Febuxostat Therapy for Patients With Stage 3 CKD and Asymptomatic Hyperuricemia: A Randomized Trial

非布索坦 医学 高尿酸血症 安慰剂 肾功能 内科学 肾脏疾病 尿酸 蛋白尿 无症状的 随机对照试验 泌尿科 肌酐 胃肠病学 病理 替代医学
作者
Kenjiro Kimura,Tatsuo Hosoya,Shunya Uchida,Masaaki Inaba,Hirofumi Makino,Shoichi Maruyama,Sadayoshi Ito,Tetsuya Yamamoto,Yasuhiko Tomino,Iwao Ohno,Yugo Shibagaki,Satoshi Iimuro,Naohiko Imai,Masanari Kuwabara,Hiroshi Hayakawa,Hiroshi Ohtsu,Yasuo Ohashi,Kenjiro Kimura,Tatsuo Hosoya,Sadayoshi Ito
出处
期刊:American Journal of Kidney Diseases [Elsevier BV]
卷期号:72 (6): 798-810 被引量:313
标识
DOI:10.1053/j.ajkd.2018.06.028
摘要

Rationale & ObjectiveEpidemiologic and clinical studies have suggested that urate-lowering therapy may slow the progression of chronic kidney disease (CKD). However, definitive evidence is lacking.Study DesignRandomized, double-blind, placebo-controlled trial.Setting & Participants467 patients with stage 3 CKD and asymptomatic hyperuricemia at 55 medical institutions in Japan.InterventionParticipants were randomly assigned in a 1:1 ratio to receive febuxostat or placebo for 108 weeks.OutcomesThe primary end point was the slope (in mL/min/1.73 m2 per year) of estimated glomerular filtration rate (eGFR). Secondary end points included changes in eGFRs and serum uric acid levels at 24, 48, 72, and 108 weeks of follow-up and the event of doubling of serum creatinine level or initiation of dialysis therapy.ResultsOf 443 patients who were randomly assigned, 219 and 222 assigned to febuxostat and placebo, respectively, were included in the analysis. There was no significant difference in mean eGFR slope between the febuxostat (0.23 ± 5.26 mL/min/1.73 m2 per year) and placebo (−0.47 ± 4.48 mL/min/1.73 m2 per year) groups (difference, 0.70; 95% CI, −0.21 to 1.62; P = 0.1). Subgroup analysis demonstrated a significant benefit from febuxostat in patients without proteinuria (P = 0.005) and for whom serum creatinine concentration was lower than the median (P = 0.009). The incidence of gouty arthritis was significantly lower (P = 0.007) in the febuxostat group (0.91%) than in the placebo group (5.86%). Adverse events specific to febuxostat were not observed.LimitationsGFR was estimated rather than measured, and patients with stages 4 and 5 CKD were excluded.ConclusionsCompared to placebo, febuxostat did not mitigate the decline in kidney function among patients with stage 3 CKD and asymptomatic hyperuricemia.FundingFunded by Teijin Pharma Limited.Trial RegistrationRegistered at the UMIN (University Hospital Medical Information Network) Clinical Trials Registry with study number UMIN000008343. Epidemiologic and clinical studies have suggested that urate-lowering therapy may slow the progression of chronic kidney disease (CKD). However, definitive evidence is lacking. Randomized, double-blind, placebo-controlled trial. 467 patients with stage 3 CKD and asymptomatic hyperuricemia at 55 medical institutions in Japan. Participants were randomly assigned in a 1:1 ratio to receive febuxostat or placebo for 108 weeks. The primary end point was the slope (in mL/min/1.73 m2 per year) of estimated glomerular filtration rate (eGFR). Secondary end points included changes in eGFRs and serum uric acid levels at 24, 48, 72, and 108 weeks of follow-up and the event of doubling of serum creatinine level or initiation of dialysis therapy. Of 443 patients who were randomly assigned, 219 and 222 assigned to febuxostat and placebo, respectively, were included in the analysis. There was no significant difference in mean eGFR slope between the febuxostat (0.23 ± 5.26 mL/min/1.73 m2 per year) and placebo (−0.47 ± 4.48 mL/min/1.73 m2 per year) groups (difference, 0.70; 95% CI, −0.21 to 1.62; P = 0.1). Subgroup analysis demonstrated a significant benefit from febuxostat in patients without proteinuria (P = 0.005) and for whom serum creatinine concentration was lower than the median (P = 0.009). The incidence of gouty arthritis was significantly lower (P = 0.007) in the febuxostat group (0.91%) than in the placebo group (5.86%). Adverse events specific to febuxostat were not observed. GFR was estimated rather than measured, and patients with stages 4 and 5 CKD were excluded. Compared to placebo, febuxostat did not mitigate the decline in kidney function among patients with stage 3 CKD and asymptomatic hyperuricemia.
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