The lipid-lowering effects of atorvastatin, a new HMG-CoA reductase inhibitor: results of a randomized, double-masked study

This randomized, placebo-controlled, double-masked, parallel-group trial assessed the serum cholesterol—lowering effects of atorvastatin, a new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, over 26 weeks in patients with primary hypercholesterolemia. Thirty-nine patients from four cente...

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Bibliographic Details
Published in:Clinical therapeutics 1996-09, Vol.18 (5), p.853-863
Main Authors: Heinonen, Therese M., Stein, Evan, Weiss, Stuart R., McKenney, James M., Davidson, Michael, Shurzinske, Linda, Black, Donald M.
Format: Article
Language:English
Subjects:
Adult
Aged
Apolipoproteins B - blood
Atorvastatin Calcium
Biological and medical sciences
Cholesterol - blood
Cholesterol, LDL - blood
Double-Blind Method
Female
General and cellular metabolism. Vitamins
Heptanoic Acids - therapeutic use
Humans
Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use
Hypercholesterolemia - drug therapy
Male
Medical sciences
Middle Aged
Pharmacology. Drug treatments
Pyrroles - therapeutic use
Triglycerides - blood
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Summary:This randomized, placebo-controlled, double-masked, parallel-group trial assessed the serum cholesterol—lowering effects of atorvastatin, a new 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor, over 26 weeks in patients with primary hypercholesterolemia. Thirty-nine patients from four centers in the United States were originally randomized to one of two treatment groups and received either atorvastatin 10 mg (20 patients) or placebo (19 patients) once daily. Atorvastatin rapidly and significantly reduced serum total cholesterol, low-density lipoprotein cholesterol (LDL-C), and apolipoprotein B levels. LDL-C was reduced 35% with atorvastatin 10 mg compared with a 0% increase in LDL-C in the placebo group. Atorvastatin significantly reduced triglyceride levels, with improvements occurring over time. At 26 weeks, triglyceride levels were reduced by 21% with atorvastatin treatment compared with a 14% increase with placebo. The drug was well tolerated and no clinically significant laboratory abnormalities were detected.
ISSN:0149-2918
1879-114X
DOI:10.1016/S0149-2918(96)80045-2