A phase 3, multicenter, randomized, allopurinol-controlled study assessing the safety and efficacy of oral febuxostat in Chinese gout patients with hyperuricemia

Shu, Xu; Li, Xiangyang; Ming, Jie; Chen, Shenren; Wang, Yangang; Liu, Xiumei; Liu, Hong; Peng, Yongde; Lin, Jianhao; Ji, Haiwang; Liu, Bin; Lü, Ying; Liu, Peng; Zhang, Yonghong; Ji, Qiuhe

doi:10.1111/1756-185x.12648

Cited by 39 publications

(46 citation statements)

References 28 publications

(87 reference statements)

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“…Similar to the previous reports, 25,26) the serum urate lowering efficacy of febuxostat was observed at an early stage, and the serum urate level was stable at 4 weeks or later (Fig. 2).…”

Section: Discussionsupporting

confidence: 90%

Previous Dosage of Allopurinol Is a Strong Determinant of Febuxostat Efficacy

Koide

Hira

Tsujimoto

et al. 2017

Biological & Pharmaceutical Bulletin

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Febuxostat has currently played pivotal role in the treatment of hyperuricemia, but there is little comprehensive information for the determinants of individual difference in efficacy of febuxostat. Therefore, the present study, a retrospective investigation, was carried out to analyze the effects of patient characteristics on the efficacy of febuxostat. A total of 225 patients who were continuously prescribed the same dose of febuxostat for 8-12 weeks from the initial therapy were enrolled in the present study. The data, including patient information and laboratory data, were collected from electronic medical records. Serum urate lowering effects of febuxostat were evaluated by calculating the change in serum urate level at baseline and at 8-12 weeks after starting febuxostat. The multiple regression analysis showed the change in serum urate level was significantly lower in male patients and in those with a lower baseline serum urate level, higher previous dose of allopurinol, lower dose of febuxostat and lower body surface area-unadjusted estimated glomerular filtration rate. Concomitantly administered drugs did not show a significantly influence on the efficacy of febuxostat. In conclusion, it should be noted that the serum urate lowering efficacy of febuxostat may decrease in patients with a higher previous dose of allopurinol, renal impairment or male patients. The basic findings of the present study are believed to contribute to the proper use of febuxostat.

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“…Similar to the previous reports, 25,26) the serum urate lowering efficacy of febuxostat was observed at an early stage, and the serum urate level was stable at 4 weeks or later (Fig. 2).…”

Section: Discussionsupporting

confidence: 90%

Previous Dosage of Allopurinol Is a Strong Determinant of Febuxostat Efficacy

Koide

Hira

Tsujimoto

et al. 2017

Biological & Pharmaceutical Bulletin

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“…The duration of the trials ranged from 4 to 52 weeks. Seven trials made a comparison between allopurinol and febuxostat1353637384647, two trials between allopurinol and benzbromarone4143, one trial between benzbromarone and probenecid42, three trials between febuxostat and placebo343940, and one trial between pegloticase and placebo45. A three-arm trial compared allopurinol, febuxostat and placebo44.…”

Section: Resultsmentioning

confidence: 99%

“…Any inconsistencies were resolved by discussion among the three authors. Finally, we identified fifteen qualified RCTs that were included in the current analysis13435363738394041424344454647. The complete process and the exclusion reasons are shown in Fig.…”

Section: Methodsmentioning

confidence: 99%

Comparative efficacy and safety of urate-lowering therapy for the treatment of hyperuricemia: a systematic review and network meta-analysis

Yang

Guo

et al. 2016

Sci Rep

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The prevalence of hyperuricemia and gout has been increasing, but the comparative effectiveness and safety of different treatments remain uncertain. We aimed to compare the effectiveness and safety of different treatments for hyperuricemia using network meta-analysis methodology. We systematically reviewed fifteen randomized controlled trials (involving 7,246 patients through January 2016) that compared the effects of different urate-lowering drugs (allopurinol, benzbromarone, febuxostat, pegloticase and probenecid) on hyperuricemia. Drug efficacy and safety, as outcomes, were measured by whether the target level of serum urate acid was achieved and whether any adverse events occurred, respectively. We derived pooled effect sizes expressed as odds ratios (ORs) and 95% confidence intervals (CIs). The efficacy and safety of the drugs were ranked by cumulative ranking probabilities. Our findings show that febuxostat, benzbromarone, probenecid, pegloticase, and allopurinol were all highly effective at reducing the risk of hyperuricemia compared to placebo. Febuxostat had the best efficacy and safety compared to the other drugs. Furthermore, febuxostat 120 mg QD was more effective at achieving urate-lowering targets (OR: 0.17, 95% CI: 0.12–0.24) and safer (OR: 0.72, 95% CI: 0.56–0.91) than allopurinol.

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“… Occurrence of adverse events in dependence on therapy duration (n (therapy duration up to one week) = 332; n (therapy duration over one week to one month) = 6525; n (therapy duration over one month to six months) = 3170; n (therapy duration over six months to one year) = 1297; n (therapy duration over one year) = 917; per therapy period differentiation between patients with at least one side effect (column 1), patients with at least one severe side effect (column 2), patients who dropped out of the study prematurely (column 3)) [ 2 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 , 46 , 47 , 48 , 49 , 50 , 51 ...…”

Section: Figurementioning

confidence: 99%

Side Effects and Interactions of the Xanthine Oxidase Inhibitor Febuxostat

Jordan

Gresser

2018

Pharmaceuticals

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The paper addresses the safety of febuxostat and summarizes reports on side effects and interactions of febuxostat published by the cut-off date (last day of literature search) of 20 March 2018. Publications on side effects and the interactions of febuxostat were considered. Information concerning the occurrence of side effects and interactions in association with the treatment with febuxostat was collected and summarized in the review. The incidence of severe side effects was much less frequent than mild side effects (1.2–3.8% to 20.1–38.7%). The rate and range of febuxostat side effects are low at doses of up to 120 mg and only increase with a daily dose of over 120 mg. The publications reveal no age-dependent increase in side effects for febuxostat. In patients with impaired renal function, no increase in adverse events is described with a dose of up to 120 mg of febuxostat per day. Patients with impaired liver function had no elevated risk for severe side effects. A known allopurinol intolerance increases the risk of skin reactions during treatment with febuxostat by a factor of 3.6. No correlation between treatment with febuxostat and agranulocytosis has been confirmed. Possible interactions with very few medications (principally azathioprine) are known for febuxostat. Febuxostat is well tolerated and a modern and safe alternative to allopurinol therapy.

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A phase 3, multicenter, randomized, allopurinol-controlled study assessing the safety and efficacy of oral febuxostat in Chinese gout patients with hyperuricemia

Abstract: Febuxostat 80 mg/day had superior urate-lowering efficacy to that of febuxostat 40 mg/day or allopurinol 300 mg/day, which was comparable in Chinese gout patients with hyperuricemia. Febuxostat, at a daily dose of 40 or 80 mg, was safe and well tolerated.

Cited by 39 publications

References 28 publications

Previous Dosage of Allopurinol Is a Strong Determinant of Febuxostat Efficacy

Previous Dosage of Allopurinol Is a Strong Determinant of Febuxostat Efficacy

Comparative efficacy and safety of urate-lowering therapy for the treatment of hyperuricemia: a systematic review and network meta-analysis

Side Effects and Interactions of the Xanthine Oxidase Inhibitor Febuxostat

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