Effects of febuxostat on serum urate level in Japanese hyperuricemia patients

Yamamoto, Tetsuya; Hidaka, Yoshiki; Inaba, Masaaki; Ishimura, Eiji; Oda, Hiroshi; Kakuta, Hirokazu; Moriwaki, Yuji; Higami, Kenshi; Ohtawara, Akira; Hosoya, Tatsuo; Nishikawa, H.; Taniguchi, Atsuo; Ueda, Takanori; Yamauchi, Takahiro; Fujimori, Shin; Mineo, Ikuo; Yamanaka, Hisashi

doi:10.3109/14397595.2015.1016257

Cited by 12 publications

(8 citation statements)

References 13 publications

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“…This prospective, multicentre, randomised, open-label comparative study was conducted by the Febuxostat Outcome Research Towards Urate Lowering in the Next Decade (FORTUNE) consortium, organised by multiple clinical sites across Japan, 28 and was designated the FORTUNE-1 study. Patients were randomised as follows: group A, stepwise dose increase of febuxostat from 10 mg/day (4 weeks), 20 mg/day (4 weeks) and 40 mg/day (until the end of the study); group B, febuxostat 40 mg/day from the start of the study, with concomitant colchicine 0.5 mg/day; or group C, febuxostat 40 mg/day from the start of the study.…”

Section: Methodsmentioning

confidence: 99%

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

Yamanaka

Tamaki

Ide³

et al. 2017

Ann Rheum Dis

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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 numberUMIN 000008414.

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Section: Methodsmentioning

confidence: 99%

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

Yamanaka

Tamaki

Ide³

et al. 2017

Ann Rheum Dis

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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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“…Gout, a common type of arthritis that features by deposits of monosodium urate crystals in the articular cavity or synovial fluid, is always accompanied by sudden joint inflammatory reaction [ 1 – 3 ]. The incidence of gout has reportedly experienced continuous growth over the last few decades around the world.…”

Section: Introductionmentioning

confidence: 99%

Urinary Metabolomics Study of Patients with Gout Using Gas Chromatography-Mass Spectrometry

Sang

et al. 2018

BioMed Research International

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Objectives Gout is a common type of inflammatory arthritis. The aim of this study was to detect urinary metabolic changes in gout patients which may contribute to understanding the pathological mechanism of gout and discovering potential metabolite markers. Methods Urine samples from 35 gout patients and 29 healthy volunteers were analyzed by gas chromatography–mass spectrometry (GC–MS). Orthogonal partial least-squares discriminant analysis (OPLS-DA) was performed to screen differential metabolites between two groups, and the variable importance for projection (VIP) values and Student's t-test results were combined to define the significant metabolic changes caused by gout. Further, binary logistic regression analysis was performed to establish a model to distinguish gout patients from healthy people, and receiver operating characteristic (ROC) curve was made to evaluate the potential for diagnosis of gout. Result A total of 30 characteristic metabolites were significantly different between gout patients and controls, mainly including amino acids, carbohydrates, organic acids, and their derivatives, associated with perturbations in purine nucleotide synthesis, amino acid metabolism, purine metabolism, lipid metabolism, carbohydrate metabolism, and tricarboxylic acid cycle. Binary logistic regression and ROC curve analysis showed the combination of urate and isoxanthopterin can effectively discriminate the gout patients from controls with the area under the curve (AUC) of 0.879. Conclusion Thus, the urinary metabolomics study is an efficient tool for a better understanding of the metabolic changes of gout, which may support the clinical diagnosis and pathological mechanism study of gout.

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Effects of febuxostat on serum urate level in Japanese hyperuricemia patients

Abstract: Febuxostat effectively reduced the concentration of urate in serum in hyperuricemic patients regardless of the level of uric acid excreted in urine without severe adverse effects.

Cited by 12 publications

References 13 publications

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

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

Side Effects and Interactions of the Xanthine Oxidase Inhibitor Febuxostat

Urinary Metabolomics Study of Patients with Gout Using Gas Chromatography-Mass Spectrometry

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