Evidence map›Paper›PMID 40522062›Full record

Observational studyEuropean journal of neurology2025

Safety and Effectiveness of PCSK9 Inhibitors and Inclisiran in Patients With Neuromuscular Disorders and Statin Intolerance.

Aikaterini Theodorou, Georgia Papagiannopoulou, Alexandra Akrivaki, Stella Fanouraki, Christos Moschovos, Marianna Papadopoulou, Lina Palaiodimou, Foteini Merkouri, Konstantinos Melanis, Stauroula Salakou and 7 more

Abstract readObservational Study
In one paragraph

Observational study in European journal of neurology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
  2. Article
  3. Review
  4. Observational
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

17 authors.

Aikaterini TheodorouSecond Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.ORCID 0000-0001-7229-2610
Georgia PapagiannopoulouSecond Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Alexandra AkrivakiSecond Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Stella FanourakiSecond Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Christos MoschovosSecond Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.ORCID 0000-0002-4885-1766
Marianna PapadopoulouSecond Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Lina PalaiodimouSecond Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Foteini MerkouriSecond Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Konstantinos MelanisSecond Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Stauroula SalakouSecond Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Dimitrios KitsosSecond Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Vaia LambadiariSecond Department of Internal Medicine, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Vasiliki ZouvelouFirst Department of Neurology, "Eginition" Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Georgios PapadimasFirst Department of Neurology, "Eginition" Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.
Sotirios GiannopoulosSecond Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.ORCID 0000-0001-7443-5179
Andrei V AlexandrovDepartment of Neurology, University of Arizona, Banner University Medical Center, Phoenix, Arizona, USA.
Georgios TsivgoulisSecond Department of Neurology, "Attikon" University Hospital, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.ORCID 0000-0002-0640-3797

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesLimited data exist on the efficacy and safety of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors and inclisiran among patients with neuromuscular disorders and statin-induced myotoxicity and/or hepatotoxicity. We assessed the safety and efficacy of PCSK9 inhibitors and inclisiran in this specific patient subgroup.

methodsWe conducted an observational cohort study evaluating patients with available clinical and laboratory data prior to and at prespecified time points following treatment initiation with PCSK9 inhibitors or inclisiran.

resultsEleven patients with neuromuscular disorders and statin intolerance were included in this study. Median follow-up time after PCSK9 inhibitor or inclisiran initiation was 14 (9-17) months. PCSK9 inhibitors or inclisiran use led to a significant decrease in mean low-density lipoprotein cholesterol levels. Moreover, all patients tolerated these lipid-lowering agents without exacerbation of their underlying myositis, myopathy, neuromuscular junction disorder, and without presenting any adverse event or relapse of myotoxicity and/or hepatotoxicity. DISCUSSION: The present real-world study highlights the potential therapeutic value of PCSK9 inhibitors and inclisiran among patients with neuromuscular disorders and statin intolerance. The findings of this study are in accordance with previous reports, showing that PCSK9 inhibitors are safe as a lipid lowering treatment for long-term use among patients with statin-associated immune-mediated necrotizing myopathy (IMNM).

Indexed as

Hydroxymethylglutaryl-CoA Reductase InhibitorsNeuromuscular DiseasesPCSK9 InhibitorsAdultAgedCohort StudiesFemaleHumansMaleMiddle AgedProprotein Convertase 9RNA, Small InterferingTreatment OutcomeALN-PCSHydroxymethylglutaryl-CoA Reductase InhibitorsPCSK9 InhibitorsPCSK9 protein, humanProprotein Convertase 9RNA, Small Interferinghepatotoxicityhyperlipidemiainclisiranmyotoxicityneuromuscular disordersPCSK9 inhibitorsstatin intolerance

Identifiers

PMID40522062
PMCPMC12168222

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Registered trials

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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 OpenQuestion graph.