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A Multicenter, Placebo-Controlled, Dose-Ranging Study of Atorvastatin
1The Lipid Center, University of Iowa, Iowa City, Iowa, USA
Insights
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.
Abstract:
BACKGROUND: Coronary heart disease (CHD) is the number one cause of death in Western societies. Elevated levels of plasma low-density lipoprotein (LDL) cholesterol and triglycerides (TG) increase the risk for CHD. 3-Hydroxy-3-methylglutaryl conenzyme A (HMG-CoA) reductase inhibitors effectively reduce plasma cholesterol levels in patients with hypercholesterolemia. This study assesses the safety and dose-related effects of atorvastatin calcium on lipoprotein fractions in patients with LDL cholesterol levels between 160 mg/dL (4.1 mM) and 250 mg/dL (6.5 mM) or less and TG levels of 400 mg/dL (4.5 mM) or less. METHODS AND RESULTS: Sixty-five patients were enrolled in a 6-week, randomized, placebo-controlled, parallel-group study. Patients received placebo or atorvastatin 10, 20, 40, 60, or 80 mg once daily. Adjusted mean decreases in LDL cholesterol for patients receiving atorvastatin 10, 20, 40, 60, and 80 mg were 37%, 42%, 50%, 52%, and 59%, respectively, compared with a mean increase of 0.3% for patients receiving placebo; the differences between each of the atorvastatin dose groups and placebo were statistically significant (P =.0001). Total cholesterol, triglycerides, and apolipoprotein B were significantly reduced in atorvastatin groups (P =.0001). Adverse events were similar in the placebo and atorvastatin treatment groups. No patient had a serious adverse event or withdrew because of an adverse event during this study. CONCLUSIONS: Atorvastatin effectively lowered plasma LDL cholesterol, triglycerides, and apoB levels in a dose-related manner. Atorvastatin was well tolerated in hyperlipidemic patients over a 6-week period.