Biography
Biography: Alice E. Zemljic-Harpf
Abstract
With more than 25 years of clinical trial data cholesterol-lowering statin drugs are used as the first-line treatment for prevention and treatment of cardiovascular disease. Currently statins are among the most widely prescribed drugs. The occurrence of statin adverse events (AEs) was underestimated in clinical trials. In November 2013 the American Heart Association and the American College of Cardiology published new guidelines that are expected to expand statin use. Gene variations have been identified that modify statin response and increase susceptibility to statin AEs (e.g. SLCO1B1, CoQ2, variants in liver transport genes, variants in drug metabolism). Over the last decade Dr. Golomb’s group investigated statin AE’s, both those reported in patients that were enrolled in the UCSD Statin Effects Study (patient-targeted AE surveillance); and in the UCSD Statin Study (>1000 person randomized double-blind placebo controlled trial). For the former, >5000 patient surveys were submitted, including patient contact information and willingness to be contacted, and these data sets are available for further analysis, with the majority of participants expressing willingness to subjects that reported AEs as well as unaffected controls that previously participated in the UCSD Statin Study. The goal would be to develop predictive models, including questionnaires and pharmacogenomic screening before initiation of statin therapy as well as follow up questionnaires, by which statin therapy/drug choice may be tailored based on the patient’s genetic profile. The hope would be to move toward safer prescribing, to reduce the adverse effect toll from this widely used drug class.