Evidence map›Paper›PMID 26771445›Full record

Trial reportScandinavian journal of rheumatology2016

Safety and efficacy of oral febuxostat for treatment of HLA-B*5801-negative gout: a randomized, open-label, multicentre, allopurinol-controlled study.

K-H Yu, J-H Lai, P-N Hsu, D-Y Chen, C-J Chen, H-Y Lin

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

Trial report in Scandinavian journal of rheumatology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 6 pooled it
4.1field-weighted citation impact, top 7% 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

9 citing papers in PubMed, 6 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Trial
  8. Article
  9. Review
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

6 authors at 6 institutions in 1 country.

K-H Yua Division of Rheumatology, Allergy and Immunology, Department of Internal Medicine , Chang Gung Memorial Hospital and Chang Gung University , Taoyuan , Taiwan , ROC.
J-H Laib Division of Rheumatology, Allergy and Immunology, Department of Internal Medicine , Chang Gung Memorial Hospital, Chang Gung University and School of Medicine, National Defense Medical Center , Taipei , Taiwan , ROC.
P-N Hsuc Department of Internal Medicine , National Taiwan University Hospital , Taipei , Taiwan , ROC.
D-Y Chend Faculty of Medicine , National Yang-Ming University , Taipei , Taiwan , ROC.
C-J Chenh Department of Internal Medicine , Kaohsiung Medical University Hospital , Kaohsiung , Taiwan , ROC.
H-Y Lini Division of Allergy, Immunology and Rheumatology , Taipei Veterans General Hospital and National Yang-Ming University School of Medicine , Taipei , Taiwan , ROC.
Chang Gung Memorial Hospital · TWChang Gung University · TWKaohsiung Medical University Chung-Ho Memorial Hospital · TWNational Taiwan University Hospital · TWNational Yang Ming Chiao Tung University · TWTaipei Medical University · TW

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesThis phase IIIB study compared the efficacy and safety of febuxostat and allopurinol in gout patients with or without tophi who were HLA-B*5801 negative.

methodEligible patients were randomized to a febuxostat group (80 mg QD) or an allopurinol group (300 mg QD). Following an initial 2-week washout period, over the next 12 weeks we made five measurements of serum urate levels along with assessments of adverse events (AEs).

resultsForty-three out of 152 screened subjects (28.3%) were ineligible either because of the presence of the HLA-B*5801 allele or for various other reasons. The febuxostat group (n = 54) and the allopurinol group (n = 55) had no significant differences in demographic or baseline characteristics. From week 2 to week 12, the febuxostat group had a significantly lower serum urate level than the allopurinol group (p ≤ 0.001 for all comparisons) and significantly more patients with serum urate levels less than 6.0 mg/dL. The serum urate levels of the febuxostat group declined by more than 40% from week 2 to week 12 and this decrease was greater than that in the allopurinol group (~30%). The two groups were similar in terms of AEs.

conclusionsFebuxostat was more effective than allopurinol in reducing the serum urate levels of Han Chinese patients with gout or tophaceous gout who were HLA-B*5801 negative, without causing any serious skin reactions. Febuxostat should be considered for treatment of Han Chinese patients with gout who are HLA-B*5801 negative.

Indexed as

Administration, OralAdultAllelesAllopurinolChinaFebuxostatFemaleGoutGout SuppressantsHLA-B AntigensHumansHyperuricemiaMaleMiddle AgedTreatment OutcomeUric AcidAllopurinolFebuxostatGout SuppressantsHLA-B*58:01 antigenHLA-B AntigensUric Acid

Identifiers

PMID26771445
PMCPMC4898137
OpenAlexW2252591348

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.