Objective To determine the occurrence of extremely low HDL-C among participants in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Lipid Trial and to examine the relationship of this finding with treatment with fenofibrate and thiazolidinedione (TZD).
Research Design and Methods The ACCORD Lipid Trial was a randomized double blind placebo controlled study conducted in patients with type 2 diabetes at 77 clinical centers across the United States and Canada in a 5,518 patient sub-set of the larger 10,251 ACCORD Glycemia Trial. Patients were enrolled from January 11, 2001 until October 29, 2005 and followed until end of study visits between March 1 and June 30, 2009. Follow-up in ACCORD Lipid was 4 to 8 years (mean 4.7 years). Patients were treated with blinded fenofibrate or placebo on a background of simvastatin therapy. The main outcome measures for these descriptive, post hoc analyses was the occurrence of extremely low HDL-C (defined as < 25 mg/dl [0.647 mmol/L]) during the trial.
Results Among ACCORD Lipid Trial participants, the occurrence of extremely low HDL-C ever during study follow-up was 106% higher among those randomized to fenofibrate (10.1% fenofibrate vs. 4.9% placebo; P<0.001). The occurrence of low HDL-C was associated with concurrent treatment with fenofibrate and TZD (7.0% for both vs. 2.2% for neither at 48 months post-randomization).
Conclusions Idiosyncratic and marked reduction in HDL-C can occur in some patients treated with both fenofibrate and TZD. Practitioners should recognize this important potential idiosyncratic reaction and take appropriate corrective action.
- Received April 2, 2013.
- Accepted November 21, 2013.
- © 2013 by the American Diabetes Association.
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