Dennis L. Sprecher, MD; Jonathan Abrams, MD; John W. Allen, MD; William F. Keane, MD; Steven G. Chrysant, MD; Henry Ginsberg, MD; Jerome J. Fischer, MD; Brian F. Johnson, MD; Pierre Theroux, MD; Leonard Jokubaitis, MD
To compare the low-density lipoprotein (LDL) cholesterol-lowering efficacy of low-dose combinations of cholestyramine and fluvastatin.
Randomized, double-blind, parallel group, placebo-controlled trial with a 24-week double-blind treatment period divided into three phases.
Hypercholesterolemic, with LDL cholesterol of 4.14 mmol/L or greater (≥ 160 mg/dL) and plasma triglycerides of 3.39 mmol/L or less (≤ 300 mg/dL). Four hundred sixty patients were screened; 224 patients were randomized into a double-blind treatment period; 203 completed the study; 6 dropped out because of adverse events.
Patients were treated with 10 mg or 20 mg of fluvastatin alone, 8 g or 16 g of cholestyramine alone, or combinations of these fluvastatin and cholestyramine dosages (six treatment groups).
Changes in lipid variables, particularly LDL cholesterol.
The 10-mg and 20-mg fluvastatin monotherapy groups showed considerable reductions in LDL cholesterol initially (−20.1% [SD, 8.8%] and −20.2% [SD, 10.1%], respectively); these reductions were maintained. Reductions in LDL cholesterol that resulted from the addition of cholestyramine, 8 g/d, to 10 mg of fluvastatin and 20 mg of fluvastatin were greater than those observed with monotherapy (10-mg fluvastatin − [10-mg fluvastatin plus cholestyramine], 9.1%; 95% CI, 3.8% to 14.4%) and 20-mg fluvastatin − [20-mg fluvastatin plus cholestyramine], 11.6%; CI, 6.5% to 16.8%). The increase in cholestyramine dose to 16 g/d in the three combination groups provided only a modest additional response.
Low-density lipoprotein cholesterol reductions of about 25% to 30% can be achieved with low-dose combination therapy with fluvastatin and cholestyramine. The addition of low-dose resin appears to produce greater overall cholesterol reduction than does a simple doubling of the fluvastatin dosage. The low-dose combination treatment was highly successful in achieving the goals of the National Cholesterol Education Program guidelines.
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Sprecher DL, Abrams J, Allen JW, Keane WF, Chrysant SG, Ginsberg H, et al. Low-Dose Combined Therapy with Fluvastatin and Cholestyramine in Hyperlipidemic Patients. Ann Intern Med. 1994;120:537-543. doi: 10.7326/0003-4819-120-7-199404010-00002
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Published: Ann Intern Med. 1994;120(7):537-543.
Cardiology, Coronary Risk Factors, Dyslipidemia, Prevention/Screening.
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