Page last updated: 2024-10-27

fenofibrate and Muscle Disorders

fenofibrate has been researched along with Muscle Disorders in 16 studies

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Research Excerpts

ExcerptRelevanceReference
"Hypothyroidism is one of the common causes of the secondary hypercholesterolemia."6.43[Fenofibrate--induced myopathy in a patient with undiagnosed hypothyroidism--case report and a review of the literature]. ( Brzosko, M; Lukjanowicz, M; Trzcińska-Butkiewicz, B, 2006)
"Hypothyroidism is one of the common causes of the secondary hypercholesterolemia."2.43[Fenofibrate--induced myopathy in a patient with undiagnosed hypothyroidism--case report and a review of the literature]. ( Brzosko, M; Lukjanowicz, M; Trzcińska-Butkiewicz, B, 2006)
"Fenofibrate (FEN) is an antilipidemic drug that increases the activity of the lipoprotein lipase enzyme, thus enhancing lipolysis; however, it may cause myopathy and rhabdomyolysis in humans."1.91Can coenzyme Q10 alleviate the toxic effect of fenofibrate on skeletal muscle? ( AbdElfattah, AA; Ayuob, NN; El-Bassouny, DR; Ellakkany, AS; Mansour, AA, 2023)
" Interactions between statins and other drugs are caused by pharmacokinetic mechanisms, mainly by changing the metabolism of statins in the CYP450 enzyme system, in the hepatic glucuronidation pathway or in the transporters responsible for statin distribution in tissues."1.40[The combinations of statins and fibrates: pharmacokinetic and clinical implications]. ( González Santos, P, 2014)
" We reviewed gemfibrozil- and fenofibrate-associated adverse event reports (AERs) submitted to the US Food and Drug Administration over a 5-year period."1.35Relative safety of gemfibrozil and fenofibrate in the absence of concomitant cerivastatin use. ( Alsheikh-Ali, AA; Holoshitz, N; Karas, RH, 2008)

Research

Studies (16)

TimeframeStudies, this research(%)All Research%
pre-19902 (12.50)18.7374
1990's1 (6.25)18.2507
2000's9 (56.25)29.6817
2010's3 (18.75)24.3611
2020's1 (6.25)2.80

Authors

AuthorsStudies
El-Bassouny, DR1
Mansour, AA1
Ellakkany, AS1
Ayuob, NN1
AbdElfattah, AA1
Streja, E1
Streja, DA1
Soohoo, M1
Kleine, CE1
Hsiung, JT1
Park, C1
Moradi, H1
González Santos, P1
Robinson, JG1
Pettersen, JC1
Pruimboom-Brees, I1
Francone, OL1
Amacher, DE1
Boldt, SE1
Kerlin, RL1
Ballinger, WE1
Ghosh, B1
Sengupta, S1
Bhattacharjee, B1
Majumder, A1
Sarkar, SB1
Grundy, SM1
Vega, GL1
Yuan, Z1
Battisti, WP1
Brady, WE1
Palmisano, J1
Ledl, M1
Hohenecker, J1
Francesconi, C1
Roots, I1
Bauer, MF1
Roden, M1
Pierno, S1
Didonna, MP1
Cippone, V1
De Luca, A1
Pisoni, M1
Frigeri, A1
Nicchia, GP1
Svelto, M1
Chiesa, G1
Sirtori, C1
Scanziani, E1
Rizzo, C1
De Vito, D1
Conte Camerino, D1
Lukjanowicz, M1
Trzcińska-Butkiewicz, B1
Brzosko, M1
Dedhia, V1
Munsi, SC1
Holoshitz, N1
Alsheikh-Ali, AA1
Karas, RH1
Giraud, P1
Cassou, M1
Paul, R1
Guidet, M1
Solsona, L1
Coll, J1
Ariza, A1
Olivé, A1
Muller, JP1
Mazingue, A1
Cotes, F1
Destée, A1
Warot, P1

Clinical Trials (2)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
FEnofibRate as a Metabolic INtervention for Coronavirus Disease 2019[NCT04517396]Phase 2701 participants (Actual)Interventional2020-08-18Completed
A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Tolerability and Efficacy of the Co-Administration of Simvastatin 20 mg/Day and Fenofibrate 160 mg/Day Compared to Simvastatin 20 mg/Day Alone for 12 Weeks of Treatment in Patie[NCT00092157]Phase 3571 participants (Actual)Interventional2002-05-01Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

