Role of febuxostat in retarding progression of diabetic kidney disease with asymptomatic hyperuricemia: A 6-months open-label, randomized controlled trial

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Abstract

Introduction: Hyperuricemia is associated with chronic kidney disease (CKD) progression and poor cardiovascular outcomes. We studied the effect of febuxostat on estimated glomerular filtration rate (eGFR), proteinuria and monitored the safety profile of the medication. Material and Methods: This is a prospective open-label, randomized study in CKD stage 3 and 4 patients with diabetic nephropathy and asymptomatic hyperuricemia. Patients were randomized into febuxostat 40 mg daily and no treatment group using block randomization method and were followed up for 6 months. Their usual care for diabetes mellitus, hypertension and dyslipidemia were continued in the study. Blood and urine investigations were monitored at baseline, 3 months and 6 months. Results: The eGFR in febuxostat group was stabilized at 6 months with no significant reduction [26.2 (IQR 14.30) at baseline to 26.3 (IQR 15.2) ml/min/1.73 m2]. Whereas, there was a significant reduction of the eGFR in no treatment group from 28.2 (IQR 17.9) to 27.6 (IQR 19.3) ml/min/1.73 m2 (p value < 0.01). We found the HbA1c (glycosylated hemoglobin) was significantly increased in febuxostat group from 7.2 ± 0.5 % at baseline to 7.6 ± 1.4 at 6 months (p value 0.04) but no significant change of HbA1c in the no treatment group. Proteinuria level was unchanged in both groups. The commonest adverse event was joint pain. Conclusions: Febuxostat was able to preserve eGFR in CKD patients with diabetic nephropathy and this effect was beyond glycemic control. Increment of HbA1c level in febuxostat group needs further larger trials.

Original languageEnglish
Pages (from-to)563-575
Number of pages13
JournalEXCLI Journal
Volume17
DOIs
Publication statusPublished - 13 Jun 2018

Fingerprint

hyperuricemia
Hyperuricemia
glomerular filtration rate
Diabetic Nephropathies
kidney diseases
glycohemoglobin
Randomized Controlled Trials
diabetic nephropathy
Glomerular Filtration Rate
Chronic Renal Insufficiency
Proteinuria
glycemic control
hyperlipidemia
diabetes mellitus
disease course
hypertension
drug therapy
preserves
pain
hemoglobin

Keywords

  • Chronic kidney failure
  • Febuxostat
  • HbA1c
  • Hyperuricemia
  • Proteinuria

ASJC Scopus subject areas

  • Molecular Medicine
  • Animal Science and Zoology
  • Pharmacology
  • Drug Discovery

Cite this

@article{1af14839fc7248b68365cd08352ffc63,
title = "Role of febuxostat in retarding progression of diabetic kidney disease with asymptomatic hyperuricemia: A 6-months open-label, randomized controlled trial",
abstract = "Introduction: Hyperuricemia is associated with chronic kidney disease (CKD) progression and poor cardiovascular outcomes. We studied the effect of febuxostat on estimated glomerular filtration rate (eGFR), proteinuria and monitored the safety profile of the medication. Material and Methods: This is a prospective open-label, randomized study in CKD stage 3 and 4 patients with diabetic nephropathy and asymptomatic hyperuricemia. Patients were randomized into febuxostat 40 mg daily and no treatment group using block randomization method and were followed up for 6 months. Their usual care for diabetes mellitus, hypertension and dyslipidemia were continued in the study. Blood and urine investigations were monitored at baseline, 3 months and 6 months. Results: The eGFR in febuxostat group was stabilized at 6 months with no significant reduction [26.2 (IQR 14.30) at baseline to 26.3 (IQR 15.2) ml/min/1.73 m2]. Whereas, there was a significant reduction of the eGFR in no treatment group from 28.2 (IQR 17.9) to 27.6 (IQR 19.3) ml/min/1.73 m2 (p value < 0.01). We found the HbA1c (glycosylated hemoglobin) was significantly increased in febuxostat group from 7.2 ± 0.5 {\%} at baseline to 7.6 ± 1.4 at 6 months (p value 0.04) but no significant change of HbA1c in the no treatment group. Proteinuria level was unchanged in both groups. The commonest adverse event was joint pain. Conclusions: Febuxostat was able to preserve eGFR in CKD patients with diabetic nephropathy and this effect was beyond glycemic control. Increment of HbA1c level in febuxostat group needs further larger trials.",
keywords = "Chronic kidney failure, Febuxostat, HbA1c, Hyperuricemia, Proteinuria",
author = "Mukri, {Mohd Noor Azreey} and Kong, {Wei Yen} and Ruslinda Mustafar and Shaharir, {Syahrul Sazliyana} and Shah, {Shamsul Azhar} and {Abdul Gafor}, {Abdul Halim} and Rozita Mohd and {Abdul Cader}, Rizna and Lydia Kamaruzaman",
year = "2018",
month = "6",
day = "13",
doi = "10.17179/excli2018-1256",
language = "English",
volume = "17",
pages = "563--575",
journal = "EXCLI Journal",
issn = "1611-2156",
publisher = "University of Mainz",

