Effects of fluvastatin and bezafibrate combination on plasma fibrinogen, t-plasminogen activator inhibitor and C reactive protein levels in coronary artery disease patients with mixed hyperlipidaemia (FACT study). Fluvastatin Alone and in Combination Treatment.
OBJECTIVE
We studied the effects of fluvastatin and bezafibrate in monotherapy and in combination on plasma fibrinogen, t-plasminogen activator inhibitor (PAI-1) and C reactive protein (CRP) in patients with coronary artery disease (CAD) and mixed hyperlipidaemia.


METHODS
In this randomised, double blind, multicentre trial 333 patients with stable angina pectoris or previous myocardial infarction or coronary revascularisation and mixed hyperlipidaemia (LDL-cholesterol 135-250 mg/dl and triglycerides (TG) 180-400 mg/dl) were randomised to fluvastatin 40 mg, bezafibrate 400 mg, fluvastatin 20 mg + bezafibrate 400 mg or fluvastatin 40 mg + bezafibrate 400 mg treatments for 24 weeks.


RESULTS
Plasma fibrinogen significantly decreased after treatment with the combinations fluvastatin+bezafibrate (-14 and -16%) and with bezafibrate monotherapy (-9%). No significant reduction was observed after fluvastatin monotherapy (-4%). No significant changes were observed in PAI-1 and CRP plasma levels. Combination therapy significantly decreased both LDL-C and TG, and significantly increased HDL-C.


CONCLUSIONS
The combined effects on fibrinogen and plasma lipids achieved by fluvastatin and bezafibrate combination treatment might be more useful than the simple reduction of cholesterol in preventing ischaemic cardiovascular disease.
Cortellaro
M
M
University of Milan, Italy. centrorc@mailserver.unimi.it
Cofrancesco
E
E
Boschetti
C
C
Cortellaro
F
F
Mancini
M
M
Mariani
M
M
Paoletti
R
R
D000328:Adult; D000368:Aged; D001629:Bezafibrate / Q000008:administration & dosage* / Q000627:therapeutic use; D002097:C-Reactive Protein / Q000032:analysis*; D008078:Cholesterol, LDL / Q000097:blood; D003327:Coronary Disease / Q000097:blood*; D004311:Double-Blind Method; D004357:Drug Synergism; D004359:Drug Therapy, Combination; D005229:Fatty Acids, Monounsaturated / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D005340:Fibrinogen / Q000032:analysis*; D000077340:Fluvastatin; D006801:Humans; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D006950:Hyperlipidemia, Familial Combined / Q000097:blood / Q000188:drug therapy*; D006938:Hyperlipoproteinemia Type II / Q000097:blood / Q000188:drug therapy; D015228:Hypertriglyceridemia / Q000097:blood / Q000188:drug therapy; D000960:Hypolipidemic Agents / Q000008:administration & dosage* / Q000627:therapeutic use; D007211:Indoles / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D010959:Tissue Plasminogen Activator / Q000097:blood*; D016896:Treatment Outcome
D008078:Cholesterol, LDL; D005229:Fatty Acids, Monounsaturated; D019161:Hydroxymethylglutaryl-CoA Reductase Inhibitors; D000960:Hypolipidemic Agents; D007211:Indoles; D000077340:Fluvastatin; D005340:Fibrinogen; D002097:C-Reactive Protein; D010959:Tissue Plasminogen Activator; D001629:Bezafibrate