fatty acid in combination with fenofibrate revealed no clinically important change compared to fenofibrate alone(1).. More than five million people in the United States have very high TG levels. This population is at elevated risk for a number of diseases, including acute pancreatitis, diabetes and cardiovascular events (e.g., sudden death, myocardial infarction, acute coronary syndrome, revascularization, stroke and atrial fibrillation).. "The results of this ...
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Fenofibrate (micronized) is a lipid regulating agent. Fenofibric acid, the active metabolite of fenofibrate, produces reductions in total-C, LDL-C, apo B, total triglycerides and VLDL in treated patients. In addition, treatment with fenofibrate results in increases in HDL-C and apoproteins apoAI and apoAII. The effects of fenofibric acid seen in clinical practice have been explained by the activation of peroxisome proliferator activated receptor (alpha) [PPAR (alpha)]. Through this mechanism, fenofibrate increases lipolysis and elimination of triglyceride-rich particles from plasma by activating lipoprotein lipase and reducing production of apoprotein C-III (an inhibitor of lipoprotein lipase activity). The resulting fall in triglycerides produces an alteration in the size and composition of LDL from small, dense particles (which are thought to be atherogenic due to their susceptibility to oxidation), to large buoyant particles. These larger particles have a greater affinity for cholesterol ...
Objective: C-reactive protein (CRP) is an inflammatory marker that contributes to the prediction of cardiovascular diseases (CVD). We investigated the influences of CRP polymorphisms on baseline CRP levels and fenofibrate-induced CRP changes in subjects with the metabolic syndrome (MetS).. RESEARCH DESIGN AND METHODS: We examined the association of CRP single nucleotide polymorphisms (SNPs) (m772A,G, m301G,A ,T, i178T,A, 3u1273C,T, 3u2131C,T) with baseline plasma CRP levels among 1123 US White participants in the Genetics of Lipid Lowering Drugs and Diet Network (GOLDN) study, and the modulating effect of these SNPs on CRP response to a 3-week fenofibrate treatment among 290 participants with the MetS.. Results: There were strong associations of m301G,A,T (rs3091244, P=0.003), i178T,A (rs1417938, P=0.001), 3u1273C,T (rs1130864, P=0.001) and 3u2131C,T (rs1205, P,0.001) with baseline CRP levels. Moreover, among MetS subjects fenofibrate induced the greatest reduction in CRP levels for TT subjects ...
In a previous study, we demonstrated significant downregulation of EET production and CYP2C23 expression in the renal tissues of rats fed an HF diet for 10 wk (42). The downregulation of renal tubular EET production is associated with hypertension, abnormal renal hemodynamics, and sodium retention (41). To substantiate these findings, we postulated that the increased production of EETs by fenofibrate and AUDA can affect blood pressure, renal hemodynamics, and sodium retention in HF rats. This study demonstrates that fenofibrate selectively increases AA epoxidation activity but does not affect ω-hydroxylase activity in renal cortical microsomes isolated from HF rats (Fig. 4). Western blot (Fig. 5) and immunohistochemical (Fig. 6) results showed that CYP2C11, CYP2C23, and CYP2J expression was also significantly elevated in the renal cortex and renal microvessels after fenofibrate treatment. Interestingly, fenofibrate-induced increases in renal CYP epoxgenase activity and expression are associated ...
As for the mechanism, our study suggests that the beneficial effects of Feno-FA on CNV are through PPARα activation, consistent with our previous study using a DR model.19 A recent study, however, reported that fenofibrate inhibits CNV partially through cytochrome P450, a target independent of PPARα.20 This disparity may be explained by the following reasons. (1) The study by Gong et al.20 used fenofibrate, whereas we used Feno-FA. Fenofibrate, a third-generation fibric acid derivative, is a prodrug, which is hydrolyzed by tissue and plasma esterases to the active metabolite Feno-FA. Fenofibrate is ,90% plasma bound, reaches peak concentration in the plasma at approximately 7 hours, and has an elimination half-life of approximately 20 hours.41 Feno-FA contains a carboxylic acid moiety but not an isopropyl ester moiety in fenofibrate.42 Feno-FA is a PPARα agonist, while fenofibrate is a LXR antagonist.43 Fenofibrate may have some off-target effects. It was shown that fenofibrate is a potent ...
OBJECTIVE: Individuals with mixed dyslipidemia have elevated triglycerides (TG), low high-density lipoprotein cholesterol (HDL-C), and increased risk for coronary disease. Fibrate therapy is commonly used to lower TG and increase HDL-C. Common genetic variants are known to affect the response to fibrate therapy. We sought to identify rare genetic variants (frequency ≤ 1%) in genes involved in TG and HDL-C metabolism that affect the response to fenofibric acid (FA) therapy. METHODS: Four genes with a major role in HDL-C and TG metabolism APOA1, APOC2, APOC-III and LPL were sequenced in 2385 participants with mixed dyslipidemia in a randomized, double-blind, active-controlled study comparing therapy with FA alone, in combination with statins, or statin alone. Rare variants collapsing or SKAT methods were used for the analysis. RESULTS: Synonymous rare variants in the LPL gene were significantly associated with absolute HDL-C change (P = 9 × 10(-4)) and TG percent change (P = 6.76 × 10(-4)) in ...
