| ObjectiveEvaluate the safety and efficacy of febuxostat in subjects with hyperuricemia and gout.Subjects and methodsSubjects were from the outpatients with hyperuricemia and gout on March 2012-2014 August,which met the inclusion criteria,did not meet the exclusion criteria.After the subjects signed informed consent,the general demographic data:age,gender,height,weight,BMI,blood pressure,comorbidities,family history,concomitant medications and related physiological and biochemical laboratory data were collected.Subjects underwent a 2-week washout period before undergoing randomization.Registered patients were randomly assigned 1:1:1 to the febuxostat 40 mg/day,80 mg/day or the allopurinol 300 mg/day groups.Meanwhile,the subjects should be educated with healthy diet,low-calorie,and low-purine diet.During the 24 weeks,Weekly visits focused on the patient's serum uric acid levels,blood pressure,heart rate,respiratory rate,adverse events,security-related physiological and biochemical index(blood,urine,liver and kidney function,thyroid function,resting 12-lead ECG,urine pregnancy test,urinary ultrasound etal).The primary efficacy end point was the proportion of subjects in each treatment group with sUA<357?mol/L at last 3 months.Secondary efficacy.end points included the proportion of subjects with serum uric acid levels that had decreased to 357?mol/L at each visit,percentage reduction from baseline sUA,incidence of acute gout flares requiring treatment.After 24 week study,basic information and statistical data before and after treatment of patients were analysed with SPSS 16.0 statistical software,for the measurement data,analysis of variance was used,the statistical results were expressed as(mean±standard deviation),for categorical variables,chi-square test was used.p<0.05 were considered statistically significant.ResultsThere was no significant difference in age,sex,body mass index,heart rate,blood pressure,blood glucose,uric acid,comorbidities and other demographic information between the allopurinol 300mg group,febuxostat 40mg and 80mg group.The proportion of subjects in each treatment group with sUA<357?mol/L at the last three monthly,was 22.2%,23.1%,58.6%in the allopurinol group,febuxostat 40 mg,and febuxostat 80 mg,the difference was statistically significant(p<0.05),allopurinol 300mg and febuxostat 40mg group were not statistically significant(p>0.05),febuxostat 80 mg was significantly higher than allopurinol 300mg and febuxostat 40 mg group(p<0.05).The proportion of subjects in each treatment group with sUA<357?mol/L at Visit 4-6(4-12 week),the difference between allopurinol 300mg and febuxostat 40mg group was not statistically significant(p>0.05),the difference between allopurinol 300mg and febuxostat 80mg group were all statistically significant(p<0.05).At visit 4-9(4-24 week),serum uric acid levels of allopurinol 300mg,febuxostat 40mg and febuxostat 80mg group were decreased comparing with baseline,the difference was statistically significance(p<0.05).Between week 2 and 28,the proportion of subjects requiring treatment for gout flares observed in the allopurinol 300mg,febuxostat 40mg and febuxostat 80mg group was 26.7%,46.7%and 33.3%,respectively.The difference was not statistically significant(p>0.05),there was no significant difference between the groups(p>0.05).During treatment,adverse events were mild to moderate in severity,there was no serious adverse event,the frequent adverse events in the febuxostat group were abnormal liver function,urinary tract infection,upper respiratory tract infection etal,there was no significant difference in the allopurinol 300mg,febuxostat 40mg and febuxostat 80mg group(p>0.05).Conclusion1.Febuxostat can reduce uric acid levels effectively in patients with hyperuricemia and gout.2.Febuxostat is safe in lowering the uric acid.3.The urate lowering efficacy of febuxostat 40 mg·d-1 was equivalent to that of allopurinol 300 mg·d-1.4.The urate lowering efficacy of febuxostat 80 mg·d-1 was superior to that of allopurinol 300 mg·d-1. |
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