PharmaCE- Continuing Education

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.

THIS ARTICLE IS APPROVED FOR CONTINUING EDUCATION CREDIT
ACPE UNIVERSAL PROGRAM NUMBER:
407-000-05-054-H01

 


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