Structural and functional changes in lipoproteins associated with diabetes substantially contribute to the increased risk of cardiovascular disease. The aim of this study was to investigate the efficacy of a fibrate derivate fenofibrate, in type II diabetic patients with combined hyperlipidemia who frequently have elevated levels of fibrinogen and C-reactive protein (CRP).
METHODS Forty-seven patients who were followed for combined hyperlipidemia refractory to diet regulation of at least 3 months and were free of coronary artery disease were enrolled in this study. Fifteen of the patients had diabetes mellitus type II. All patients received fenofibrate therapy (250 mg once a day PO) for 6 months. Serum lipid profiles, CRP and fibrinogen levels, whole blood counts, urine and blood chemistry analyses were tracked during therapy. At the end of 6 months, efficacy and side effects were evaluated. Diabetic and non-diabetic patients were compared according to their response to fenofibrate therapy.
RESULTS At the end of 6 months, there were favourable results in respect to lipid profiles, and CRP and fibrinogen levels in all patients. There were statistically significant reductions in the serum levels of total-cholesterol (-%9), triglycerides (-%58), and LDL (-%17) in both groups. The levels of HDL and apo A1 were significantly elevated. The changes observed in lipoprotein levels were quite similar in diabetic and non-diabetic group. Baseline fibrinogen levels were sligthly higher in diabetics (378±82 mg/dl vs 350±76 mg/dl, p>0,05). After treatment fibrinogen levels decreased significantly in both diabetic (16%) and nondiabetic patients (12%). At baseline the CRP levels were also slightly higher in diabetics (0,855( 0,681 mg/dl vs 0,578( 0,584 mg/dl; p=0,05). In both groups CRP levels decreased significantly (54% in diabetics and 35% in non-diabetics). There were no significant adverse events during the study.
CONCLUSION Fenofibrate is an efficient and safe antihyperlipidemic agent in the treatment of both diabetic and non-diabetic patients with combined hyperlipidemia. Fenofibrate may also be a possible antiatherosclerotic agent due to both CRP and fibrinogen lowering effects.
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