Effects of Long-Term Fenofibrate Treatment on Markers of Renal Function in Type 2 Diabetes
The FIELD Helsinki substudy
- Carol Forsblom, DMSC1,2,
- Anne Hiukka, MD3,
- Eeva S. Leinonen, MD, PHD3,
- Jouko Sundvall, MSC4,
- Per-Henrik Groop, MD, PHD1,2 and
- Marja-Riitta Taskinen, MD, PHD3
- 1Folkhalsan Institute of Genetics, Folkhalsan Research Center, Biomedicum, Helsinki, Finland;
- 2Division of Nephrology, Department of Medicine, Helsinki University Central Hospital, Helsinki, Finland;
- 3Division of Cardiology, Department of Medicine, Helsinki University Central Hospital, Biomedicum, Helsinki, Finland;
- 4Department of Chronic Disease Prevention, National Institute for Health and Welfare, Helsinki, Finland.
- Corresponding author: Marja-Riitta Taskinen, .
C.F. and A.H. contributed equally to this study.
OBJECTIVE Although fenofibrate was associated with less progression of albuminuria in the Fenofibrate Intervention and Event Lowering in Diabetes (FIELD) study, it is unknown if it has any effect on renal function. We explored if there were changes in commonly available markers of renal function during fenofibrate treatment in the FIELD Helsinki cohort excluding statin users.
RESEARCH DESIGN AND METHODS One hundred and seventy subjects with type 2 diabetes were randomly assigned to micronized fenofibrate (200 mg/day) or placebo for 5 years. In this substudy, we measured several markers of albumin excretion and renal function.
RESULTS After intensified treatment, blood pressure and fasting glucose decreased in both groups while A1C remained at 7.2%. Plasma creatinine increased with fenofibrate while urine creatinine remained comparable between the groups, resulting in significant decreases in both creatinine clearance and estimated glomerular filtration rate (eGFR) by the Modification of Diet in Renal Disease (MDRD)-4 and Cockroft-Gault equations in the fenofibrate group. Cystatin C increased during fenofibrate treatment. Urinary albumin-to-creatinine ratio and diurnal urine protein remained unchanged, whereas overnight urinary albumin excretion rate showed minor decreases in both groups.
CONCLUSIONS We report concomitant decreases in creatinine clearance and eGFR by fenofibrate. These changes complicate the clinical surveillance during fenofibrate treatment. We could not demonstrate the beneficial effects of fenofibrate on albumin excretion. A novel finding is the increase of cystatin C in type 2 diabetic patients during fenofibrate treatment. The clinical relevance of the changes needs to be assessed in a long-term outcome study of renal function.
Clinical trial reg. no. ISCRTN 64783481, www.ISRCTN.org.
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- Received March 31, 2009.
- Accepted October 16, 2009.
- © 2010 by the American Diabetes Association.
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