Dipankar Sircar1, Soumya Chatterjee2, Rajesh Waikhom3, Vishal Golay4, Arpita Raychaudhury4, Suparna Chatterjee2, Rajendra Pandey4. 1. Department of Nephrology, Institute of Postgraduate Medical Education and Research (IPGMER), Kolkata, India. Electronic address: deepsircar@gmail.com. 2. Department of Pharmacology, Institute of Postgraduate Medical Education and Research (IPGMER), Kolkata, India. 3. Department of Nephrology, Jawaharlal Nehru Institute of Medical Sciences, Imphal, Manipur, India. 4. Department of Nephrology, Institute of Postgraduate Medical Education and Research (IPGMER), Kolkata, India.
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 theplacebo 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.
RCT Entities:
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: U Kiltz; R Alten; M Fleck; K Krüger; B Manger; U Müller-Ladner; H Nüßlein; M Reuss-Borst; A Schwarting; H Schulze-Koops; A Tausche; J Braun Journal: Z Rheumatol Date: 2016-08 Impact factor: 1.372