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Cited by 31Lipoproteins and Cardiovascular HealthCholesterol and Lipid MetabolismAntiplatelet Therapy and Cardiovascular Diseases

Efficacy and Safety of Inclisiran in Asian Patients

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Huo, Yong, Lesogor, Anastasia, Lee, Cheol Whan, Chiang, Chern-En, Mena-Madrazo, Jorge, Poh, Kian Keong, Jeong, Myung Ho, Maheux, Pierre +4 more·2024·JACC: Asia
DOI 10.1016/j.jacasi.2023.09.006PMC PMC10866732
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Abstract

Background: Management of low-density lipoprotein cholesterol (LDL-C) in Asia remains suboptimal, with ∼50% of patients who are treated with lipid-lowering therapies (LLTs) unable to achieve their guideline-recommended LDL-C goals. Asian-representative studies of the use of inclisiran are needed. Objectives: The authors sought to evaluate the efficacy and safety of inclisiran in Asian patients with atherosclerotic cardiovascular disease (ASCVD) or high risk of ASCVD, as an adjunct to diet and maximally tolerated statin dose, with or without additional LLTs. Methods: The ORION-18 was a phase 3 double-blind trial in which patients were randomized 1:1 to receive either 300 mg inclisiran sodium or matching placebo on days 1, 90, and 270. Percentage change in LDL-C from baseline to day 330 was the primary endpoint. Results: < 0.001). Time-adjusted percentage reduction in LDL-C from baseline after day 90 and up to day 360 was 56.3%. At day 330, 71.7% of participants with inclisiran achieved ≥50% reduction in LDL-C compared with 1.5% with placebo. Over the study period, total cholesterol, apolipoprotein B, and non-high-density lipoprotein cholesterol (HDL-C) levels were decreased significantly, and HDL-C levels increased. The incidence of adverse events with inclisiran was similar to that with placebo. Conclusions: In Asian patients with ASCVD or high risk of ASCVD, inclisiran was effective and safe. (Study of Efficacy and Safety of Inclisiran in Asian Participants With Atherosclerotic Cardiovascular Disease [ASCVD] or ASCVD High Risk and Elevated Low-Density Lipoprotein Cholesterol [LDL-C] [ORION-18]; NCT04765657).

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  • Clinically, inclisiran offers a valuable treatment option for patients who do not achieve LDL-C targets with standard therapies such as statins.

    “Clinically, inclisiran offers a valuable treatment option for patients who do not achieve LDL-C targets with standard therapies such as statins.11”

    From Small Interfering RNA for LDL-Cholesterol Reduction (2026) · cites this paper as [11]

    The Discussion describes inclisiran as an effective, well-tolerated add-on option for Asian patients with ASCVD or high ASCVD risk who need further LDL-C lowering despite maximally tolerated statins. The citing sentence extends that conclusion to patients generally, without the study’s population and risk qualifiers. (LLM, conf=0.83)

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Research works printed but not linked: 27

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Authors
Huo, Y., Lesogor, A., Lee, C. W., Chiang, C.-E., Mena-Madrazo, J., Poh, K. K., Jeong, M. H., Maheux, P., Zhang, M., Wei, S., Han, Y., & Li, Y.
Affiliations
  • Peking University First Hospital (CN)
  • Novartis (Switzerland) (CH)
  • Asan Medical Center (KR)
  • Taipei Veterans General Hospital (TW)
  • National University of Singapore (SG)
  • Chonnam National University (KR)
  • Novartis (China) (CN)
  • Inner Mongolia People's Hospital (CN)
  • Fudan University (CN)
Corresponding author
Huo, Yong
ORCID
Venue
JACC: Asia
Publisher
Elsevier BV
Published
2024-02
Volume
4
Issue
2
Pages
123-134
ISSN
2772-3747 (ISSN-L)
DOI
10.1016/j.jacasi.2023.09.006
PMC
PMC10866732
OpenAlex
W4388666456
Cited by
31
References
7
Citations by year
2026: 12 · 2025: 14 · 2024: 5
FWCI
8.31
Type
journal article
Language
en
Open access
Licence
Locations
  • JACC Asia (publishedVersion, cc-by-nc-nd)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
  • Health Sciences › Medicine › Surgery › Cholesterol and Lipid Metabolism
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
Keywords
inclisiran, LDL cholesterol lowering, atherosclerotic cardiovascular disease, Asian patients, PCSK9 inhibition, statin therapy, lipid-lowering therapy, apolipoprotein B, HDL cholesterol, adverse events, hypercholesterolemia

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