Evidence map›Paper›PMID 29102957›Full record

Trial reportAnnals of the rheumatic diseases2018

Stepwise dose increase of febuxostat is comparable with colchicine prophylaxis for the prevention of gout flares during the initial phase of urate-lowering therapy: results from FORTUNE-1, a prospective, multicentre randomised study.

Hisashi Yamanaka, Shigenori Tamaki, Yumiko Ide, Hyeteko Kim, Kouichi Inoue, Masayuki Sugimoto, Yuji Hidaka, Atsuo Taniguchi, Shin Fujimori, Tetsuya Yamamoto

Open access · hybridAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Annals of the rheumatic diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed, 4 pooled it
4.9field-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.

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

46 citing papers in PubMed, 4 syntheses or guidelines pooled it, 118 citations in OpenAlex.

  1. Korean guidelines for the management of gout.The Korean journal of internal medicine · 2023
    Guideline
  2. Colchicine for acute gout.The Cochrane database of systematic reviews · 2021
    Pooled it
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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

10 authors at 6 institutions in 3 countries.

Hisashi YamanakaInstitute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan.
Shigenori TamakiNagoya Rheumatology Clinic, Nagoya, Japan.
Yumiko IdeTokyo Center Clinic, Tokyo, Japan.
Hyeteko KimYokohama Minoru Clinic, Yokohama, Japan.
Kouichi InoueInoue Clinic, Ibaraki, Japan.
Masayuki SugimotoShoi-kai Medical Association, Koganeibashi Sakura Clinic, Tokyo, Japan.
Yuji HidakaTaizan-kai Medical Association, Akasaka Central Clinic, Tokyo, Japan.
Atsuo TaniguchiInstitute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan.
Shin FujimoriTeikyo University Shinjuku Clinic, Tokyo, Japan.
Tetsuya YamamotoDepartment of Diabetes, Endocrinology and Metabolism, Hyogo College of Medicine, Hyogo, Japan.
Japan Medical Association · JPDiabetes Australia · AUInoue Hospital · JPInstitute of Rheumatology · CZTeikyo University Hospital · JPTokyo Women's Medical University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo determine whether febuxostat with stepwise dose increase is as useful as colchicine prophylaxis in reducing gout flares during the initial introduction of urate-lowering therapy in patients with gout in comparison with febuxostat with no dose titration.

methodsIn this prospective, multicentre, randomised open-label comparative study, patients were randomised to group A (stepwise dose increase of febuxostat from 10 to 40 mg/day), group B (fixed-dose febuxostat 40 mg/day plus colchicine 0.5 mg/day) or group C (fixed-dose febuxostat 40 mg/day) and observed for 12 weeks. Gout flare was defined as non-steroidal anti-inflammatory drug use for gout symptoms.

resultsA total of 255 patients were randomised, and 241 patients were treated. Among the treated patients, gout flares were experienced by 20/96 (20.8%) in group A, 18/95 (18.9%) in group B and 18/50 (36.0%) in group C. The incidence of flare was significantly lower in groups A and B than that in group C (P=0.047 and P=0.024, respectively), although the differences were not significant after correction for multiple comparisons. No significant difference was noted between the incidence of gout flare in groups A and B.

conclusionsOur data suggested that stepwise dose increase of febuxostat and low-dose colchicine prophylaxis effectively reduced gout flares in comparison with fixed-dose febuxostat alone. Stepwise dose increase of febuxostat may be an effective alternative to low-dose colchicine prophylaxis during the introduction of urate-lowering therapy. TRIAL REGISTRATION NUMBER: UMIN 000008414

Indexed as

AdultAnti-Inflammatory Agents, Non-SteroidalColchicineDose-Response Relationship, DrugFebuxostatGoutGout SuppressantsHumansIncidenceMaleMiddle AgedProspective StudiesSymptom Flare UpUric AcidAnti-Inflammatory Agents, Non-SteroidalColchicineFebuxostatGout SuppressantsUric Acidarthritisgouttreatment

Identifiers

PMID29102957
PMCPMC5867413
OpenAlexW2765452810

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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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.