Study On The Efficacy And Safety Of Febuxostat In Gout Patients With Renal Impairment

Objectives:Using the electronic case data to explore the efficacy and safety of febuxostat in the treatment of gout with renal impairment patients,analyse the factors that affecting the rate of achieving target s UA.Methods:By using the outpatient and ward medical system of second affiliated hospital of Zhejiang university medical college,99 male patients with gout were selected from January 1,2015 to February 28,2019.The patients were treated with febuxostat for 48 weeks regularly.Collection the selected cases of clinical data,including:follow-up time,age,course of the disease,height,weight,body mass index(BMI),tophus,kidney stones,complications,blood pressure,serum uric acid level,serum creatinine,liver function,acute gout flare,adverse events and so on.The primary endpoint events(serum uric acid level and the rate of achieving target s UA,estimated glomerular filtration rate and adverse events)and the secondary endpoint events(blood pressure,serum lipid,liver function and erythrocyte sedimentation rate,c-reactive protein,hemoglobin,platelet count,white blood cell count)were recoded and analysed.According to the level of eGFR to analyse the effect of renal function on the efficacy of febuxostat.Logistic regression analysis was used for finding out the predictive factors which affecting the rate of achieving target s UA.Calculating the area under the curve and testing the degree of model fitting.Results:99 patients were enrolled in the study.After 48 weeks,overall serum urate acid level was significantly lower(594.73±95.83μmol/L VS 404.87±87.42μmol/L,P<0.05),30.3%(30 cases)achieved the target s UA.Serum urate acid level in eGFR<90m L/min/1.73m~2group and eGFR≥90m L/min/1.73m~2group were significantly lower,statistically significant difference was showed before and after treatment(P<0.05),not between the two groups(P>0.05).There were no significant change in eGFR and creatinine of the two groups.There were no statistically significant difference before and after treatment(P>0.05),while the difference were showed between the two groups(P<0.05).eGFR in 1 patient with CKD4was significantly increased(27.25m L/min/1.73m~2VS 44.22 m L/min/1.73m~2).Acute attack of gout and abnormal liver function were the main adverse events.There were 26 patients(26.3%),33 patients(33.3%)and 21 patients(21.2%)with acute gout attack at 12 weeks,24 weeks and 48 weeks respectively.After exclude the patients with abnormal liver function and fatty liver,there were 59 patients remained.12 patients(20.3%),11 patients(18.6%)and 6 patients(10.2%)with ALT elevation(45U/L-135u/L)at 12weeks,24 weeks and 48 weeks respectively.1 patient with ALT elevated higher than 135U/L at 12 weeks and 1 patient at 48 weeks.The cholesterin,triglyceride,AST,hemoglobin in eGFR<90 group were elevated at 48weeks(P<0.05).Logistic regression analysis showed that tophus was a predictor of the outcome of the rate of achieving target uric acid.Conclusion:1.Febuxostat has a good uric acid lowering effect in terms of long-term therapy,and the effect is not affected by renal function.2.Long-term treatment with febuxostat does not affect renal function.3.Long-term treatment of febuxostat has a good safety.Abnormal liver function and acute attack of gout are the main adverse events.The cholesterin,triglyceride,AST,hemoglobin in eGFR<90 group are elevated after treatment.4.Tophous is an important factor affecting the rate of target uric acid.