516 SAFETY OF PCSK9I IN A SINGLE COUNTRY, MULTICENTER, OBSERVATIONAL STUDY: A POST-HOC ANALYSIS OF THE AT-TARGET-IT STUDY


 
 
 PCSK9 inhibitors (PCSK9i) significantly decrease LDL cholesterol (LDL-C), either as monotherapy or in addition to the maximally tolerated dose of statin and/or ezetimibe. Yet, few data are available in real-world observations.
 
 
 
 AT-TARGET-IT is an Italian multicenter registry involving 9 Italian centers, designed to assess efficacy, adherence, and persistence of PCSK9i, as well as prescribing doctors’ behavior in patients with atherosclerotic cardiovascular disease (ASCVD) or familial hypercholesterolemia (FH). The aim of the present analysis was to assess differences between evolocumab and alirocumab on safety in patients on PCSK9i in a real-world single country observational study.
 
 
 
 From June through November 2021, we enrolled patients with PCSK9i first prescription from 6 months before inclusion through starting of PCSK9i use. Clinical and demographic characteristics, concomitant therapies, blood chemistry, were recorded at the time of first prescription and at the latest observation preceding inclusion in the study.
 
 
 
 Of 798 patients enrolled, 566 (70.9%) patients took Evolocumab and 232 (29.1%) Alirocumab (of them, 117 patients Alirocumab 75 mg and 115 Alirocumab 150 mg). The LDL-C values reductions did not significantly differ between Evolocumab and Alirocumab groups (65.1% for Evolocumab; 64.5% for Alirocumab, p=ns). Regarding safety events, after a median observation period of 19.3 months (6; 57), 19 patients (2.4%) had acute coronary syndrome, 18 (2.3%) hospitalization for CV causes, 3 (0.4%) stroke, 6 (0.8%) new-onset heart failure (HF) and 68 (4.9%) the composite endpoints of ACS, CV hospitalization, new onset HF, new onset chronic kidney disease, stroke and cerebrovascular insufficiency. Comparing events between patients in Alirocumab and in Evolocumab, no significant difference was found between the two groups. Combined endpoint of adverse events occurred more frequently in patients in Alirocumab (27; 11.6%), in comparison with those in Evolocumab (41; 7.2%) (p=0.044) (Figure).
 
 
 
 AT-TARGET-IT study shows that between evolocumab and alirocumab there was a statistically significant difference on the combined endpoint of adverse events.
