Clinica e investigacion en arteriosclerosis : publicacion oficial de la Sociedad Espanola de Arteriosclerosis · 2026
First real-world experience with inclisiran in Spain: Efficacy, safety, and prescription patterns in clinical practice.
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Velasco Alvaro, Costa Ramón, Alonso-Carrillo Jesús, de Castro Marta, Hayes Meizoso Cristina, Blanco-Echevarria Agustín, Tello Rocío, Solís Jorge
Аннотация
BACKGROUND: Low-density lipoprotein cholesterol (LDL-C) is a key causal factor in atherosclerotic cardiovascular disease. Although statins remain the cornerstone of treatment, their use is limited by adverse effects, variable response and poor adherence. Inclisiran, a small interfering RNA that inhibits hepatic PCSK9 synthesis, has demonstrated marked LDL-C reductions in clinical trials. However, real-world evidence remains limited.
METHODS: Observational longitudinal study in a Spanish tertiary hospital including all patients prescribed inclisiran since its approval. Baseline characteristics were analysed. LDL-C target achievement and safety outcomes were assessed.
RESULTS: Seventy-seven patients were included (median age 59 years), most of whom were at high or very high cardiovascular risk; 82% were treated for secondary prevention and 41% had statin intolerance. Median baseline LDL-C was 115 [103-133]mg/dL. Mean LDL-C reductions were 52% at 3 months, 61% at 9 months and 52% at 15 months. Greater reductions were observed in patients receiving concomitant high-potency statins. Individualised LDL-C targets were achieved in 59%, 52% and 56% of patients at 3, 9 and 15 months, respectively. Adverse events were infrequent (5%) and limited to mild injection-site reactions. Eleven per cent of patients were lost to follow-up, mainly due to poor adherence.
CONCLUSIONS: In routine clinical practice, inclisiran was effective and well tolerated, producing substantial and sustained reductions in LDL-C in a predominantly high-cardiovascular-risk population. Its favourable safety profile and twice-yearly administration make it a practical therapeutic option, particularly for patients with statin intolerance or adherence difficulties, and support its integration into real-world care pathways.
METHODS: Observational longitudinal study in a Spanish tertiary hospital including all patients prescribed inclisiran since its approval. Baseline characteristics were analysed. LDL-C target achievement and safety outcomes were assessed.
RESULTS: Seventy-seven patients were included (median age 59 years), most of whom were at high or very high cardiovascular risk; 82% were treated for secondary prevention and 41% had statin intolerance. Median baseline LDL-C was 115 [103-133]mg/dL. Mean LDL-C reductions were 52% at 3 months, 61% at 9 months and 52% at 15 months. Greater reductions were observed in patients receiving concomitant high-potency statins. Individualised LDL-C targets were achieved in 59%, 52% and 56% of patients at 3, 9 and 15 months, respectively. Adverse events were infrequent (5%) and limited to mild injection-site reactions. Eleven per cent of patients were lost to follow-up, mainly due to poor adherence.
CONCLUSIONS: In routine clinical practice, inclisiran was effective and well tolerated, producing substantial and sustained reductions in LDL-C in a predominantly high-cardiovascular-risk population. Its favourable safety profile and twice-yearly administration make it a practical therapeutic option, particularly for patients with statin intolerance or adherence difficulties, and support its integration into real-world care pathways.