All-Cause Death

Death from any cause during the observation period (NCT04517396)
Timeframe: Up to 30 days

InterventionParticipants (Count of Participants)
Fenofibrate + Usual Care19
Placebo + Usual Care22

Exploratory Hierarchical Composite Endpoint

The exploratory global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) The number of days out of the hospital during the 30 day-period following randomization. (NCT04517396)
Timeframe: Up to 30 days

Interventionscore on a scale (Median)
Fenofibrate + Usual Care5.03
Placebo + Usual Care5.03

Number of Days Alive and Out of the Hospital During the 30 Days Following Randomization

Number of days that participants were alive and out of the hospital during the 30 days following randomization (NCT04517396)
Timeframe: Up to 30 days

Interventiondays (Median)
Fenofibrate + Usual Care30
Placebo + Usual Care30

Number of Days Alive, Out of the Intensive Care Unit, Free of Mechanical Ventilation/Extracorporeal Membrane Oxygenation, or Maximal Available Respiratory Support in the 30 Days Following Randomization

Number of days participants were alive, out of the intensive care unit, free of mechanical ventilation/extracorporeal membrane oxygenation, or maximal available respiratory support during the 30 days that followed randomization (NCT04517396)
Timeframe: Up to 30 days

Interventiondays (Mean)
Fenofibrate + Usual Care28.8
Placebo + Usual Care28.3

Primary Hierarchical Composite Endpoint

The primary endpoint of the trial is a global rank score that ranks patient outcomes according to 5 factors. The global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) For participants enrolled as outpatients who are subsequently hospitalized, the number of days out of the hospital during the 30 day-period following randomization; (5) For participants enrolled as outpatients who don't get hospitalized during the 30-day observation period, the modified Borg dyspnea scale (NCT04517396)
Timeframe: 30 days

InterventionRanked Severity Score (Median)
Fenofibrate + Usual Care5.32
Placebo + Usual Care5.33

Secondary Hierarchical Composite Endpoint

The secondary global rank score, or global severity score, is a nonparametric, hierarchically ranked outcome. The global rank score was generated by ranking all 701 participants on a scale of 1 to 701, from worst to best clinical outcomes. Participants were ranked by (1) time to death; (2) the number of days supported by invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO); (3) The inspired concentration of oxygen/percent oxygen saturation (FiO2/SpO2) ratio area under the curve; (4) For participants enrolled as outpatients who are subsequently hospitalized, the number of days out of the hospital during the 30 day-period following randomization; (5) For participants enrolled as outpatients who don't get hospitalized during the 30-day observation period, a COVID-19 symptom scale rating fever, cough, dyspnea, muscle aches, sore throat, loss of smell or taste, headache, diarrhea, fatigue, nausea/vomiting, chest pain (each are rated from 0-10 then summed). (NCT04517396)
Timeframe: Up to 30 days

Interventionscore on a scale (Median)
Fenofibrate + Usual Care5.05
Placebo + Usual Care5.05

Seven-category Ordinal Scale

A seven-category ordinal scale consisting of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring extracorporeal membrane oxygenation (ECMO), invasive mechanical ventilation, or both; and 7, death. (NCT04517396)
Timeframe: At 15 days

Interventionscore on a scale (Median)
Fenofibrate + Usual Care1
Placebo + Usual Care1

Reviews

3 reviews available for fenofibrate and Muscle Disorders

ArticleYear
Precision Medicine and Personalized Management of Lipoprotein and Lipid Disorders in Chronic and End-Stage Kidney Disease.
    Seminars in nephrology, 2018, Volume: 38, Issue:4

    Topics: Anticholesteremic Agents; Cardiovascular Diseases; Dyslipidemias; Ezetimibe; Fenofibrate; Humans; Hy

2018
LDL reduction: how low should we go and is it safe?
    Current cardiology reports, 2008, Volume: 10, Issue:6

    Topics: Allylamine; Anticholesteremic Agents; Azetidines; Cholesterol, LDL; Colesevelam Hydrochloride; Coron

2008
[Fenofibrate--induced myopathy in a patient with undiagnosed hypothyroidism--case report and a review of the literature].
    Polskie Archiwum Medycyny Wewnetrznej, 2006, Volume: 115, Issue:1