TY - JOUR. T1 - Effect of fenofibrate in 1113 patients at lowdensity lipoprotein cholesterol goal but high triglyceride levels. T2 - Real-world results and factors associated with triglyceride reduction. AU - Woo, Yeongmin. AU - Shin, Jeong Soo. AU - Shim, Chi Young. AU - Kim, Jung Sun. AU - Kim, Byeong Keuk. AU - Park, Sungha. AU - Chang, Hyuk Jae. AU - Hong, Geu Ru. AU - Ko, Young Guk. AU - Kang, Seok Min. AU - Choi, Donghoon. AU - Ha, Jong Won. AU - Hong, Myeong Ki. AU - Jang, Yangsoo. AU - Lee, Sang Hak. PY - 2018/10. Y1 - 2018/10. N2 - Fibrates are used in patients with dyslipidemia and high cardiovascular risk. However, information regarding drug response to fibrate has been highly limited. We investigated treatment results and factors associated with triglyceride reduction after fenofibrate therapy using large-scale real-world data. Patients with one or more cardiovascular risk factors, at low-density lipoprotein-cholesterol goal but with triglyceride level 150 mg/dL, and undergoing ...
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Fenofibrate is a PPARα ligand that has been widely used as a lipid lowering agent in the treatment of hypertriglyceridemia. ABCD2 (D2) is a peroxisomal long-chain acyl-CoA transporter that is highly induced by fenofibrate in the livers of mice. To determine if D2 is a modifier of fibrate responses, wild-type and D2 deficient mice were treated with fenofibrate for 14 days. The absence of D2 altered expression of gene clusters associated with lipid metabolism, including PPARα signaling. Using 3T3-L1 adipocytes, which express high levels of D2, we confirmed that knock-down of D2 modified genomic responses to fibrate treatment. We next evaluated the impact of D2 on effects of fibrates in a mouse model of diet-induced obesity. Fenofibrate treatment opposed the development of obesity, hypertriglyceridemia, and insulin resistance. However, these effects were unaffected by D2 genotype. We concluded that D2 can modulate genomic responses to fibrates, but that these effects are not sufficiently robust ...
Case Report: Patient 1, a 42-year-old man with type 2 diabetes mellitus, was referred for evaluation of a very low HDL cholesterol level (Table). He had been taking insulin; troglitazone, 400 mg/d; and metformin, 850 mg/d. Gemfibrozil was initially prescribed for hypertriglyceridemia, but fenofibrate, 201 mg, was then substituted. When the patient was first seen, his HDL cholesterol level was 0.39 mmol/L (15 mg/dL) and his apolipoprotein A-I (apo A-I) level, 0.29 g/L, was very low. Fenofibrate therapy was discontinued, and therapy with atorvastatin, 10 mg, was started. His HDL cholesterol level increased to 1.06 mmol/L (41 mg/dL). Currently, the patient is receiving simvastatin, 20 mg/d; gemfibrozil, 600 mg twice daily; fish oil, 1 g/d; pioglitazone, 45 mg/d; metformin, 500 mg three times per day; and ramipril, 10 mg/d. His apo A-I level has increased to 1.14 g/L, and his HDL cholesterol level is 1.19 mmol/L (46 mg/dL ...
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URL Pharma (a subsidiary of Takeda) has developed a proprietary formulation of fenofibric acid (a derivative of fenofibrate), an orally available
Healthcare Sales & Marketing Network: Abbotts TRILIPIX(R) (Fenofibric Acid) in Combination With Rosuvastatin Calcium Helps Patients With Mixed Dyslipidemia and Type 2 Diabetes Meet American Diabetes Association Lipid Targets
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A Four Arm, Single-Dose, Food Effect Evaluation With 105 mg Fenofibric Acid Tablets Administered in a Fasted State and Three Different Fed Conditions, Low-Fat/Low Calorie Meal, Standard Meal, and High-Fat/High Calorie Meal ...
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... helps reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries). Fenofibrate may also be used for purposes not listed in this medication guide.
A new study shows that the drug fenofibrate might reduce the risk of cardiovascular events, such as heart attacks, in certain people with type 2 diabetes.
June 30, 2012 Health Care, Medicine Comments Off A population-based study has shown an association between new fibrate use in older patients and nephrologist consultations and hospital admissions for a rise in creatinine level [1].. Though the rise may prompt clinical concern but it is uncertain that the changes in creatinine reflect renal injury. The results of FIELD trial has shown that the increase in serum creatinine with fenofibrate was reversible on discontinuation, and at the end of the trial fenofibrate treatment appeared to have slowed loss of renal function and reduced proteinuria [2].. References. 1. Zhao YY, Weir MA, Manno M, et al. New fibrate use and acute renal outcomes in elderly adults: a population-based study. Ann Intern Med 2012;156:560 ...
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The plenary lecture, given by RSA Early Career Investigator 2016 winner Dr. Lorenzo Leggio, featured an article written by Cassie Moore on compulsive eating behavior1 (slide pictured) with her PI, Dr. Pietro Cottone, Dr. Valentina Sabino, and Dr. George Koob.. The Genetic Analysis Workshop 20 (GAW20) 2017. TTPAS student, Jiayi Wu, attended The Genetic Analysis Workshop 20 (GAW20) in March 2017 where she gave the presentation on:. "An efficient analytic approach in genome-wide identification of methylation quantitative trait loci in response to fenofibrate treatment.". The study of DNA methylation quantitative trait loci (mQTLs) helps dissect regulatory mechanisms underlying genetic associations of human diseases. We used GAW20 real dataset and conducted the first genome-wide examination of genetic drivers of methylation variation in response to a triglyceride lowering treatment fenofibrate (response-mQTL) by using an efficient analytic approach. For the result, a lipid SNP rs10903129 located in ...
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