Long-term efficacy of adding fenofibric acid to moderate-dose statin therapy in patients with persistent elevated triglycerides.

Abstract

OBJECTIVE:

The objective of this study was to evaluate the long-term efficacy of adding fenofibric acid to moderate-dose statin therapy in patients at goal for low-density lipoprotein cholesterol (LDL-C) but with persistent hypertriglyceridemia.

METHODS:

This is a post hoc analysis of a subset of patients (N = 92) with mixed dyslipidemia treated with moderate-dose statin (rosuvastatin 20 mg, simvastatin 40 mg, or atorvastatin 40 mg) for 12 weeks in three controlled trials who had achieved LDL-C <100 mg/dL but whose triglycerides remained >200 mg/dL, and had fenofibric acid 135 mg added to the moderate-dose statin in a 52-week open-label extension study. Lipid and apolipoprotein (Apo) values and the proportion of patients meeting individual and combined treatment targets with combination therapy were determined at scheduled visits during the 52-week study and compared with baseline (start of extension study).

RESULTS:

Addition of fenofibric acid to moderate-dose statin for 52 weeks resulted in significant (P < 0.001) improvements in non-high-density lipoprotein cholesterol (non-HDL-C; -9.0%), ApoB (-9.8%), HDL-C (14.9%), and triglycerides (-37.6%) compared with baseline. At final visit, greater proportions of patients achieved optimal levels of individual parameters as well as combined targets of LDL-C + non-HDL-C (60.0% vs 52.2%), LDL-C + non-HDL-C + ApoB (53.3% vs 37.8%, P = 0.007), and LDL-C + non-HDL-C + ApoB + HDL-C + triglycerides (25.6% vs 0.0%) than at baseline.

CONCLUSIONS:

The addition of fenofibric acid to moderate-dose statin in patients whose LDL-C was optimal but whose triglycerides remained >200 mg/dL led to additional improvements in non-HDL-C, ApoB, HDL-C, and triglycerides that resulted in greater proportions of patients attaining optimal levels of the individual parameters as well as simultaneously achieving optimal levels of these parameters and LDL-C.

• Authors: Christie M Ballantyne, Peter H Jones, Maureen T Kelly, Carolyn M Setze, Aditya Lele, Kamlesh M Thakker, James C Stolzenbach
• Journal: Cardiovascular drugs and therapy (Cardiovasc Drugs Ther) Vol. 25 Issue 1 Pg. 59-67 (Feb 2011) ISSN: 1573-7241 [Electronic] United States
• PMID: 21416219 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Anticholesteremic Agents
• Apolipoproteins B
• Cholesterol, LDL
• Fluorobenzenes
• Heptanoic Acids
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Pyrimidines
• Pyrroles
• Sulfonamides
• Triglycerides
• Rosuvastatin Calcium
• Atorvastatin
• Simvastatin
• fenofibric acid
• Fenofibrate

Topics

• Anticholesteremic Agents (therapeutic use)
• Apolipoproteins B (blood)
• Atorvastatin
• Cholesterol, LDL (blood)
• Double-Blind Method
• Drug Interactions
• Drug Therapy, Combination
• Female
• Fenofibrate (analogs & derivatives, therapeutic use)
• Fluorobenzenes (therapeutic use)
• Heptanoic Acids (therapeutic use)
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (therapeutic use)
• Hypertriglyceridemia (blood, drug therapy)
• Male
• Middle Aged
• Pyrimidines (therapeutic use)
• Pyrroles (therapeutic use)
• Rosuvastatin Calcium
• Simvastatin (therapeutic use)
• Sulfonamides (therapeutic use)
• Triglycerides (blood)