Predictors of reaching a serum uric acid goal in patients with gout and treated with febuxostat
Authors Sheer R, Null KD, Szymanski KA, Sudharshan L, Banovic J, Pasquale MK
Received 19 April 2017
Accepted for publication 27 June 2017
Published 10 October 2017 Volume 2017:9 Pages 629—639
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Dr Lucy Goodman
Peer reviewer comments 2
Editor who approved publication: Professor Dean Smith
Richard Sheer,1 Kyle D Null,2 Keith A Szymanski,2 Lavanya Sudharshan,1 Jennifer Banovic,2 Margaret K Pasquale1
1Comprehensive Health Insights, Inc., Louisville, KY, 2Takeda Pharmaceuticals U.S.A., Inc., Deerfield, IL, USA
Purpose: 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 and methods: 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.
Results: 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 baseline sUA level (all p<0.0001) vs patients in the sUA ≥6 mg/dL group. In the logistic model, febuxostat adherence (odds ratio [OR]=1.03, p<0.0001) and baseline sUA level (OR=0.84, p<0.0001) increased the odds of attaining sUA <6 mg/dL. In the linear regression model, increase in febuxostat adherence (p<0.0001), baseline sUA level (p<0.0001), advanced age (p=0.0021), and not having congestive heart failure (p<0.05) were associated with a reduction of sUA level. Pre-index allopurinol use was a marginally significant predictor of sUA level reduction (p=0.06).
Conclusions: 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.
Keywords: hyperuricemia, xanthine oxidase inhibitors, logistic regression, linear regression, urate, sUA
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