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ATORVASTATIN: AN UPDATE
OF RECENT CLINICAL TRIAL EXPERIENCE
Philip M Mendys and
Ross J Simpson Jr
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OBJECTIVE: To demonstrate how evaluative studies of atorvastatin have progressed from surrogate markers to more complex head-to-head clinical experiments.
DATA SOURCES: A search of MEDLINE was conducted (1994-April 2004), and an extensive manual review of journals was performed using the key search terms atorvastatin, coronary heart disease, and lipid-lowering therapy.
STUDY SELECTION AND DATA EXTRACTION: All articles identified from the data sources were evaluated. Studies were selected to track both sponsor-supported and non-sponsor-funded experiments designed to evaluate atorvastatin.
DATA SYNTHESIS: Originally introduced in 1997, atorvastatin was considered to be a potent addition to the hydroxymethylglutaryl coenzyme A reductase inhibitors (statins). Atorvastatin significantly reduces low-density lipoprotein cholesterol and triglyceride levels with a starting dose of 10 mg/day. Broad acceptance and utilization of the statin class was still evolving at that time. Pfizer/W-L directed a comprehensive clinical trial program. Currently, there are >400 ongoing and completed clinical experiments with >80,000 patients involved. Along with an extensive safety record, atorvastatin will likely continue to change the way in which statin therapy is applied in various clinical settings.
CONCLUSIONS: The experimental and clinical trial data with atorvastatin demonstrate a broad database supporting how atorvastatin impacts cardiovascular risk. As studies within the atorvastatin clinical program continue, we will undoubtedly gain additional insight on how patients can benefit from statin therapy.
J Pharm Technol 2005;21:197-202.
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