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.

STUDY DESIGN:

This was a single-center, double-blind, randomized, parallel-group, placebo-controlled study.

SETTING & PARTICIPANTS:

Eligible participants were adults from Eastern India aged 18 to 65 years with CKD stages 3 and 4, with asymptomatic hyperuricemia.

INTERVENTION:

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.

OUTCOMES:

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).

LIMITATIONS:

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: Dipankar Sircar, Soumya Chatterjee, Rajesh Waikhom, Vishal Golay, Arpita Raychaudhury, Suparna Chatterjee, Rajendra Pandey
• Journal: American journal of kidney diseases : the official journal of the National Kidney Foundation (Am J Kidney Dis) Vol. 66 Issue 6 Pg. 945-50 (Dec 2015) ISSN: 1523-6838 [Electronic] United States
• PMID: 26233732 (Publication Type: Journal Article, Randomized Controlled Trial)
• Copyright: Copyright © 2015 National Kidney Foundation, Inc. Published by Elsevier Inc. All rights reserved.

Chemical References

• Gout Suppressants
• Febuxostat

Topics

• Adult
• Aged
• Asymptomatic Diseases (epidemiology, therapy)
• Double-Blind Method
• Febuxostat (pharmacology, therapeutic use)
• Female
• Glomerular Filtration Rate (drug effects, physiology)
• Gout Suppressants (pharmacology, therapeutic use)
• Humans
• Hyperuricemia (diagnosis, drug therapy, epidemiology)
• India (epidemiology)
• Male
• Middle Aged
• Renal Insufficiency, Chronic (diagnosis, drug therapy, epidemiology)
• Time Factors
• Treatment Outcome