Abstract 16976: From Clinical Trial to Clinical Setting: What are the Observed Prescribing Behaviors in the United States Since the Launch of PCSK9 Inhibitors?
Introduction: Recently, the FDA approved two proprotein convertase subtilisin/kexin 9 inhibitors (PCSK9i), alirocumab and evolocumab, for the treatment of clinical atherosclerotic cardiovascular disease (ASCVD) and/or familial hypercholesterolemia (FH) for patients (pts) who need additional LDL-C lowering ("PCSK9i eligible pt"). Among the PCSK9i eligible pts, little is known about the prescribing patterns of those receiving vs not receiving these innovative therapies. This study sought to determine differences in characteristics among eligible pts who received a PCSK9i prescription (Rx) versus those who did not.
Methods: The study included adults from Accenture’s Predictive Health Intelligence Environment electronic medical record (EMR) system who had any evidence of ASCVD or FH, with at least one LDL-C lab value >70mg/dL, and a rx for lipid modifying treatment (LMT) from Aug 1, 2013 through July 26, 2015. Pts with at least 1 encounter in the EMR post-index were then stratified from July 27, 2015 (index) through May 18, 2016 based upon evidence of a PCSK9i Rx. Patient demographic and clinical and treatment characteristics were evaluated descriptively.
Results: There were 272,845 identified PCSK9i eligible pts (see table) of which 605 pts received a PCSK9i rx (0.2% ASCVD; 0.5% FH of eligible pts). Mean baseline LDL-C values for PCSK9i pts were significantly higher at 144 mg/dL versus 103.7mg/dL for the remaining eligible pts, and 53% versus 19% had baseline LDL-C above 130 mg/dL, respectively. PCSK9i pts were significantly more likely to be on ezetimibe, alone or in combination, during baseline (26% versus 7.2%; p<0.0001) as compared to the remaining eligible patients.
Conclusions: Few eligible high risk patients are receiving a PCSK9i rx, and there remains a population of high risk patients that could benefit from additional LDL-C lowering with PCSK9i.
Author Disclosures: D. Karalis: Employment; Significant; University of Pennsylvania. Consultant/Advisory Board; Modest; Regeneron Pharmaceuticals, Inc. S. Boklage: Employment; Significant; Regeneron Pharmaceuticals, Inc.. Ownership Interest; Modest; Regeneron Pharmaceuticals, Inc. J. Elassal: Employment; Significant; Regeneron Pharmaceuticals, Inc.. Ownership Interest; Modest; Regeneron Pharmaceuticals, Inc. A. Ghannam: Employment; Significant; Sanofi US. Ownership Interest; Modest; Sanofi US. R. Gupta: None. U. Mallya: Employment; Significant; Sanofi US. Ownership Interest; Modest; Sanofi US.
- © 2016 by American Heart Association, Inc.