Efficacy and Safety of Fenofibric Acid Co-Administered with Low- or Moderate-Dose Statin in Patients with Mixed Dyslipidemia and Type 2 Diabetes Mellitus: Results of a Pooled Subgroup Analysis from Three Randomized, Controlled, Double-Blind Trials

• Published in: American journal of cardiovascular drugs : drugs, devices, and other interventions devices, and other interventions, 2010-01, Vol.10 (2), p.73-84
• Main Authors: Jones, Peter H., Cusi, Kenneth, Davidson, Michael H., Kelly, Maureen T., Setze, Carolyn M., Thakker, Kamlesh, Sleep, Darryl J., Stolzenbach, C.
• Format: Article
• Language: English
• Subjects: Aged; Atorvastatin Calcium; Cardiology; Clinical Trials, Phase III as Topic; Diabetes Mellitus, Type 2 - complications; Dosage and administration; Dose-Response Relationship, Drug; Double-Blind Method; Drug therapy; Drug Therapy, Combination; Dyslipidemias; Dyslipidemias - complications; Dyslipidemias - drug therapy; Female; Fenofibrate; Fenofibrate - administration & dosage; Fenofibrate - adverse effects; Fenofibrate - analogs & derivatives; Fenofibrate - therapeutic use; Fluorobenzenes - administration & dosage; Fluorobenzenes - adverse effects; Fluorobenzenes - therapeutic use; Health aspects; Heptanoic Acids - administration & dosage; Heptanoic Acids - adverse effects; Heptanoic Acids - therapeutic use; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - administration & dosage; Hydroxymethylglutaryl-CoA Reductase Inhibitors - adverse effects; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Hypolipidemic Agents - administration & dosage; Hypolipidemic Agents - adverse effects; Hypolipidemic Agents - therapeutic use; Male; Medicine; Medicine & Public Health; Middle Aged; Original Research Article; Patient outcomes; Pharmacology/Toxicology; Pharmacotherapy; Pyrimidines - administration & dosage; Pyrimidines - adverse effects; Pyrimidines - therapeutic use; Pyrroles - administration & dosage; Pyrroles - adverse effects; Pyrroles - therapeutic use; Randomized Controlled Trials as Topic; Rosuvastatin Calcium; Simvastatin - administration & dosage; Simvastatin - adverse effects; Simvastatin - therapeutic use; Statins; Sulfonamides - administration & dosage; Sulfonamides - adverse effects; Sulfonamides - therapeutic use
• ISSN: 1175-3277; 1179-187X
• DOI: 10.2165/10061630-000000000-00000

Background Monotherapy with lipid-modifying medication is frequently insufficient to normalize lipid abnormalities in patients with mixed dyslipidemia and type 2 diabetes mellitus. Objective To evaluate the efficacy and safety of fenofibric acid + statin combination therapy in this population. Study Design A pooled, subgroup analysis of three randomized, controlled, double-blind, 12-week trials. Setting Multiple clinical research facilities in the US and Canada. Patients Patients with mixed dyslipidemia and type 2 diabetes (n= 586). Intervention Fenofibric acid (Trilipix®) 135 mg monotherapy; low-, moderate-, or high-dose statin monotherapy (rosuvastatin [Crestor®] 10, 20, or 40 mg; simvastatin [Zocor®] 20, 40, or 80 mg; or atorvastatin [Lipitor®] 20, 40, or 80 mg); or fenofibric acid + low- or moderate-dose statin. Main Outcome Measure Mean percentage changes in lipid parameters, percentages of patients achieving optimal serum lipid/apolipoprotein levels, and incidence of adverse events. Results Fenofibric acid + low-dose statin resulted in significantly (p