Navigation Links
International, Well-Known Scientific Experts Say That New GFT505 Data Unlikely to Have the Potential to Affect the Established Role of Generic Fenofibrate and Bezafibrate in Managing Atherogenic Dyslipidemia

NEW YORK, December 16 /PRNewswire/ -- International, well-known scientific experts were surprised by the publication of GFT505 (80 mg/day) data presented as "extremely promising."[1] More than 50 internationally recognized expert scientists and clinicians critically reviewed these data. These experts reaffirmed the continuing role of generic lipid-modifying treatments, fenofibrate and bezafibrate, in treating atherogenic dyslipidemia, which is commonly observed in patients with metabolic syndrome and type 2 diabetes and is characterized by elevated triglycerides and low 'good' high-density lipoprotein (HDL) cholesterol. Published clinical data also already indicate a potential role for fenofibrate in treating non-alcoholic fatty liver disease.[1]

    Reviewing published evidence, these experts argued that:

    - Elevated triglycerides (>150 mg/dL) are decreased by 43% with
      generic fenofibrate[2] and 32% with generic bezafibrate[2]
    - Low HDL cholesterol (<40 mg/dL) is increased by 18%[3],[4]

Either agent is approximately two-fold more effective than 80 mg of GFT505, an investigational agent currently in early phase II development.[5]

                      GFT505     Fenofibrate        Bezafibrate

    Triglycerides      -21%     -43 percent[6]     -32 percent[7]

    HDL-C (<40mg/dL)    +9%    +18,8 percent[8]   +17,9 percent[9]

Published data show a potential role for fenofibrate in treating non-alcoholic fatty liver disease, significantly decreasing the proportion of patients with liver dysfunction.[1]

Fenofibrate significantly reduced both liver enzymes, alanine amino transferase (ALT) and aspartate amino transferase (AST), unlike GFT505.[10]

Commenting on these data, these experts said: 'These new data show that GFT505 is unlikely to have the potential to replace generic fenofibrate and bezafibrate in treating patients with atherogenic dyslipidemia.'


    [1] Fernández-Miranda C, Pérez-Carreras M, Colina F, López-Alonso G,
        Vargas C, Solís-Herruzo JA. A pilot trial of fenofibrate for the
        treatment of non-alcoholic fatty liver disease. Dig Liver Dis
    [2] Ruotolo G, Ericsson CG, Tettamanti C, Karpe F, Grip L, Svane B,
        Nilsson J, de Faire U, Hamsten A. Treatment effects on serum
        lipoprotein lipids, apolipoproteins and low density lipoprotein
        particle size and relationships of lipoprotein variables to
        progression of coronary artery disease in the Bezafibrate Coronary
        Atherosclerosis Intervention Trial (BECAIT). J Am Coll Cardiol
    [3] Farnier M, Freeman MW, Macdonell G, Perevozskaya I, Davies MJ,
        Mitchel YB, Gumbiner B; Ezetimibe Study Group. Efficacy and safety
        of the coadministration of ezetimibe with fenofibrate in patients
        with mixed hyperlipidaemia Eur Heart J 2005;26:897.
    [4] The BIP Study Group. Secondary prevention by raising HDL cholesterol
        and reducing triglycerides in patients with coronary artery disease:
        the Bezafibrate Infarction Prevention (BIP) study. Circulation
    [5] Press release. GENFIT: Extremely promising GFT505 results in
        Phase II.
        PR_GENFIT_GFT505_Results.pdf. [Accessed 4 Dec 2009].
    [6] Farnier et al, Eu Heart J. 2005,26:897
    [7] Ruotulo et al, JACC Vol 32, b 6 November 15 1998:1648-56
    [8] Farnier et al, Eu Heart J, 2005, 26:897
    [9] The BIO Study Group, Circulation, Volume 102(1)4 July 2000pp 21-27
    [10] Press release. GENFIT: A new potential indication for GFT505,
         diabetes associated fatty liver disease.

(Due to the length of the above URLs, it may be necessary to copy and paste those hyperlinks into your Internet browser's URL address field. Remove the space if one exists.)

SOURCE international experts

SOURCE international experts
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Arno Therapeutics, Inc. Completes $18 Million Financing and Reverse Merger with Laurier International, Inc.
2. Medizone International, Inc. (MZEI.PK): Trials of the AsepticSure Hospital Sterilization System Have Begun
3. Chindex International, Inc. to Report Second Quarter Fiscal 2010 Financial Results
4. Chindex International, Inc. Reports Second Quarter and First Half Fiscal 2010 Financial Results
5. Natural Alternatives International, Inc. Announces Filing of Patent Infringement Lawsuit
6. New Database from ANSI, AAMI, ASTM International, and DIN Provides Centralized Source of Information for Medical Device Professionals
7. DAVISCO Foods International, Inc. and MEGGLE Group Announce a Joint Venture for the Production of Pharmaceutical Lactose.
8. Lexington International, LLC Receives 2009 U.S. Presidents E Award Recognizing its Export Achievements
9. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
10. Avicena Scientific Collaborator Advances Program for Using Energy Enhancing Molecules to Treat Neuromuscular Diseases
11. Boston Scientific Announces Schedule for European Society of Cardiology Congress 2007
Post Your Comments:
(Date:12/1/2015)... December 1, 2015 Biovicas ... Study Group (IBCSG, Bern ) ... i en klinisk studie av palbociclib, ett nytt ... --> Studien, med namn PYTHIA, kommer följa ... läkemedel i kombination med palbociclib, som tillhör klassen ...
(Date:11/30/2015)... Dec. 1, 2015 Researchers have developed software ... part thickness and checks for motion, positioning and beam ... study presented today at the annual meeting of the ... (RSNA). Steven Don , M.D., associate professor ... School of Medicine in St. Louis, Mo. ...
(Date:11/30/2015)... TOKYO , 1. Dezember 2015 /PRNewswire/ ... größte Messe und Konferenz für Entwicklung ... 20. bis 22. April 2016 in ... Foto:- ... Logo: Logo: ...
Breaking Medicine Technology:
(Date:12/1/2015)... ... , ... Nurotron Biotechnology Co., Ltd., maker of cochlear implant systems, has won ... order will be from the China Disabled Persons’ Federation, a central government association, for ... for children and adults suffering from severe and profound hearing loss . The ...
(Date:12/1/2015)... ... December 01, 2015 , ... Tympani Inc., ... Provider (ATP) status from Cisco. This designation recognizes Tympani as having fulfilled the ... Center solutions targeted to the high-end enterprise contact center marketplace. , Ed Kapelinski, ...
(Date:11/30/2015)... ... November 30, 2015 , ... Trevor and Taylor Crabb have unveiled an exciting ... chance to represent the United States. This hybrid crowdfunding campaign is designed ... their journey in addition to offering corporate sponsors with some great marketing deliverables with ...
(Date:11/30/2015)... ... December 01, 2015 , ... The National Association of Professional ... VIP Woman of the Year Circle. She is recognized with this prestigious distinction for ... for professional women, boasting more than 850,000 members and over 200 operating Local Chapters. ...
(Date:11/30/2015)... ... December 01, 2015 , ... Live Very Well is ... insurance plans on . The multi-carrier insurance exchange platform offers individual ... allowing consumers to compare, quote and match plans to meet their needs. ...
Breaking Medicine News(10 mins):