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A High-Throughput Luciferase Assay to Evaluate Proteolysis of the Single-Turnover Protease PCSK9
Published on: August 28, 2018
Patient Characteristics and Real-World Treatment Patterns Among Early Users of PCSK9 Inhibitors
Pallavi B Rane1, Jeetvan Patel2, David J Harrison2
1Amgen Inc., One Amgen Center Drive, Thousand Oaks, CA, USA. prane@amgen.com.
Insights
Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are effective for patients with high LDL-C. Real-world data shows PCSK9i users have more comorbidities and statin intolerance than other lipid-lowering therapy patients.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Clinical Research
Background:
- Proprotein convertase subtilisin/kexin type 9 inhibitors (PCSK9i) are approved for managing high LDL-C in specific patient groups.
- These therapies are crucial for patients with familial hypercholesterolemia or atherosclerotic cardiovascular disease needing enhanced LDL-C reduction.
Purpose of the Study:
- To characterize real-world patient profiles on PCSK9i therapy.
- To describe physician-reported treatment patterns for dyslipidemia patients using PCSK9i versus other lipid-lowering therapies.
Main Methods:
- Analysis of data from a 2016 US Adelphi dyslipidemia disease-specific programme (DSP) survey.
- Physicians provided patient data including treatment history, lab values, characteristics, and comorbidities.
- Systematic oversampling of PCSK9i-treated patients ensured adequate sample size.
Main Results:
- The study included 159 physicians and 1522 patients (304 PCSK9i, 1218 non-PCSK9i).
- PCSK9i patients had higher baseline LDL-C (180.0 mg/dl vs 159.2 mg/dl) and higher rates of prior statin use (69.1%) and statin intolerance (31.6%).
- Common reasons for switching to PCSK9i included lack of efficacy (70.2%) and muscle-related symptoms (myalgia 28.6%, myopathy 11.1%).
Conclusions:
- Physicians appear to prescribe PCSK9i appropriately in real-world settings.
- PCSK9i patients exhibited higher cardiovascular comorbidity rates, physician-determined statin intolerance, elevated LDL-C, and received more prior lines of therapy compared to non-PCSK9i patients.
Background:
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.
Objective:
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.
Methods:
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.
Results:
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%).
Conclusions:
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.
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