Identification of Secondary Prevention Patients Eligible for PCSK9 Inhibitors Therapy According to the Routine Clinical Practice in Spain

Adv Ther. 2023 Jun;40(6):2710-2724. doi: 10.1007/s12325-022-02384-y. Epub 2022 Dec 16.

Abstract

Introduction: Many patients at very high risk of cardiovascular (CV) events would benefit from lipid-lowering therapies (LLT) intensification to decrease their risk. This study aimed to identify the real-world secondary prevention patients potentially eligible for proprotein convertase subtilisin-kexin type 9 inhibitors (PCSK9i) in Spain.

Methods: This retrospective cohort study included adult patients registered in the IQVIA Spanish Electronic Medical Records outpatient database (2014-2020), diagnosed with myocardial infarction (MI), unstable angina (UA), ischaemic stroke (IS), transient ischaemic attack (TIA) or peripheral artery disease (PAD) and with ≥ 1 low-density lipoprotein cholesterol (LDL-C) or total cholesterol measurements. Longitudinal data were collected from the initial diagnosis to the end of the study period or follow-up loss.

Results: The study included 9516 patients, 63.9% male, mean (SD) age 67.7 (12.5) years and mean LDL-C 117.3 (38.8) mg/dL. MI, IS and PAD were the most severe events reported during the study period (28.5%, 18.7% and 29.3% of patients, respectively). At the time of last available LDL-C assessment (≥ 3 months post-event), 64.4% patients were on LLT. Of those, 45.4%, 46.9% and 7.7% were on high-, moderate- and low-intensity LLT. Overall, 9.6% patients achieved LDL-C < 55 mg/dL (24.2% LDL-C < 70 mg/dL). Furthermore, 17.9% patients receiving optimized oral LLT showed LDL-C > 100 mg/dL (LDL-C reimbursement threshold for PCSK9i in Spain).

Conclusion: Up to 82% of patients with atherosclerotic CV disease do not achieve LDL-C levels recommended by the 2019 ESC/EAS guidelines despite being on optimized oral LLT therapy. In 17.9% of these patients LDL-C levels exceed 100 mg/dL, being eligible for PCSK9i in Spain.

Keywords: Acute cardiovascular events; Atherosclerotic cardiovascular disease; Cardiovascular disease; Lipid-lowering therapies; PCSK9 inhibitors.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Anticholesteremic Agents* / therapeutic use
  • Brain Ischemia* / chemically induced
  • Brain Ischemia* / drug therapy
  • Cholesterol, LDL
  • Female
  • Humans
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors* / therapeutic use
  • Male
  • Myocardial Infarction* / drug therapy
  • PCSK9 Inhibitors
  • Proprotein Convertase 9
  • Retrospective Studies
  • Secondary Prevention
  • Spain
  • Stroke* / drug therapy

Substances

  • PCSK9 Inhibitors
  • Cholesterol, LDL
  • PCSK9 protein, human
  • Proprotein Convertase 9
  • Anticholesteremic Agents
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors