Evaluation of a New Formulation of Fenofibric Acid, ABT-335,Co-Administered with Statins: Study Design and Rationale of a Phase III Clinical Programme

• Published in: Clinical drug investigation 2008-01, Vol.28 (10), p.625-634
• Main Authors: Jones, Peter H., Bays, Harold E., Davidson, Michael H., Kelly, Maureen T., Buttler, Susan M., Setze, Carolyn M., Sleep, Darryl J., Stolzenbach, James C.
• Format: Article
• Language: English
• Subjects: Analysis of Variance; Atorvastatin Calcium; Double-Blind Method; Drug Therapy, Combination; Dyslipidemias - drug therapy; Female; Fenofibrate - adverse effects; Fenofibrate - analogs & derivatives; Fenofibrate - therapeutic use; Fluorobenzenes - adverse effects; Fluorobenzenes - therapeutic use; Heptanoic Acids - adverse effects; Heptanoic Acids - therapeutic use; Humans; Hypolipidemic Agents - adverse effects; Hypolipidemic Agents - therapeutic use; Internal Medicine; Male; Medicine; Medicine & Public Health; Original Research Article; Pharmacology/Toxicology; Pharmacotherapy; Prospective Studies; Pyrimidines - adverse effects; Pyrimidines - therapeutic use; Pyrroles - adverse effects; Pyrroles - therapeutic use; Research Design; Rosuvastatin Calcium; Simvastatin - adverse effects; Simvastatin - therapeutic use; Sulfonamides - adverse effects; Sulfonamides - therapeutic use; Time Factors; Treatment Outcome
• ISSN: 1173-2563; 1179-1918
• DOI: 10.2165/00044011-200828100-00003

Background and objective: Atherogenic lipid parameters in patients with mixed dyslipidaemia have been demonstrated to increase atherosclerotic coronary heart disease (CHD) risk. Clinical studies have shown that HMG-CoA reductase inhibitor (statin) and fibric acid derivative (fibrate) combination therapy is effective at improving multiple lipid abnormalities in different patient populations at increased risk of CHD. However, inconsistencies with respect to trial designs and safety issues have limited the clinical use of this combination therapy. A comprehensive, controlled clinical trial programme was thus designed to evaluate three separate statins in combination with ABT-335, a new formulation of fenofibric acid. Methods: Three separate 22-week, phase III, double-blind, active-controlled trials will evaluate combination therapy with ABT-335 135 mg/day and either rosuvastatin (10 mg/day and 20 mg/day), atorvastatin (20 mg/day and 40 mg/day) or simvastatin (20 mg/day and 40 mg/day) in comparison to either ABT-335 or the corresponding statin monotherapy. An approximate total of 2400 patients with elevated triglycerides (TG) [≥150 mg/dL], reduced high-density lipoprotein cholesterol (HDL-C) [