Evidence map›Paper›PMID 42332816›Full record

ArticleBiology direct2026

PCSK9 inhibitors do not increase cognitive risk.

Dongsheng Ni, Zeying Feng, Dehuan Liang, Zhaolai Qi, Yao Lu, Liyong Zhu, Guoping Li

Abstract read
In one paragraph

Article in Biology direct, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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0cells of the map it votes in
0citing papers in PubMed
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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

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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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

7 authors.

Dongsheng Ni *Department of Basic Innovation Research, Beijing Hospital, National Center for Gerontology; National Clinical Research Center for Gerontology; The Key Laboratory of Geriatrics of NHC; Beijing Key Laboratory of Aging Mechanism and Intervention Research on Aging-Related Diseases; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences & Peking Union Medical College, No. 1, Dahua Road, Dongdan, Beijing, 100730, Dongcheng District, P. R. China.
Zeying Feng *Clinical Research Center, The Third Xiangya Hospital, Central South University, 138 Tongzipo Road, Changsha, 410013, P. R. China.
Dehuan Liang *Department of Basic Innovation Research, Beijing Hospital, National Center for Gerontology; National Clinical Research Center for Gerontology; The Key Laboratory of Geriatrics of NHC; Beijing Key Laboratory of Aging Mechanism and Intervention Research on Aging-Related Diseases; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences & Peking Union Medical College, No. 1, Dahua Road, Dongdan, Beijing, 100730, Dongcheng District, P. R. China.
Zhaolai QiDepartment of Basic Innovation Research, Beijing Hospital, National Center for Gerontology; National Clinical Research Center for Gerontology; The Key Laboratory of Geriatrics of NHC; Beijing Key Laboratory of Aging Mechanism and Intervention Research on Aging-Related Diseases; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences & Peking Union Medical College, No. 1, Dahua Road, Dongdan, Beijing, 100730, Dongcheng District, P. R. China.
Yao LuClinical Research Center, The Third Xiangya Hospital, Central South University, 138 Tongzipo Road, Changsha, 410013, P. R. China. luyao0719@163.com.
Liyong ZhuDepartment of Bariatric and Metabolic Surgery, The Third Xiangya Hospital of Central South University, 138 Tongzipo Road, Changsha, 410013, Hunan, P. R. China. zly8128@csu.edu.cn.
Guoping LiDepartment of Basic Innovation Research, Beijing Hospital, National Center for Gerontology; National Clinical Research Center for Gerontology; The Key Laboratory of Geriatrics of NHC; Beijing Key Laboratory of Aging Mechanism and Intervention Research on Aging-Related Diseases; Institute of Geriatric Medicine, Chinese Academy of Medical Sciences & Peking Union Medical College, No. 1, Dahua Road, Dongdan, Beijing, 100730, Dongcheng District, P. R. China. liguoping4195@bjhmoh.cn.ORCID http://orcid.org/0009-0002-8512-8902

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProprotein convertase subtilisin-kexin type 9 (PCSK9) inhibitors are potent lipid-lowering therapies, however, concerns regarding their neurocognitive safety persist because of conflicting evidence.

methodsWe applied an integrated approach combining real-world pharmacovigilance, genetic epidemiology, and preclinical models. Disproportionality analysis was performed using the FDA Adverse Event Reporting System (FAERS) data to assess cognitive adverse events. Two-sample Mendelian randomization (MR) was used to assess the causal effects of apolipoprotein B (ApoB) lowering and PCSK9 inhibition on Alzheimer's disease (AD) using UK Biobank and FinnGen data, with a factorial MR design to evaluate interactions stratified by ApoB and PCSK9 polygenic risk. Preclinically, hepatocyte-specific knockout and pharmacological inhibition of PCSK9 in AD-transgenic mice were assessed through cognitive testing and neuropathological assessment.

resultsFAERS analysis showed no increased reporting signal for cognitive adverse events with PCSK9 inhibitors. For AD, the ROR was below unity (ROR = 0.62, 95% CI 0.45-0.87), whereas no statistically significant signal was observed for dementia (ROR = 0.92, 95% CI 0.79-1.08). In contrast, statins showed significant disproportionality signals for AD (ROR = 2.86, 95% CI 2.51-3.26) and dementia (ROR = 1.51, 95% CI 1.36-1.67). MR analysis revealed no causal association between genetically proxied PCSK9 inhibition and AD risk (OR = 1.00, 95% CI 0.93-1.07), or between ApoB and AD risk (OR = 0.79, 95% CI 0.56-1.11). In AD-transgenic mice, PCSK9 knockout reduced low-density lipoprotein-cholesterol by 54% without impairing cognition or neuronal integrity, or increasing amyloid-β plaques and astrocytes. Pharmacological inhibition of PCSK9 similarly showed no cognitive deficits.

conclusionsIntegrated evidence from pharmacovigilance, genetic epidemiology, and preclinical models robustly supports the neurocognitive safety of PCSK9 inhibitors, including in individuals with high ApoB levels. These findings affirm their long-term neurocognitive safety profile in the management of atherosclerotic cardiovascular disease.

Indexed as

Alzheimer DiseaseCognitionPCSK9 InhibitorsAnimalsApolipoproteins BFemaleHumansMiceMice, TransgenicProprotein Convertase 9Apolipoproteins BPCSK9 InhibitorsPCSK9 protein, humanProprotein Convertase 9

Identifiers

PMID42332816
PMCPMC13543531

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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.