Efficacy, safety, adherence and persistence of PCSK9 inhibitors in clinical practice: A single country, multicenter, observational study (AT-TARGET-IT). (February 2023)

• Record Type: Journal Article
• Authors: Gargiulo, Paola; Basile, Christian; Cesaro, Arturo; Marzano, Federica; Buonocore, Davide; Asile, Gaetano; Abbate, Vincenza; Vicidomini, Francesca; Paolillo, Stefania; Spaccarotella, Carmen Anna Maria; Catalano, Angelo; Spirito, Giulio; Merlini, Piera Angelica; Maloberti, Alessandro; Iannuzzo, Gabriella; Ciccone, Marco Matteo; Zito, Anna Paola; Paloscia, Leonardo; D'Alleva, Alberto; Varbella, Ferdinando; Corleto, Antonella; Brunetti, Natale Daniele; Corbo, Maria Delia; Calabrò, Paolo; Indolfi, Ciro; Perrone-Filardi, Pasquale
• Is Part Of: Atherosclerosis. Volume 366(2023)
• Page Start: 32
• Page End: 39
• Publication Date: 2023-02
• Subjects: LDL-cholesterol -- PCSK9 inhibitors -- Adherence -- Persistence -- Safety -- Efficacy; Arteriosclerosis -- Periodicals; Electronic journals; 616.136
• DOI: 10.1016/j.atherosclerosis.2023.01.001
• Languages: English
• ISSNs: 0021-9150

Abstract

Abstract: Background and aims: Proprotein Convertase Subtilisin/Kexin type 9 inhibitors (PCSK9i) are recommended in patients at high and very-high cardiovascular (CV) risk, with documented atherosclerotic CV disease (ASCVD), and for very-high risk patients with familial hypercholesterolaemia not achieving LDL-cholesterol (LDL-C) goal while receiving maximally tolerated dose of lipid-lowering therapy (LLT). However, single country real-life data, reporting the use of PCSK9i in clinical practice, are limited. Therefore, we designed AT-TARGET-IT, an Italian, multicenter, observational registry on the use of PCSK9i in clinical practice. Methods: All data were recorded at the time of the first prescription and at the latest observation preceding inclusion in the study. Results: 798 patients were enrolled. The median reduction in LDL-C levels was 64.9%. After stratification for CV risk, 63.8% achieved LDL-C target; of them, 83.3% took LLTs at PCSK9i initiation and 16.7% did not. 760 patients (95.2%) showed high adherence to therapy, 13 (1.6%) partial adherence, and 25 (3.1%) poor adherence. At 6 months, 99.7% of patients enrolled in the study remained on therapy; there were 519 and 423 patients in the study with a follow-up of at least 12 and 18 months, respectively. Persistence in these groups was 98.1% and 97.5%, respectively. Overall, 3.5% of patients discontinued therapy. No differences in efficacy, adherence, and persistence were found between alirocumab and evolocumab. Conclusions: PCSK9i are safe and effective in clinical practice, leading to very high adherence and persistence to therapy, and achievement of recommended LDL-C target in most patients, especially when used as combination therapy. Graphical abstract: Image 1 Highlights: PCSK9i have been proven to reduce cardiovascular events in hypercholesterolemia patients. Few studies are available in a real-world setting on the use and effects of PCSK9i. AT-TARGET-IT is the first Italian nation-wide registry on PCSK9i. PCSK9i were very effective, leading to high adherence and persistence to therapy. LDL-C target was reached in most patients, especially when used in combined therapy.