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Individual and Combined Effects of Peroxisome Proliferator-Activated Receptor and Agonists, Fenofibrate and Rosiglitazone, on Biomarkers of Lipid and Glucose Metabolism in Healthy Nondiabetic Volunteers

From Merck Research Laboratories, Merck & Co Inc, Rahway, New Jersey (Dr Wagner, P. J. Larson, J. L. Miller, Dr Doebber, M. S. Wu, Dr Moller, Dr Gottesdiener) and Radiant Research, San Diego, California (Dr Weiss).

This open-label, randomized, placebo-controlled, incomplete-block, 3-period crossover pilot study investigated the effects of peroxisome proliferator-activated receptor - and -agonists on biomarkers of lipid and glucose metabolism in 12 nondiabetic subjects. Plasma samples were collected before and after each 14-day treatment with placebo, fenofibrate (201 mg/d), rosiglitazone (4 mg twice daily), and combined fenofibrate (201 mg/d) plus rosiglitazone (4 mg twice daily). Except for triglycerides (P < .042) and free fatty acids (P < .074), no significant interaction was demonstrated between fenofibrate and rosiglitazone; thus, the effect due to each drug alone was evaluated (presence/absence of drug). Fenofibrate significantly (P < .050) increased lipoprotein lipase activity (35%) and decreased apolipoproteins B (13%) and C-III (20%). Rosiglitazone significantly (P < .050) decreased fasting glucose (7.3%) and increased apolipoprotein C-III (19%) and adiponectin (137%). Fenofibrate and rosiglitazone also produced effects on triglyoerides and free fatty acids, but it was not possible to determine if these effects were synergistic in nature.

Key Words: Peroxisome proliferator-activated receptor (PPAR) / agonists • fenofibrate • rosiglitazone • lipid • glucose

Address for reprints: J. A. Wagner, MD, PhD, Department of Clinical Pharmacology, Merck Research Laboratories, 126 East Lincoln Avenue, P.O. Box 2000, RY34-A548, Rahway, NJ 07065.

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