Evidence map›Paper›PMID 25561459›Full record

Trial reportJournal of lipid research2015

Effect of open-label infusion of an apoA-I-containing particle (CER-001) on RCT and artery wall thickness in patients with FHA.

Ruud S Kootte, Loek P Smits, Fleur M van der Valk, Jean-Louis Dasseux, Constance H Keyserling, Ronald Barbaras, John F Paolini, Raul D Santos, Theo H van Dijk, Geesje M Dallinga-van Thie and 6 more

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of lipid research, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 42 papers.

0numbers the graph read from it
0cells of the map it votes in
42citing papers in PubMed
15.3field-weighted citation impact, top 1% 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.

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

42 citing papers in PubMed, 84 citations in OpenAlex.

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  12. HDL and ASCVD.Advances in experimental medicine and biology · 2022
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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

16 authors at 4 institutions in 3 countries.

Ruud S KootteDepartments of Vascular Medicine and Experimental Vascular Medicine Academic Medical Center, Amsterdam, The Netherlands.
Loek P SmitsDepartments of Vascular Medicine and Experimental Vascular Medicine Academic Medical Center, Amsterdam, The Netherlands.
Fleur M van der ValkDepartments of Vascular Medicine and Experimental Vascular Medicine Academic Medical Center, Amsterdam, The Netherlands.
Jean-Louis DasseuxCerenis Therapeutics Holding, Toulouse, France.
Constance H KeyserlingCerenis Therapeutics Holding, Toulouse, France.
Ronald BarbarasCerenis Therapeutics Holding, Toulouse, France.
John F PaoliniCerenis Therapeutics Holding, Toulouse, France.
Raul D SantosHeart Institute (Incor), University of Sao Paolo Medical School Hospital, Sao Paulo, Brazil.
Theo H van DijkDepartment of Laboratory Medicine, University Medical Center Groningen, Groningen, The Netherlands.
Geesje M Dallinga-van ThieDepartments of Vascular Medicine and Experimental Vascular Medicine Academic Medical Center, Amsterdam, The Netherlands.
Aart J NederveenRadiology, Academic Medical Center, Amsterdam, The Netherlands.
WillemJ M MulderDepartments of Vascular Medicine and Experimental Vascular Medicine Academic Medical Center, Amsterdam, The Netherlands.
G Kees HovinghDepartments of Vascular Medicine and Experimental Vascular Medicine Academic Medical Center, Amsterdam, The Netherlands.
JohnJ P KasteleinDepartments of Vascular Medicine and Experimental Vascular Medicine Academic Medical Center, Amsterdam, The Netherlands.
Albert K GroenDepartment of Laboratory Medicine, University Medical Center Groningen, Groningen, The Netherlands.
ErikS StroesDepartments of Vascular Medicine and Experimental Vascular Medicine Academic Medical Center, Amsterdam, The Netherlands. Electronic address: e.s.stroes@amc.nl.
Academic Medical Center · NLCerenis Therapeutics (France) · FRUniversity Medical Center Groningen · NLHospital São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Reverse cholesterol transport (RCT) contributes to the anti-atherogenic effects of HDL. Patients with the orphan disease, familial hypoalphalipoproteinemia (FHA), are characterized by decreased tissue cholesterol removal and an increased atherogenic burden. We performed an open-label uncontrolled proof-of-concept study to evaluate the effect of infusions with a human apoA-I-containing HDL-mimetic particle (CER-001) on RCT and the arterial vessel wall in FHA. Subjects received 20 infusions of CER-001 (8 mg/kg) during 6 months. Efficacy was assessed by measuring (apo)lipoproteins, plasma-mediated cellular cholesterol efflux, fecal sterol excretion (FSE), and carotid artery wall dimension by MRI and artery wall inflammation by (18)F-fluorodeoxyglucose-positron emission tomography/computed tomography scans. We included seven FHA patients: HDL-cholesterol (HDL-c), 13.8 [1.8-29.1] mg/dl; apoA-I, 28.7 [7.9-59.1] mg/dl. Following nine infusions in 1 month, apoA-I and HDL-c increased directly after infusion by 27.0 and 16.1 mg/dl (P = 0.018). CER-001 induced a 44% relative increase (P = 0.018) in in vitro cellular cholesterol efflux with a trend toward increased FSE (P = 0.068). After nine infusions of CER-001, carotid mean vessel wall area decreased compared with baseline from 25.0 to 22.8 mm(2) (P = 0.043) and target-to-background ratio from 2.04 to 1.81 (P = 0.046). In FHA-subjects, CER-001 stimulates cholesterol mobilization and reduces artery wall dimension and inflammation, supporting further evaluation of CER-001 in FHA patients.

Indexed as

Carotid ArteriesHypoalphalipoproteinemiasMagnetic Resonance AngiographyPositron-Emission TomographyAdultApolipoprotein A-ICholesterol, HDLFemaleHumansMaleMiddle AgedPhospholipidsRadiographyRecombinant ProteinsApolipoprotein A-ICER-001Cholesterol, HDLPhospholipidsRecombinant Proteinsapolipoprotein A-Ifamilial hypoalphalipoproteinemiareverse cholesterol transport

Identifiers

PMID25561459
PMCPMC4340317
OpenAlexW2320090292

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.