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Combined Fluvastatin-Fibrate Therapy Improves Lipid Profile of Hypercholesterolaemic Patients: Presented at ISA

By Eurona Earl Tilley

KYOTO, JAPAN -- October 1, 2003 -- A combination of fluvastatin and a fibrate agent was shown to improve the lipid abnormalities present in patients with combined hyperlipidemia who do not respond to fluvastatin alone.

Michael Farnier, MD, PhD, Nutrilip Point Medical, Dijon, France, presented these findings at the 13^th International Symposium on Atherosclerosis yesterday, September 30^th.

Dr. Farnier and associates analysed data from 10 studies with 1,018 patients who had either mixed hyperlipidaemia or primary hypercholesterolaemia. They evaluated the efficacy and safety of fluvastatin therapy combined with bezafibrate, fenofibrate, or gemfibrozil for approximately 37 weeks.

Among the 10 studies, 4 included treatment with bezafibrate 200 mg or 400 mg, 3 with fenofibrate 200 mg in standard and micronised formulations, and 3 with gemfibrozil 600 mg or 1200 mg. Patients received fluvastatin in doses of 20 mg, 40 mg, or 80 mg per day.

The percent changes in levels of low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, and total non-high density lipoproteins (non-HDL) were evaluated for each patient.

The combination of fluvastatin with each fibrate improved the lipid profile of patients by reducing levels of LDL, triglycerides, and total non-HDL compared to baseline. The greatest percent reduction in LDL and other non-HDL cholesterol occurred in the subgroup of patients who had a baseline triglyceride level of less than 150 mg/dL. In addition, HDL levels increased as a result of combining fluvastatin with bezafibrate, fenofibrate, or gemfibrozil.

Combinations of fluvastatin with each fibrate produced no adverse effects. Two patients had creatine kinase levels more than 10 times the normal upper limit. In both cases, the creatine kinase levels returned to normal without interruption of therapy. Eleven patients had elevated alanine transaminase levels, and 7 patients had elevated aspartate transaminase levels. These cases represent approximately 1% of all participating patients.

Dr. Farnier concluded that the most important aspect of this study is the safety of combining fluvastatin with a fibrate. He stated that this treatment is effective and should be considered for high-risk patients with combined hyperlipidaemia who do not respond to fluvastatin alone.


[Study title: Combination of Fluvastatin and Fibrates: Effects of Baseline Triglycerides on Changes in Lipid Profile. Abstract 2P-0578]

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