Patient Characteristics and Real-World Treatment Patterns Among Early Users of PCSK9 Inhibitors

Am J Cardiovasc Drugs. 2018 Apr;18(2):103-108. doi: 10.1007/s40256-017-0246-z.

Abstract

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.

MeSH terms

  • Anticholesteremic Agents / therapeutic use
  • Atherosclerosis / drug therapy
  • Atherosclerosis / metabolism
  • Cholesterol, LDL
  • Dyslipidemias / drug therapy*
  • Dyslipidemias / metabolism
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors / therapeutic use
  • Hyperlipoproteinemia Type II / drug therapy
  • Hyperlipoproteinemia Type II / metabolism
  • Hypolipidemic Agents / therapeutic use
  • Male
  • Middle Aged
  • PCSK9 Inhibitors*

Substances

  • Anticholesteremic Agents
  • Cholesterol, LDL
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Hypolipidemic Agents
  • PCSK9 Inhibitors
  • PCSK9 protein, human