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. 2025 Jul 15.
doi: 10.1007/s10557-025-07749-3. Online ahead of print.

Real-World Efficacy of Inclisiran in Veneto Region (Italy): The INCLIVEN Multicenter Registry

Francesco Briani  1 , Elena Sani  2 , Gabriele Venturi  1 , Francesco Bacchion  1 , Sara Balzano  3 , Marialberta Battocchio  4 , Katia D'Elia  5 , Giulia Maria Frigo  6 , Luca Licchelli  7 , Antonio Lupo  8 , Alberto Marangoni  9 , Luigi Rivetti  10 , Mauro Scanferlato  11 , Sabina Zambon  12 , Maria Grazia Zenti  13 , Elisabetta Rinaldi  2 , Antonio Mugnolo  14
Affiliations

Real-World Efficacy of Inclisiran in Veneto Region (Italy): The INCLIVEN Multicenter Registry

Francesco Briani et al. Cardiovasc Drugs Ther. .

Abstract

Purpose: Inclisiran is a long-acting small interfering RNA (siRNA) which prevents the synthesis of PCSK9 in hepatocytes, reducing LDL-C concentration. Only limited data are available in the literature regarding its use in real-world settings.

Methods: In this observational multicenter registry, we included high cardiovascular risk patients from 12 lipid clinics in the Veneto region of Italy who started inclisiran therapy between October 2022 and February 2024. Primary endpoint was changes in LDL-C concentrations at 3 months of follow-up after inclisiran administration. Secondary endpoints were changes in LDL-C concentrations at 9 months of follow-up, safety, percentage of patients reaching LDL-C targets and efficacy of inclisiran according to background therapy and clinical characteristics of the population.

Results: Mean LDL-C levels at baseline (n = 240) were 118.7 ± 48.7 mg/dl, then they significantly fell to 56.7 ± 40.4 mg/dl (-52.3 ± 24.3%; p < 0.001) at 3 months (n = 238) and to 60.5 ± 40.1 mg/dl (-50.0 ± 22.7%; p < 0.001) at 9 months (n = 138). Three (1.3%) patients reported mild injection-site side effects. LDL-C target achievement according to ESC/EAS 2019 guidelines was 64.7% at 3 months and 62.3% at 9 months. Patients on statin therapy had a greater LDL-C reduction compared to patients with statin intolerance. At 3 months across we observed greater LDL-C reduction in patients with diabetes (59.9 ± 23.2% vs 49.7 ± 24.1%; p = 0.004). In the multivariable analysis diabetes mellitus (p = 0.006) and background statin therapy (p = 0.034) were independent predictors for greater LDL-C reduction.

Conclusion: This real-world multicenter registry supports inclisiran as an effective, well-tolerated option for managing hypercholesterolemia in high cardiovascular risk patients.

Keywords: Atherosclerotic cardiovascular disease (ASCVD); Inclisiran; Lipid-lowering therapy; Low-density lipoprotein cholesterol; Small interfering RNA (siRNA).

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Conflict of interest statement

Declarations. Conflicts of interest/Competing interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. Ethics Approval: The study was performed according to the Declaration of Helsinki and the local Ethics Committee approved the study protocol. Consent to Participate: Informed consent was obtained from all individual participants included in the study. Consent for Publication: All participants gave their consent for publication.

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