Lertnawapan Ratchaya, Jatuworapruk Kanon
Division of Allergy, Immunology and Rheumatology, Department of Medicine, Faculty of Medicine, Thammasat University (Rangsit Campus), 99/209 Paholyotin Road, Khlong Luang, Pathum Thani, 12120, Thailand.
Clin Rheumatol. 2021 Jan;40(1):255-262. doi: 10.1007/s10067-020-05262-6. Epub 2020 Jun 30.
The objectives of our study were to compare the efficacy of febuxostat with allopurinol in Thai subjects with gout, as well as to determine the predictive factors of responsiveness to urate-lowering agents and to evaluate the safety of febuxostat in a real-world setting.
The study was a retrospective cohort study; a total of 354 gout patients were recruited from February 2015 to November 2018. The patients were categorized according to prescription of allopurinol or febuxostat. Demographic data, comorbidities, concomitant medications, gout-related clinical parameters, and the laboratory results were collected. The serial serum urate (sUA) levels were recorded at the beginning of the treatment (baseline), and after treatment at 12 weeks, 18 weeks, and 27 weeks. The primary efficacy endpoint was the achievement of target urate of < 6 mg/dl in people taking febuxostat, compared with those taking allopurinol. The secondary endpoints were the predictive factors of achieving target urate level and adverse drug reactions in patients taking febuxostat. Multivariable regression analysis was used to determine factors associated with achieving target serum urate.
After the treatment, the febuxostat groups had significantly lower mean sUA compared with the allopurinol groups across all follow-up periods. The proportion of people who achieved target serum urate was also higher in the febuxostat groups compared with the allopurinol groups throughout the follow-up periods. The multivariable regression analysis showed that febuxostat 40 mg (OR = 10.96 (95% CI 4.32-27.80); p value < 0.001), febuxostat 80 mg (OR = 9.54 (95% CI 3.91-23.28), smoking (OR = 2.35 (95% CI 1.13-4.91); p value = 0.023), and low baseline serum urate (OR = 0.62 (95% CI 0.52-0.74); p value < 0.001) were associated with the achievement of target serum urate. No adverse drug reaction from febuxostat was observed even among people with renal insufficiency.
In a Thai cohort, people receiving febuxostat are more likely to achieve target serum urate level, compared with people receiving allopurinol. Febuxostat (40 or 80 mg), smoking, and low baseline serum urate were associated with the achievement of target serum urate.
• Febuxostat showed superior urate-lowering efficacy compared with allopurinol in an Asian population. • In addition to febuxostat, lower baseline serum urate level and history of smoking were associated with achieving target serum urate in gout patients.
我们研究的目的是比较非布司他与别嘌醇在泰国痛风患者中的疗效，确定尿酸降低药物反应性的预测因素，并在真实环境中评估非布司他的安全性。
该研究为回顾性队列研究；2015年2月至2018年11月共招募了354例痛风患者。患者根据别嘌醇或非布司他的处方进行分类。收集人口统计学数据、合并症、伴随用药、痛风相关临床参数和实验室结果。在治疗开始时（基线）以及治疗12周、18周和27周后记录系列血清尿酸（sUA）水平。主要疗效终点是服用非布司他的人群与服用别嘌醇的人群相比，实现目标尿酸<6mg/dl。次要终点是服用非布司他的患者实现目标尿酸水平的预测因素和药物不良反应。采用多变量回归分析确定与实现目标血清尿酸相关的因素。
治疗后，在所有随访期内，非布司他组的平均sUA显著低于别嘌醇组。在整个随访期内，非布司他组实现目标血清尿酸的人群比例也高于别嘌醇组。多变量回归分析显示，40mg非布司他（OR = 10.96（95%CI 4.32 - 27.80）；p值<0.001）、80mg非布司他（OR = 9.54（95%CI 3.91 - 23.28））、吸烟（OR = 2.35（95%CI 1.13 - 4.91）；p值 = 0.023）和低基线血清尿酸（OR = 0.62（95%CI 0.52 - 0.74）；p值<0.001）与实现目标血清尿酸相关。即使在肾功能不全的人群中也未观察到非布司他的药物不良反应。
在泰国队列中，与接受别嘌醇的人群相比，接受非布司他的人群更有可能实现目标血清尿酸水平。非布司他（40或80mg）、吸烟和低基线血清尿酸与实现目标血清尿酸相关。
• 在亚洲人群中，非布司他显示出比别嘌醇更优的尿酸降低疗效。• 除了非布司他外，较低的基线血清尿酸水平和吸烟史与痛风患者实现目标血清尿酸相关。
