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
Date:12/16/2009

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]
    (>150mg/dL)

    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.'

    References:
    ---------------------------------

    [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
        2008;40:200-5.
    [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
        1998;32:1648-56.
    [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
        2000;102:21-7.
    [5] Press release. GENFIT: Extremely promising GFT505 results in
        Phase II.
        http://www.genfit.com/fileadmin/press/press/press_release/
        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.
         http://www.genfit.com/fileadmin/press/press/press_release/
         20091126_PR_GENFIT_GFT505.pdf

(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:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... AAIPharma Services Corp./Cambridge Major Laboratories, Inc. ... development services for the pharmaceutical and biotechnology industries, ... in its Charleston, SC ... recent investments. Charleston ... with small-scale lyophilization. The site has invested in ...
(Date:2/11/2016)... , 11 de fevereiro de 2016  A ... sua fábrica de soroalbumina bovina (BSA -- ... fábrica fica na Ilha Norte da Nova Zelândia, ... e estabelecido na fábrica da Proliant nos EUA, ... O projeto e instalação dos equipamentos foram feitos ...
(Date:2/11/2016)... Breast Cancer Therapeutics in Asia-Pacific Markets to 2021 ... breast cancer market will experience considerable expansion from $1.9 billion ... Annual Growth Rate (CAGR) of 8.5%. --> Breast ... that the Asia-Pacific (APAC) breast cancer ... to $3.4 billion by 2021, at a Compound Annual Growth ...
Breaking Medicine Technology:
(Date:2/11/2016)... ... February 11, 2016 , ... Pediatric ... to improve care by making data on heart procedures public and easily understandable ... Transparency and Public Reporting of Pediatric and Congenital Heart Disease Outcomes will bring ...
(Date:2/11/2016)... ... February 11, 2016 , ... In a ... Dallas plastic surgeon , Dr. Rod J. Rohrich, and colleagues, examine and underscore ... outlines recommendations for rhinoplasty surgeons when addressing this vital area. , The upper ...
(Date:2/11/2016)... ... February 11, 2016 , ... veEDIS Clinical Systems, ... with highly adaptable algorithms, has been updated to help Emergency Department physicians and ... consistent with Zikas and a travel history to affected regions, or potential exposure ...
(Date:2/11/2016)... ... February 11, 2016 , ... "What holds ... author Ray Clarke poses a question as a challenge for his readers to ... "Being in the Being" (published by Partridge Singapore), Clarke explores the subject with ...
(Date:2/11/2016)... ... 11, 2016 , ... Life is known for throwing curves. It’s thrown quite ... gather once a year to play softball to raise money through Sun Health ... than 50 players who competed in this year’s softball tournament share a history of ...
Breaking Medicine News(10 mins):