Evidence map›Paper›PMID 31531831›Full record

ArticleRheumatology and therapy2019

A Randomized, Double-Blind, Non-Inferiority Study of Febuxostat Versus Allopurinol in Hyperuricemic Chinese Subjects With or Without Gout.

Fengchun Zhang, Zhichun Liu, Lindi Jiang, Hao Zhang, Dongbao Zhao, Yang Li, Hejian Zou, Xiaoyue Wang, Xiangpei Li, Bingyin Shi and 4 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Rheumatology and therapy, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
0.9field-weighted citation impact, top 27% 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

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 19 citations in OpenAlex.

  1. Pooled it
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  10. ProbioticiScience · 2022
    Article
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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

14 authors at 14 institutions in 1 country.

Fengchun ZhangDepartment of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China. zhangfccra@aliyun.com.
Zhichun LiuDepartment of Rheumatology, The Second Affiliated Hospital of Soochow University, Suzhou, Jiangsu, China.
Lindi JiangDepartment of Rheumatology, Zhongshan Hospital, Fudan University, Shanghai, China.
Hao ZhangDepartment of Nephrology, The Third Xiangya Hospital of Central South University, Changsha, Hunan, China.
Dongbao ZhaoDepartment of Rheumatology and Immunology, Shanghai Changhai Hospital, Shanghai, China.
Yang LiDepartment of Rheumatology and Immunology, The Second Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China.
Hejian ZouDepartment of Rheumatology, Huashan Hospital, Fudan University, Shanghai, China.
Xiaoyue WangDepartment of Endocrinology, The First People Hospital of Yueyang, Yueyang, Hunan, China.
Xiangpei LiDepartment of Rheumatology and Immunology, The First Affiliated Hospital, University of Science and Technology of China, Hefei, Anhui, China.
Bingyin ShiDepartment of Endocrinology, The First Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi, China.
Jianhua XuDepartment of Rheumatology and Immunology, The First Affiliated Hospital of Anhui Medical University, Hefei, Anhui, China.
Hongjie YangDepartment of Endocrinology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Shaoxian HuDepartment of Rheumatology and Immunology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China.
Shen QuDepartment of Endocrinology and Metabolism, Shanghai Tenth People's Hospital, Zhabei, Shanghai, China.
Anhui Medical University · CNCentral South University · CNChanghai Hospital · CNChinese Academy of Medical Sciences & Peking Union Medical College · CNFirst Affiliated Hospital of Xi'an Jiaotong University · CNFudan University · CNSecond Affiliated Hospital of Harbin Medical University · CNShanghai Tenth People's Hospital · CNShanghai University of Traditional Chinese Medicine · CNSoochow University · CNTongji Hospital · CNUniversity of Science and Technology of China · CNYueyang Second People's Hospital · CNZhongshan Hospital · CN

Funding

Astellas Pharma Global Development n/a
6 · The paper itself

Abstract

introductionThis 24-week randomized, double-blind, non-inferiority study compared the efficacy and safety of febuxostat, a xanthine oxidase inhibitor, with allopurinol using an up-titration method in hyperuricemic Chinese subjects with or without gout.

methodsEligible adults (serum uric acid [SUA] > 7.0 mg/dl with a history of gout, SUA ≥ 8.0 mg/dl with complications or SUA ≥ 9.0 mg/dl without complications) were randomized (1:1:1) to febuxostat 40 mg/day, 80 mg/day, or allopurinol 300 mg/day. Starting doses of febuxostat 20 mg/day and allopurinol 100 mg/day were up-titrated, up to 16 weeks, to the randomized doses and maintained to week 24. Primary endpoint was non-inferiority of febuxostat 40 mg/day versus allopurinol 300 mg/day based on the percentage of subjects with SUA ≤ 6.0 mg/dl at week 24. The same comparison was made between febuxostat 60 mg/day or 80 mg/day versus allopurinol 300 mg/day. Safety assessments included measurement of treatment-emergent adverse events (TEAEs).

resultsThe per-protocol population comprised 472 subjects. Non-inferiority of febuxostat 40 mg/day versus allopurinol 300 mg/day was not demonstrated based on the protocol-defined margin of - 10% (44.7 vs. 50.0%; - 5.3% difference; 95% confidence interval [CI]: - 16.4%, 5.8%); however, superiority over allopurinol 300 mg/day was demonstrated for febuxostat 60 mg/day at week 16 (66.3 vs. 51.2%; a 15.0% difference; 95% CI: 4.2%, 25.9%) and febuxostat 80 mg/day at week 24 (70.0 vs. 50.0%; a 20.0% difference; 95% CI: 9.3%, 30.7%). The frequency of TEAEs was similar across groups, with gout flares occurring frequently.

conclusionsUsing a novel dose-titration method, although the primary endpoint of non-inferiority of febuxostat 40 mg/day versus allopurinol 300 mg/day was not reached, non-inferiority and superiority of febuxostat 60 mg/day and 80 mg/day versus allopurinol 300 mg/day was demonstrated at weeks 16 and 24, respectively. Febuxostat demonstrated an acceptable tolerability profile in the treatment of hyperuricemia in Chinese subjects with or without gout.

trial registrationJapicCTI-132106.

fundingAstellas Pharma Global Development, Inc.

Indexed as

FebuxostatGoutHyperuricemiaXanthine oxidase inhibitor

Identifiers

PMID31531831
PMCPMC6858416
OpenAlexW2974082536

What OpenQuestion holds

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LicenceCC BY-NC
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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.