CLINICAL RESEARCH: TREATMENT OF HYPERLIPIDEMIA
Additive Beneficial Effects of Fenofibrate Combined With Atorvastatin in the Treatment of Combined Hyperlipidemia
Kwang Kon Koh, MD, FACC*,*,
Michael J. Quon, MD, PhD ,
Seung Hwan Han, MD*,
Wook-Jin Chung, MD*,
Jeong Yeal Ahn, MD ,
Yiel-Hea Seo, MD ,
In Suck Choi, MD* and
Eak Kyun Shin, MD*
* Department of Cardiology, Gachon Medical School, Incheon, Korea
Department of Laboratory Medicine, Gachon Medical School, Incheon, Korea
Diabetes Unit, National Center for Complementary and Alternative Medicine, National Institutes of Health, Bethesda, Maryland.
Manuscript received November 17, 2004;
revised manuscript received January 17, 2005,
accepted February 8, 2005.
* Reprint requests and correspondence: Dr. Kwang Kon Koh, Director, Vascular Medicine and Atherosclerosis Unit, Gil Heart Center, Gachon Medical School, 1198 Kuwol-dong, Namdong-gu, Incheon, Korea 405-760. (Email: kwangk{at}ghil.com).
OBJECTIVES: We compared vascular and metabolic responses (and adverse responses) to statin and fibrate therapies alone or in combination in patients with combined hyperlipidemia.
BACKGROUND: The mechanisms of action for statins and fibrates are distinct.
METHODS: Fifty-six patients were given atorvastatin 10 mg and placebo, atorvastatin 10 mg and fenofibrate 200 mg, or fenofibrate 200 mg and placebo daily during each two-month treatment period of a randomized, double-blind, placebo-controlled crossover trial with two washout periods of two months each.
RESULTS: Lipoproteins were changed to a greater extent with combined therapy when compared with atorvastatin or fenofibrate alone. Flow-mediated dilator response to hyperemia and plasma high-sensitivity C-reactive protein and fibrinogen levels were changed to a greater extent with combined therapy when compared with atorvastatin or fenofibrate alone (p < 0.001, p = 0.182, and p = 0.015 by analysis of variance [ANOVA], respectively). The effects of combined therapy or fenofibrate alone on plasma adiponectin levels and insulin sensitivity (determined by the Quantitative Insulin-Sensitivity Check Index [QUICKI]) were significantly greater than those of atorvastatin alone (p = 0.022 for adiponectin and p = 0.049 for QUICKI by ANOVA). No patients were withdrawn from the study as the result of serious adverse effects.
CONCLUSIONS: Combination therapy is safe and has beneficial additive effects on endothelial function in patients with combined hyperlipidemia.
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Abbreviations and Acronyms
| | ANOVA = analysis of variance | | FMD = flow-mediated dilation | | HDL = high-density lipoprotein | | LDL = low-density lipoprotein | | QUICKI = Quantitative Insulin-Sensitivity Check Index |
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