Multiple-dose pharmacokinetics, pharmacodynamics, and safety of atorvastatin, an inhibitor of HMG-CoA reductase, in healthy subjects
Abstract
This study examined the pharmacokinetics, pharmacodynamics, and safety of atorvastatin, an investigational inhibitor of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase, in 50 healthy subjects by means of a randomized, double-blind parallel-group design. Volunteers received rising single and multiple doses of 0.5 to 80 mg/day atorvastatin (40 subjects) or placebo (10 subjects). The drug was administered once or twice daily for 14 days. Atorvastatin was well tolerated by healthy subjects. The most common adverse events reported after atorvastatin-headache and nausea-occurred as frequently after placebo. Atorvastatin peak concentration and area under the plasma concentration-time curve (AUC) values increased more than proportionally with atorvastatin dose after both single and multiple drug doses. The extent of atorvastatin absorption (AUC) was similar after once- or twice-daily drug administration. Steady-state drug concentrations were achieved by the third day of drug dosing. Mean elimination half-life values ranged from 11 to 24 hours. Atorvastatin accumulation was approximately 1.5- and 3.0-fold after once- and twice-daily administration, respectively. Atorvastatin produced dose-related reductions in total cholesterol and low-density lipoprotein cholesterol that were similar after once- and twice-daily drug administration. Reductions in mean total cholesterol and low-density lipoprotein cholesterol values ranged from 13% and 22% (2.5 mg/day) to 45% and 58% (80 mg/day), respectively (p < or = 0.0013 in comparison with placebo and with baseline over this dose range). In summary, atorvastatin doses of up to 80 mg/day were well tolerated and had significant cholesterol-lowering effects.
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Similar high daily doses of atorvastatin have been used in some subject groups.
“While the dose we employed is higher than the one typically employed in man, similar high daily doses have been used in some subject groups (Cilla et al., 1996)”
From Atorvastatin Reduces the Survival of Candida albicans-Infected BALB/c Mice (2015) · cites this paper as Cilla et al., 1996
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Treatment of experimental autoimmune uveoretinitis with atorvastatin and lovastatin
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PD-PK evaluation of freeze-dried atorvastatin calcium-loaded poly-ε-caprolactone nanoparticles
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Statins in Low Doses Reduce VEGF and bFGF Serum Levels in Patients with Type 2 Diabetes Mellitus
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Could Statins Be Useful in the Treatment of Patients With Migraine?
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Atorvastatin inhibits angiotensin-converting enzyme induction in differentiating human macrophages
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Alternate-day Dosing with Statins
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- Authors
- Cilla, D. D., Whitfield, L. R., Gibson, D. M., Sedman, A. J., & Posvar, E. L.
- Corresponding author
- Sedman, Allen J.
- Venue
- Clinical Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 1996-12
- Volume
- 60
- Issue
- 6
- Pages
- 687-695
- ISSN
- 0009-9236 (ISSN-L)
- 1532-6535
- OpenAlex
- W1971242943
- Cited by
- 204
- References
- 8
- Citations by year
- 2026: 1 · 2025: 5 · 2024: 5 · 2023: 9 · 2022: 2 · 2021: 7 · 2020: 5 · 2019: 7 · 2018: 4 · 2017: 4 · 2016: 6 · 2015: 8 · 2014: 11 · 2013: 4 · 2012: 9
- FWCI
- 4.99
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
- Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmacogenetics and Drug Metabolism
- Keywords
- atorvastatin, statins, multiple-dose pharmacokinetics, pharmacodynamics, dose proportionality, LDL cholesterol lowering, total cholesterol, elimination half-life, drug accumulation, adverse events, drug safety, healthy volunteers
- MeSH terms
- Atorvastatin, Acyl Coenzyme A, Adult, Anticholesteremic Agents, Cholesterol, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Schedule, Enzyme Inhibitors, Female, Half-Life, Heptanoic Acids, Humans, Male, Middle Aged, Pyrroles, Reference Values, Linear Models, Least-Squares Analysis, Area Under Curve
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