Twenty-five RCTs (2,220 patients) and 51 non-comparative studies (3,218 patients) were included.
The results from the fenofibrate arms of the comparative trials were reported as mean percentage alterations from baseline.
Total cholesterol.
Fenofibrate decreased total cholesterol levels by 20% (range: 17 to 28) in type IIa hyperlipidaemias, by 20% (range: 14 to 25) in type IIb, by 24% in type III, and by 14% in type IV.
Triglyceride.
Fenofibrate decreased triglyceride concentrations by 33% (range: 24 to 38) in type IIa hyperlipidaemias, by 46% (range: 41 to 53) in type IIb, by 51% in type III, and by 53% in type IV.
High-density lipoprotein cholesterol.
Fenofibrate increased high-density lipoprotein concentrations by 12% (range: 10 to 15) in type IIa hyperlipidaemias, by 20% (range: 8 to 34) in type IIb, by 21% in type III, and by 15% (range: 14 to 15) in type IV.
Low-density lipoprotein cholesterol
Fenofibrate decreased low-density lipoprotein concentrations by 26% (range: 20 to 24) in type IIa hyperlipidaemias and by 23% (range: 6 to 35) in type IIb. The concentrations were increased by 6% (range: -9 to +20) in type IV hyperlipidaemias.
Very low-density lipoprotein cholesterol.
Fenofibrate decreased very low-density lipoprotein concentrations by 44% (range: 38 to 61) in type IIa hyperlipidaemias, by 51% (range: 48 to 53) in type IIb, by 63% in type III, and by 60% (range: 56 to 63) in type IV.
Very low-density lipoprotein triglycerides.
Fenofibrate decreased very low-density lipoprotein triglyceride levels by 34% in type IIa hyperlipidaemias, by 52% in type IIb, by 58% in type III, and by 61% (range: 59 to 63) in type IV.
The comparative trials did not present data for low-density lipoprotein triglycerides.
Adverse events.
Twelve of the 25 comparative RCTs included did not present data on adverse effects.
The authors reported that from the included studies and the manufacturer's data on file, 'a constellation of events probably causally related can be constructed including: hepatitis; cholelithiasis; cholecystitis; hepatomegaly; myalgia; myasthenia; rhabdomyolysis; photosensitivity; eczema; and allergic pulmonary alveolitis. The overall frequency of these events with long-term therapy are not well established but appear to be no more than 10% per event'.
The findings of 4 studies on cholesterol gallstone formation indicated that fenofibrate may predispose to cholesterol cholelithiasis.
Drug interactions.
Four clinical trials and 1 case report revealed that fenofibrate can enhance the effect of oral anticoagulants.
One study indicated that myopathy was associated with combination statin-fenofibrate therapy.
Higher statin doses (pravastatin 40 mg/day, simvastatin 60 mg/day) may cause myotoxicity with symptoms.
Pregnancy and lactation.
The safety of fenofibrate in pregnant and lactating women has not been established, and few data are available on fenofibrate in paediatric populations.