Cited by 81Lipoproteins and Cardiovascular HealthCoronary Interventions and DiagnosticsAntiplatelet Therapy and Cardiovascular Diseases

An “Inclisiran First” Strategy vs Usual Care in Patients With Atherosclerotic Cardiovascular Disease

Open access
Koren, Michael J., Rodriguez, Fatima, East, Cara, Toth, Peter P., Watwe, Veena, Abbas, Cheryl A., Sarwat, Samiha, Kleeman, Kelly +3 more·2024·Journal of the American College of Cardiology

Abstract

Background Most patients with atherosclerotic cardiovascular disease fail to achieve guideline-directed low-density lipoprotein cholesterol (LDL-C) goals. Twice-yearly inclisiran lowers LDL-C by ∼50% when added to statins. Objectives This study evaluated the effectiveness of an "inclisiran first" implementation strategy (adding inclisiran immediately upon failure to reach LDL-C Methods VICTORION-INITIATE, a prospective, pragmatically designed trial, randomized patients 1:1 to inclisiran (284 mg at days 0, 90, and 270) plus usual care (lipid management at treating physician's discretion) vs usual care alone. Primary endpoints were percentage change in LDL-C from baseline and statin discontinuation rates. Results We randomized 450 patients (30.9% women, 12.4% Black, 15.3% Hispanic); mean baseline LDL-C was 97.4 mg/dL. The "inclisiran first" strategy led to significantly greater reductions in LDL-C from baseline to day 330 vs usual care (60.0% vs 7.0%; P Conclusions An "inclisiran first" implementation strategy led to greater LDL-C lowering compared with usual care without discouraging statin use or raising new safety concerns. (A Randomized, Multicenter, Open-label Trial Comparing the Effectiveness of an "Inclisiran First" Implementation Strategy to Usual Care on LDL Cholesterol [LDL-C] in Patients With Atherosclerotic Cardiovascular Disease and Elevated LDL-C [≥70 mg/dL] Despite Receiving Maximally Tolerated Statin Therapy [VICTORION-INITIATE]; NCT04929249).

Integrity signals

Registry

Crossref · 10.1016/j.jacc.2024.03.382

Cites

35 of 35 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

We couldn’t retrieve this paper’s full text, so its claims and self-check weren’t run. The registry and citation checks still apply.

Claims other papers make about this one

Each is checked against this paper’s own text: does it say what the citing paper says it does?

  • The comparative advantage of inclisiran over statins, combined with biannual dosing, supports its potential to improve lipid management and treatment adherence in clinical practice.

    “This comparative advantage, combined with inclisiran’s biannual dosing regimen, supports its potential to improve both lipid management and treatment adherence in clinical practice.12”

    From Small Interfering RNA for LDL-Cholesterol Reduction (2026) · cites this paper as [12]

  • VICTORION-INITIATE head-to-head evidence demonstrates that inclisiran provides superior LDL-C lowering compared to standard statin therapy in certain patient populations.

    “This head-to-head evidence demonstrates that inclisiran not only significantly reduces LDL-C compared to placebo but also provides superior LDL-C lowering compared to standard statin therapy in certain patient populations.”

    From Small Interfering RNA for LDL-Cholesterol Reduction (2026) · cites this paper as [12]

Cites

Flagged first, then by citations

2 of the 37 references couldn’t be matched to a known paper.

Cited by

Sorted by citations

Authors
Koren, M. J., Rodriguez, F., East, C., Toth, P. P., Watwe, V., Abbas, C. A., Sarwat, S., Kleeman, K., Kumar, B., Ali, Y., & Jaffrani, N.
Affiliations
  • Jacksonville Center for Clinical Research (US)
  • Baylor Scott & White Research Institute (US)
  • Johns Hopkins University (US)
  • Novartis (United States) (US)
  • Rapides Regional Medical Center (US)
Corresponding author
Koren, Michael J.
Venue
Journal of the American College of Cardiology
Publisher
Elsevier BV
Published
2024-05
Volume
83
Issue
20
Pages
1939-1952
ISSN
0735-1097 (ISSN-L)
OpenAlex
W4394060983
Cited by
81
References
37
Citations by year
2026: 26 · 2025: 27 · 2024: 28
FWCI
33.95
Type
journal article
Language
en
Open access
Locations
  • Journal of the American College of Cardiology (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
Funders
Novartis Pharmaceuticals Corporation
Topics
  • Health Sciences › Medicine › Surgery › Lipoproteins and Cardiovascular Health
  • Health Sciences › Medicine › Surgery › Coronary Interventions and Diagnostics
  • Health Sciences › Medicine › Cardiology and Cardiovascular Medicine › Antiplatelet Therapy and Cardiovascular Diseases
Keywords
inclisiran, atherosclerotic cardiovascular disease, LDL cholesterol lowering, statin discontinuation, LDL-C goal attainment, PCSK9 inhibition, usual care, lipid control, injection-site adverse events, treatment-emergent adverse events, statin-sparing therapy
MeSH terms
Aged, Female, Humans, Cholesterol, LDL, Male, Middle Aged, Oligonucleotides, Prospective Studies, Treatment Outcome, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Atherosclerosis

About these checks

Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.

Statistics and arithmetic are recomputed, not judged.

Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.

What counts as a claim ›How we measure confidence ›How we check this ›

Are you an author, or do you see a problem with this page? Request a review