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2017 ; 36
(3
): 649-656
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gab.com Text
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Clinical efficacy and safety of topiroxostat in Japanese hyperuricemic patients
with or without gout: a randomized, double-blinded, controlled phase 2b study
#MMPMID27832384
Hosoya T
; Sasaki T
; Ohashi T
Clin Rheumatol
2017[Mar]; 36
(3
): 649-656
PMID27832384
show ga
Topiroxostat, a selective xanthine oxidoreductase inhibitor, is used in Japan for
the treatment of hyperuricemic patients with or without gout. In terms of the
effectiveness of topiroxostat in lowering serum urate levels, the dose-response
relationship has been evaluated; however, it remains to be verified. A
randomized, multi-center, double-blinded study of topiroxostat was performed for
Japanese hyperuricemic patients with or without gout. During the 16-week study,
157 Japanese hyperuricemic patients with or without gout were randomly assigned
to receive a placebo, topiroxostat at 120 or 160 mg/day, or allopurinol at
200 mg/day. The primary endpoint of this study was to determine the lowering rate
of serum uric acid levels compared to those of baseline at the end of
administration. A dose-response relationship (regarding decreases in the serum
urate levels) was confirmed for the placebo and topiroxostat at 120 and at
160 mg/day. Moreover, at the end of administration, the lowering rate of serum
urate levels was determined to be -44.8% in the topiroxostat 160-mg/day group. No
significant difference in the incidence of adverse events was observed among all
groups, including the allopurinol group. The serum urate-lowering effect of
topiroxostat was found to have a dose-response relationship in Japanese
hyperuricemic patients with or without gout.
|Adult
[MESH]
|Allopurinol/adverse effects/therapeutic use
[MESH]
|Double-Blind Method
[MESH]
|Female
[MESH]
|Gout Suppressants/adverse effects/*therapeutic use
[MESH]
|Gout/blood/*drug therapy
[MESH]
|Humans
[MESH]
|Hyperuricemia/blood/*drug therapy
[MESH]
|Japan
[MESH]
|Male
[MESH]
|Middle Aged
[MESH]
|Nitriles/adverse effects/*therapeutic use
[MESH]
|Pyridines/adverse effects/*therapeutic use
[MESH]