Sheer Richard, Null Kyle D, Szymanski Keith A, Sudharshan Lavanya, Banovic Jennifer, Pasquale Margaret K
Comprehensive Health Insights, Inc., Louisville, KY.
Takeda Pharmaceuticals U.S.A., Inc., Deerfield, IL, USA.
Clinicoecon Outcomes Res. 2017 Oct 10;9:629-639. doi: 10.2147/CEOR.S139939. eCollection 2017.
Clinical guidelines recommend febuxostat as first-line pharmacologic urate-lowering therapy for patients with gout to achieve a goal serum uric acid (sUA) <6 mg/dL; however, little is known about other contributing factors. This study identified clinical characteristics of patients treated with febuxostat to develop and validate a predictive model for achieving a goal sUA.
Patients with Humana Medicare or commercial insurance, diagnosed with gout and newly initiated on febuxostat (index date February 1, 2009 - December 31, 2013), were identified for a retrospective cohort study. Patients were followed for 365 days and the first valid sUA test result ≥120 days after index was retained. A stepwise logistic regression with backward elimination was estimated to model sUA goal attainment, and a linear model was estimated to model the impact of predictor variables on sUA level.
The study sample (n=678) was divided into a development (training) dataset (n=453) and a validation (holdout) dataset (n=225). In the training sample, patients in the sUA <6 mg/dL group were on febuxostat for a longer time, were more adherent, and had a lower average base-line sUA level (all <0.0001) vs patients in the sUA ≥6 mg/dL group. In the logistic model, febuxostat adherence (odds ratio [OR]=1.03, <0.0001) and baseline sUA level (OR=0.84, <0.0001) increased the odds of attaining sUA <6 mg/dL. In the linear regression model, increase in febuxostat adherence (<0.0001), baseline sUA level (<0.0001), advanced age (=0.0021), and not having congestive heart failure (<0.05) were associated with a reduction of sUA level. Pre-index allopurinol use was a marginally significant predictor of sUA level reduction (=0.06).
Among febuxostat users diagnosed with gout in a real-world setting, adherence to febuxostat and lower baseline sUA level were the strongest predictors of attaining sUA goal. These findings may help clinicians to identify appropriate patients most likely to benefit from febuxostat treatment, and underscore the importance of medication adherence in this challenging patient population.
临床指南推荐非布司他作为痛风患者降尿酸治疗的一线药物,目标是使血清尿酸(sUA)<6mg/dL;然而,对于其他影响因素知之甚少。本研究确定了接受非布司他治疗患者的临床特征,以建立并验证实现目标sUA的预测模型。
纳入有Humana医疗保险或商业保险、诊断为痛风且新开始使用非布司他(索引日期为2009年2月1日至2013年12月31日)的患者进行回顾性队列研究。对患者随访365天,并保留索引日期后≥120天的首个有效sUA检测结果。采用逐步向后消除的逻辑回归来建立sUA目标达成情况的模型,并采用线性模型来建立预测变量对sUA水平影响的模型。
研究样本(n=678)分为一个开发(训练)数据集(n=453)和一个验证(保留)数据集(n=225)。在训练样本中,与sUA≥6mg/dL组的患者相比,sUA<6mg/dL组的患者使用非布司他的时间更长、依从性更高,且平均基线sUA水平更低(均<0.0001)。在逻辑模型中,非布司他依从性(比值比[OR]=1.03,<0.0001)和基线sUA水平(OR=0.84,<0.0001)增加了达到sUA<6mg/dL的几率。在线性回归模型中,非布司他依从性增加(<0.0001)、基线sUA水平增加(<0.0001)、高龄(=0.0021)以及没有充血性心力衰竭(<0.05)与sUA水平降低相关。索引前使用别嘌醇是sUA水平降低的一个边缘显著预测因素(=0.06)。
在现实环境中诊断为痛风的非布司他使用者中,非布司他依从性和较低的基线sUA水平是实现sUA目标的最强预测因素。这些发现可能有助于临床医生识别最有可能从非布司他治疗中获益的合适患者,并强调在这一具有挑战性的患者群体中药物依从性的重要性。