The effect of dual PPAR alpha/gamma stimulation with combination of rosiglitazone and fenofibrate on metabolic parameters in type 2 diabetic patients.

We assessed the additive effect of dual peroxisome proliferators activated receptors (PPAR) alpha/gamma induction, achieved by the addition of fenofibrate to rosiglitazone, on metabolic control and diabetic dyslipidemia. Fourty type 2 diabetic patients with poor metabolic control who were taking oral antidiabetic agents and/or insulin were included in the study. Patients received 4 mg of rosiglitazone per day for 12 weeks. Later, 200mg of fenofibrate per day was added to the therapy regimen for another 12 weeks. HbA1c, uric acid, serum lipid profile and body mass index (BMI) were assessed at the start and at the 12th and the 24th weeks of the study. BMI values at the 12th and the 24th weeks of the study increased significantly (p<0.01) while for HbA1c levels there was a reduction at the 12th and the 24th weeks of 11% (p<0.001) and 13% (p<0.002), respectively. The change in HbA1c levels after the addition of fenofibrate to the rosiglitazone therapy was not statistically significant. The change in LDL levels with rosiglitazone at the 12th week was not statistically significant while the addition of fenofibrate to rosiglitazone decreased mean LDL levels from 126.8+/-29.6 mg/dL to 106.7+/-26.7 mg/dL (p<0.001). The mean percent reduction in triglyceride levels at the 12th and the 24th weeks were 19% and 33%, respectively (p<0.001). HDL levels increased from 44.59 mg/dL to 50.14 mg/dL (p<0.001) at week 12. A further increase of 16% (p<0.001) was observed after the addition of fenofibrate to rosiglitazone. In type 2 diabetic patients dual PPAR alpha/gamma stimulation by means of concomitant administration of rosiglitazone and fenofibrate improves the atherogenic dyslipidemic profile of these patients with good tolerability.

RCT Entities:   Population Interventions Outcomes