}

TY - JOUR

T1 - Role of febuxostat in retarding progression of diabetic kidney disease with asymptomatic hyperuricemia

T2 - A 6-months open-label, randomized controlled trial

AU - Mukri, Mohd Noor Azreey

AU - Kong, Wei Yen

AU - Mustafar, Ruslinda

AU - Shaharir, Syahrul Sazliyana

AU - Shah, Shamsul Azhar

AU - Abdul Gafor, Abdul Halim

AU - Mohd, Rozita

AU - Abdul Cader, Rizna

AU - Kamaruzaman, Lydia

PY - 2018/6/13

Y1 - 2018/6/13

N2 - Introduction: Hyperuricemia is associated with chronic kidney disease (CKD) progression and poor cardiovascular outcomes. We studied the effect of febuxostat on estimated glomerular filtration rate (eGFR), proteinuria and monitored the safety profile of the medication. Material and Methods: This is a prospective open-label, randomized study in CKD stage 3 and 4 patients with diabetic nephropathy and asymptomatic hyperuricemia. Patients were randomized into febuxostat 40 mg daily and no treatment group using block randomization method and were followed up for 6 months. Their usual care for diabetes mellitus, hypertension and dyslipidemia were continued in the study. Blood and urine investigations were monitored at baseline, 3 months and 6 months. Results: The eGFR in febuxostat group was stabilized at 6 months with no significant reduction [26.2 (IQR 14.30) at baseline to 26.3 (IQR 15.2) ml/min/1.73 m2]. Whereas, there was a significant reduction of the eGFR in no treatment group from 28.2 (IQR 17.9) to 27.6 (IQR 19.3) ml/min/1.73 m2 (p value < 0.01). We found the HbA1c (glycosylated hemoglobin) was significantly increased in febuxostat group from 7.2 ± 0.5 % at baseline to 7.6 ± 1.4 at 6 months (p value 0.04) but no significant change of HbA1c in the no treatment group. Proteinuria level was unchanged in both groups. The commonest adverse event was joint pain. Conclusions: Febuxostat was able to preserve eGFR in CKD patients with diabetic nephropathy and this effect was beyond glycemic control. Increment of HbA1c level in febuxostat group needs further larger trials.

AB - Introduction: Hyperuricemia is associated with chronic kidney disease (CKD) progression and poor cardiovascular outcomes. We studied the effect of febuxostat on estimated glomerular filtration rate (eGFR), proteinuria and monitored the safety profile of the medication. Material and Methods: This is a prospective open-label, randomized study in CKD stage 3 and 4 patients with diabetic nephropathy and asymptomatic hyperuricemia. Patients were randomized into febuxostat 40 mg daily and no treatment group using block randomization method and were followed up for 6 months. Their usual care for diabetes mellitus, hypertension and dyslipidemia were continued in the study. Blood and urine investigations were monitored at baseline, 3 months and 6 months. Results: The eGFR in febuxostat group was stabilized at 6 months with no significant reduction [26.2 (IQR 14.30) at baseline to 26.3 (IQR 15.2) ml/min/1.73 m2]. Whereas, there was a significant reduction of the eGFR in no treatment group from 28.2 (IQR 17.9) to 27.6 (IQR 19.3) ml/min/1.73 m2 (p value < 0.01). We found the HbA1c (glycosylated hemoglobin) was significantly increased in febuxostat group from 7.2 ± 0.5 % at baseline to 7.6 ± 1.4 at 6 months (p value 0.04) but no significant change of HbA1c in the no treatment group. Proteinuria level was unchanged in both groups. The commonest adverse event was joint pain. Conclusions: Febuxostat was able to preserve eGFR in CKD patients with diabetic nephropathy and this effect was beyond glycemic control. Increment of HbA1c level in febuxostat group needs further larger trials.

KW - Chronic kidney failure

KW - Febuxostat

KW - HbA1c

KW - Hyperuricemia

KW - Proteinuria

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U2 - 10.17179/excli2018-1256

DO - 10.17179/excli2018-1256

M3 - Article

AN - SCOPUS:85051531531

VL - 17

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EP - 575

JO - EXCLI Journal

JF - EXCLI Journal

SN - 1611-2156

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