Evidence map›Paper›PMID 24070911›Full record

Trial reportJournal of the American College of Cardiology2013

High-dose atorvastatin reduces periodontal inflammation: a novel pleiotropic effect of statins.

Sharath Subramanian, Hamed Emami, Esad Vucic, Parmanand Singh, Jayanthi Vijayakumar, Kenneth M Fifer, Achilles Alon, Sudha S Shankar, Michael Farkouh, James H F Rudd and 3 more

2 registry-linked trialsAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of the American College of Cardiology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It reports registered trial NCT00703261. Cited by 59 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
59citing papers in PubMed, 5 pooled it
11.3field-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.

NCT00703261 phase1completed

A Randomized, Double-Blind, Parallel Group Study to Evaluate the Effects of High Dose Statin Therapy on 18Fluorine Fluorodeoxyglucose (18FDG) Uptake in Arteries of Patients With Atherosclerotic Vascular Disease

Ran2008Enrolled83Registered outcomes2Posted comparisons4ConditionsAtherosclerotic Vascular DiseaseArmsAtorvastatin, Placebo
Open the trial in the graph
NCT04046237 narecruitingnot on this mapstarted 2019, after this paper: background citation

Impact of Treating Severe Periodontitis on Inflammatory Activity of Atheromatous Plaques in Patients With Acute Myocardial Infarction (AMI)

TypeinterventionalSponsorAssistance Publique - Hôpitaux de ParisRan2019 to 2028Enrolled210ConditionsAcute Myocardial Infarction, Severe Periodontitis, Carotid AtherosclerosisArmsPeriodontal treatment
3 · Its place in the literature

Who cites it

59 citing papers in PubMed, 5 syntheses or guidelines pooled it, 124 citations in OpenAlex.

  1. Pooled it
  2. Efficacy Evaluation of High-Dose Atorvastatin Pretreatment in Patients with Acute Coronary Syndrome: A Meta-Analysis of Randomized Controlled Trials.Medical science monitor : international medical journal of experimental and clinical research · 2018
    Pooled it
  3. Guideline
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  19. Exploring Vessel Wall Biology In Vivo by Ultrasensitive Total-Body PET.Journal of nuclear medicine : official publication, Society of Nuclear Medicine · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 6 institutions in 3 countries.

Sharath SubramanianMassachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Hamed EmamiMassachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Esad VucicMassachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Parmanand SinghMassachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Jayanthi VijayakumarMassachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Kenneth M FiferMassachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Achilles AlonMerck Sharp & Dohme Corp., Whitehouse Station, New Jersey.
Sudha S ShankarMerck Sharp & Dohme Corp., Whitehouse Station, New Jersey.
Michael FarkouhPeter Munk Cardiac Centre and the Heart and Stroke Richard Lewar Centre of Excellence, the University of Toronto, Toronto, Ontario, Canada.
James H F RuddDivision of Cardiovascular Medicine, University of Cambridge, Cambridge, United Kingdom.
Zahi A FayadTranslational and Molecular Imaging Institute, Icahn School of Medicine at Mount Sinai, New York, New York.
Thomas E Van DykeForsyth Institute, Cambridge, Massachusetts.
Ahmed TawakolMassachusetts General Hospital and Harvard Medical School, Boston, Massachusetts. Electronic address: atawakol@partners.org.
Harvard University · USMerck & Co., Inc., Rahway, NJ, USA (United States) · USIcahn School of Medicine at Mount Sinai · USMassachusetts General Hospital · USUniversity of Cambridge · GBUniversity of Toronto · CA

Funding

Harvard Clinical and Translational Science Center (UL1)UL1TR000170 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2012 to 2013
$31.4M
Cardiac MR and CT ResearchT32HL076136 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI NEILAN, TOMAS G · 2004 to 2019
$4.9M
Cardiovascular Imaging in Ischemic Heart DiseaseK24HL113128 · NHLBI · MASSACHUSETTS GENERAL HOSPITAL · PI HOFFMANN, UDO · 2012 to 2020
$1.1M
British Heart Foundation FS/12/29/29463British Heart Foundation PG/09/083/27667NCATS NIH HHS 8UL1TR000170-05NCATS NIH HHS UL1 TR000170NHLBI NIH HHS K24 HL113128NHLBI NIH HHS T32 HL076136
6 · The paper itself

Abstract

objectivesThe purpose of this study was to test whether high-dose statin treatment would result in a reduction in periodontal inflammation as assessed by (18)F-fluorodeoxyglucose positron emission tomography (FDG-PET)/computed tomography (CT).

backgroundPeriodontal disease (PD) is an independent risk factor for atherosclerosis.

methodsEighty-three adults with risk factors or with established atherosclerosis and who were not taking high-dose statins were randomized to atorvastatin 80 mg vs. 10 mg in a multicenter, double-blind trial to evaluate the impact of atorvastatin on arterial inflammation. Subjects were evaluated using FDG-PET/CT at baseline and at 4 and 12 weeks. Arterial and periodontal tracer activity was assessed while blinded to treatment allocation, clinical characteristics, and temporal sequence. Periodontal bone loss (an index of PD severity) was evaluated using contrast-enhanced CT images while blinded to clinical and imaging data.

resultsSeventy-one subjects completed the study, and 59 provided periodontal images for analysis. At baseline, areas of severe PD had higher target-to-background ratio (TBR) compared with areas without severe PD (mean TBR: 3.83 [95% confidence interval (CI): 3.36 to 4.30] vs. 3.18 [95% CI: 2.91 to 3.44], p = 0.004). After 12 weeks, there was a significant reduction in periodontal inflammation in patients randomized to atorvastatin 80 mg vs. 10 mg (ΔTBR 80 mg vs. 10 mg group: mean -0.43 [95% CI: -0.83 to -0.02], p = 0.04). Between-group differences were greater in patients with higher periodontal inflammation at baseline (mean -0.74 [95% CI: -1.29 to -0.19], p = 0.01) and in patients with severe bone loss at baseline (-0.61 [95% CI: -1.16 to -0.054], p = 0.03). Furthermore, the changes in periodontal inflammation correlated with changes in carotid inflammation (R = 0.61, p < 0.001).

conclusionsHigh-dose atorvastatin reduces periodontal inflammation, suggesting a newly recognized effect of statins. Given the concomitant changes observed in periodontal and arterial inflammation, these data raise the possibility that a portion of that beneficial impact of statins on atherosclerosis relate to reductions in extra-arterial inflammation, for example, periodontitis. (Evaluate the Utility of 18FDG-PET as a Tool to Quantify Atherosclerotic Plaque; NCT00703261).

Indexed as

AdultAgedAged, 80 and overAtorvastatinDouble-Blind MethodFemaleHeptanoic AcidsHumansHydroxymethylglutaryl-CoA Reductase InhibitorsInflammationMaleMiddle AgedPeriodontal DiseasesPyrrolesTreatment OutcomeAtorvastatinHeptanoic AcidsHydroxymethylglutaryl-CoA Reductase InhibitorsPyrroles(18)F-fluorodeoxyglucoseatherosclerosiscomputed tomographyC-reactive proteinCRPCTFDGHDLhigh-density lipoproteinimaginginflammationLDL-Clow-density lipoprotein cholesterolnuclear medicinePDperiodontal diseasePETpositron emission tomographyregion of interestROIstandardized uptake valuestatinsSUVtarget-to-background ratioTBR

Identifiers

PMID24070911
PMCPMC6849694
OpenAlexW2146669088

What OpenQuestion holds

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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 OpenQuestion graph.