Patient Characteristics and Real-World Treatment Patterns Among Early Users of PCSK9 Inhibitors
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Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) reduce low-density lipoprotein cholesterol (LDL-C) levels and are approved for patients with familial hypercholesterolemia or atherosclerotic cardiovascular disease who require additional LDL-C lowering.
Our objective was to characterize patients receiving PCSK9i medications in real-world practice and describe physician-reported treatment patterns among dyslipidemia patients using PCSK9i or other lipid-lowering therapy.
We analyzed data from a point-in-time Adelphi dyslipidemia disease-specific programme (DSP) survey conducted in the USA in 2016. Physicians provided treatment history, laboratory values, patient characteristics, and comorbidities for treated patients. To ensure sufficient numbers of PCSK9i-treated patients, we conducted systematic oversampling of patients being prescribed PCSK9i. Outcomes included patient characteristics and physician-reported treatment patterns.
The DSP included 159 physicians, who provided information on 1522 patients (304 PCSK9i; 1218 non-PCSK9i). Mean ± standard deviation (SD) baseline LDL-C levels were 180.0 ± 39.7 mg/dl for PCSK9i patients and 159.2 ± 40.5 mg/dl for non-PCSK9i patients. Prior statin use was reported in 69.1% of PCSK9i patients and 19.5% of non-PCSK9i patients, and physician-reported statin intolerance was observed in 31.6% of PCSK9i and 5.3% of non-PCSK9i patients. Use of statins only was reported in 40.5% of PCSK9i and 88.8% of non-PCSK9i patients. The most common physician-reported reasons for change to PCSK9i were lack of efficacy (70.2%) and muscle-related symptoms (myalgia 28.6%; myopathy 11.1%).
Physicians surveyed appeared to prescribe PCSK9i medications appropriately. PCSK9i-treated patients had higher rates of cardiovascular comorbidities and physician-determined statin intolerance, had higher LDL-C levels, and received more lines of therapy than non-PCSK9i patients.
Annalise M. Nawrocki, PhD (Amgen Inc.), and Julia R. Gage, PhD (on behalf of Amgen Inc.), provided medical writing support.
Compliance with Ethical Standards
Conflicts of interest
P. B. Rane, J. Patel, and D. J. Harrison are employees and shareholders of Amgen Inc. J. Shepherd, A. Leith, H. Bailey, and J. Piercy are employees of Adelphi Real World, which received funding from Amgen Inc. for this study.
This study was sponsored by Amgen Inc.
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