Jan W. Smit, MD; Herman J. Wijnne, PhD; Fred Schobben, PhD; Ad Sitsen, MD, PhD; Tjerk W. De Bruin, MD, PhD; D. Willem Erkelens, MD, PhD
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.
Randomized, placebo-controlled, crossover study.
Lipid clinic of a university hospital.
31 patients with primary hypercholesterolemia (low-density lipoprotein cholesterol levels ≥ 4.2 mmol/L) who had previously received a lipid-lowering diet.
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.
Plasma fluvastatin levels, lipid levels, and clinical variables were determined at the end of each treatment period.
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 × 103 ng x 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.
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.
Smit JW, Wijnne HJ, Schobben F, Sitsen A, De Bruin TW, Erkelens DW. Effects of Alcohol and Fluvastatin on Lipid Metabolism and Hepatic Function. Ann Intern Med. 1995;122:678–680. doi: 10.7326/0003-4819-122-9-199505010-00006
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Published: Ann Intern Med. 1995;122(9):678-680.
Cardiology, Coronary Risk Factors, Dyslipidemia.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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