title: Efficacy of Febuxostat for Slowing the GFR Decline in Patients With CKD and Asymptomatic Hyperuricemia: A 6-Month, Double-Blind, Randomized, Placebo-Controlled Trial.
abstract: BACKGROUND
  Hyperuricemia is a putative risk factor for the progression of chronic kidney disease (CKD). We hypothesized that control of asymptomatic hyperuricemia may slow disease progression in CKD.
  
  
  METHODS
  This was a single-center, double-blind, randomized, parallel-group, placebo-controlled study.
  
  
  METHODS
  Eligible participants were adults from Eastern India aged 18 to 65 years with CKD stages 3 and 4, with asymptomatic hyperuricemia.
  
  
  METHODS
  The intervention group received febuxostat, 40mg, once daily for 6 months, while the placebo group received placebo; both groups were followed up for 6 months.
  
  
  RESULTS
  The primary outcome was the proportion of patients showing a >10% decline in estimated glomerular filtration rate (eGFR) from baseline in the febuxostat and placebo groups. Secondary outcomes included changes in eGFRs in the 2 groups from baseline and at the end of the study period.
  
  
  RESULTS
  45 patients in the febuxostat group and 48 in the placebo group were analyzed. Mean eGFR in the febuxostat group showed a nonsignificant increase from 31.5±13.6 (SD) to 34.7±18.1mL/min/1.73m(2) at 6 months. With placebo, mean eGFR decreased from a baseline of 32.6±11.6 to 28.2±11.5mL/min/1.73m(2) (P=0.003). The difference between groups was 6.5 (95% CI, 0.08-12.81) mL/min/1.73m(2) at 6 months (P=0.05). 17 of 45 (38%) participants in the febuxostat group had a >10% decline in eGFR over baseline compared with 26 of 48 (54%) from the placebo group (P<0.004).
  
  
  CONCLUSIONS
  Limitations of this study included small numbers of patients and short follow-up, and ∼10% of the randomly assigned population dropped out prior to completion.
  
  
  CONCLUSIONS
  Febuxostat slowed the decline in eGFR in CKD stages 3 and 4 compared to placebo.
authors.affiliation: Department of Nephrology, Institute of Postgraduate Medical Education and Research (IPGMER), Kolkata, India. Electronic address: deepsircar@gmail.com.
authors.forename: Dipankar
authors.initials: D
authors.lastname: Sircar
authors.affiliation: Department of Pharmacology, Institute of Postgraduate Medical Education and Research (IPGMER), Kolkata, India.
authors.forename: Soumya
authors.initials: S
authors.lastname: Chatterjee
authors.affiliation: Department of Nephrology, Jawaharlal Nehru Institute of Medical Sciences, Imphal, Manipur, India.
authors.forename: Rajesh
authors.initials: R
authors.lastname: Waikhom
authors.affiliation: Department of Nephrology, Institute of Postgraduate Medical Education and Research (IPGMER), Kolkata, India.
authors.forename: Vishal
authors.initials: V
authors.lastname: Golay
authors.affiliation: Department of Nephrology, Institute of Postgraduate Medical Education and Research (IPGMER), Kolkata, India.
authors.forename: Arpita
authors.initials: A
authors.lastname: Raychaudhury
authors.affiliation: Department of Pharmacology, Institute of Postgraduate Medical Education and Research (IPGMER), Kolkata, India.
authors.forename: Suparna
authors.initials: S
authors.lastname: Chatterjee
authors.affiliation: Department of Nephrology, Institute of Postgraduate Medical Education and Research (IPGMER), Kolkata, India.
authors.forename: Rajendra
authors.initials: R
authors.lastname: Pandey
mesh_terms: D000328:Adult; D000368:Aged; D058070:Asymptomatic Diseases / Q000453:epidemiology / Q000628:therapy*; D004311:Double-Blind Method; D000069465:Febuxostat / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects* / Q000502:physiology; D006074:Gout Suppressants / Q000494:pharmacology / Q000627:therapeutic use*; D006801:Humans; D033461:Hyperuricemia / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D007194:India / Q000453:epidemiology; D008297:Male; D008875:Middle Aged; D051436:Renal Insufficiency, Chronic / Q000175:diagnosis / Q000188:drug therapy* / Q000453:epidemiology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D006074:Gout Suppressants; D000069465:Febuxostat
keywords: Chronic kidney disease (CKD); disease progression; estimated glomerular filtration rate (eGFR); febuxostat; hyperuricemia; randomized controlled trial (RCT); renal function; uric acid; xanthine oxidase inhibitor