Evidence map›Paper›PMID 19095138›Full record

Trial reportJournal of the American College of Cardiology2008

Long-term effects of fenofibrate on carotid intima-media thickness and augmentation index in subjects with type 2 diabetes mellitus.

Anne Hiukka, Jukka Westerbacka, Eeva S Leinonen, Hiroshi Watanabe, Olov Wiklund, Lillemor Mattson Hulten, Jukka T Salonen, Tomi-Pekka Tuomainen, Hannele Yki-Järvinen, Anthony C Keech and 1 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of the American College of Cardiology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00132886 (Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Single Oral Tolvaptan Tablets on Hemodynamic Parameters in Subjects With Heart Failure), which is not on this map. Cited by 26 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 3 pooled it
5.5field-weighted citation impact, top 4% 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.

NCT00132886 phase2completednot on this map

Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Single Oral Tolvaptan Tablets on Hemodynamic Parameters in Subjects With Heart Failure

TypeinterventionalSponsorOtsuka Pharmaceutical Development & Commercialization, Inc.Ran2004 to 2006Enrolled140ConditionsHeart Failure, CongestiveArmstolvaptan
3 · Its place in the literature

Who cites it

26 citing papers in PubMed, 3 syntheses or guidelines pooled it, 72 citations in OpenAlex.

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  14. Ocular Effects of Niacin: A Review of the Literature.Medical hypothesis, discovery & innovation ophthalmology journal · 2015
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 4 institutions in 3 countries.

Anne HiukkaDepartment of Medicine, University of Helsinki, Helsinki University Central Hospital and Biomedicum, Helsinki, Finland.
Jukka Westerbacka
Eeva S Leinonen
Hiroshi Watanabe
Olov Wiklund
Lillemor Mattson Hulten
Jukka T Salonen
Tomi-Pekka Tuomainen
Hannele Yki-Järvinen
Anthony C Keech
Marja-Riitta Taskinen
University of Helsinki · FISahlgrenska University Hospital · SEUniversity of Eastern Finland · FIThe University of Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThe aim of this substudy was to ascertain whether long-term treatment with fenofibrate reduces surrogate measures of atherosclerosis, biomarkers of inflammation, and endothelial activation in patients with type 2 diabetes.

backgroundSome fibrates may decrease cardiovascular events, improve endothelial function, and reduce levels of acute-phase proteins. In the FIELD (Fenofibrate Intervention and Event Lowering in Diabetes) study, fenofibrate failed to decrease the primary end point of coronary events in patients with type 2 diabetes.

methodsA total of 170 patients with type 2 diabetes of the FIELD Helsinki cohort were randomly assigned to micronized fenofibrate 200 mg/day or placebo in a double-blind design. Carotid intima-media thickness (IMT) and the augmentation index (a measure of large artery stiffness) were measured at baseline and at second- and fifth-year visits. Plasma levels of interleukin (IL)-6, C-reactive protein (CRP), serum amyloid A (SAA), secretory phospholipase A2 IIA (SPLA2), E-selectin, vascular cellular adhesion molecule (VCAM)-1, and intercellular adhesion molecule (CAM)-1 were determined by commercial enzyme-linked immunosorbent assay kits at the same visits.

resultsIMT and the augmentation index increased similarly in both treatment groups during the study. Plasma levels of CRP, IL-6, SPLA2, SAA, VCAM-1, ICAM-1, and E-selectin remained unchanged in both groups.

conclusionsFenofibrate treatment was not associated with beneficial changes in IMT, augmentation index, or biomarkers of inflammation and endothelial function. (Fenofibrate Intervention and Event Lowering in Diabetes; NCT00132886).

Indexed as

Acute-Phase ProteinsAgedBiomarkersCarotid ArteriesCarotid Artery DiseasesC-Reactive ProteinDiabetes ComplicationsDiabetes Mellitus, Type 2Double-Blind MethodFemaleFenofibrateHumansHypolipidemic AgentsInflammationMaleMiddle AgedAcute-Phase ProteinsBiomarkersC-Reactive ProteinFenofibrateHypolipidemic Agents

Identifiers

PMID19095138
OpenAlexW2008695819

What OpenQuestion holds

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Read underepoch 390

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.