Effect of combined fluvastatin-fenofibrate therapy compared with fenofibrate monotherapy in severe primary hypercholesterolemia

This double-blind study was designed to assess the efficacy and safety of f luvastatin-fenofibrate combination therapy compared with fenofibrate monoth erapy in severe primary hypercholesterolemia (low-density lipoprotein [LDL] cholesterol greater than or equal to 190 mg/dl [4.9 mmol/L], triglycerides less than or equal to 350mg/dl [3.9 mmol/l]). After a 10-week placebo and dietary baseline period, 102 patients were randomized to receive micronized fenofibrate 200 mg, fluvastatin 20 mg plus micronized fenofibrate 200 mg, or fluvastatin 40 mg plus micronized fenofibrate 200 mg. At week 16, fenofi brate 200 mg alone lowered LDL cholesterol from baseline by 21% compared wi th 32% for fluvastatin 20 mg plus fenofibrate 200 mg and 41% for fluvastati n 40 mg plus fenofibrate 200 mg (p < 0.001). Triglycerides decreased by 29% with fenofibrate 200 mg alone, 39% with fluvastatin 20 mg plus fenofibrate 200 mg, and 40% with fluvastatin 40 mg plus fenofibrate 200 mg (p < 0.05). Safety was assessed by recording adverse events and measuring clinical lab oratory parameters. The adverse event profile wets similar for the 3 treatm ent groups. One patient withdrew due to an increase in transaminase levels. No significant increase in creatine phosphokinase levels was observed with combination therapy. In conclusion, the addition of fluvastatin to microni zed fenofibrate results in substantial improvement in atherogenic plasma li pids and is well tolerated. (C) 2000 by Excerpta Medica, Inc.