Evidence map›Paper›PMID 28975718›Full record

Trial reportArthritis & rheumatology (Hoboken, N.J.)2017

Effects of Febuxostat in Early Gout: A Randomized, Double-Blind, Placebo-Controlled Study.

Nicola Dalbeth, Kenneth G Saag, William E Palmer, Hyon K Choi, Barbara Hunt, Patricia A MacDonald, Ulrich Thienel, Lhanoo Gunawardhana

Open access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Arthritis & rheumatology (Hoboken, N.J.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 48 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 5 pooled it
6.2field-weighted citation impact, top 2% 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

48 citing papers in PubMed, 5 syntheses or guidelines pooled it, 90 citations in OpenAlex.

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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

8 authors at 5 institutions in 2 countries.

Nicola DalbethUniversity of Auckland, Auckland, New Zealand.
Kenneth G SaagUniversity of Alabama at Birmingham.
William E PalmerMassachusetts General Hospital, Harvard Medical School, Boston.
Hyon K ChoiMassachusetts General Hospital, Harvard Medical School, Boston.
Barbara HuntTakeda Development Center Americas, Deerfield, Illinois.
Patricia A MacDonaldTakeda Development Center Americas, Deerfield, Illinois.
Ulrich ThienelRRD International, Rockville, Maryland.
Lhanoo GunawardhanaTakeda Development Center Americas, Deerfield, Illinois.
Deerfield (United States) · USHarvard University · USMassachusetts General Hospital · USUniversity of Alabama at Birmingham · USUniversity of Auckland · NZ

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the effect of treatment with febuxostat versus placebo on joint damage in hyperuricemic subjects with early gout (1 or 2 gout flares).

methodsIn this double-blind, placebo-controlled study, 314 subjects with hyperuricemia (serum uric acid [UA] level of ≥7.0 mg/dl) and early gout were randomized 1:1 to receive once-daily febuxostat 40 mg (increased to 80 mg if the serum UA level was ≥6.0 mg/dl on day 14) or placebo. The primary efficacy end point was the mean change from baseline to month 24 in the modified Sharp/van der Heijde erosion score for the single affected joint. Additional efficacy end points included change from baseline to month 24 in the Rheumatoid Arthritis Magnetic Resonance Imaging Scoring (RAMRIS) scores for synovitis, erosion, and edema in the single affected joint, the incidence of gout flares, and serum UA levels. Safety was assessed throughout the study.

resultsTreatment with febuxostat did not lead to any notable changes in joint erosion over 2 years. In both treatment groups, the mean change from baseline to month 24 in the modified Sharp/van der Heijde erosion score for the single affected joint was minimal, with no between-group differences. However, treatment with febuxostat significantly improved the RAMRIS synovitis score at month 24 compared with placebo treatment (change from baseline -0.43 versus -0.07; P <0.001), decreased the overall incidence of gout flares (29.3% versus 41.4%; P < 0.05), and improved serum UA control (62.8% versus 5.7%; P < 0.001). No major safety concerns were reported.

conclusionUrate-lowering therapy with febuxostat improved magnetic resonance imaging-determined synovitis and reduced the incidence of gout flares in subjects with early gout.

Indexed as

AdultDouble-Blind MethodFebuxostatFemaleGoutGout SuppressantsHumansHyperuricemiaJointsMagnetic Resonance ImagingMaleMiddle AgedSynovitisTreatment OutcomeUric AcidFebuxostatGout SuppressantsUric Acid

Identifiers

PMID28975718
PMCPMC5725733
OpenAlexW2761615158

What OpenQuestion holds

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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.