Fluvastatin efficacy and tolerability in comparison and in combination with cholestyramine.
The aim of this study was to investigate the new synthetic HMG-CoA reductase inhibitor, fluvastatin, for efficacy, safety and tolerability in comparison to cholestyramine. One hundred fifty one primary hypercholesterolaemic patients participated in this double-blind, parallel-group, randomized study. During the first 12 weeks of the study, fluvastatin (20 mg and 40 mg daily) was compared with cholestyramine (16 g per day). In the subsequent, 6-week part of the study, the comparative efficacy, safety and tolerability of 20 mg fluvastatin, combined with cholestyramine (4 g, 8 g, or 16 g) were assessed. Fluvastatin (40 mg) reduced LDL cholesterol by 28.0%, triglycerides by 10.5% and increased HDL cholesterol by 3.7%. Cholestyramine (16 g) reduced LDL cholesterol by 35.0%, but raised triglycerides and HDL cholesterol by 12.3% (p < 0.01) and 3.7% respectively. The combination of fluvastatin 20 mg and cholestyramine (4 g, 8 g and 16 g) induced the following reductions in LDL cholesterol: 30.4%, 35.6% and 46.6% respectively. There was no significant change in triglycerides in either group although HDL cholesterol was raised by 4.9%, 8.3% and 7.2% respectively. One patient treated with fluvastatin and two treated with cholestyramine were withdrawn from the study due to elevation of liver transaminases. The most frequent subjective adverse effects in both treatment groups were mild, transient gastrointestinal complaints. Thus, fluvastatin was effective as a lipid-lowering agent; the effect was further enhanced when fluvastatin was combined with cholestyramine.
Hagen
E
E
Medical Department A, National Hospital, Oslo, Norway.
Istad
H
H
Ose
L
L
Bodd
E
E
Eriksen
H M
HM
Selvig
V
V
Bard
J M
JM
Fruchart
J C
JC
Borge
M
M
Wolf
M C
MC
D000924:Anticholesteremic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002792:Cholestyramine Resin / Q000009:adverse effects / Q000627:therapeutic use*; D004032:Diet; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005229:Fatty Acids, Monounsaturated / Q000009:adverse effects / Q000627:therapeutic use*; D000077340:Fluvastatin; D006801:Humans; D006937:Hypercholesterolemia / Q000097:blood / Q000188:drug therapy*; D007211:Indoles / Q000009:adverse effects / Q000627:therapeutic use*; D008055:Lipids / Q000097:blood; D010349:Patient Compliance
D000924:Anticholesteremic Agents; D005229:Fatty Acids, Monounsaturated; D007211:Indoles; D008055:Lipids; D002792:Cholestyramine Resin; D000077340:Fluvastatin