Whether the clinical trial treatment effect of urate-lowering therapy (ULT) in patient with chronic kidney disease (CKD) is generalizable to real-word settings is unclear. This study aimed to compare febuxostat with allopurinol for uric acid reduction and renal protection in patients with CKD. Adult CKD patients newly treated with ULT were identified using electronic health records from 2010 to 2015 from a large healthcare delivery system in Taiwan. Patients with renal replacement therapy or undergoing ULT for <3 months were excluded. Propensity score-matched cohort study design was conducted to compare outcomes between patients initiated with febuxostat or allopurinol therapy. Cox regression analyses were employed to compare the adjusted hazards ratio (aHR) of incident event of estimated glomerular filtration rate (eGFR) ≥ 30% decrease, and the difference in longitudinal changes in serum uric acid (SUA) and eGFR between groups was analyzed using linear mixed model. Overall, 1050 CKD patients who initiated febuxostat (n = 525) or allopurinol (n = 525) treatment were observed for 2.5 years. Compared with allopurinol, febuxostat use was associated with higher rate of patients maintaining SUA target <6 mg/dL in >80% of follow-up time with a reduction in mean SUA change. There were no significant differences in the mean eGFR changes over time between the febuxostat and allopurinol groups or in the risk of eGFR decline ≥30% of baseline. Febuxostat was associated with greater reduction in SUA level than allopurinol in patients with CKD. However, febuxostat and allopurinol showed no difference in renal function changes during study follow-up. These findings require further investigation with long-term follow up in CKD patients with hyperuricemia. Hyperuricemia has been related to the onset of chronic kidney disease (CKD) 1 and increased risk of CKD progression 2,3 as well as cardiovascular disease morbidity and mortality 4,5. The level of serum uric acid (SUA) increases in parallel with the estimated glomerular filtration rate (eGFR) decline, which is present in 40% to 60% of patients with CKD stages 1 to 3 and in 70% of patients with CKD stage 4 or 5 3,6. Thus, lowering uric acid presents a critical strategy in the management and prevention of renal disease progression among patients with CKD. For patients with gout or symptomatic hyperuricemia 7-9 , lowering the SUA below the target of 6 mg/dL is recommended to prevent acute flares 10 , quality of life deficit 11 , and additional medical costs 12. The current urate-lowering therapy (ULT) includes xanthine oxidase inhibitors (XOIs), such as allopurinol and febuxostat, and uricosuric agents, such as benzbromarone, probenecid, and sulfinpyrazone. Because allopurinol carries a life-threatening risk of HLA-B*58:01-mediated cutaneous adverse drug reactions in some Asian populations and CKD increases additional risk for allopurinol side effects, genotyping screening before allopurinol initiation 13 and starting at a lower dose then slowly titrating the dose upward to achieve...
Objectives Changes in treatment choice of therapy and size of treated population that can lead to under- or overestimate of payer’s budget are less likely to be reassured after reimbursement adoption of a new drug. The aim of this study was to evaluate the effects of febuxostat introduction and the modifications in its insurance coverage on the utilization and expenditure of urate-lowering therapy (ULT). Methods Electronic medical records for adults patients prescribed any ULT during 2010–2015 was derived from the largest medical organization in Taiwan. Aggregated estimates of ULT use and costs were assessed per 3-month and per patient per month (PPPM). Factors associated with total ULT expenditure were assessed using a time series design with factored Autoregressive Integrated Moving Average (ARIMA) models. Results ULT prevalent users increased 34.1% from 2010 to 2015 and a 123% increase in total ULT expenditure. Numbers on allopurinol and sulfinpyrazone both declined 31%, and on benzbromarone and febuxostat gradually increased to 38.21% and 22.89% of all users in 2015. Insurance payments PPPM ($4.44 to $9.22) and total monthly ULT cost ($32,946 to $ 85,732) growth more than doubled in 6 years, trend changes generated mostly by individuals switching to febuxostat. Conclusions ULT use moved to favor benzbromarone and febuxostat; greater expensive uptake for febuxostat led to a rapid rise in ULT cost. Marginal values of increasing access to febuxostat for asymptomatic hyperuricemia should be focus on future studies to facilitate drug prices negotiation and ensure appropriate ULT use.
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