Efficacy and safety of fenofibrate or gemfibrozil on serum lipid profiles in Chinese patients with type IIb hyperlipidemia: A single-blind, randomized, and cross-over study

Background. The purpose of the study was to evaluate the effects and safety of fenofibrate or gemfibrozil on plasma lipid profiles in Chinese patients with type IIb hyperlipidemia. Methods. Patients with previously diagnosed type IIb hyperlipidemia were initially evaluated in this single- blind, randomized, cross-over study. Only those who had persistent hyperlipidemia after a two-month diet control period were included. The patients were randomized to either fenofibrate 100 mg tid or gemfibrozil 600 mg bid for three months, then shifted to alternate drug for another three months after a two-month washout period. During the whole 10-month period, a prudent diet was maintained. Each patient was followed up at Out-patient Clinic regularly for diet interview, compliance and possible adverse events. Results. A total of 12 patients, 11 males and 1 female, completed the whole study. After a three-month treatment of fenofibrate, there was significant reduction in plasma total cholesterol (22.7%, p<0.001), total triglycerides, (43.2%, p<0.001), and low-density lipoprotein (LDL)-cholesterol (25.7%, p=0.001). Serum high density lipoprotein (HDL) cholesterol was also increased by the 30.2% (p=0.055). On the other hand, only total triglyceride was significantly reduced by 36.5% (p=0.005) with gemfibrozil treatment. There was no significant change of serum total, HDL- and LDL-cholesterol after the three-month treatment of gemfibrozil. Besides, serum uric acid and alkaline phosphatase were significantly reduced with fenofibrate but not with gemfibrozil treatment. There was no obvious adverse event noted during each treatment period with either drug. Conclusions: The findings suggest that in Chinese patients with type IIb hyperlipidemia, both fenofibrate and gemfibrozil can safely and significantly reduce serum triglyceride. Fenofibrate, but not gemfibrozil, could also reduce serum total cholesterol, LDL and uric acid. The results were compatible with the findings of previous studies in western patients with hyperlipidemia.