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Effects of alcohol and fluvastatin on lipid metabolism and hepatic function.

Abstract：

OBJECTIVE:To determine the effects of fluvastatin, a synthetic 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, combined with moderate alcohol consumption on lipid profiles and hepatic function in patients with primary hypercholesterolemia. DESIGN:Randomized, placebo-controlled, crossover study. SETTING:Lipid clinic of a university hospital. PATIENTS:31 patients with primary hypercholesterolemia (low-density lipoprotein cholesterol levels > or = 4.2 mmol/L) who had previously received a lipid-lowering diet. INTERVENTIONS:After a dietary baseline period, 26 patients were randomly assigned to receive 6 weeks of treatment with either 1) fluvastatin, 40 mg/d, added to 20 g of ethanol and diluted to 20% with orange juice or 2) fluvastatin added to orange juice alone. After a 6-week washout period, the two groups crossed over. MAIN OUTCOME MEASURES:Plasma fluvastatin levels, lipid levels, and clinical variables were determined at the end of each treatment period. RESULTS:Six patients left the study prematurely. The remaining patients (15 men, 5 women; mean age +/- SD 49.1 +/- 14.5 years; mean body mass index +/- SD 24.5 +/- 2.2 kg/m2) completed the study. Fluvastatin, alone and combined with alcohol, resulted in similar decreases in levels of total cholesterol (22% and 23%, respectively; P < 0.001 when compared with baseline), low-density lipoprotein cholesterol (28% and 29%, respectively; P < 0.001 compared with baseline), and apolipoprotein B (17% and 20%, respectively; P < 0.001 compared with baseline). High-density lipoprotein cholesterol and triglyceride levels were not changed. Fluvastatin with alcohol resulted in a significantly greater area under the plasma concentration curve (23.4 +/- 4.7 compared with 18.2 +/- 3.2 x 10(3) ng.min/mL) and in a greater time to maximum concentration (187.5 +/- 16.6 min compared with 130.9 +/- 7.0 min) than fluvastatin alone. Terminal half-life tended to increase. No important adverse clinical effects were observed. CONCLUSION:Six weeks of daily, moderate alcohol consumption influenced the metabolism of fluvastatin but did not interfere with its lipid-lowering efficacy and had no adverse effects.

journal_name

Ann Intern Med

journal_title

Annals of internal medicine

authors

Smit JW,Wijnne HJ,Schobben F,Sitsen A,De Bruin TW,Erkelens DW

doi

10.7326/0003-4819-122-9-199505010-00006

subject

Has Abstract

pub_date

1995-05-01 00:00:00

pages

678-80

issue

eissn

0003-4819

issn

1539-3704

journal_volume

122

pub_type

临床试验,杂志文章,随机对照试验

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Effects of alcohol and fluvastatin on lipid metabolism and hepatic function.