Evidence mapPaperPMID 38371290Full record

ArticleJACC. Asia2024

Efficacy and Safety of Inclisiran in Asian Patients: Results From ORION-18.

Yong Huo, Anastasia Lesogor, Cheol Whan Lee, Chern-En Chiang, Jorge Mena-Madrazo, Kian Keong Poh, Myung Ho Jeong, Pierre Maheux, Mengli Zhang, Suning Wei and 2 more

2 registry-linked trialsOpen access · goldAbstract read
In one paragraph

Article in JACC. Asia, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT06586684. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
7.0field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06586684 phase4not yet recruiting

The Effect of Small Interfering RNA Inclisiran on Carotid Plaques in Patients with Atherosclerosis: a Real-world Study Using Carotid Ultrasound.

Ran2024Enrolled40Registered outcomes5Posted comparisons0ConditionsCarotid Plaque, Echocardiography, HyperlipidemiaArmsInclisiran
Open the trial in the graph
NCT04765657 phase3active not recruitingnot on this map

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Inclisiran in Asian Patients With ASCVD or ASCVD High Risk and Elevated Low-density Lipoprotein Cholesterol as an Adjunct to Diet and Maximally Tolerated Statins With or Without Additional Lipid-lowering Therapy (ORION-18)

TypeinterventionalSponsorNovartis PharmaceuticalsRan2021 to 2026Enrolled345ConditionsHypercholesterolemiaArmsinclisiran sodium, Placebo
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 22 citations in OpenAlex.

  1. Pooled it
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  14. Therapeutic Management of LDL-C: Efficacy and Economic Impact Assessment.Journal of cardiovascular development and disease · 2025
    Review
  15. Review
  16. Inclisiran in Cardiovascular Health: A Review of Mechanisms, Efficacy, and Future Prospects.Medical science monitor : international medical journal of experimental and clinical research · 2025
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 5 countries.

Yong HuoDepartment of Cardiology, Peking University First Hospital, Beijing, China.
Anastasia LesogorNovartis Pharma, Basel, Switzerland.
Cheol Whan LeeAsan Medical Center, University of Ulsan, Seoul, Korea.
Chern-En ChiangGeneral Clinical Research Center and Division of Cardiology, Taipei Veterans General Hospital and Yang Ming Chiao Tung University, Taipei, Taiwan.
Jorge Mena-MadrazoNovartis Pharma, Basel, Switzerland.
Kian Keong PohDepartment of Cardiology, National University Heart Centre Singapore and Yong Loo Lin School of Medicine, National University of Singapore, Singapore.
Myung Ho JeongDivision of Cardiology, Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Korea.
Pierre MaheuxNovartis Pharma, Basel, Switzerland.
Mengli ZhangChina Novartis Institutes for Biomedical Research Co., Shanghai, China.
Suning WeiBeijing Novartis Pharma, Beijing, China.
Yajun HanMongolia People's Hospital, Hohhot, China.
Yong LiFudan University Hua Shan Hospital, Shanghai, China.
Novartis (Switzerland) · CHNovartis (China) · CNChonnam National University Hospital · KRFudan University · CNInner Mongolia People's Hospital · CNNational University of Singapore · SGPeking University · CNTaipei Veterans General Hospital · TWUniversity of Ulsan · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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: A total of 345 patients (mean age 59.5 years, mean baseline LDL-C 109 mg/dL, 74.7% male) were randomized to inclisiran or placebo. Baseline characteristics were similar in both groups. The percentage decrease in LDL-C from baseline to day 330 was 57.2% ( 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).

Indexed as

ASCVDAsiainclisiranLDL-C loweringlipid-lowering therapiesPCSK9siRNA

Identifiers

PMID38371290
PMCPMC10866732
OpenAlexW4388666456

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.