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
Department of Advanced Biomedical Sciences, University of Naples Federico II, Naples, Italy.
Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, Naples, Italy.
Atherosclerosis. 2023 Feb;366:32-39. doi: 10.1016/j.atherosclerosis.2023.01.001. Epub 2023 Jan 13.
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.
All data were recorded at the time of the first prescription and at the latest observation preceding inclusion in the study.
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.
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.
前蛋白转化酶枯草溶菌素9型抑制剂（PCSK9i）被推荐用于心血管（CV）高危和极高危患者，这些患者有动脉粥样硬化性心血管疾病（ASCVD）记录，以及用于接受最大耐受剂量降脂治疗（LLT）但未达到低密度脂蛋白胆固醇（LDL-C）目标的极高危家族性高胆固醇血症患者。然而，单国家关于临床实践中使用PCSK9i的真实世界数据有限。因此，我们设计了AT-TARGET-IT，这是一项关于PCSK9i在临床实践中使用情况的意大利多中心观察性登记研究。
所有数据在首次处方时以及纳入研究前的最新观察时记录。
共纳入798例患者。LDL-C水平的中位数降低了64.9%。根据CV风险分层后，63.8%的患者达到了LDL-C目标；其中，83.3%在开始使用PCSK9i时接受了LLT，16.7%未接受。760例患者（95.2%）对治疗表现出高依从性，13例（1.6%）部分依从，25例（3.1%）依从性差。在6个月时，99.7%纳入研究的患者仍在接受治疗；研究中有519例和423例患者分别随访了至少12个月和18个月。这些组中的持续治疗率分别为98.1%和97.5%。总体而言，3.5%的患者停止了治疗。阿利西尤单抗和依洛尤单抗在疗效、依从性和持续性方面未发现差异。
PCSK9i在临床实践中安全有效，导致对治疗的极高依从性和持续性，并使大多数患者达到推荐的LDL-C目标，尤其是作为联合治疗使用时。
