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." 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.
Reviewing published evidence, these experts argued that: - Elevated triglycerides (>150 mg/dL) are decreased by 43% with generic fenofibrate and 32% with generic bezafibrate - Low HDL cholesterol (<40 mg/dL) is increased by 18%,
Either agent is approximately two-fold more effective than 80 mg of GFT505, an investigational agent currently in early phase II development.
GFT505 Fenofibrate Bezafibrate Triglycerides -21% -43 percent -32 percent (>150mg/dL) HDL-C (<40mg/dL) +9% +18,8 percent +17,9 percent
Published data show a potential role for fenofibrate in treating non-alcoholic fatty liver disease, significantly decreasing the proportion of patients with liver dysfunction.
Fenofibrate significantly reduced both liver enzymes, alanine amino transferase (ALT) and aspartate amino transferase (AST), unlike GFT505.
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: ---------------------------------  FernÃ¡ndez-Miranda C, PÃ©rez-Carreras M, Colina F, LÃ³pez-Alonso G, Vargas C, SolÃs-Herruzo JA. A pilot trial of fenofibrate for the treatment of non-alcoholic fatty liver disease. Dig Liver Dis 2008;40:200-5.  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.  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.  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.  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].  Farnier et al, Eu Heart J. 2005,26:897  Ruotulo et al, JACC Vol 32, b 6 November 15 1998:1648-56  Farnier et al, Eu Heart J, 2005, 26:897  The BIO Study Group, Circulation, Volume 102(1)4 July 2000pp 21-27  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
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SOURCE international experts
|SOURCE international experts|
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