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EXPEDITED PUBLICATION

Long-Term Effects of Fenofibrate on Carotid Intima-Media Thickness and Augmentation Index in Subjects With Type 2 Diabetes Mellitus

Anne Hiukka, MD^_*, Jukka Westerbacka, MD, PhD, Eeva S. Leinonen, MD, PhD^_*, Hiroshi Watanabe, MD, PhD^_*, Olov Wiklund, MD, PhD, Lillemor Mattson Hulten, PhD, Jukka T. Salonen, DMedSc^,||, Tomi-Pekka Tuomainen, MD, PhD, Hannele Yki-Järvinen, MD, PhD, Anthony C. Keech, MD, PhD^¶ and Marja-Riitta Taskinen, MD, PhD^_*,_*

^_* Department of Medicine, University of Helsinki, Helsinki University Central Hospital and Biomedicum, Helsinki, Finland
Department of Diabetes, University of Helsinki, Helsinki University Central Hospital and Biomedicum, Helsinki, Finland
Wallenberg Laboratory for Cardiovascular Research, Sahlgrenska University Hospital, Göteborg, Sweden
Research Institute of Public Health, University of Kuopio, Kuopio, Finland
^|| Oy Jurilab Ltd., Kuopio, Finland
^¶ NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia

Manuscript received June 9, 2008; revised manuscript received September 22, 2008, accepted September 29, 2008.

^_* Reprint requests and correspondence: Dr. Marja-Riitta Taskinen, Department of Medicine, Division of Cardiology, Helsinki University Hospital and Biomedicum, Haartmaninkatu 8, 00029 Helsinki, Finland (Email: marja-riitta.taskinen{at}helsinki.fi).

Objectives: The aim of this substudy was to ascertain whether long-term treatment with fenofibrate reduces surrogate measures of atherosclerosis, biomarkers of inflammation, and endothelial activation in patients with type 2 diabetes.

Background: Some fibrates may decrease cardiovascular events, improve endothelial function, and reduce levels of acute-phase proteins. In the FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) study, fenofibrate failed to decrease the primary end point of coronary events in patients with type 2 diabetes.

Methods: A total of 170 patients with type 2 diabetes of the FIELD Helsinki cohort were randomly assigned to micronized fenofibrate 200 mg/day or placebo in a double-blind design. Carotid intima-media thickness (IMT) and the augmentation index (a measure of large artery stiffness) were measured at baseline and at second- and fifth-year visits. Plasma levels of interleukin (IL)-6, C-reactive protein (CRP), serum amyloid A (SAA), secretory phospholipase A2 IIA (SPLA2), E-selectin, vascular cellular adhesion molecule (VCAM)-1, and intercellular adhesion molecule (CAM)-1 were determined by commercial enzyme-linked immunosorbent assay kits at the same visits.

Results: IMT and the augmentation index increased similarly in both treatment groups during the study. Plasma levels of CRP, IL-6, SPLA2, SAA, VCAM-1, ICAM-1, and E-selectin remained unchanged in both groups.

Conclusions: Fenofibrate treatment was not associated with beneficial changes in IMT, augmentation index, or biomarkers of inflammation and endothelial function. (Fenofibrate Intervention and Event Lowering in Diabetes; NCT00132886)

Key Words: type 2 diabetes • fenofibrate • intima-media thickness • augmentation index • inflammation

Abbreviations and Acronyms   CRP = C-reactive protein   HDL = high-density lipoprotein   ICAM = intercellular adhesion molecule   IL = interleukin   IMT = intima-media thickness   MI = myocardial infarction   SAA = serum amyloid A   SPLA2 = secretory phospholipase A2 IIA   VCAM = vascular cellular adhesion molecule

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