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Trilipix (Choline Fenofibrate) - Summary

 
 



TRILIPIX SUMMARY

Trilipix (fenofibric acid) is a lipid regulating agent available as delayed release capsules for oral administration. Each delayed release capsule contains choline fenofibrate, equivalent to 45 mg or 135 mg of fenofibric acid.

Co-administration Therapy with Statins for the Treatment of Mixed Dyslipidemia

Trilipix is indicated as an adjunct to diet in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal.

CHD risk equivalents comprise:

  • Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease);

  • Diabetes;

  • Multiple risk factors that confer a 10-year risk for CHD > 20%

Treatment of Severe Hypertriglyceridemia

Trilipix is indicated as adjunctive therapy to diet to reduce TG in patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacological intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of Trilipix therapy on reducing this risk has not been adequately studied.

Treatment of Primary Hyperlipidemia or Mixed Dyslipidemia

Trilipix is indicated as adjunctive therapy to diet to reduce elevated LDL-C, Total-C, TG, and Apo B, and to increase HDL-C in patients with primary hyperlipidemia or mixed dyslipidemia.

Important Limitations of Use

No incremental benefit of Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established.

General Considerations for Treatment

Fenofibrate at a dose equivalent to 135 mg of Trilipix was not shown to reduce coronary heart disease morbidity and mortality in a large, randomized controlled trial of patients with type 2 diabetes mellitus.

Laboratory studies should be performed to establish that lipid levels are abnormal before instituting Trilipix therapy.

Every reasonable attempt should be made to control serum lipids with non-drug methods including appropriate diet, exercise, weight loss in obese patients, and control of any medical problems such as diabetes mellitus and hypothyroidism that may be contributing to the lipid abnormalities. Medications known to exacerbate hypertriglyceridemia (beta-blockers, thiazides, estrogens) should be discontinued or changed if possible, and excessive alcohol intake should be addressed before triglyceride-lowering drug therapy is considered. If the decision is made to use lipid-altering drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.

Drug therapy is not indicated for patients who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of VLDL.


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NEWS HIGHLIGHTS

Published Studies Related to Trilipix (Fenofibrate)

Paradoxical reduction in HDL-C with fenofibrate and thiazolidinedione therapy in type 2 diabetes: the ACCORD Lipid Trial. [2014]
CONCLUSIONS: Idiosyncratic and marked reduction in HDL-C can occur in some

Long-term safety and efficacy of fenofibrate/pravastatin combination therapy in high risk patients with mixed hyperlipidemia not controlled by pravastatin monotherapy. [2011.11]
OBJECTIVE: To assess the long-term safety and efficacy of a fenofibrate/pravastatin 160/40 mg fixed-dose combination in high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg monotherapy... CONCLUSIONS: Long-term co-administration of fenofibrate/pravastatin 160/40 mg in a single capsule was well tolerated and produced complementary benefits on the overall lipid profile of high-risk patients with mixed hyperlipidemia not controlled by pravastatin 40 mg.

Fenofibrate: a review of its lipid-modifying effects in dyslipidemia and its vascular effects in type 2 diabetes mellitus. [2011.08.01]
Fenofibrate is a fibric acid derivative with lipid-modifying effects that are mediated by the activation of peroxisome proliferator-activated receptor-alpha... In conclusion, monotherapy with fenofibrate remains a useful option in patients with dyslipidemia, particularly in atherogenic dyslipidemia characterized by high TG and low HDL-C levels.

Combination of niacin and fenofibrate with lifestyle changes improves dyslipidemia and hypoadiponectinemia in HIV patients on antiretroviral therapy: results of "heart positive," a randomized, controlled trial. [2011.07]
CONTEXT: HIV patients on antiretroviral therapy (ART) have a unique dyslipidemia [elevated triglycerides and non-high-density lipoprotein-cholesterol (HDL-C), low HDL-C] with insulin resistance (characterized by hypoadiponectinemia). OBJECTIVE: The aim was to test a targeted, comprehensive, additive approach to treating the dyslipidemia... CONCLUSIONS: A combination of fenofibrate and niacin with low-saturated-fat D/E is effective and safe in increasing HDL-C, decreasing non-HDL-C and hypertriglyceridemia, and ameliorating hypoadiponectinemia in patients with HIV/ART-associated dyslipidemia.

Single-dose bioequivalence of 105-mg fenofibric acid tablets versus 145-mg fenofibrate tablets under fasting and fed conditions: a report of two phase I, open-label, single-dose, randomized, crossover clinical trials. [2011.06]
BACKGROUND: Fenofibrate is used to treat primary hypercholesterolemia, mixed lipidemia, and hypertriglyceridemia in adults who do not respond to nonpharmacologic measures. Fenofibrate is a prodrug that is rapidly and completely hydrolyzed to fenofibric acid, the active moiety. A new orally administered agent, fenofibric acid, was developed as an alternative to fenofibrate. OBJECTIVE: Two separate studies were conducted to evaluate the bioequivalence of fenofibric acid relative to fenofibrate under fasted and fed (standard breakfast) conditions, characterize the pharmacokinetic profile, and assess the safety and tolerability of fenofibric acid... CONCLUSIONS: In these 2 single-dose studies, these healthy volunteers administered a single oral dose of 105-mg fenofibric acid met the US Food and Drug Administration regulatory criteria for assuming bioequivalence to a single oral dose of 145-mg fenofibrate tablets with respect to the rate and extent of fenofibric acid absorption in both fed and fasted states. Fenofibric acid at the dose studied was well tolerated in this population. Copyright (c) 2011 Elsevier HS Journals, Inc. All rights reserved.

