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

• Published in: Advances in therapy Vol. 40; no. 6; pp. 2710 - 2724
• Main Authors: Cosin-Sales, Juan, Sidelnikov, Eduard, Villamayor, Santiago, Fernández, Miriam, Merino-Montero, Sandra, Zamora, Alberto
• Format: Journal Article
• Language: English
• Published: Cheshire Springer Healthcare 01.06.2023
• Subjects: Adult; Aged; Anticholesteremic Agents - therapeutic use; Brain Ischemia - chemically induced; Brain Ischemia - drug therapy; Cardiology; Cholesterol, LDL; Endocrinology; Female; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors - therapeutic use; Internal Medicine; Male; Medicine; Medicine & Public Health; Myocardial Infarction - drug therapy; Oncology; Original Research; PCSK9 Inhibitors; Pharmacology/Toxicology; Proprotein Convertase 9; Retrospective Studies; Rheumatology; Secondary Prevention; Spain; Stroke - drug therapy; Spain; Lipid-lowering therapies; PCSK9 inhibitors; Cardiovascular disease; Atherosclerotic cardiovascular disease; Acute cardiovascular events
• ISSN: 0741-238X; 1865-8652; 1865-8652
• DOI: 10.1007/s12325-022-02384-y

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. Graphical Abstract