Abstract
Attribute-based medicine is essential for patient-centered medicine. To date, the groups of patients with chronic kidney disease (CKD) requiring urate-lowering therapy are clinically unknown. Herein, we evaluated the efficacy of febuxostat using a cross-classification, attribute-based research approach. We performed post hoc analysis of multicenter, randomized, double-blind, placebo-controlled trial data for 395 patients with stage 3 CKD and asymptomatic hyperuricemia. Participants were divided into febuxostat or placebo groups and subcohorts stratified and cross-classified by proteinuria and serum creatinine concentrations. In patients stratified based on proteinuria, the mean eGFR slopes were significantly higher in the febuxostat group than in the placebo group (P = 0.007) in the subcohort without proteinuria. The interaction between febuxostat treatment and presence of proteinuria in terms of eGFR slope was significant (P for interaction = 0.019). When cross-classified by the presence of proteinuria and serum creatinine level, the mean eGFR slopes significantly differed between the febuxostat and placebo groups (P = 0.040) in cross-classified subcohorts without proteinuria and with serum creatinine level ≥ median, but not in the cross-classified subcohorts with proteinuria and serum creatinine level < median. Febuxostat mitigated the decline in kidney function among stage 3 CKD patients with asymptomatic hyperuricemia without proteinuria.
Highlights
The definition of chronic kidney disease (CKD) has been widely disseminated and generally a ccepted[1]
The prognosis for slowly progressive kidney disease caused by hyperuricemia with febuxostat treatment should be assessed in cohorts presenting similar conditions, etiology, and pathophysiology
In the present post hoc analysis of the FEATHER study results, we clarified the differences between patients with and without proteinuria in terms of the efficacy of febuxostat in patients with stage 3 CKD using a cross-classification approach
Summary
The definition of chronic kidney disease (CKD) has been widely disseminated and generally a ccepted[1]. Subgroup analyses of the heterogeneity of treatment effects will provide valuable information for patient c are[15] and can lead to personalized E BM16,19, the characteristics of patients may influence the efficacy of therapy; conventional subgroup analyses are typically not informative[16,20]. This is because RCT results are generally examined through conventional subgroup analyses, contrasting effects in groups of patients, and defining one variable or attribute at a time[18,21]. To overcome the limitations of the conventional one-attribute-at-a-time subgroup analysis and to adjust two major and interactive risk factors in CKD simultaneously, we performed novel cross-classification subgroup analyses of patients in the FEATHER study. We aimed to investigate whether proteinuria or kidney function affects the efficacy of febuxostat
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