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Clinical Trials Related to Trilipix (Fenofibrate)

Effect of Fenofibrate on Endothelial Function and High-density Lipoproteins (HDL) Physicochemical and Functional Characteristics in Patients With Coronary Heart Disease [Recruiting]
Fenofibrate is a drug that acts on the PPAR alpha receptors, increasing HDL-cholesterol and decreasing triglyceride levels. The interaction with these receptors has antiatherogenic actions by regulating the expression con key proteins that participate in vascular inflammation, plaque stability and thrombosis.

Fenofibrate reduces triglycerides and increases HDL-C in plasma. It also decreases small, dense LDL particles. The use of this drug has resulted in improvement of vascular function measured by endothelial function. Our hypotheses state that fenofibrate will improve: endothelial function, improve HDL antioxidant capacity and size distribution towards a predominance of small HDL particles.

A Pilot Study to Assess the Efficacy and Safety of LCQ908 Alone and in Combination With Fenofibrate or Lovaza´┐Ż in Patients With Severe Hypertriglyceridemia [Recruiting]

A Study to Evaluate Fenofibrate Combination With Statin in Chinese Patients With Dyslipidemic [Recruiting]
Atherogenic dyslipidemia includes patients who have coronary heart disease (CHD) or CHD risk equivalents, whose TG level is not adequately controlled after statin monotherapy. According to the recent published EAS consensus, fibrate is suggested to be added to this type of patient who has insufficient improvement. The purpose of the study is to evaluate the efficacy on lipid control and the safety of adding fenofibrate in patients on a background of statin treatment.

Predictors of Response to Fenofibrate [Recruiting]
Fenofibrate is one of the best options for treating hypertriglyceridemia. In the majority of patients, fenofibrate lowers triglycerides (TG) by 24-55% and improves HDL- and LDL-cholesterol. However, the response to fenofibrate is highly variable and currently there are no screening tests to identify poor responders. Genetic and environmental factors may explain the high variability in response. Although exploratory in nature, this study is of clinical and public health importance because prediction of drug response among those with hypertriglyceridemia is clinically challenging and fenofibrate prescription costs are large ($90 to $130/patient/month); targeting the responsive patients at the outset will help improve treatment outcomes at a lower cost. If successful, the investigators will propose to conduct a large, randomized trial on the effect of pre-prescription genotyping on fenofibrate response.

Fenofibrate and Omega-3 Fatty Acid Modulation of Endotoxemia [Recruiting]
The purpose of this study is to better understand the anti-inflammatory benefits of two prescription medicines that are currently used to help people with cholesterol problems.

Fish oil, from eating certain kinds of fish and from supplement pills, has been used to help control cholesterol and reduce inflammation (the body's response to injury or sickness). Lovaza« is the brand name for prescription strength fish oil pills. In this study, we will be looking at how Lovaza« works to help reduce inflammation in healthy volunteers.

Tricor« is the brand name for prescription fenofibrate pills. Fenofibrate is a prescription medicine that many doctors give to people with high triglyceride (fat in the blood) levels. In this study, we will be looking at how Tricor┬« works to help reduce inflammation in healthy volunteers.

Endotoxin or lipopolysaccharide (LPS) is a small part of bacteria (that is no longer living) that can cause many of the effects similar to bacterial infections in humans. However, it can be administered in very small amounts to produce a mild immune response much the same as

a 'flu' like illness. Within 1 ┬Ż - 3 hours after giving LPS by vein, a response consisting

of fever, chills, headache, nausea and vomiting and generalized aches and pains will occur which lasts up to 6-8 hours. In addition to the flu like symptoms, the response causes temporary changes in cholesterol, triglycerides and blood sugar. Different people respond differently to LPS. We are using LPS in this study to bring on a temporary inflammatory response in the body and to compare the responses of people who receive Lovaza® or Tricor® to the responses of people who receive a placebo (pill that does not contain medicine).

more trials >>

Reports of Suspected Trilipix (Fenofibrate) Side Effects

Blood Triglycerides Increased (8)Upper Respiratory Tract Infection (8)Myalgia (7)Muscle Spasms (7)Vomiting (7)Muscular Weakness (7)Headache (6)Hepatic Enzyme Increased (6)Drug Dose Omission (5)Diabetes Mellitus (5)more >>


PATIENT REVIEWS / RATINGS / COMMENTS

Based on a total of 1 ratings/reviews, Trilipix has an overall score of 8. The effectiveness score is 8 and the side effect score is 8. The scores are on ten point scale: 10 - best, 1 - worst.
 

Trilipix review by 48 year old male patient

  Rating
Overall rating:  
Effectiveness:   Considerably Effective
Side effects:   Mild Side Effects
  
Treatment Info
Condition / reason:   high ldl
Dosage & duration:   135 mg taken once per day for the period of 4 months
Other conditions:   low t, low thyroid
Other drugs taken:   levoxyl, clomid
  
Reported Results
Benefits:   Quickly lowered ldl 100 points.
Side effects:   knee tenderness
Comments:   blood tests done 2 months after initial use showed dramatic drop in ldl and small particles. Its unknown what synergistic effect , if any can be attributed to Clomid for low T and levoxyl for low thyroid function, which were prescribed at the same time as the trilipix.. Both Testosterone and thyroid function were normalized simultaneously with ldl reduction. No severe side effects have been noticed from any of the drugs.

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Page last updated: 2014-11-30

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