    Topics: Contraindications; Fenofibrate; Humans; Hyperlipidemias; Hypolipidemic Agents; Hypothyroidism; Male;

2006

Trials

1 trial available for fenofibrate and Muscle Disorders

ArticleYear
Effectiveness and tolerability of simvastatin plus fenofibrate for combined hyperlipidemia (the SAFARI trial).
    The American journal of cardiology, 2005, Feb-15, Volume: 95, Issue:4

    Topics: Adult; Aged; Alanine Transaminase; Apolipoproteins; Aspartate Aminotransferases; Double-Blind Method

2005

Other Studies

12 other studies available for fenofibrate and Muscle Disorders

ArticleYear
Can coenzyme Q10 alleviate the toxic effect of fenofibrate on skeletal muscle?
    Histochemistry and cell biology, 2023, Volume: 160, Issue:2

    Topics: Adult; Animals; Fenofibrate; Humans; Male; Muscle Fibers, Skeletal; Muscle, Skeletal; Muscular Disea

2023
[The combinations of statins and fibrates: pharmacokinetic and clinical implications].
    Clinica e investigacion en arteriosclerosis : publicacion oficial de la Sociedad Espanola de Arteriosclerosis, 2014, Volume: 26 Suppl 1

    Topics: Atherosclerosis; Drug Interactions; Drug Therapy, Combination; Dyslipidemias; Fenofibrate; Fibric Ac

2014
The PPARα agonists fenofibrate and CP-778875 cause increased β-oxidation, leading to oxidative injury in skeletal and cardiac muscle in the rat.
    Toxicologic pathology, 2012, Volume: 40, Issue:3

    Topics: Animals; Blood Chemical Analysis; Body Weight; Dose-Response Relationship, Drug; Female; Fenofibrate

2012
Fenofibrate-induced myopathy.
    Neurology India, 2004, Volume: 52, Issue:2

    Topics: Fenofibrate; Humans; Hyperlipidemias; Hypolipidemic Agents; Male; Middle Aged; Muscular Diseases

2004
Acute myopathy in a type 2 diabetic patient on combination therapy with metformin, fenofibrate and rosiglitazone.
    Diabetologia, 2005, Volume: 48, Issue:10

    Topics: Aged; Creatine Kinase; Diabetes Mellitus, Type 2; Drug Interactions; Electromyography; Fenofibrate;

2005
Effects of chronic treatment with statins and fenofibrate on rat skeletal muscle: a biochemical, histological and electrophysiological study.
    British journal of pharmacology, 2006, Volume: 149, Issue:7

    Topics: Action Potentials; Animals; Aquaporin 4; Atorvastatin; Body Weight; Chloride Channels; Dose-Response

2006
Myopathy caused by a combination rosuvastatin and fenofibrate.
    The Journal of the Association of Physicians of India, 2007, Volume: 55

    Topics: Aged; Coronary Artery Disease; Drug Interactions; Fenofibrate; Fluorobenzenes; Humans; Hydroxymethyl

2007
Relative safety of gemfibrozil and fenofibrate in the absence of concomitant cerivastatin use.
    The American journal of cardiology, 2008, Jan-01, Volume: 101, Issue:1

    Topics: Adverse Drug Reaction Reporting Systems; Chemical and Drug Induced Liver Injury; Databases, Factual;

2008
[Muscular toxicity due to fenofibrate. Apropos of a case].
    Revue du rhumatisme et des maladies osteo-articulaires, 1982, Volume: 49, Issue:2

    Topics: Aged; Female; Fenofibrate; Humans; Hypolipidemic Agents; Muscular Diseases; Propionates

1982
Choice of lipid-regulating drugs.
    The Medical letter on drugs and therapeutics, 2001, May-28, Volume: 43, Issue:1105

    Topics: Apolipoproteins; Arteriosclerosis; Cholesterol, HDL; Cholesterol, LDL; Coronary Disease; Drug Intera

2001
[Myopathy caused by fenofibrate].
    Medicina clinica, 1991, Nov-16, Volume: 97, Issue:17

    Topics: Aged; Aged, 80 and over; Female; Fenofibrate; Humans; Muscles; Muscular Diseases; Pain

1991
[Muscular toxicity caused by fenofibrate].
    Presse medicale (Paris, France : 1983), 1989, May-20, Volume: 18, Issue:20

    Topics: Female; Fenofibrate; Humans; Middle Aged; Muscular Diseases; Propionates

1989