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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

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Abstract

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<0.001) greater mean percentage changes in high-density lipoprotein cholesterol (HDL-C) [16.8%] and triglycerides (−43.9%) than low-dose statin monotherapy (4.7% and −18.1%, respectively) and significantly (p<0.001) greater reductions in lowdensity lipoprotein cholesterol (LDL-C) [−34.0%] than fenofibric acid monotherapy (−5.3%). Similarly, fenofibric acid + moderate-dose statin resulted in significantly (p≤0.011) greater mean percentage changes in HDL-C (16.3%) and triglycerides (−43.4%) than moderate-dose statin monotherapy (8.7% and −24.2%, respectively) and significantly (p<0.001) greater reductions in LDL-C (−32.6%) than fenofibric acid monotherapy (−5.3%). Compared with low- or moderate-dose statin, fenofibric acid + low- or moderate-dose statin resulted in over 5-fold higher percentages of patients achieving optimal levels of LDL-C, non-HDL-C, apolipoprotein B, HDL-C, and triglycerides simultaneously. Incidence of adverse events was generally similar among treatments.

Conclusion

Fenofibric acid + statin combination therapy in patients with mixed dyslipidemia and type 2 diabetes was well tolerated and resulted in more comprehensive improvement in the lipid/apolipoprotein profile than either monotherapy.

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Acknowledgments

Abbott sponsored the primary trials and was involved in the design and conduct; collection, analysis, and interpretation of the data; and the preparation, review, and approval of this manuscript.

Author conflict of interest statements: PHJ has received research support from Abbott and AstraZeneca, and has served as a consultant for Abbott and Roche, on advisory panels for Abbott and AstraZeneca, and on speakers’ bureaus for Merck, Daiichi Sankyo, and Takeda. KC has received research support from Abbott, Amylin, Lilly, and Novo-Nordisk, and has served on speakers’ bureaus for Abbott, Merck/Schering-Plough, Bristol-Myers Squibb/AstraZeneca, and as a consultant for Daiichi Sankyo and Merck/Schering-Plough. MHD has received research support from Abbott Laboratories, AstraZeneca Pharmaceuticals, Daiichi-Sankyo, Inc., Merck & Co., Inc., Merck/Schering-Plough, Pfizer Laboratories, Roche Pharmaceuticals, and Takeda Pharmaceuticals; has served as a consultant for Abbott Laboratories, AcademicCME, AstraZeneca Pharmaceuticals, Daiichi-Sankyo, Inc., diaDexus, Inc., GlaxoSmithKline, Merck & Co., Inc., Merck/Schering-Plough, Omthera, Pfizer Laboratories, Roche Pharmaceuticals, sanofi-aventis, Synarc, Takeda Pharmaceuticals, and Vindico; has served on speakers’ bureaus for Abbott Laboratories, AstraZeneca Pharmaceuticals, Daiichi-Sankyo, Inc., diaDexus, Inc., GlaxoSmithKline, Merck & Co., Inc., Merck/Schering-Plough, and Takeda Pharmaceuticals; has received honoraria from Abbott Laboratories, AcademicCME, AstraZeneca Pharmaceuticals, Daiichi-Sankyo, Inc., diaDexus, Inc., GlaxoSmithKline, Kinemed, Merck & Co., Inc., Merck/Schering-Plough, Omthera, Roche Pharmaceuticals, sanofiaventis, Synarc, Takeda Pharmaceuticals, and Vindico; and is on the board of directors for Omthera; Professional Evaluation, Inc. Medical Education Company; and Sonogene. MTK, CMS, KT, DJS, and JCS are Abbott employees and stockholders.

Assistance with statistical analyses of this paper was provided by Aditya Lele, MS, and Hsiaoming Sun, MS, and medical writing assistance was provided by Erin Blondell, PhD, on behalf of Abbott.

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Authors and Affiliations

  1. Baylor College of Medicine, Houston, Texas, USA

    Peter H. Jones

  2. University of Texas Health Science Center, San Antonio, Texas, USA

    Kenneth Cusi

  3. Pritzker School of Medicine, University of Chicago, Chicago, Illinois, USA

    Michael H. Davidson

  4. Abbott, Abbott Park, Illinois, USA

    Maureen T. Kelly, Carolyn M. Setze, Kamlesh Thakker, Darryl J. Sleep & C. Stolzenbach

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  1. Peter H. Jones
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Correspondence to Peter H. Jones.

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Jones, P.H., Cusi, K., Davidson, M.H. et al. Efficacy and Safety of Fenofibric Acid Co-Administered with Low- or Moderate-Dose Statin in Patients with Mixed Dyslipidemia and Type 2 Diabetes Mellitus. Am J Cardiovasc Drugs 10, 73–84 (2010). https://doi.org/10.2165/10061630-000000000-00000

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