Sarah L Rosquist, BS¹, Aaron B Mendelsohn, PhD, MPH², Gianna Rigoni, PharmD, MS², and Manya Magnus, PhD, MPH¹. (1) School of Public Health and Health Services, George Washington University, 2300 Eye Street, Ross Hall, Washington, DC 20037, (703) 431-3242, slrosq@gwu.edu, (2) Office of Drug Safety, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20817

HMG-CoA reductase inhibitors (statins) have been increasingly prescribed in recent years due to their cholesterol-lowering properties. Although studies have demonstrated that statins are a safe and effective way to lower LDL cholesterol, their effectiveness is dependent upon continuous use. In addition, a potential for adverse events resulting from statin use exists, particularly a risk of myopathy and rhabdomyolysis resulting from concomitant medication use or when higher doses of statins are prescribed. Limited information is available, however, on duration and patterns of statin use and the frequency of concomitant medication use. To examine patterns of use and concomitancy, data from AdvancePCS, a large pharmacy benefits management company representing over 54 million patients and over 300 million prescription claims, will be analyzed for the three-year period between January 2001 to December 2003, inclusive. The statins will be evaluated individually and collectively based on their metabolic pathways: CYP3A4 (atorvastatin, cerivastatin, lovastatin, simvastatin), CYP2C9 (fluvastatin, rosuvastatin), and unknown pathway (pravastatin). Concomitant medications to be examined include selected anti-infectives, anti-depressants, cardiovascular agents, immunosuppresants, anti-coagulants, along with non-statin lipid lowering drugs (fibric acid derivatives, niacins, bile acid sequestrants). This study is the first to examine longitudinal patterns of statin drug use and concomitant medication use. The results will help to identify patients at increased risk of statin-associated adverse events and provide further evidence leading to improved use of these products in ways to enhance their benefits.

Learning Objectives: At the conclusion of the presentation, attendees will be able to

• Describe the benefits of proper use of statins in reducing cholesterol.
• Recognize the risk for adverse events when statins are taken concomitantly with certain other medications.
• Understand the patterns of statin use with concomitant medications in a large, insured patient population.

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.