Efficacy and safety of a combination of fluvastatin and bezafibrate in patients with mixed hyperlipidaemia (FACT study)

Preliminary data suggest that fluvastatin may be safely combined with fibra tes. The Fluvastatin Alone and in Combination Treatment Study examined the effects on plasma lipids and safety of a combination of fluvastatin and bez afibrate in patients with coronary artery disease and mixed hyperlipidaemia . A total of 333 patients were randomly allocated in this multicentre doubl e-blind trial to receive 40 mg fluvastatin alone (n = 80), 400 mg bezafibra te (n = 86), 20 mg fluvastatin + 400 mg bezafibrate (n = 85) or 40 mg fluva statin + 400 mg bezafibrate (n = 82) for 24 weeks. Low-density lipoprotein (LDL)-cholesterol decreased >20% in all fluvastatin-containing regimens, wi th significantly greater decreases compared with bezafibrate alone (P < 0.0 01). Bezafibrate alone and fluvastatin + bezafibrate combinations resulted in greater increases in high-density lipoprotein (HDL)cholesterol and decre ases in triglycerides compared with fluvastatin alone (P < 0.001). Fluvasta tin (40 mg)+ bezafibrate was the most effective for all lipid parameters wi th a decrease from baseline at endpoint in LDL-cholesterol of 24%, a decrea se in triglycerides of 38% and an increase in HDL-cholesterol of 22%. All t reatments were well tolerated with no increase in adverse events for combin ation therapy versus monotherapy, or between combination regimens. No clini cally relevant liver (aspartate aminotransferase or alanine aminotransferas e (ASAT or ALAT) greater than three times the upper limit of normal) or mus cular (creatine phosphokinase (CPK) greater than four times the upper limit of normal) laboratory abnormalities were reported. This large study shows 40 mg fluvastatin in combination with 400 mg bezafibrate to be highly effec tive and superior to either drug given as monotherapy in mixed hyperlipidae mia, and to be safe and well tolerated. (C) 2000 Elsevier Science Ireland L td. All rights reserved.