The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibito
rs have rapidly become widespread in the treatment of hypercholesterol
emia and are known to be variable in efficacy. To investigate the effe
ct on biliary lipids, a 3-month study using fluvastatin was devised. A
total of 19 patients were enrolled in this study: all had hypercholes
terolemia (7 men, 12 women; 13 with type IIa, 6 with type IIb). After
an observation period of 4-6 weeks with placebo, fluvastatin at a dail
y dose of 30 mg was administered for 3 months. Fasting blood samples w
ere taken early in the morning, before, and once a month during 3 mont
hs of fluvastatin treatment, for measurement of serum lipids. Cerulein
-stimulated bile in the gallbladder was sampled using a duodenal tube,
and the changes in biliary lipids were assessed. There was a marked d
ecrease in serum total cholesterol after 12 weeks of treatment (21%; p
<0.001). However, there was no significant difference in the bile cho
lesterol saturation index (CSI): values before and after 3 months of d
rug administration were 0.93 and 0.99, respectively (Admirand-Small me
thod). There were no significant changes in either the fatty acid comp
osition of biliary lecithin or in the bile acid composition of bile. I
n conclusion, on the basis of these results, short-term (3 months) adm
inistration of fluvastatin does not appear to affect CSI.