50644
document
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 . 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 .
50645
Intervention_Pharmacological
allopurinol-controlled
50646
Intervention_Pharmacological
febuxostat ( TMX-67 )
50647
Intervention_Pharmacological
non-purine-selective inhibitor of xanthine oxidase
50648
Intervention_Pharmacological
Allopurinol
50649
Intervention_Pharmacological
Febuxostat
50650
Intervention_Pharmacological
allopurinol
50651
Intervention_Pharmacological
febuxostat
50652
Intervention_Pharmacological
allopurinol
50653
Intervention_Pharmacological
febuxostat
50654
Intervention_Pharmacological
allopurinol
50655
Intervention_Pharmacological
allopurinol
50656
Intervention_Pharmacological
febuxostat
50657
Intervention_Pharmacological
febuxostat
50658
Intervention_Pharmacological
allopurinol
50659
Intervention_Pharmacological
febuxostat
50660
Intervention_Pharmacological
Febuxostat
50661
Intervention_Pharmacological
allopurinol
50662
Outcome_Other
efficacy
50663
Outcome_Other
safety
50664
Outcome_Physical
changes in serum uric acid levels
50665
Outcome_Physical
serum uric acid levels
50666
Outcome_Other
safety
50667
Outcome_Adverse-effects
adverse events
50668
Outcome_Adverse-effects
severe adverse drug reactions
50669
Outcome_Physical
gout attacks
50670
Outcome_Physical
sudden reduction in blood uric acid levels
50671
Outcome_Physical
potent hypouricemic effects
50672
Outcome_Physical
hyperuricemia
50673
Participant_Condition
hyperuricemia
50674
Participant_Condition
hyperuricemia
50675
Participant_Condition
gout