An allopurinol-controlled, randomized, double-dummy, double-blind, parallel
between-group, comparative study of febuxostat (TMX-67), a non-purine-selective
inhibitor of xanthine oxidase, in patients with hyperuricemia including those
with gout in Japan: phase 3 clinical study.
Author(s): Kamatani N, Fujimori S, Hada T, Hosoya T, Kohri K, Nakamura T, Ueda T, Yamamoto
T, Yamanaka H, Matsuzawa Y.
Affiliation(s): Institute of Rheumatology, Tokyo Women's Medical University, Japan.
kamatani@msb.biglobe.ne.jp
Publication date & source: 2011, J Clin Rheumatol. , 17(4 Suppl 2):S13-8
BACKGROUND: Allopurinol has been widely used for treatment of hyperuricemia,
however, it may be associated with various adverse effects. Febuxostat is
potentially a safe and efficacious alternative.
OBJECTIVES: Febuxostat or allopurinol was administered to patients with
hyperuricemia including gout for 8 weeks to compare the efficacy and safety of
these drugs.
METHODS: Doses of febuxostat and allopurinol were 10 and 100 mg/d, respectively,
during a 12-day introduction period and were increased to 40 and 200 mg/d for the
subsequent treatment period of 44 days.
RESULTS: : The percent changes in serum uric acid levels after 8 weeks were
-40.75% for the febuxostat group and -34.41% for the allopurinol group (P <
0.001, analysis of variance, closing testing procedure). The percentage of
patients achieving serum uric acid levels 6.0 mg/dL or less after 8 weeks was
82.0% for the febuxostat group and 70.0% for the allopurinol group (P = 0.019,
logistic regression analysis). Regarding safety, 213 adverse events were observed
in the febuxostat group and 220 events in the allopurinol group. For 10 patients
(8.2%) in the febuxostat group and 14 patients (11.6%) in the allopurinol group,
association with the study drugs could not be ruled out. There were no severe
adverse drug reactions in the febuxostat group other than a high frequency of
gout attacks induced by the sudden reduction in blood uric acid levels during the
early treatment period.
CONCLUSIONS: Febuxostat at 40 mg/d demonstrated more potent hypouricemic effects
than allopurinol at 200 mg/d, was efficacious regardless of medical history of
gout, and is considered safe for treatment of hyperuricemia.
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