Abstract 17012: Who is Today’s Alirocumab Patient? A Real World Perspective of Patients Prescribed Alirocumab in the United States
Introduction: In July 2015, the FDA approved alirocumab (ALI), a first in class PCSK9-inhibitor indicated for cholesterol lowering as adjunct to diet and maximum tolerated statin therapy for adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Furthermore, in March 2016, the ACC released the expert consensus pathway on the role of non-statin therapies in LDL-C reduction. To understand early prescribing patterns, this study aims to describe the types of patients (pts) prescribed ALI.
Methods: All adult pts with a written prescription (Rx) of ALI were included from Accenture’s Predictive Health Intelligence Environment dataset consisting of electronic medical records from 26 integrated delivery networks (IDN). Pts were further required to have one encounter with the IDN within 12 months prior to the first Rx of ALI (index), used to classify pts’ other lipid modifying treatment (LMT) and past medical history. Probable HeFH pts were identified using either the modified Dutch Lipid Criteria Network (score ≥ 6) or an LDL-C ≥190 mg/dL.
Results: Among the 564 pts who met study criteria as of May 18, 2016, 69% had ASCVD, 13% were probable HeFH, and 18% were not identified as ASCVD or HeFH. The average age was 65.9 years (SD 10.1), 51% were male, and 74% Caucasian. About 79% had hypertension, 32% had diabetes, 14% had chronic kidney disease and 28% had a history of smoking. Prior to the ALI Rx, for those pts with an LDL-C value, the mean was 135.0 mg/dL (SD 57.5) with 72% having an LDL-C >100 mg/dL. About 72% of the pts had evidence of LMT during the prior 12 months to index; conversely, 28% of pts did not in the same period. Of those with LMT in this period, 29% were on high-intensity statins. Ezetimibe rxs were seen in 31% of pts with LMT, either alone or in combination with statins. Cardiologists were the specialists who prescribed ALI most often (43.1%).
Conclusions: ALI was predominantly prescribed in pts with ASCVD whose LDL-C was high and far from clinical goals. In light of the new ACC consensus pathway for non-statins, there is still a large population of high-risk pts who have unmet lipid lowering needs and would benefit from alirocumab.
Author Disclosures: D. Karalis: Employment; Significant; University of Pennsylvania. Consultant/Advisory Board; Modest; Regeneron Pharmaceuticals, Inc. U. Mallya: Employment; Significant; Sanofi US. Ownership Interest; Modest; Sanofi US. 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. S. Boklage: Employment; Significant; Regeneron Pharmaceuticals, Inc.. Ownership Interest; Modest; Regeneron Pharmaceuticals, Inc..
- © 2016 by American Heart Association, Inc.