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A Multicenter, Placebo-Controlled, Dose-Ranging Study of Atorvastatin
1The Lipid Center, University of Iowa, Iowa City, Iowa, USA
Journal of Cardiovascular Pharmacology and Therapeutics
|February 23, 2000
Summary
Atorvastatin effectively reduces LDL cholesterol and triglycerides in patients with high cholesterol. This study found atorvastatin calcium to be safe and well-tolerated across various doses over six weeks.
Area of Science:
- Cardiology
- Pharmacology
- Biochemistry
Background:
- Coronary heart disease (CHD) is a leading cause of death.
- Elevated low-density lipoprotein (LDL) cholesterol and triglycerides (TG) are significant risk factors for CHD.
- 3-Hydroxy-3-methylglutaryl conenzyme A (HMG-CoA) reductase inhibitors are effective in managing hypercholesterolemia.
Purpose of the Study:
- To evaluate the safety and dose-response effects of atorvastatin calcium.
- To assess atorvastatin's impact on lipoprotein fractions in patients with specific LDL cholesterol and TG levels.
Main Methods:
- A 6-week, randomized, placebo-controlled, parallel-group study.
- Sixty-five patients received placebo or atorvastatin (10, 20, 40, 60, or 80 mg) daily.
- Lipoprotein levels and adverse events were monitored.
Main Results:
- Atorvastatin significantly decreased LDL cholesterol in a dose-dependent manner (37%–59%) compared to placebo (P =.0001).
- Significant reductions in total cholesterol, triglycerides, and apolipoprotein B were observed across atorvastatin groups (P =.0001).
- Adverse events were comparable between atorvastatin and placebo groups, with no serious events or withdrawals due to adverse events.
Conclusions:
- Atorvastatin demonstrates effective dose-related reductions in plasma LDL cholesterol, triglycerides, and apolipoprotein B.
- The study confirms atorvastatin's good tolerability in hyperlipidemic patients over a 6-week treatment period.