Efficacy and safety of fenofibric acid in combination with atorvastatin and ezetimibe in patients with mixed dyslipidemia.

Abstract

BACKGROUND:

Statin and ezetimibe combination therapy may be insufficient to improve lipid and nonlipid parameters beyond low-density lipoprotein cholesterol (LDL-C) in patients with mixed dyslipidemia.

METHODS:

In this phase 3, multicenter, double-blind study, a total of 543 patients with triglycerides ≥150 mg/dL and <400 mg/dL, high-density lipoprotein cholesterol (HDL-C) <40 mg/dL (<50 mg/dL for women), and LDL-C ≥130 mg/dL were randomized to 12 weeks of treatment with fenofibric acid 135 mg (FA) or placebo, each coadministered with atorvastatin 40 mg + ezetimibe 10 mg (Atorva/Eze).

RESULTS:

Both treatment regimens lowered LDL-C by >50%; however, FA + Atorva/Eze resulted in significantly (P < .001) greater improvements in HDL-C (13.0% vs 4.2%), triglycerides (-57.3% vs -39.7%), non-HDL-C (-55.6% vs -51.0%), and apoprotein B (-49.1% vs -44.7%) compared with Atorva/Eze. Overall, adverse events were similar in the 2 treatment groups. No unexpected muscle, hepatic, or renal safety signals were identified with either treatment combination.

CONCLUSIONS:

In patients with mixed dyslipidemia, the combination of FA + Atorva/Eze significantly improved lipid and nonlipid parameters compared with Atorva/Eze and was generally well tolerated.

• Authors: Peter H Jones, Anne C Goldberg, Howard R Knapp, Maureen T Kelly, Carolyn M Setze, James C Stolzenbach, Darryl J Sleep
• Journal: American heart journal (Am Heart J) Vol. 160 Issue 4 Pg. 759-66 (Oct 2010) ISSN: 1097-6744 [Electronic] United States
• PMID: 20934572 (Publication Type: Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2010 Mosby, Inc. All rights reserved.

Chemical References

• Anticholesteremic Agents
• Azetidines
• Heptanoic Acids
• Hydroxymethylglutaryl-CoA Reductase Inhibitors
• Pyrroles
• Cholesterol
• Atorvastatin
• fenofibric acid
• Ezetimibe
• Fenofibrate

Topics

• Adult
• Aged
• Aged, 80 and over
• Anticholesteremic Agents (administration & dosage, therapeutic use)
• Atorvastatin
• Azetidines (administration & dosage, therapeutic use)
• Cholesterol (blood)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Drug Therapy, Combination
• Dyslipidemias (blood, drug therapy)
• Ezetimibe
• Female
• Fenofibrate (administration & dosage, analogs & derivatives, therapeutic use)
• Follow-Up Studies
• Heptanoic Acids (administration & dosage, therapeutic use)
• Humans
• Hydroxymethylglutaryl-CoA Reductase Inhibitors (administration & dosage, therapeutic use)
• Male
• Middle Aged
• Pyrroles (administration & dosage, therapeutic use)
• Treatment Outcome
• Young Adult